scholarly journals Molecular chlamydia and gonorrhoea point of care tests implemented into routine practice: Systematic review and value proposition development

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259593
Author(s):  
Sebastian S. Fuller ◽  
Eleanor Clarke ◽  
Emma M. Harding-Esch

Background 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. Methods 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. Findings 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. Conclusions 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.

2020 ◽  
Author(s):  
Sebastian Fuller ◽  
Emma Harding-Esch

IntroductionSexually Transmitted Infections (STIs), including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), continue to be a global health problem, with the majority of the disease burden in Low and Middle Income Countries. This could in part be addressed through increased access to rapid point-of-care-tests (POCTs) for infection detection and appropriate clinical management. Guidelines and criteria for the development of STI POCTs have been established, and several POCTs for CT and NG have been brought to market. Yet even those diagnostics with good evidence of clinical effectiveness often fail to be implemented and adopted into routine care. Here we review the current literature for test development and implementation alongside studies of how the Cepheid CT/NG GeneXpert POCT has been utilised in different healthcare settings, to develop a value proposition for CT/NG POCT adoption.MethodsWe review whether the Cepheid CT/NG GeneXpert fulfil the (RE)ASSURED and Target Product Profile (TPP) criteria, and present published literature reporting on the test’s implementation, to demonstrate its range of values in different settings and to a variety of stakeholders. This information is then applied to the value proposition for laboratory medicine, to form the basis of a value proposition for a CT/NG POCT. ResultsThe Cepheid CT/NG GeneXpert did not fulfil all (RE)ASSURED or TPP criteria, however, studies of test implementation showed multiple stakeholder values for the use of the test across various healthcare settings and geographic locations. The majority of values identified were setting specific. Sexual health services and outreach services had the least overlap in values, whereas General Practice and other non-sexual health specialist services served as a “bridge” between the two.ConclusionWe recommend that those wishing to improve CT/NG diagnosis be supported to identify the values most relevant to their settings and context, and prioritise implementation of those tests most closely aligned with those values.


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Pakpoom Subsoontorn ◽  
Manupat Lohitnavy ◽  
Chuenjid Kongkaew

AbstractMany recent studies reported coronavirus point-of-care tests (POCTs) based on isothermal amplification. However, the performances of these tests have not been systematically evaluated. Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy was used as a guideline for conducting this systematic review. We searched peer-reviewed and preprint articles in PubMed, BioRxiv and MedRxiv up to 28 September 2020 to identify studies that provide data to calculate sensitivity, specificity and diagnostic odds ratio (DOR). Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) was applied for assessing quality of included studies and Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) was followed for reporting. We included 81 studies from 65 research articles on POCTs of SARS, MERS and COVID-19. Most studies had high risk of patient selection and index test bias but low risk in other domains. Diagnostic specificities were high (> 0.95) for included studies while sensitivities varied depending on type of assays and sample used. Most studies (n = 51) used reverse transcription loop-mediated isothermal amplification (RT-LAMP) to diagnose coronaviruses. RT-LAMP of RNA purified from COVID-19 patient samples had pooled sensitivity at 0.94 (95% CI: 0.90–0.96). RT-LAMP of crude samples had substantially lower sensitivity at 0.78 (95% CI: 0.65–0.87). Abbott ID Now performance was similar to RT-LAMP of crude samples. Diagnostic performances by CRISPR and RT-LAMP on purified RNA were similar. Other diagnostic platforms including RT- recombinase assisted amplification (RT-RAA) and SAMBA-II also offered high sensitivity (> 0.95). Future studies should focus on the use of un-bias patient cohorts, double-blinded index test and detection assays that do not require RNA extraction.


2016 ◽  
Vol 130 ◽  
pp. 18-32 ◽  
Author(s):  
Elise H. Tatone ◽  
Jessica L. Gordon ◽  
Jessie Hubbs ◽  
Stephen J. LeBlanc ◽  
Trevor J. DeVries ◽  
...  

2018 ◽  
Vol 5 (1) ◽  
pp. e20 ◽  
Author(s):  
Christiaan Vis ◽  
Mayke Mol ◽  
Annet Kleiboer ◽  
Leah Bührmann ◽  
Tracy Finch ◽  
...  

Background Electronic mental health interventions (eMental health or eMH) can be used to increase accessibility of mental health services for mood disorders, with indications of comparable clinical outcomes as face-to-face psychotherapy. However, the actual use of eMH in routine mental health care lags behind expectations. Identifying the factors that might promote or inhibit implementation of eMH in routine care may help to overcome this gap between effectiveness studies and routine care. Objective This paper reports the results of a systematic review of the scientific literature identifying those determinants of practices relevant to implementing eMH for mood disorders in routine practice. Methods A broad search strategy was developed with high sensitivity to four key terms: implementation, mental health care practice, mood disorder, and eMH. The reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework was applied to guide the review and structure the results. Thematic analysis was applied to identify the most important determinants that facilitate or hinder implementation of eMH in routine practice. Results A total of 13,147 articles were screened, of which 48 studies were included in the review. Most studies addressed aspects of the reach (n=33) of eMH, followed by intervention adoption (n=19), implementation of eMH (n=6), and maintenance (n=4) of eMH in routine care. More than half of the studies investigated the provision of mental health services through videoconferencing technologies (n=26), followed by Internet-based interventions (n=20). The majority (n=44) of the studies were of a descriptive nature. Across all RE-AIM domains, we identified 37 determinants clustered in six main themes: acceptance, appropriateness, engagement, resources, work processes, and leadership. The determinants of practices are expressed at different levels, including patients, mental health staff, organizations, and health care system level. Depending on the context, these determinants hinder or facilitate successful implementation of eMH. Conclusions Of the 37 determinants, three were reported most frequently: (1) the acceptance of eMH concerning expectations and preferences of patients and professionals about receiving and providing eMH in routine care, (2) the appropriateness of eMH in addressing patients’ mental health disorders, and (3) the availability, reliability, and interoperability with other existing technologies such as the electronic health records are important factors for mental health care professionals to remain engaged in providing eMH to their patients in routine care. On the basis of the taxonomy of determinants of practices developed in this review, implementation-enhancing interventions can be designed and applied to achieve better implementation outcomes. Suggestions for future research and implementation practice are provided.


2021 ◽  
Vol 37 ◽  
pp. 100961
Author(s):  
Ying Zhou ◽  
Ting-Ting Jiang ◽  
Jing Li ◽  
Yue-Ping Yin ◽  
Xiang-Sheng Chen

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