大众免费医疗应用的同行评审证据的数量和类型：横断面研究。

Quantity and type of peer-reviewed evidence for popular free medical apps: Cross-sectional review.

Centre for Health Informatics, University of Manchester, UK.

Leeds Institute of Health Sciences, University of Leeds, UK.

Int J Med Inform. 2021 Apr;148:104416. doi: 10.1016/j.ijmedinf.2021.104416. Epub 2021 Feb 10.

Abstract

Mobile apps are being increasingly used as a tool to deliver clinical care. Evidence of efficacy for such apps varies, and appropriate levels of evidence may depend on the app's intended use. The UK's National Institute for Health and Care Excellence (NICE) recently developed an evidence standards framework, aiming to explicitly set out the required standards of evidence for different categories of digital health technologies. To determine current compliance with the evidence standards framework, the current study quantified the amount and type of peer-reviewed evidence associated with a cross-section of popular medical apps.

Apps were identified by selecting the top 100 free medical apps in the Apple App Store and all free apps in the NHS Apps Library. Each app was assigned to one of the four tiers (1, 2, 3a, 3b) in the NICE evidence standards framework. For each app, we conducted searches in Ovid-MEDLINE, Web of Science, Google Scholar, and via manufacturer websites to identify any published articles that assessed the app. This allowed us to determine our primary outcome, whether apps in tiers 3a/3b were more likely than apps in tier 1/2 to be associated with academic peer-reviewed evidence.

We reviewed 125 apps in total (Apple App Store (n = 72), NHS Apps Library (n = 45), both (n = 8), of which 54 were categorized into the higher evidence standards framework tiers, 3a/3b. After screening, we extracted 105 relevant articles which were associated with 25 of the apps. Only 6 articles, pertaining to 3 apps, were reports of randomised controlled trials. Apps in tiers 3a/3b were more likely to be associated with articles than apps in lower tiers (χ = 5.54, p = .01). The percentage of tier 3a/3b apps with associated articles was similar for both the NHS Apps Library (10/28) and Apple App store (7/24), (χ = 0.042, p = .84).

Apps that were in higher tiers 3a and 3b, indicating higher clinical risk, were more likely to have an associated article than those in lower categories. However, even in these tiers, supporting peer-reviewed evidence was missing in the majority of instances. In our sample, Apps from the NHS Apps Library were more no more likely to have supporting evidence than popular Apple App Store apps. This is of concern, given that NHS approval may influence uptake of app usage.

摘要

移动应用程序正越来越多地被用作提供临床护理的工具。此类应用程序的疗效证据各不相同，适当的证据水平可能取决于应用程序的预期用途。英国国家卫生与保健卓越研究所（NICE）最近制定了一个证据标准框架，旨在明确规定不同类别的数字健康技术所需的证据标准。为了确定当前对证据标准框架的遵守情况，本研究量化了与一系列流行医疗应用程序相关的同行评议证据的数量和类型。

通过选择苹果应用商店中的前 100 个免费医疗应用程序和 NHS 应用程序库中的所有免费应用程序，确定了应用程序。为每个应用程序分配到 NICE 证据标准框架中的四个级别（1、2、3a、3b）之一。对于每个应用程序，我们在 Ovid-MEDLINE、Web of Science、Google Scholar 以及制造商网站上进行了搜索，以确定评估该应用程序的任何已发表文章。这使我们能够确定我们的主要结果，即 3a/3b 级别的应用程序是否比 1/2 级别的应用程序更有可能与学术同行评议证据相关联。

我们总共审查了 125 个应用程序（苹果应用商店（n=72），NHS 应用程序库（n=45），两者（n=8），其中 54 个被归类为更高的证据标准框架级别，3a/3b。经过筛选，我们提取了 105 篇与 25 个应用程序相关的相关文章。仅有 6 篇文章，涉及 3 个应用程序，是关于随机对照试验的报告。3a/3b 级别的应用程序与文章的关联比低级别应用程序更常见（χ=5.54，p=0.01）。NHS 应用程序库（10/28）和苹果应用商店（7/24）中 3a/3b 级别的应用程序的相关文章比例相似（χ=0.042，p=0.84）。

处于较高风险级别 3a 和 3b 的应用程序比处于较低类别应用程序更有可能具有相关文章。然而，即使在这些级别中，大多数情况下也缺乏支持性的同行评议证据。在我们的样本中，NHS 应用程序库中的应用程序并不比流行的苹果应用商店应用程序更有可能具有支持性证据。这令人担忧，因为 NHS 的批准可能会影响应用程序使用的采用。