Institute for Infection and Immunity, Applied Diagnostic Research and Evaluation Unit, St George's University of London, London, United Kingdom.
Nuffield Department of Medicine, Health Systems Collaborative, University of Oxford, Headington, Oxford, United Kingdom.
PLoS One. 2021 Nov 8;16(11):e0259593. doi: 10.1371/journal.pone.0259593. eCollection 2021.
Sexually Transmitted Infections, including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), continue to be a global health problem. Increased access to point-of-care-tests (POCTs) could help detect infection and lead to appropriate management of cases and contacts, reducing transmission and development of reproductive health sequelae. Yet diagnostics with good clinical effectiveness evidence can fail to be implemented into routine care. Here we assess values beyond clinical effectiveness for molecular CT/NG POCTs implemented across diverse routine practice settings.
We conducted a systematic review of peer-reviewed primary research and conference abstract publications in Medline and Embase reporting on molecular CT/NG POCT implementation in routine clinical practice until 16th February 2021. Results were extracted into EndNote software and initially screened by title and abstract by one author according to the inclusion and exclusion criteria. Articles that met the criteria, or were unclear, were included for full-text assessment by all authors. Results were synthesised to assess the tests against guidance criteria and develop a CT/NG POCT value proposition for multiple stakeholders and settings.
The systematic review search returned 440 articles; 28 were included overall. The Cepheid CT/NG GeneXpert was the only molecular CT/NG POCT implemented and evaluated in routine practice. It did not fulfil all test guidance criteria, however, studies of test implementation showed multiple values for test use across various healthcare settings and locations. Our value proposition highlights that the majority of values are setting-specific. Sexual health services and outreach services have the least overlap, with General Practice and other non-sexual health specialist services serving as a "bridge" between the two.
Those wishing to improve CT/NG diagnosis should be supported to identify the values most relevant to their settings and context, and prioritise implementation of tests that are most closely aligned with those values.
性传播感染，包括淋病奈瑟菌（NG）和沙眼衣原体（CT），仍然是一个全球性的健康问题。增加即时检测（POCT）的可及性有助于发现感染，并对病例和接触者进行适当的管理，从而减少传播和生殖健康后遗症的发生。然而，具有良好临床效果证据的诊断方法可能无法纳入常规护理。在这里，我们评估了在不同常规实践环境中实施的分子 CT/NG POCT 的临床效果以外的价值。
我们对截至 2021 年 2 月 16 日在 Medline 和 Embase 中发表的同行评议原始研究和会议摘要进行了系统回顾，这些研究报告了在常规临床实践中实施分子 CT/NG POCT 的情况。结果被提取到 EndNote 软件中，并由一名作者根据纳入和排除标准对标题和摘要进行初步筛选。符合标准或不明确的文章由所有作者进行全文评估。结果被综合评估，以评估这些检测对指导标准的符合情况，并为多个利益相关者和设置制定 CT/NG POCT 的价值主张。
系统综述搜索返回了 440 篇文章；共有 28 篇文章被纳入。Cepheid 的 CT/NG GeneXpert 是唯一在常规实践中实施和评估的分子 CT/NG POCT。它没有满足所有检测指导标准，但对检测实施的研究表明，在各种医疗保健环境和地点，该检测的使用具有多种价值。我们的价值主张强调，大多数价值是特定于设置的。性健康服务和外展服务的重叠最少，而全科医生和其他非性健康专科服务则是两者之间的“桥梁”。
那些希望改善 CT/NG 诊断的人应该得到支持，以确定与他们的设置和背景最相关的价值，并优先实施最符合这些价值的检测。
