Valproate MHRA guidance: limitations and opportunities

Recent publication of the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has strengthened the regulatory measures for valproate medicines. It highlights the importance of making women of childbearing age with epilepsy aware of the teratogenic risks of valproate and encourages the withdrawal of it from those currently prescribed. While a significant directive, it raises concerns of not having considered the impact on special populations such as women with Intellectual Disability (ID). While it is important that women with ID are not excluded from such safety initiatives, due caution needs to be taken on a case by case basis preferably, to ensure their best interests are central to the decision making. Many women with moderate to profound ID cannot have informed consented sexual relationships not to mention cognitive incapability to make informed choices on medication suitability. These women are at potential risk of having their epilepsy control undermined due to the MHRA directives. Around 30% of people with moderate to profound ID have seizures of which 60% are considered treatment resistant. In this vulnerable population changes to medication without clear clinical and social insights could lead to increased harm levels. This paper enumerates the challenges of application of the new directive to these special populations and proposes a pathway based on individual cognitive ability to provide informed consent to facilitate the continuation or removal of valproate. It is important not to lose sight of individual circumstances and the importance of working collaboratively toward providing person center care

Measuring Kruger visitors’ place attachment to specific camps

Tourists become emotionally, physically and socially attached to national parks as they become familiar with the park’s settings and endow it with value. Researchers have pointed out that place attachment leads to environmentally responsible behaviour and higher levels of visitor satisfaction. Therefore, increasing the level of attachment that visitors feel is vital for park and camp managers, and to do so a greater understanding of the various dimensions of it is needed. While attachment to parks has been evaluated previously, attachment to specific camps in parks has not been done. The main purpose of this research study was to measure the extent to which visitors to the Tamboti and Satara camps in the Kruger National Park feel attached to these camps. We also determined whether differences exist between visitors in terms of the level of attachment that they experience towards these camps. Finally, we established the variables that influence place attachment. A self-administered paper-based questionnaire was distributed to visitors to the Tamboti and Satara camps, with 201 questionnaires completed. The results show that visitors generally have a neutral feeling towards the camps. Furthermore, the differences in visitors’ levels of attachment could be attributed to their nationality, wild card membership and frequency of visits. Various managerial implications are drawn and recommendations made on how to increase place attachment to these camps. Conservation implications: This results indicate that visitors do not show particularly strong attachment towards Tamboti and Satara. Recommendations are given for camp managers to increase place attachment to the camps. If camp managers can succeed in fostering stronger levels of attachment to these camps, visitors are more likely to display environmentally responsible behaviour in the camps, with positive conservation implications

Gendered nationalism : the gender gap in support for the Scottish National Party

Recent major surveys of the Scottish electorate and of Scottish National Party (SNP) members have revealed a distinct gender gap in support for the party. Men are markedly more likely than women to vote for the SNP and they comprise more than two-thirds of its membership. In this article, we use data from those surveys to test various possible explanations for the disproportionately male support for the SNP. While popular accounts have focused on the gendered appeal of recent leaders and on the party’s fluctuating efforts at achieving gender equality in its parliamentary representation, we find much stronger support for a different explanation. Women are less inclined to support and to join the SNP because they are markedly less supportive of its central objective of independence for Scotland. Since men and women barely differ in their reported national identities, the origins of this gender gap in support for independence presents a puzzle for further research

Measuring Kruger visitors’ place attachment to specific camps

Tourists become emotionally, physically and socially attached to national parks as they become familiar with the park’s settings and endow it with value. Researchers have pointed out that place attachment leads to environmentally responsible behaviour and higher levels of visitor satisfaction. Therefore, increasing the level of attachment that visitors feel is vital for park and camp managers, and to do so a greater understanding of the various dimensions of it is needed. While attachment to parks has been evaluated previously, attachment to specific camps in parks has not been done. The main purpose of this research study was to measure the extent to which visitors to the Tamboti and Satara camps in the Kruger National Park feel attached to these camps. We also determined whether differences exist between visitors in terms of the level of attachment that they experience towards these camps. Finally, we established the variables that influence place attachment. A self-administered paper-based questionnaire was distributed to visitors to the Tamboti and Satara camps, with 201 questionnaires completed. The results show that visitors generally have a neutral feeling towards the camps. Furthermore, the differences in visitors’ levels of attachment could be attributed to their nationality, wild card membership and frequency of visits. Various managerial implications are drawn and recommendations made on how to increase place attachment to these camps. CONSERVATION IMPLICATIONS : This results indicate that visitors do not show particularly strong attachment towards Tamboti and Satara. Recommendations are given for camp managers to increase place attachment to the camps. If camp managers can succeed in fostering stronger levels of attachment to these camps, visitors are more likely to display environmentally responsible behaviour in the camps, with positive conservation implications.The National Research Foundation of South Africa (Grant Number 114916).http://www.koedoe.co.zaam2020Tourism Managemen

"We are the heroes because we are ready to die for this country": Participants' decision-making and grounded ethics in an Ebola vaccine clinical trial.

The 2014-2016 Ebola epidemic presented a challenging setting in which to carry out clinical trials. This paper reports findings from social science research carried out in Kambia, Northern Sierra Leone during first year of an Ebola vaccine trial (August 2015-July 2016). The social science team collected data through ethnographic observation, 42 in depth interviews; 4 life narratives; 200 exit interviews; 31 key informant interviews; and 8 focus group discussions with trial participants and community members not enrolled in the trial. Whilst research often focuses on why people refuse vaccination, we instead explore participant motivations for volunteering for the study, in spite of prevailing anxieties, rumours and mistrust during and after the Ebola outbreak. In so doing the paper contributes to on-going debates about research ethics and community engagement in resource poor contexts, offering reflections from an emergency and post-epidemic setting. We analyse participants' perceptions of the risks and benefits of participations, highlighting the importance of a contextual approach. We focus on four types of motivation: altruism; curiosity and hope; health-seeking; and notions of exchange, and argue for the role of social science in developing grounded research ethics and community engagement strategies that can take into account context and local realities

Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial.

BACKGROUND: Optimum surgical intervention for low-grade haemorrhoids is unknown. Haemorrhoidal artery ligation (HAL) has been proposed as an efficacious, safe therapy while rubber band ligation (RBL) is a commonly used outpatient treatment. We compared recurrence after HAL versus RBL in patients with grade II-III haemorrhoids. METHODS: This multicentre, open-label, parallel group, randomised controlled trial included patients from 17 acute UK NHS trusts. We screened patients aged 18 years or older presenting with grade II-III haemorrhoids. We excluded patients who had previously received any haemorrhoid surgery, more than one injection treatment for haemorrhoids, or more than one RBL procedure within 3 years before recruitment. Eligible patients were randomly assigned (in a 1:1 ratio) to either RBL or HAL with Doppler. Randomisation was computer-generated and stratified by centre with blocks of random sizes. Allocation concealment was achieved using a web-based system. The study was open-label with no masking of participants, clinicians, or research staff. The primary outcome was recurrence at 1 year, derived from the patient's self-reported assessment in combination with resource use from their general practitioner and hospital records. Recurrence was analysed in patients who had undergone one of the interventions and been followed up for at least 1 year. This study is registered with the ISRCTN registry, ISRCTN41394716. FINDINGS: From Sept 9, 2012, to May 6, 2014, of 969 patients screened, 185 were randomly assigned to the HAL group and 187 to the RBL group. Of these participants, 337 had primary outcome data (176 in the RBL group and 161 in the HAL group). At 1 year post-procedure, 87 (49%) of 176 patients in the RBL group and 48 (30%) of 161 patients in the HAL group had haemorrhoid recurrence (adjusted odds ratio [aOR] 2·23, 95% CI 1·42-3·51; p=0·0005). The main reason for this difference was the number of extra procedures required to achieve improvement (57 [32%] participants in the RBL group and 23 [14%] participants in the HAL group had a subsequent procedure for haemorrhoids). The mean pain 1 day after procedure was 3·4 (SD 2·8) in the RBL group and 4·6 (2·8) in the HAL group (difference -1·2, 95% CI -1·8 to -0·5; p=0·0002); at day 7 the scores were 1·6 (2·3) in the RBL group and 3·1 (2·4) in the HAL group (difference -1·5, -2·0 to -1·0; p<0·0001). Pain scores did not differ between groups at 21 days and 6 weeks. 15 individuals reported serious adverse events requiring hospital admission. One patient in the RBL group had a pre-existing rectal tumour. Of the remaining 14 serious adverse events, 12 (7%) were among participants treated with HAL and two (1%) were in those treated with RBL. Six patients had pain (one treated with RBL, five treated with HAL), three had bleeding not requiring transfusion (one treated with RBL, two treated with HAL), two in the HAL group had urinary retention, two in the HAL group had vasovagal upset, and one in the HAL group had possible sepsis (treated with antibiotics). INTERPRETATION: Although recurrence after HAL was lower than a single RBL, HAL was more painful than RBL. The difference in recurrence was due to the need for repeat bandings in the RBL group. Patients (and health commissioners) might prefer such a course of RBL to the more invasive HAL. FUNDING: NIHR Health Technology Assessment programme

mNCEA policy brief - Mind the Gap – The need to continue long-term plankton monitoring

This policy brief argues that while it is beneficial to explore novel plankton survey technology, it is essential that we also continue to maintain traditional long-term monitoring programmes to generate the necessary information to inform policy. Changes in plankton have important implications for the continued provision of ecosystem services, including supporting commercial fish stocks, carbon sequestration, and oxygen production. Such changes can only be detected by studying long-term, consistent plankton datasets which are needed to understand the pressures driving these changes and how we can manage them. Traditional long-term plankton monitoring relies on light microscopy to identify and count plankton taxa, with methods fully supported by national / international QA/QC standards and providing high quality trusted data. Novel technologies, including imaging and molecular methods, offer more efficient means of collecting some types of plankton data, filling targeted knowledge gaps left by traditional monitoring. However, these data are often semi-quantitative, lacking in QA/QC standards, and/or in taxonomic resolution. While these technologies are developed it remains critical to maintain the continuity of traditional plankton monitoring to inform policy assessments of important changes in biodiversity. Losing these time-series, many of which span multiple decades, would impair our ability to detect important change in pelagic habitats, as most changes cannot be detected from short-term data. This would also accelerate the loss of taxonomic expertise, already under threat globally, diminishing our UK skill-base. Novel technologies should be explored in parallel to traditional monitoring, as they can provide complementary data to support policy assessments and research, however, it is important that we do not attempt to replace traditional monitoring with new technology before it has been thoroughly integrated into long-term monitoring programmes. This project was funded by the Department for Environment, Food and Rural Affairs (Defra) as part of the marine arm of the Natural Capital and Ecosystem Assessment (NCEA) programme. The marine NCEA programme is leading the way in supporting Government ambition to integrate natural capital approaches into decision making for the marine environment. Find out more at https://www.gov.uk/government/publications/natural-capital-and-ecosystem-assessment-programme

Did the evidence-based intervention (EBI) programme reduce inappropriate procedures, lessen unwarranted variation or lead to spill-over effects in the National Health Service?

Background Health systems are under pressure to maintain services within limited resources. The Evidence-Based Interventions (EBI) programme published a first list of guidelines in 2019, which aimed to reduce inappropriate use of interventions within the NHS in England, reducing potential harm and optimising the use of limited resources. Seventeen procedures were selected in the first round, published in April 2019. Methods We evaluated changes in the trends for each procedure after its inclusion in the EBI’s first list of guidelines using interrupted time series analysis. We explored whether there was any evidence of spill-over effects onto related or substitute procedures, as well as exploring changes in geographical variation following the publication of national guidance. Results Most procedures were experiencing downward trends in the years prior to the launch of EBI. We found no evidence of a trend change in any of the 17 procedures following the introduction of the guidance. No evidence of spill-over increases in substitute or related procedures was found. Geographic variation in the number of procedures performed across English CCGs remained at similar levels before and after EBI. Conclusions The EBI programme had little success in its aim to further reduce the use of the 17 procedures it deemed inappropriate in all or certain circumstances. Most procedure rates were already decreasing before EBI and all continued with a similar trend afterwards. Geographical variation in the number of procedures remained at a similar level post EBI. De-adoption of inappropriate care is essential in maintaining health systems across the world. However, further research is needed to explore context specific enablers and barriers to effective identification and de-adoption of such inappropriate health care to support future de-adoption endeavours