Acute effects of mango leaf extract on cognitive function in healthy adults: a randomised, double-blind, placebo-controlled crossover study

IntroductionExtracts made from the leaves of the edible mango plant (Mangifera indica L., Anacardiaceae) have a long history of medicinal usage, most likely due to the presence of high levels of mangiferin, a polyphenol compound. Previous research has demonstrated that mango leaf extract (MLE) can beneficially modulate cognitive function in both animals and humans. This study aimed to assess the effects of an acute dose of 300 mg MLE (standardised to contain ≥60% mangiferin) on cognitive performance and mood in healthy adults.MethodsIn this double-blind, placebo-controlled, crossover study, 114 healthy men and women (18–43 years) received either MLE or a matched placebo at each testing visit (separated by at least 7 days). Cognitive performance (including the cognitive demand battery) and mood were measured at 30, 180, and 300 min post-dose.ResultsThe results showed that, compared to placebo, the group taking MLE displayed a significant increase in serial 3 s and serial 7 s subtraction errors overall. There were no other significant effects on cognitive performance.DiscussionThe results of the current study suggest that the consumption of 300 mg MLE in the absence of an observed multitasking psychological stressor does not improve cognitive performance or mood at up to 300 min post-dose. Due to the very limited nature of the effects and since they were observed among many analyses, these findings should be treated with caution.Clinical trial registration: http://ClinicalTrials.gov, identifier [NCT05182450]

The Long-Term Effects of a Peer-Led Sex Education Programme (RIPPLE): A Cluster Randomised Trial in Schools in England

Judith Stephenson and colleagues report on a cluster randomized trial in London of school-based peer-led sex education and whether it reduced unintended teenage pregnancy

Achieving a low-carbon society: CCS expertise and opportunity in the UK

The outcome of the Paris climate talks in late 2015 was hailed as a “turning point” for international action on climate change, with 195 countries agreeing to limit the increase in average global temperatures to 1.5oC by the end of this century. It is an ambitious and necessary goal, but is it achievable? An increasing emphasis on clean, renewable energy is essential, as are more efficient ways of using energy. However, the best of intentions will hit an insurmountable roadblock if we continue to burn fossil fuels without deploying Carbon Capture and Storage (CCS). CCS is a chain of proven technologies that can take us all the way to a zero-carbon future. For many economies that will be reliant on fossil fuels for several decades, CCS can support a gradual phasing in of renewable energy. CCS remains the only path to deep cuts in carbon emissions from products such as cement, steel and fertiliser - even whisky - and will effectively decarbonise power and heat generation. Deployed on gas or sustainable biomass power, it can plug the gaps in the intermittency of power supply from renewables. And there are many studies that show that the UK and its assets are best placed to deliver CCS for the whole of Europe. Although CCS is already operating in other parts of the world, this climate change technology has had a tough time making progress in the UK. The latest blow came in the last quarter of 2015, within days of the Paris talks. Two major UK CCS projects were poised to begin construction after completing front-end engineering and design (FEED) studies. Without warning, anticipated funding from the UK Government's £1 billion CCS Commercialisation Competition was withdrawn before these studies had been submitted. The Peterhead CCS Project, set to become the world's first CCS project on gas power, and White Rose, which would demonstrate oxyfuel with CCS technology on coal power, have had little choice but to consider closure. In the aftermath of the COP21 climate deal, and with the UK's own climate change advisers restating the importance of the technology in meeting the UK's Fifth Carbon Budget, the case for CCS remains as cogent as ever. In the UK, we have access to an immense CO2 storage asset beneath the North Sea, which could contain a century of Europe's carbon emissions. Added to that is an impressive track record of world-leading research and development (R&D), decades of oil and gas industry knowledge and skills and an infrastructure facing decommissioning that can be repurposed to put carbon back below ground. The progress and potential of CCS in the UK is much more than a government competition. This report describes why we need to get one of the most obvious and effective climate change tools back on track and highlights the strengths of and opportunities for the UK - and Scotland, in particular.The outcome of the Paris climate talks in late 2015 was hailed as a “turning point” for international action on climate change, with 195 countries agreeing to limit the increase in average global temperatures to 1.5oC by the end of this century. It is an ambitious and necessary goal, but is it achievable? An increasing emphasis on clean, renewable energy is essential, as are more efficient ways of using energy. However, the best of intentions will hit an insurmountable roadblock if we continue to burn fossil fuels without deploying Carbon Capture and Storage (CCS). CCS is a chain of proven technologies that can take us all the way to a zero-carbon future. For many economies that will be reliant on fossil fuels for several decades, CCS can support a gradual phasing in of renewable energy. CCS remains the only path to deep cuts in carbon emissions from products such as cement, steel and fertiliser - even whisky - and will effectively decarbonise power and heat generation. Deployed on gas or sustainable biomass power, it can plug the gaps in the intermittency of power supply from renewables. And there are many studies that show that the UK and its assets are best placed to deliver CCS for the whole of Europe. Although CCS is already operating in other parts of the world, this climate change technology has had a tough time making progress in the UK. The latest blow came in the last quarter of 2015, within days of the Paris talks. Two major UK CCS projects were poised to begin construction after completing front-end engineering and design (FEED) studies. Without warning, anticipated funding from the UK Government's £1 billion CCS Commercialisation Competition was withdrawn before these studies had been submitted. The Peterhead CCS Project, set to become the world's first CCS project on gas power, and White Rose, which would demonstrate oxyfuel with CCS technology on coal power, have had little choice but to consider closure. In the aftermath of the COP21 climate deal, and with the UK's own climate change advisers restating the importance of the technology in meeting the UK's Fifth Carbon Budget, the case for CCS remains as cogent as ever. In the UK, we have access to an immense CO2 storage asset beneath the North Sea, which could contain a century of Europe's carbon emissions. Added to that is an impressive track record of world-leading research and development (R&D), decades of oil and gas industry knowledge and skills and an infrastructure facing decommissioning that can be repurposed to put carbon back below ground. The progress and potential of CCS in the UK is much more than a government competition. This report describes why we need to get one of the most obvious and effective climate change tools back on track and highlights the strengths of and opportunities for the UK - and Scotland, in particular

Usability and acceptability of self-testing for hepatitis C virus infection among the general population in the Nile Delta region of Egypt.

BACKGROUND: Self-testing for hepatitis C virus antibodies (HCVST) may be an additional strategy to expand access to hepatitis C virus (HCV) testing and support elimination efforts. We conducted a study to assess the usability and acceptability of HCVST among the general population in a semi-rural, high-HCV prevalence region in Egypt. METHODS: An observational study was conducted in two hospitals in the Nile Delta region. A trained provider gave an in-person demonstration on how to use the oral fluid HCVST followed by observation of the participant performing the test. Usability was assessed by observing errors made and difficulties faced by participants. Acceptability of HCV self-testing was assessed using an interviewer-administered semi-structured questionnaire. RESULTS: Of 116 participants enrolled, 17 (14.6%) had received no formal education. The majority (72%) of participants completed all testing steps without any assistance and interpreted the test results correctly. Agreement between participant-reported HCVST results and interpretation by a trained user was 86%, with a Cohen's kappa of 0.6. Agreement between participant-reported HCVST results and provider-administered oral fluid HCV rapid test results was 97.2%, with a Cohen's kappa of 0.75. The majority of participants rated the HCVST process as easy (53%) or very easy (44%), and 96% indicated they would be willing to use HCVST again and recommend it to their family and friends. CONCLUSION: Our study demonstrates the high usability and acceptability of oral fluid HCVST in a general population. Further studies are needed to establish the optimal positioning of self-testing alongside facility-based testing to expand access to HCV diagnosis in both general and high-risk populations

Usability and acceptability of oral fluid hepatitis C self-testing among people who inject drugs in Coastal Kenya: a cross-sectional pilot study.

BACKGROUND: People who inject drugs (PWID) are disproportionally affected by hepatitis C virus (HCV) infection and many remain undiagnosed. HCV self-testing (HCVST) may be an effective approach to increase testing uptake, but has rarely been used among PWID. We assessed the usability and acceptability of HCVST among PWID in Kenya. METHODS: We conducted a cross-sectional study nested within a cohort study between August and December 2020 on Kenya's North Coast region. Participants were handed a prototype oral fluid HCVST kit and asked to conduct the test relying on the instructions for use. Usability was assessed by documenting errors made and difficulties faced by participants. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. RESULTS: Among 150 participants, 19% were female and 65.3% had primary level education or lower. 71.3% made at least one error, 56.7% experienced some difficulty during at least one step, and the majority of participants (78%) required assistance during at least one step of the procedure. Most common errors occurred when placing the tube into the stand (18%), collecting the oral fluid sample (24%) and timing of reading results (53%). There was a strong association between presence of symptoms of opiate withdrawals and observed errors (94% vs 62%; p = 0.016) in a sub-group of 74 participants assessed. Inter-reader and inter-operator concordance were 97.7% (kappa: 0.92) and 99.2% (kappa: 0.95), respectively. Acceptability assessed by asking whether participants would choose to use HCVST prior to and after conducting HCVST was 98% and 95%, respectively. CONCLUSIONS: We found a high acceptability of oral fluid HCVST among PWID. User errors were common and were associated with the presence of withdrawal symptoms among users. Despite errors, most participants were able to obtain and interpret results correctly. These findings suggest that this group of users may benefit from greater messaging and education including options to receive direct assistance when self-testing for HCV

HCV Self-Testing to Expand Testing: A Pilot Among Men Who Have Sex With Men in China

Background Hepatitis C virus self-testing (HCVST) may increase test uptake especially among marginalized key populations such as men who have sex with men (MSM). We conducted an observational study to assess the usability, acceptability and feasibility of HCVST among MSM in China. Methods An observational study with convenience sampling was performed among MSM in Guangzhou, China in 2019. The OraQuick® HCV Rapid Antibody Test kits were used in this study. Participants performed all 12 HCVST steps and interpreted the results in the presence of a trained observer. Usability was defined as the number and percentage of participants who completed all testing steps correctly without assistance and interpreted the results correctly. Inter-reader concordance was calculated as the percentage agreement between the results interpreted by the participant and those interpreted by a trained staff member. The same process was used to estimate inter-operator agreement between the self-testing and professional use test results. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. Results Among 100 participants with median age 27 (interquartile range 23–30) years, 4% reported prior history of HCV testing, 41% reported using blood-based HIV self-testing in the past, 54% (95%CI: 43.7–64.0%) completed all self-testing steps correctly without assistance and interpreted the results correctly. Both the inter-reader and inter-operator concordance were excellent at 97% (95%CI: 91.5–99.4%) and 98% (95%CI: 93.0–99.8%), respectively. The majority rated the HCVST process as very easy (52%, 95%CI: 41.8–62.1%) or easy (41%, 95%CI: 31.3–51.3%), 76% (95%CI: 66.4–84.0%) were willing to use HCVST again, and 75% (95%CI: 65.3–83.1%) would recommend it to their family and friends. Conclusions Our findings demonstrate that oral fluid HCVST has high usability and acceptability among Chinese MSM. More implementation research is needed to plan how best to position and scale-up HCVST alongside other facility-and community-based testing approaches and ensure data linkage into health systems

HCV Self-Testing to Expand Testing: A Pilot Among Men Who Have Sex With Men in China.

Background: Hepatitis C virus self-testing (HCVST) may increase test uptake especially among marginalized key populations such as men who have sex with men (MSM). We conducted an observational study to assess the usability, acceptability and feasibility of HCVST among MSM in China. Methods: An observational study with convenience sampling was performed among MSM in Guangzhou, China in 2019. The OraQuick® HCV Rapid Antibody Test kits were used in this study. Participants performed all 12 HCVST steps and interpreted the results in the presence of a trained observer. Usability was defined as the number and percentage of participants who completed all testing steps correctly without assistance and interpreted the results correctly. Inter-reader concordance was calculated as the percentage agreement between the results interpreted by the participant and those interpreted by a trained staff member. The same process was used to estimate inter-operator agreement between the self-testing and professional use test results. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. Results: Among 100 participants with median age 27 (interquartile range 23-30) years, 4% reported prior history of HCV testing, 41% reported using blood-based HIV self-testing in the past, 54% (95%CI: 43.7-64.0%) completed all self-testing steps correctly without assistance and interpreted the results correctly. Both the inter-reader and inter-operator concordance were excellent at 97% (95%CI: 91.5-99.4%) and 98% (95%CI: 93.0-99.8%), respectively. The majority rated the HCVST process as very easy (52%, 95%CI: 41.8-62.1%) or easy (41%, 95%CI: 31.3-51.3%), 76% (95%CI: 66.4-84.0%) were willing to use HCVST again, and 75% (95%CI: 65.3-83.1%) would recommend it to their family and friends. Conclusions: Our findings demonstrate that oral fluid HCVST has high usability and acceptability among Chinese MSM. More implementation research is needed to plan how best to position and scale-up HCVST alongside other facility-and community-based testing approaches and ensure data linkage into health systems

Usability and acceptability of oral-based HCV self-testing among key populations: a mixed-methods evaluation in Tbilisi, Georgia

Background: Hepatitis C virus self-testing (HCVST) is an additional approach that may expand access to HCV testing. We conducted a mixed-methods cross-sectional observational study to assess the usability and acceptability of HCVST among people who inject drugs (PWID), men who have sex with men (MSM) and transgender (TG) people in Tbilisi, Georgia. Methods: The study was conducted from December 2019 to June 2020 among PWID at one harm reduction site and among MSM/TG at one community-based organization. We used a convergent parallel mixed-methods design. Usability was assessed by observing errors made and difficulties faced by participants. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. A subset of participants participated in cognitive and in-depth interviews. Results: A total of 90 PWID, 84 MSM and 6 TG were observed performing HCVST. PWID were older (median age 35 vs 24) and had a lower level of education compared to MSM/TG (27% vs 59%). The proportion of participants who completed all steps successfully without assistance was 60% among PWID and 80% among MSM/TG. The most common error was in sample collection and this was observed more often among PWID than MSM/TG (21% vs 6%; p = 0.002). More PWID requested assistance during HCVST compared to MSM/TG (22% vs 8%; p = 0.011). Acceptability was high in both groups (98% vs 96%; p = 0.407). Inter-reader agreement was 97% among PWID and 99% among MSM/TG. Qualitative data from cognitive (n = 20) and in-depth interviews (n = 20) was consistent with the quantitative data confirming a high usability and acceptability. Conclusions: HCVST was highly acceptable among key populations in Georgia of relatively high educational level, and most participants performed HCVST correctly. A significant difference in usability was observed among PWID compared to MSM/TG, indicating that PWID may benefit from improved messaging and education as well as options to receive direct assistance when self-testing for HCV

Understanding implementability in clinical trials : a pragmatic review and concept map

Background The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability. Methods Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019. Results Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map. Conclusions The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia