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

"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

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

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

Production of Androgens by Microbial Transformation of Progesterone in Vitro: A Model for Androgen Production in Rivers Receiving Paper Mill Effluent

We have previously documented the presence of progesterone and androstenedione in the water column and bottom sediments of the Fenholloway River, Taylor County, Florida. This river receives paper mill effluent and contains masculinized female mosquitofish. We hypothesized that plant sterols (e.g., β-sitosterol) derived from the pulping of pine trees are transformed by bacteria into progesterone and subsequently into 17α-hydroxyprogesterone, androstenedione, and other androgens. In this study, we demonstrate that these same androgens can be produced in vitro from the bacterium Mycobacterium smegmatis. In a second part to this study, we reextracted and reanalyzed the sediment from the Fenholloway River and verified the presence of androstadienedione, a Δ1 steroid with androgen activity

The politicisation of science in the Murray-Darling Basin, Australia:discussion of ‘Scientific integrity, public policy and water governance’

Many water scientists aim for their work to inform water policy and management, and in pursuit of this objective, they often work alongside government water agencies to ensure their research is relevant, timely and communicated effectively. A paper in this issue, examining 'Science integrity, public policy and water governance in the Murray-Darling Basin, Australia’, suggests that a large group of scientists, who work on water management in the Murray-Darling Basin (MDB) including the Basin Plan, have been subject to possible ‘administrative capture'. Specifically, it is suggested that they have advocated for policies favoured by government agencies with the objective of gaining personal benefit, such as increased research funding. We examine evidence for this claim and conclude that it is not justified. The efforts of scientists working alongside government water agencies appear to have been misinterpreted as possible administrative capture. Although unsubstantiated, this claim does indicate that the science used in basin water planning is increasingly caught up in the politics of water management. We suggest actions to improve science-policy engagement in basin planning, to promote constructive debate over contested views and avoid the over-politicisation of basin science