Public policies, law and bioethics: : a framework for producing public health policy across the European Union

Unlike the duties of clinicians to patients, professional standards for ethical practice are not well defined in public health. This is mainly due to public health practice having to reconcile tensions between public and private interest(s). This involves at times being paternalistic, while recognising the importance of privacy and autonomy, and at the same time balancing the interests of some against those of others. The Public Health specialist operates at the macro level, frequently having to infer the wishes and needs of individuals that make up a population and may have to make decisions where the interests of people conflict. This is problematic when devising policy for small populations; however, it becomes even more difficult when there is responsibility for many communities or nation states. Under the Treaty on European Union, the European Commission was given a competence in public health. Different cultures will give different moral weight to protecting individual interests versus action for collective benefit. However, even subtle differences in moral preferences may cause problems in deriving public health policy within the European Union. Understanding the extent to which different communities perceive issues such as social cohesion by facilitating cultural dialogues will be vital if European institutions are to work towards new forms of citizenship. The aim of EuroPHEN was to derive a framework for producing common approaches to public health policy across Europe. Little work has been done on integrating ethical analysis with empirical research, especially on trade-offs between private and public interests. The disciplines of philosophy and public policy have been weakly connected. Much of the thinking on public health ethics has hitherto been conducted in the United States of America, and an ethical framework for public health within Europe would need to reflect the greater respect for values such as solidarity and integrity which are more highly valued in Europe. Towards this aim EuroPHEN compared the organisation of public health structures and public policy responses to selected public health problems in Member States to examine how public policy in different countries weighs competing claims of private and public interest. Ethical analysis was performed of tensions between the private and public interest in the context of various ethical theories, principles and traditions. During autumn 2003, 96 focus groups were held across 16 European Union Member States exploring public attitudes and values to public versus private interests. The groups were constructed to allow examination of differences in attitudes between countries and demographic groups (age, gender, smoking status, educational level and parental and marital status). Focus group participants discussed issues such as attitudes to community; funding of public services; rights and responsibilities of citizens; rules and regulations; compulsory car seat belts; policies to reduce tobacco consumption; Not-In-My-Back-Yard arguments; banning of smacking of children; legalising cannabis and parental choice with regards to immunisation. This project proposes a preliminary framework and stresses that a European policy of Public Health will have to adopt a complex, pluralistic and dynamic goal structure, capable of accommodating variations in what specific goals should be prioritised in the specific socio-economic settings of individual countries

Investigating the effect of independent blinded digital image assessment on the STOP GAP trial

Background Blinding is the process of keeping treatment assignment hidden and is used to minimise the possibility of bias. Trials at high risk of bias have been shown to report larger treatment effects than low risk studies. In dermatology, one popular method of blinding is to have independent outcome assessors who are unaware of treatment allocation assessing the end point using digital photographs. However, this can be complex, expensive and time-consuming. The objective of this study was to compare the effect of blinded and unblinded outcome assessment on the results of the STOP GAP trial. Methods The STOP GAP trial compared prednisolone to ciclosporin in treating pyoderma gangrenosum. Participants’ lesions were measured at baseline and 6 weeks to calculate the primary outcome, speed of healing. Independent blinded assessors obtained measurements from digital photographs using specialist software. In addition, unblinded treating clinicians estimated lesion area by measuring length and width. The primary outcome was determined using blinded measurements where available, otherwise unblinded measurements were used (method referred to as trial measurements). In this study, agreement between the trial and unblinded measurements was determined using the intraclass correlation coefficient (ICC). The STOP GAP primary analysis was repeated using unblinded measurements only. We introduced differential and non-differential error in unblinded measurements and investigated the effect on the STOP GAP primary analysis. Results 86 (80%) of the 108 patients were assessed using digital images. Agreement between trial and unblinded measurements was excellent (ICC=0.92 at baseline; 0.83 at 6 weeks). There was no evidence that the results of the trial primary analysis differed according to how the primary outcome was assessed (p-value for homogeneity = 1.00). Conclusions Blinded digital image assessment in STOP GAP did not meaningfully alter trial conclusions compared with unblinded assessment. However, as the process brought added accuracy and credibility to the trial it was considered worthwhile. These findings question the usefulness of digital image assessment in a trial with an objective outcome and where bias is not expected to be excessive. Further research should investigate if there are alternative, less complex ways of incorporating blinding in clinical trials

2024 UK and Ireland modified Delphi consensus on myopia management in children and young people

Introduction: This work aimed to establish the largest UK and Ireland consensus on myopia management in children and young people (CYP). Methods: A modified Delphi consensus was conducted with a panel of 34 optometrists and ophthalmologists with expertise in myopia management. Results: Two rounds of voting took place and 131 statements were agreed, including that interventions should be discussed with parents/carers of all CYP who develop myopia before the age of 13 years, a recommendation for interventions to be publicly funded for those at risk of fast progression and high myopia, that intervention selection should take into account the CYP's hobbies and lifestyle and that additional training for eye care professionals should be available from non-commercial sources. Topics for which published evidence is limited or lacking were areas of weaker or no consensus. Modern myopia management contact and spectacles are suitable first-line treatments. The role and provision of low-concentration atropine needs to be reviewed once marketing authorisations and funding decisions are in place. There is some evidence that a combination of low-concentration atropine with an optical intervention can have an additive effect; further research is needed. Once an intervention is started, best practice is to monitor non-cycloplegic axial length 6 monthly. Conclusion: Research is needed to identify those at risk of progression, the long-term effectiveness of individual and combined interventions, and when to discontinue treatment when myopia has stabilised. As further evidence continues to emerge, this consensus work will be repeated to ensure it remains relevant.</p

The Clinical Outcome Study for dysferlinopathy: An international multicenter study

Objective: To describe the baseline clinical and functional characteristics of an international cohort of 193 patients with dysferlinopathy. Methods: The Clinical Outcome Study for dysferlinopathy (COS) is an international multicenter study of this disease, evaluating patients with genetically confirmed dysferlinopathy over 3 years. We present a cross-sectional analysis of 193 patients derived from their baseline clinical and functional assessments. Results: There is a high degree of variability in disease onset, pattern of weakness, and rate of progression. No factor, such as mutation class, protein expression, or age at onset, accounted for this variability. Among patients with clinical diagnoses of Miyoshi myopathy or limb-girdle muscular dystrophy, clinical presentation and examination was not strikingly different. Respiratory impairment and cardiac dysfunction were observed in a minority of patients. A substantial delay in diagnosis was previously common but has been steadily reducing, suggesting increasing awareness of dysferlinopathies. Conclusions: These findings highlight crucial issues to be addressed for both optimizing clinical care and planning therapeutic trials in dysferlinopathy. This ongoing longitudinal study will provide an opportunity to further understand patterns and variability in disease progression and form the basis for trial design

Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial

Background Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy

Parasite Burden and CD36-Mediated Sequestration Are Determinants of Acute Lung Injury in an Experimental Malaria Model

Although acute lung injury (ALI) is a common complication of severe malaria, little is known about the underlying molecular basis of lung dysfunction. Animal models have provided powerful insights into the pathogenesis of severe malaria syndromes such as cerebral malaria (CM); however, no model of malaria-induced lung injury has been definitively established. This study used bronchoalveolar lavage (BAL), histopathology and gene expression analysis to examine the development of ALI in mice infected with Plasmodium berghei ANKA (PbA). BAL fluid of PbA-infected C57BL/6 mice revealed a significant increase in IgM and total protein prior to the development of CM, indicating disruption of the alveolar–capillary membrane barrier—the physiological hallmark of ALI. In contrast to sepsis-induced ALI, BAL fluid cell counts remained constant with no infiltration of neutrophils. Histopathology showed septal inflammation without cellular transmigration into the alveolar spaces. Microarray analysis of lung tissue from PbA-infected mice identified a significant up-regulation of expressed genes associated with the gene ontology categories of defense and immune response. Severity of malaria-induced ALI varied in a panel of inbred mouse strains, and development of ALI correlated with peripheral parasite burden but not CM susceptibility. Cd36−/− mice, which have decreased parasite lung sequestration, were relatively protected from ALI. In summary, parasite burden and CD36-mediated sequestration in the lung are primary determinants of ALI in experimental murine malaria. Furthermore, differential susceptibility of mouse strains to malaria-induced ALI and CM suggests that distinct genetic determinants may regulate susceptibility to these two important causes of malaria-associated morbidity and mortality

EphA4 Blockers Promote Axonal Regeneration and Functional Recovery Following Spinal Cord Injury in Mice

Upregulation and activation of developmental axon guidance molecules, such as semaphorins and members of the Eph receptor tyrosine kinase family and their ligands, the ephrins, play a role in the inhibition of axonal regeneration following injury to the central nervous system. Previously we have demonstrated in a knockout model that axonal regeneration following spinal cord injury is promoted in the absence of the axon guidance protein EphA4. Antagonism of EphA4 was therefore proposed as a potential therapy to promote recovery from spinal cord injury. To further assess this potential, two soluble recombinant blockers of EphA4, unclustered ephrin-A5-Fc and EphA4-Fc, were examined for their ability to promote axonal regeneration and to improve functional outcome following spinal cord hemisection in wildtype mice. A 2-week administration of either of these blockers following spinal cord injury was sufficient to promote substantial axonal regeneration and functional recovery by 5 weeks following injury. Both inhibitors produced a moderate reduction in astrocytic gliosis, indicating that much of the effect of the blockers may be due to promotion of axon growth. These studies provide definitive evidence that soluble inhibitors of EphA4 function offer considerable therapeutic potential for the treatment of spinal cord injury and may have broader potential for the treatment of other central nervous system injuries

Improving physical health and reducing substance use in psychosis - randomised control trial (IMPACT RCT): study protocol for a cluster randomised controlled trial

The National Institute for Health Research funds the IMPACT programme at King’s College London and South London and Maudsley NHS Foundation Trust (ref: RP-PG-0606-1049)

Resisting the mantle of the monstrous feminine : women's construction and experience of premenstrual embodiment

The female reproductive body is positioned as abject, as other, as site of defciency and disease, the epitome of the ‘monstrous feminine.’ Premenstrual change in emotion, behavior or embodied sensation is positioned as a sign of madness within, necessitating restraint and control on the part of the women experiencing it (Ussher 2006). Breakdown in this control through manifestation of ‘symptoms’ is diagnosed as PMS (Premenstrual Syndrome) or PMDD (Premenstrual Dysphoric Disorder), a pathology deserving of ‘treatment.’ In this chapter, we adopt a feminist material-discursive theoretical framework to examine the role of premenstrual embodiment in relation to women’s adoption of the subject position of monstrous feminine, drawing on interviews we have conducted with women who self-diagnose as ‘PMS sufferers.’ We theorize women’s self-positioning as subjectifcation, wherein women take up cultural discourse associated with idealized femininity and the reproductive body, resulting in self-objectifcation, distress, and self-condemnation. However, women can resist negative cultural constructions of premenstrual embodiment and the subsequent self-policing. We describe the impact of women-centered psychological therapy which increases awareness of embodied change, and leads to greater acceptance of the premenstrual body and greater self-care, which serves to reduce premenstrual distress