Health-related quality of life and psychosocial impacts of a diagnosis of non-specific genital infection in symptomatic heterosexual men attending UK sexual health clinics: a feasibility study.

Introduction Non-specific genital infection (NSGI; non-Chlamydia trachomatis, non-Neisseria gonorrhoeae-associated urethritis) is a common diagnosis in symptomatic heterosexual men attending UK sexual health clinics (SHCs). but little is known about the psychosocial impact of this diagnosis. Methods We conducted an observational study among symptomatic heterosexual men attending SHCs to evaluate the psychosocial impact of an NSGI diagnosis compared with a diagnosis of Chlamydia trachomatis (CT), Neisseria gonorrhoeae or no abnormalities detected focusing on the feasibility of our study methodology. Participants completed a computer-assisted self-interviewing (CASI) including two validated measures of psychosocial impact: the EQ-5D-5L health-related quality of life and Rosenberg Self-Esteem Scale, before diagnostic testing and 2 weeks after receiving test results (follow-up 1 (FU-1)) and a qualitative interview. We compared scores between diagnostic groups using paired t-tests, qualitative data were analysed thematically and feasibility was assessed by process analysis. Results 60 men completed the baseline CASI (75% response rate). 46 (76.6%) were eligible for follow-up; 11/46 (23.9%) completed the follow-up CASI, and 3/11 (27.3%) completed the qualitative interview. 81.7% of all participants left CASI feedback at baseline: 73.5% reported the questionnaire as ‘fine’ or ‘very good’. Qualitative interview participants reported the study was acceptable. Compared with baseline, among patients completing FU-1, only patients with a diagnosis of NSGI (p<0.05) or CT (p<0.05) showed increased EQ-5D-5L Index, whereas patients with a diagnosis of NSGI (p=0.05) showed decreased mean Rosenberg Self-Esteem Scale score. Conclusions Although most participants indicated study acceptability at baseline, and we employed measures to increase retention (CASI questionnaires, reminder messages and a focus on men’s health), we experienced high loss to follow-up. We found that heterosexual men attending SHCs with symptoms of urethritis experience both positive and negative psychosocial impacts following their clinic attendance, which warrants further investigation

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

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

Modelling-based evaluation of the costs, benefits and cost-effectiveness of multipathogen point-of-care tests for sexually transmitted infections in symptomatic genitourinary medicine clinic attendees

Objectives To quantify the costs, benefits and cost-effectiveness of three multipathogen point-of-care (POC) testing strategies for detecting common sexually transmitted infections (STIs) compared with standard laboratory testing. Design Modelling study. Setting Genitourinary medicine (GUM) services in England. Population A hypothetical cohort of 965 988 people, representing the annual number attending GUM services symptomatic of lower genitourinary tract infection. Interventions The decision tree model considered costs and reimbursement to GUM services associated with diagnosing and managing STIs. Three strategies using hypothetical point-of-care tests (POCTs) were compared with standard care (SC) using laboratory-based testing. The strategies were: A) dual POCT for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG); B) triplex POCT for CT-NG and Mycoplasma genitalium (MG); C) quadruplex POCT for CT-NG-MG and Trichomonas vaginalis (TV). Data came from published literature and unpublished estimates. Primary and secondary outcome measures Primary outcomes were total costs and benefits (quality-adjusted life years (QALYs)) for each strategy (2016 GB, £) and associated incremental cost-effectiveness ratios (ICERs) between each of the POC strategies and SC. Secondary outcomes were inappropriate treatment of STIs, onward STI transmission, pelvic inflammatory disease in women, time to cure and total attendances. Results In the base-case analysis, POC strategy C, a quadruplex POCT, was the most cost-effective relative to the other strategies, with an ICER of £36 585 per QALY gained compared with SC when using microcosting, and cost-savings of £26 451 382 when using tariff costing. POC strategy C also generated the most benefits, with 240 467 fewer clinic attendances, 808 fewer onward STI transmissions and 235 135 averted inappropriate treatments compared with SC. Conclusions Many benefits can be achieved by using multipathogen POCTs to improve STI diagnosis and management. Further evidence is needed on the underlying prevalence of STIs and SC delivery in the UK to reduce uncertainty in economic analyses

Hydrological (in)stability in Southern Siberia during the Younger Dryas and early Holocene

Southern Siberia is currently undergoing rapid warming, inducing changes in vegetation, loss of permafrost, and impacts on the hydrodynamics of lakes and rivers. Lake sediments are key archives of environmental change and contain a record of ecosystem variability, as well as providing proxy indicators of wider environmental and climatic change. Investigating how hydrological systems have responded to past shifts in climate can provide essential context for better understanding future ecosystem changes in Siberia. Oxygen isotope ratios within lacustrine records provide fundamental information on past variability in hydrological systems. Here we present a new oxygen isotope record from diatom silica (ẟ18Odiatom) at Lake Baunt (55°11′15″N, 113°01,45″E), in the southern part of eastern Siberia, and consider how the site has responded to climate changes between the Younger Dryas and Early to Mid Holocene (ca. 12.4 to 6.2 ka cal BP). Excursions in ẟ18Odiatom are influenced by air temperature and the seasonality, quantity, and source of atmospheric precipitation. These variables are a function of the strength of the Siberian High, which controls temperature, the proportion and quantity of winter versus summer precipitation, and the relative dominance of Atlantic versus Pacific air masses. A regional comparison with other Siberian ẟ18Odiatom records, from lakes Baikal and Kotokel, suggests that ẟ18Odiatom variations in southern Siberia reflect increased continentality during the Younger Dryas, delayed Early Holocene warming in the region, and substantial climate instability between ~10.5 to ~8.2 ka cal BP. Unstable conditions during the Early Holocene thermal optimum most likely reflect localised changes from glacial melting. Taking the profiles from three very different lakes together, highlight the influence of site specific factors on the individual records, and how one site is not indicative of the region as a whole. Overall, the study documents how sensitive this important region is to both internal and external forcing

Facilitators and barriers for clinical implementation of a 30-minute point-of-care test for Neisseria gonorrhoeae and Chlamydia trachomatis into clinical care: A qualitative study within sexual health services in England.

Point-of-care tests (POCTs) to diagnose sexually transmitted infections (STIs) have potential to positively impact patient management and patient perceptions of clinical services. Yet there remains a disconnect between development of new technologies and their implementation into clinical care. With the advent of new STI POCTs arriving to the global market, guidance for their successful adoption and implementation into clinical services is urgently needed. We conducted qualitative in-depth interviews with professionals prior to and post-implementation of a Chlamydia trachomatis/Neisseria gonorrhoeae POCT into clinical services in England to define key stakeholder roles and explore the process of POCT integration. Participants self-identified themselves as key stakeholders in the STI POCT adoption and/or implementation processes. Data consisted of interview transcripts, which were analysed thematically using NVIVO 11. Six sexual health services were included in the study; three of which have implemented POCTs. We conducted 40 total interviews: 31 prior to POCT implementation and 9 follow-up post-implementation. Post-implementation data showed that implementation plans required little or no change during service evaluation. Lead clinicians and managers self-identified as key stakeholders for the decision to purchase, while nurses self-identified as "change champions" for implementation. Many identified senior clinical staff as those most likely to introduce and drive change. However, participants stressed the importance of engaging all clinical staff in implementation. While the accuracy of the POCT, its positive impact on patient management and the ease of its integration within existing pathways were considered essential, costs of purchasing and utilising the technology were identified as central to the decision to purchase. Our study shows that key decision-makers for adoption and implementation require STI POCTs to have laboratory-comparable accuracy and be affordable for purchase and ongoing use. Further, successful integration of POCTs into sexual health services relies on supportive interpersonal relationships between all levels of staff

A 30-Min Nucleic Acid Amplification Point-of-Care Test for Genital Chlamydia trachomatis Infection in Women: A Prospective, Multi-center Study of Diagnostic Accuracy.

BACKGROUND: Rapid Point-Of-Care Tests for Chlamydia trachomatis (CT) may reduce onward transmission and reproductive sexual health (RSH) sequelae by reducing turnaround times between diagnosis and treatment. The io® single module system (Atlas Genetics Ltd.) runs clinical samples through a nucleic acid amplification test (NAAT)-based CT cartridge, delivering results in 30min. METHODS: Prospective diagnostic accuracy study of the io® CT-assay in four UK Genito-Urinary Medicine (GUM)/RSH clinics on additional-to-routine self-collected vulvovaginal swabs. Samples were tested "fresh" within 10days of collection, or "frozen" at -80°C for later testing. Participant characteristics were collected to assess risk factors associated with CT infection. RESULTS: CT prevalence was 7.2% (51/709) overall. Sensitivity, specificity, positive and negative predictive values of the io® CT assay were, respectively, 96.1% (95% Confidence Interval (CI): 86.5-99.5), 97.7% (95%CI: 96.3-98.7), 76.6% (95%CI: 64.3-86.2) and 99.7% (95%CI: 98.9-100). The only risk factor associated with CT infection was being a sexual contact of an individual with CT. CONCLUSIONS: The io® CT-assay is a 30-min, fully automated, high-performing NAAT currently CE-marked for CT diagnosis in women, making it a highly promising diagnostic to enable specific treatment, initiation of partner notification and appropriately intensive health promotion at the point of care

A 30-minute nucleic acid amplification point-of-care test for genital<i>Chlamydia trachomatis</i>infection in women: a prospective, multi-centre study of diagnostic accuracy

ABSTRACTBackgroundRapid Point-Of-Care Tests (POCTs) forChlamydia trachomatis(CT) may reduce onward transmission and reproductive sexual health (RSH) sequelae by reducing turnaround times between diagnosis and treatment. The io®single module system (Atlas Genetics Ltd) runs clinical samples through a microfluidic CT cartridge, delivering results in 30 minutes. We evaluated its performance on female genital samples in four UK Genito-Urinary Medicine (GUM)/RSH clinics.MethodsProspective diagnostic accuracy study, using BD ProbeTec CT/GC assay as the routine clinic nucleic acid amplification test (NAAT) as the initial comparator test, and the QIAgen Artus CT assay to resolve discrepancies. In these instances, the reference standard was defined as the resolved result when two out of three assay results concurred. Female participants aged ≥16 provided additional-to-routine self-collected vulvovaginal swabs. Samples were tested fresh with the io®CT assay within 7 days of collection, or were frozen at −80°C for later testing. Participant clinical, demographic and behavioural characteristics were collected to assess risk factors associated with CT infection.ResultsOf 785 participants recruited, final analyses were conducted on 709 (90.3%). CT prevalence was 7.2% (51/709) overall. Sensitivity, specificity, positive and negative predictive values of the io®CT assay were, respectively, 96.1% (95% Confidence Interval (CI): 86.5-99.5), 97.7% (95%CI: 96.3-98.7), 76.6% (95%CI: 64.3-86.2) and 99.7% (95%CI: 98.9-100). There was no significant difference in performance measures between fresh and frozen samples, or between symptomatic and asymptomatic participants (p&gt;0.05). The only risk factor associated with CT infection was being a sexual contact of an individual with CT.ConclusionsThe io®CT-assay is the only 30-minute, fully automated, high-performing NAAT currently CE-marked for CT diagnosis in women, making it a highly promising diagnostic to enable specific treatment, initiation of partner notification and appropriately intensive health promotion at the point of care. Future research is required to evaluate acceptability by clinicians and patients in GUM/RSH clinics, impact on clinical pathways and patient management, and cost-effectiveness.</jats:sec