Power, discourse and participation in nature conflicts: the case of turf cutters in the governance of Ireland's raised bog designations

This paper explores how participatory processes and the politics of contestation and resistance converge to influence changes in discourses and institutional structures underpinning the implementation of the EU Habitats Directive in Ireland. It highlights the potential of environmental partnership processes to disrupt the usual scalar hierarchy for regulation. The focus is specifically on the designation of raised bogs and the role of power relations and legitimacy discourses in participatory governance processes established by government. In particular this paper critiques the participatory governance process and attempts to legitimise the enforcement of the Habitats Directive in the face of resistance by the TCCA (Turf Cutters and Contractors Association). Whilst the purpose of the designation is to protect unique habitats, another effect has been to prohibit the traditional right to cut turf on Special Areas of Conservation (SACs). The rationale behind the designation and the mechanisms by which this process has been mediated has been highly contested, with the TCCA claiming the scope inherent in the Directive to consider the de-classification of SACs to have been inadequately addressed by government. The paper concludes with a Foucauldian critique of regulatory authority, legitimacy discourses and agency in the application of participatory processes underpinning environmental regulatio

The welfare of animals transported from Ireland to Spain AND The Physiological haematological and immunological responses of 9-month old bulls (250kg) to transport at two stocking densities (0.85m2 and 1.27m2 /250kg animal) on a 12-hour journey by road.

End of Project ReportFifty-two weanling continental x beef heifers (mean liveweight 269kg) were transported from Ireland to France on a roll-on roll-off ferry (RO-RO), and onwards by road for 3-hours to a French lairage, rested for 24 hours at a staging post and taken by road on an 18-hour journey through France to a feedlot in Spain. Animals transported to France lost 7.6 % of their bodyweight, and gained 3.3 % of their bodyweight by time of arrival in Spain and recovered to pre-transport liveweight values by day 6. Although there was some evidence that transport affected physiological and immunological variables, there was no evidence to suggest that it adversely affected the health or the performance of the animals post transport. Creatine kinase activities were increased but values were still within normal acceptable ranges. Increases in non-esterified fatty acids, beta-hydroxybutyrate and urea concentrations suggested that the animals' normal pattern of feeding was disrupted during transport. Increases in albumin, total plasma protein and osmolality would indicate slight dehydration during transit. However, albumin concentrations returned to control levels by day 38 of the study. While haematocrit values were decreased, they are within the range of normal referenced data (24 - 48%). Similarly, changes in the RBC numbers and haemoglobin were within the normal blood referenced ranges ((RBC; 5.0 – 10.0 x106 /ml) and (haemoglobin 8-14 g%)(Schalm, 1961)). The only time at which white blood counts increased above the upper limit of 12, was 12 hours after arrival at the French lairage. The aspartate transaminase concentrations for the transported animals at arrival in France and Spain were not significantly different from their pre-transport concentrations but were increased at day 11 when compared with baseline levels. Concanavalin-A induced interferon-g levels were lower on arrival in the Spanish feedlot and on Day 11 of the study, when compared with pre-transport baseline levels. Compared with pre-transport levels, keyhole limpet haemocyanin-induced interferon-g levels for the transported animals were significantly decreased on the day of arrival in France, with no significant difference on the day of arrival in Spain or on day 11 of the study. Interferon-g is produced by activated T lymphocytes and natural killer cells in response to antigen. The percentage (%) of lymphocytes decreased and the % neutrophils increased post-transport indicating a shift in the population of these blood cells relative to pre-transport baseline values. There was no significant change in plasma cortisol concentrations in transported animals at arrival in France and in Spain. On Day 11, the plasma cortisol concentrations of transported animals were significantly higher than control animals. There were significantly higher glucose concentrations on arrival in France, and in samples taken at 12 and 24 hours post-arrival in France, on arrival in Spain, and on days 7 and 11 compared with control levels. Transported animals had significantly higher glucose levels at sample 2 on the day of arrival in France compared with their pre-transport values. Transported animals had significantly higher fibrinogen levels at arrival in France compared with their pre-transport baseline concentrations. Inflammation resulting from stress can cause the release of acute phase proteins such as haptoglobin and fibrinogen, and acute phase proteins in cattle have been associated with immunosuppression, however, much higher levels have been reported in inflammatory conditions. Transported animals had significantly higher non-esterified fatty acid (NEFA) levels on arrival in France and Spain and on day 11 compared with their pre-transport baseline concentrations. Control animals had significantly higher levels on day 5 compared with their pre-transport baseline NEFA concentrations. However, all levels were within the normal acceptable ranges. The study concluded that transport had no adverse effect on animal welfare based on the physiological, immunological and haematological measurements made

The Welfare of Animals Transported From Ireland to Italy.

End of Project ReportThe overall objective of the present study was to investigate the physiological, haematological and immunological responses of weanling bulls transported to Italy under present EU legislation and to evaluate the implications in terms of animal welfare

Effects of Pre-Journey Fasting on the Physiological Responses of Young Cattle to 8-hour Road Transport.

End of Project ReportThe present study evaluated the effects of fasting animals for 8 hours prior to an 8-hour road journey and their ability to cope with the stress of transport.There was no significant difference in rectal body temperature, pre and post transport and there were no significant differences in liveweight among treatments on days 0 (pre-transport), 1, 4 and 10 (post-transport). Bulls (230kg) undergoing an 8-h transportation at stocking densities of 0.82 m2 /animal showed physiological and haematological responses that were within normal referenced ranges. Animals that were fasted for 8-hours and then transported lost 9.4% bodyweight following the 8-hour journey, while non-fasted and transported animals (NF+T) lost 7.2%. The control animals remaining at grass and non-fasted (NF+G) gained 2%. The animals that were fasted continuously and not transported (F+F) and the non-fasted control animals that were fasted for 8 hours (NF+F) lost 6.1% and 6.2% respectively. There was no significant change in globulin, glucose, urea, haemoglobin, beta-hydroxy butyrate, fibrinogen concentrations, haematocrit and monocyte percentages, monocyte and red blood cell numbers, platelet numbers among treatments prior to or after transport. The % lymphocytes were reduced in the fasted and non-fasted transported animals and post-transport and there was no significant change in lymphocyte numbers. The % of neutrophils and the number of neutrophils were significantly increased in the fasted and non-fasted transported animals. Baseline protein concentrations were significantly lower in the non-fasted and transported and nonfasted then fasted treatments initially. Following transport, protein concentrations were significantly higher in the fasted and transported treatment compared with the non-fasted animals at grass. White blood cell (WBC) numbers were not significantly different prior to transport. Following transport, the WBC numbers were significantly higher in the fasted and transported treatment compared with the non-fasted at grass, fasted and then fasted, and the non-fasted and fasted treatments. Albumin concentrations were significantly higher following transport in the F+T treatment compared with the NF+G, F+F, and NF+F treatments and the NF+T treatment had significantly lower albumin levels than the F+T and NF+F treatments. Haptoglobin concentrations were not significantly different prior to transport. Following transport, haptoglobin concentrations were significantly higher in the F+T compared with the NF+G treatment. Lactate concentrations were significantly higher in the F+T and NF+T compared with the NF+G, F+F, and NF+F treatments following transport. In conclusion, from the physiological and haematological measurements, an 8 hour journey time, even without access to feed for 8 hours prior to transport did not impact negatively on animal welfare

Learning from patients : trainers' use of narratives for learning and teaching

There is a growing interest in how doctors learn from narratives about individual cases, reflected, for example, in the use of e-portfolios. This study aimed to evaluate how GP trainers conceptualised 'learning from patients', and what use they currently made of narrative recounts in training. Thematic analysis (TA) and corpus-linguistic (CL) analysis, with data collected from a convenience sample of trainers in the UK, Ireland, and Spain. GP trainers in the three settings were contacted, and volunteers recruited (22 in UK, 24 in Ireland, and 16 in Spain). Volunteers were interviewed and asked to offer a narrative about 'a patient you learned from' and whether they used narratives as a training device. There were no differences between settings. Trainers described an engaged and personal relationship with patients. They described learning about themselves, the human condition, and about how to live and die well. Their narratives were structured in various ways. At times, they led to precise conclusions: at times, they were perceived as meaningful, but resisting analysis. As regards teaching through narrative, it was reported as commonly used, but present practice appears ad hoc rather than planned. The lack of difference between settings suggests a degree of commonality about how trainers perceive learning and teaching in the areas explored, but cannot be generalised further. The level of personal engagement was more than anticipated, and suggests the label 'doctor-patient relationship', as the term is used, may not be adequate to describe the nature of some interactions

Stakeholders’ knowledge, attitudes and practices to pharmacovigilance and adverse drug reaction reporting in clinical trials: a mixed methods study

Purpose: The purpose of this study was to explore the knowledge, attitudes and practices of health professionals working in clinical trials, to pharmacovigilance and adverse drug reaction (ADR) reporting. Methods: A mixed methods study comprising an online questionnaire disseminated from September to November 2018, three semi-structured interviews and four focus groups. The qualitative components were conducted with a random sample of questionnaire participants who had provided their contact details (n = 24). The qualitative interviews were conducted at a location convenient to the participant’s place of work between October and December 2018. Results: One hundred forty-eight participants completed the questionnaire. Study coordinators/project managers represented the largest group of participants ( 28.6%, n = 38). Poor knowledge or understanding of ADR reporting was the most frequently cited barrier to ADR reporting (75%, n = 93). The most common enabler to reporting was having a clear understanding of an ADR definition (85.7%, n = 108). Focus group and interview participants described having limited staff as a barrier to reporting an ADR. They welcomed the prospect of pharmacovigilance training and indicated that face-to-face training would be preferred to provision of online training. Conclusion: This study highlights key factors that influence the reporting of ADRs in clinical trials. Although the findings are specifically related to the clinical trial environment in Ireland, they may provide a useful platform for optimising the future conduct of trials. This research suggests that ADR reporting may be improved through provision of enhanced pharmacovigilance training to clinical trial staff

Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial

Background: Children with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for HIV-associated TB. Methods: We nested a two-period, fixed-order pharmacokinetic substudy within the open-label, multicentre, randomised, controlled, non-inferiority ODYSSEY trial at research centres in South Africa, Uganda, and Zimbabwe. Children (aged 4 weeks to <18 years) with HIV-associated TB who were receiving rifampicin and twice-daily dolutegravir were eligible for inclusion. We did a 12-h pharmacokinetic profile on rifampicin and twice-daily dolutegravir and a 24-h profile on once-daily dolutegravir. Geometric mean ratios for trough plasma concentration (Ctrough), area under the plasma concentration time curve from 0 h to 24 h after dosing (AUC0–24 h), and maximum plasma concentration (Cmax) were used to compare dolutegravir concentrations between substudy days. We assessed rifampicin Cmax on the first substudy day. All children within ODYSSEY with HIV-associated TB who received rifampicin and twice-daily dolutegravir were included in the safety analysis. We described adverse events reported from starting twice-daily dolutegravir to 30 days after returning to once-daily dolutegravir. This trial is registered with ClinicalTrials.gov (NCT02259127), EudraCT (2014–002632-14), and the ISRCTN registry (ISRCTN91737921). Findings: Between Sept 20, 2016, and June 28, 2021, 37 children with HIV-associated TB (median age 11·9 years [range 0·4–17·6], 19 [51%] were female and 18 [49%] were male, 36 [97%] in Africa and one [3%] in Thailand) received rifampicin with twice-daily dolutegravir and were included in the safety analysis. 20 (54%) of 37 children enrolled in the pharmacokinetic substudy, 14 of whom contributed at least one evaluable pharmacokinetic curve for dolutegravir, including 12 who had within-participant comparisons. Geometric mean ratios for rifampicin and twice-daily dolutegravir versus once-daily dolutegravir were 1·51 (90% CI 1·08–2·11) for Ctrough, 1·23 (0·99–1·53) for AUC0–24 h, and 0·94 (0·76–1·16) for Cmax. Individual dolutegravir Ctrough concentrations were higher than the 90% effective concentration (ie, 0·32 mg/L) in all children receiving rifampicin and twice-daily dolutegravir. Of 18 children with evaluable rifampicin concentrations, 15 (83%) had a Cmax of less than the optimal target concentration of 8 mg/L. Rifampicin geometric mean Cmax was 5·1 mg/L (coefficient of variation 71%). During a median follow-up of 31 weeks (IQR 30–40), 15 grade 3 or higher adverse events occurred among 11 (30%) of 37 children, ten serious adverse events occurred among eight (22%) children, including two deaths (one tuberculosis-related death, one death due to traumatic injury); no adverse events, including deaths, were considered related to dolutegravir. Interpretation: Twice-daily dolutegravir was shown to be safe and sufficient to overcome the rifampicin enzyme-inducing effect in children, and could provide a practical ART option for children with HIV-associated TB

Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial

BACKGROUND: Cohort studies in adults with HIV showed that dolutegravir was associated with neuropsychiatric adverse events and sleep problems, yet data are scarce in children and adolescents. We aimed to evaluate neuropsychiatric manifestations in children and adolescents treated with dolutegravir-based treatment versus alternative antiretroviral therapy. METHODS: This is a secondary analysis of ODYSSEY, an open-label, multicentre, randomised, non-inferiority trial, in which adolescents and children initiating first-line or second-line antiretroviral therapy were randomly assigned 1:1 to dolutegravir-based treatment or standard-of-care treatment. We assessed neuropsychiatric adverse events (reported by clinicians) and responses to the mood and sleep questionnaires (reported by the participant or their carer) in both groups. We compared the proportions of patients with neuropsychiatric adverse events (neurological, psychiatric, and total), time to first neuropsychiatric adverse event, and participant-reported responses to questionnaires capturing issues with mood, suicidal thoughts, and sleep problems. FINDINGS: Between Sept 20, 2016, and June 22, 2018, 707 participants were enrolled, of whom 345 (49%) were female and 362 (51%) were male, and 623 (88%) were Black-African. Of 707 participants, 350 (50%) were randomly assigned to dolutegravir-based antiretroviral therapy and 357 (50%) to non-dolutegravir-based standard-of-care. 311 (44%) of 707 participants started first-line antiretroviral therapy (ODYSSEY-A; 145 [92%] of 157 participants had efavirenz-based therapy in the standard-of-care group), and 396 (56%) of 707 started second-line therapy (ODYSSEY-B; 195 [98%] of 200 had protease inhibitor-based therapy in the standard-of-care group). During follow-up (median 142 weeks, IQR 124–159), 23 participants had 31 neuropsychiatric adverse events (15 in the dolutegravir group and eight in the standard-of-care group; difference in proportion of participants with ≥1 event p=0·13). 11 participants had one or more neurological events (six and five; p=0·74) and 14 participants had one or more psychiatric events (ten and four; p=0·097). Among 14 participants with psychiatric events, eight participants in the dolutegravir group and four in standard-of-care group had suicidal ideation or behaviour. More participants in the dolutegravir group than the standard-of-care group reported symptoms of self-harm (eight vs one; p=0·025), life not worth living (17 vs five; p=0·0091), or suicidal thoughts (13 vs none; p=0·0006) at one or more follow-up visits. Most reports were transient. There were no differences by treatment group in low mood or feeling sad, problems concentrating, feeling worried or feeling angry or aggressive, sleep problems, or sleep quality. INTERPRETATION: The numbers of neuropsychiatric adverse events and reported neuropsychiatric symptoms were low. However, numerically more participants had psychiatric events and reported suicidality ideation in the dolutegravir group than the standard-of-care group. These differences should be interpreted with caution in an open-label trial. Clinicians and policy makers should consider including suicidality screening of children or adolescents receiving dolutegravir

Prescribing Data in General Practice Demonstration (PDGPD) project - a cluster randomised controlled trial of a quality improvement intervention to achieve better prescribing for chronic heart failure and hypertension

The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1472-6963/12/273 Extent: 11p.Background: Research literature consistently documents that scientifically based therapeutic recommendations are not always followed in the hospital or in the primary care setting. Currently, there is evidence that some general practitioners in Australia are not prescribing appropriately for patients diagnosed with 1) hypertension (HT) and 2) chronic heart failure (CHF). The objectives of this study were to improve general practitioner’s drug treatment management of these patients through feedback on their own prescribing and small group discussions with peers and a trained group facilitator. The impact evaluation includes quantitative assessment of prescribing changes at 6, 9, 12 and 18 months after the intervention. Methods: A pragmatic multi site cluster RCT began recruiting practices in October 2009 to evaluate the effects of a multi-faceted quality improvement (QI) intervention on prescribing practice among Australian general practitioners (GP) in relation to patients with CHF and HT. General practices were recruited nationally through General Practice Networks across Australia. Participating practices were randomly allocated to one of three groups: two groups received the QI intervention (the prescribing indicator feedback reports and small group discussion) with each group undertaking the clinical topics (CHF and HT) in reverse order to the other. The third group was waitlisted to receive the intervention 6 months later and acted as a "control" for the other two groups. De-identified data on practice, doctor and patient characteristics and their treatment for CHF and HT are extracted at six-monthly intervals before and after the intervention. Post-test comparisons will be conducted between the intervention and control arms using intention to treat analysis and models that account for clustering of practices in a Network and clustering of patients within practices and GPs. Discussion: This paper describes the study protocol for a project that will contribute to the development of acceptable and sustainable methods to promote QI activities within routine general practice, enhance prescribing practices and improve patient outcomes in the context of CHF and HT. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR), Trial # 320870.Margaret Williamson, Magnolia Cardona-Morrell, Jeffrey D Elliott, James F Reeve, Nigel P Stocks, Jon Emery, Judith M Mackson and Jane M Gun