Microbial community profiling shows dysbiosis in the lesional skin of Vitiligo subjects

Healthy human skin harbours a diverse array of microbes that comprise the skin microbiome. Commensal bacteria constitute an important component of resident microbiome and are intricately linked to skin health. Recent studies describe an association between altered skin microbial community and epidemiology of diseases, like psoriasis, atopic dermatitis etc. In this study, we compare the differences in bacterial community of lesional and non-lesional skin of vitiligo subjects. Our study reveals dysbiosis in the diversity of microbial community structure in lesional skin of vitiligo subjects. Although individual specific signature is dominant over the vitiligo-specific microbiota, a clear decrease in taxonomic richness and evenness can be noted in lesional patches. Investigation of community specific correlation networks reveals distinctive pattern of interactions between resident bacterial populations of the two sites (lesional and non-lesional). While Actinobacterial species constitute the central regulatory nodes (w.r.t. degree of interaction) in non-lesional skin, species belonging to Firmicutes dominate on lesional sites. We propose that the changes in taxonomic characteristics of vitiligo lesions, as revealed by our study, could play a crucial role in altering the maintenance and severity of disease. Future studies would elucidate mechanistic relevance of these microbial dynamics that can provide new avenues for therapeutic interventions.

Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research.

Like other emerging economies, India's quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of 20.4% between 2005 and 2010. However, while the fundamental drivers and strengths are still strong, the past few years witnessed a declining trend (CAGR -16.7%) amid regulatory concerns, activist protests, and sponsor departure. And although India accounts for 17.5% of the world's population, it currently conducts only 1% of clinical trials. Indian and international experts and public stakeholders gathered for a 2-day conference in June 2013 in New Delhi to discuss the challenges facing clinical research in India and to explore solutions. The main themes discussed were ethical standards, regulatory oversight, and partnerships with public stakeholders. The meeting was a collaboration of AAHRPP (Association for the Accreditation of Human Research Protection Programs)-aimed at establishing responsible and ethical clinical research standards-and PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)-aimed at informing and engaging the public in clinical research. The present article covers recent clinical research developments in India as well as associated expectations, challenges, and suggestions for future directions. AAHRPP and PARTAKE provide etiologically based solutions to protect, inform, and engage the public and medical research sponsors.

Working with a child Exposed to Community and Domestic violence in Northern Ireland: An Illustrated Case Example.

The focus of this paper is on the author’s multi-modal therapeutic practice with a 7-year-old boy referred to the Family Trauma Centre, following paramilitary assaults on his father. The work also addresses the boy’s experience of domestic violence. The work is contextualised in terms of the ‘Peace Process’ in Northern Ireland, including the establishment of the Family Trauma Centre as a response to the needs of victims of the Troubles. A rationale for working with children using a multi-modal approach is presented.

KAIRON PROJECT : assessing the role of expressive arts in community-based breast cancer support systems in the Niagara Region

Research Report Written for the Canadian Breast Cancer Foundation.

Advances in therapeutic risk management through signal detection and risk minimisation tool analyses

Les quatre principales activités de la gestion de risque thérapeutique comportent l’identification, l’évaluation, la minimisation, et la communication du risque. Ce mémoire aborde les problématiques liées à l’identification et à la minimisation du risque par la réalisation de deux études dont les objectifs sont de: 1) Développer et valider un outil de « data mining » pour la détection des signaux à partir des banques de données de soins de santé du Québec; 2) Effectuer une revue systématique afin de caractériser les interventions de minimisation de risque (IMR) ayant été implantées. L’outil de détection de signaux repose sur la méthode analytique du quotient séquentiel de probabilité (MaxSPRT) en utilisant des données de médicaments délivrés et de soins médicaux recueillis dans une cohorte rétrospective de 87 389 personnes âgées vivant à domicile et membres du régime d’assurance maladie du Québec entre les années 2000 et 2009. Quatre associations « médicament-événement indésirable (EI) » connues et deux contrôles « négatifs » ont été utilisés. La revue systématique a été faite à partir d’une revue de la littérature ainsi que des sites web de six principales agences réglementaires. La nature des RMIs ont été décrites et des lacunes de leur implémentation ont été soulevées. La méthode analytique a mené à la détection de signaux dans l'une des quatre combinaisons médicament-EI. Les principales contributions sont: a) Le premier outil de détection de signaux à partir des banques de données administratives canadiennes; b) Contributions méthodologiques par la prise en compte de l'effet de déplétion des sujets à risque et le contrôle pour l'état de santé du patient. La revue a identifié 119 IMRs dans la littérature et 1,112 IMRs dans les sites web des agences réglementaires. La revue a démontré qu’il existe une augmentation des IMRs depuis l’introduction des guides réglementaires en 2005 mais leur efficacité demeure peu démontrée.

Improving quality of mother-infant relationship and infant attachment in socioeconomically deprived community in South Africa: randomised controlled trial

Objective To assess the efficacy of an intervention designed to improve the mother-infant relationship and security of infant attachment in a South African peri-urban settlement with marked adverse socioeconomic circumstances. Design Randomised controlled trial. Setting Khayelitsha, a peri-urban settlement in South Africa. Participants 449 pregnant women. Interventions The intervention was delivered from late pregnancy and for six months postpartum. Women were visited in their homes by previously untrained lay community workers who provided support and guidance in parenting. The purpose of the intervention was to promote sensitive and responsive parenting and secure infant attachment to the mother. Women in the control group received no therapeutic input from the research team. Main outcome measures Primary outcomes: quality of mother-infant interactions at six and 12 months postpartum; infant attachment security at 18 months. Secondary outcome: maternal depression at six and 12 months. Results The intervention was associated with significant benefit to the mother-infant relationship. At both six and 12 months, compared with control mothers, mothers in the intervention group were significantly more sensitive (6 months: mean difference=0.77 (SD 0.37), t=2.10, P<0.05, d=0.24; 12 months: mean difference=0.42 (0.18), t=-2.04, P<0.05, d=0.26) and less intrusive (6 months: mean difference=0.68 (0.36), t=2.28, P<0.05, d=0.26; 12 months: mean difference=-1.76 (0.86), t=2.28, P<0.05, d=0.24) in their interactions with their infants. The intervention was also associated with a higher rate of secure infant attachments at 18 months (116/156 (74%) v 102/162 (63%); Wald=4.74, odds ratio=1.70, P<0.05). Although the prevalence of maternal depressive disorder was not significantly reduced, the intervention had a benefit in terms of maternal depressed mood at six months (z=2.05, P=0.04) on the Edinburgh postnatal depression scale). Conclusions The intervention, delivered by local lay women, had a significant positive impact on the quality of the mother-infant relationship and on security of infant attachment, factors known to predict favourable child development. If these effects persist, and if they are replicated, this intervention holds considerable promise for use in the developing world. Trial registration Current Controlled Trials ISRCTN25664149.

Improving quality of mother-infant relationship and infant attachment in socioeconomically deprived community in South Africa: randomised controlled trail

Objective To assess the efficacy of an intervention designed to improve the mother-infant relationship and security of infant attachment in a South African peri-urban settlement with marked adverse socioeconomic circumstances. Design Randomised controlled trial. Setting Khayelitsha, a peri-urban settlement in South Africa. Participants 449 pregnant women. Interventions The intervention was delivered from late pregnancy and for six months postpartum. Women were visited in their homes by previously untrained lay community workers who provided support and guidance in parenting. The purpose of the intervention was to promote sensitive and responsive parenting and secure infant attachment to the mother. Women in the control group received no therapeutic input from the research team. Main outcome measures Primary outcomes: quality of mother-infant interactions at six and 12 months postpartum; infant attachment security at 18 months. Secondary outcome: maternal depression at six and 12 months. Results The intervention was associated with significant benefit to the mother-infant relationship. At both six and 12 months, compared with control mothers, mothers in the intervention group were significantly more sensitive (6 months: mean difference=0.77 (SD 0.37), t=2.10, P<0.05, d=0.24; 12 months: mean difference=0.42 (0.18), t=−2.04 , P<0.05, d=0.26) and less intrusive (6 months: mean difference=0.68 (0.36), t=2.28, P<0.05, d=0.26; 12 months: mean difference=−1.76 (0.86), t=2.28 , P<0.05, d=0.24) in their interactions with their infants. The intervention was also associated with a higher rate of secure infant attachments at 18 months (116/156 (74%) v 102/162 (63%); Wald=4.74, odds ratio=1.70, P<0.05). Although the prevalence of maternal depressive disorder was not significantly reduced, the intervention had a benefit in terms of maternal depressed mood at six months (z=2.05, P=0.04) on the Edinburgh postnatal depression scale). Conclusions The intervention, delivered by local lay women, had a significant positive impact on the quality of the mother-infant relationship and on security of infant attachment, factors known to predict favourable child development. If these effects persist, and if they are replicated, this intervention holds considerable promise for use in the developing world.

Care in the community? Interpretations of a fractured goat bone from Neolithic Jarmo, Iraq

A case study of a goat metatarsal exhibiting a complex diaphyseal fracture from Pottery Neolithic Jarmo in the Central Zagros region of the eastern Fertile Crescent is here described and analysed. The Central Zagros is one of the areas with the earliest evidence for goat domestication. The significance of the pathology may be viewed within the context of domestic goat ecology in the landscape of Jarmo, potentially impacting browsing behaviour (goats raise themselves on their hind limbs to browse) and movement with the herd in the landscape (the terrain around Jarmo is very steep in places, which would be difficult for an animal to navigate on three legs). In the light of this, possible levels of care that the Neolithic human community may have afforded this animal are discussed – from a situation where therapeutic intervention may have occurred, to one of stall confinement of the animal to allow the pathology to heal, to a position of simple awareness of the condition – and how this impacts on our understanding of changes in attitudes towards animals through the process of domestication.

The cost of community-managed viral respiratory illnesses in a cohort of healthy preschool-aged children

Background : Acute respiratory illnesses (ARIs) during childhood are often caused by respiratory viruses, result in significant morbidity, and have associated costs for families and society. Despite their ubiquity, there is a lack of interdisciplinary epidemiologic and economic research that has collected primary impact data, particularly associated with indirect costs, from families during ARIs in children.
Methods : We conducted a 12-month cohort study in 234 preschool children with impact diary recording and PCR testing of nose-throat swabs for viruses during an ARI. We used applied values to estimate a virus-specific mean cost of ARIs.
Results : Impact diaries were available for 72% (523/725) of community-managed illnesses between January 2003 and January 2004. The mean cost of ARIs was AU$309 (95% confidence interval $263 to $354). Influenza illnesses had a mean cost of $904, compared with RSV, $304, the next most expensive single-virus illness, although confidence intervals overlapped. Mean carer time away from usual activity per day was two hours for influenza ARIs and between 30 and 45 minutes for all other ARI categories.
Conclusion : From a societal perspective, community-managed ARIs are a significant cost burden on families and society. The point estimate of the mean cost of community-managed influenza illnesses in healthy preschool aged children is three times greater than those illnesses caused by RSV and other respiratory viruses. Indirect costs, particularly carer time away from usual activity, are the key cost drivers for ARIs in children. The use of parent-collected specimens may enhance ARI surveillance and reduce any potential Hawthorne effect caused by compliance with study procedures. These findings reinforce the need for further integrated epidemiologic and economic research of ARIs in children to allow for comprehensive cost-effectiveness assessments of preventive and therapeutic options.

Where the home in valley meets the damp dirty prison : a human rights perspective on therapeutic jurisprudence and the rule of forensic psychologists in correctional settings

The roles of forensic psychologists in coerced environments such as corrections include that of treatment provider (for the offender) and that of organizational consultant (for the community). This dual role raises ethical issues between offender rights and community rights; an imbalance results in the violation of human rights. A timely reminder of a slippery ethical slope that can arise is the failure of the American Psychological Association to manage this balance regarding interrogation and torture of detainees under the Bush administration. To establish a “bright-line position” regarding ethical practice, forensic psychologists need to be cognizant of international human rights law. In this endeavor, international covenants and a universal ethical code ought to guide practice, although seemingly unresolveable conflicts between the law and ethics codes may arise. A solution to this problem is to devise an ethical framework that is based on enforceable universally shared human values regarding dignity and rights. To this end, the legal theory of therapeutic jurisprudence can assist psychologists to understand the law, the legal system, and their role in applying the law therapeutically to support offender dignity, freedom, and well-being. In this way, a moral stance is taken and the forensic role of treatment provider and/or organizational consultant is not expected to trump the prescriptions and the proscriptions of the law.

Belonging to a Victorian community choir : ageing, music and culture

Australia's ageing population created challenges for maintaining well-being and combating social isolation. Older Australians frequently rely on community arts organizations to enhance quality of life, specifically in health, happiness and community. Arts engagement takes place in many different contexts, from formal to informal and throughout the lifespan of the individual. Culture shapes the way in which we age and cultural identity is celebrated through the arts. This study will explore ageing and cultural diversity within Australian society through an examination of community arts engagement, specifically a community choir in Melbourne, Victoria, Australia. Much previous research concerning music engagement by older people has focused on its therapeutic applications, but there have been less attention given to healthy older people still living in communities. This paper reports on how music engagement can facilitate successful ageing be encouraging a sense of community, enhancing well-being and supporting cultural identity.

Improving outcomes of preschool language delay in the community : protocol for the Language for Learning randomised controlled trial

Background

Early language delay is a high-prevalence condition of concern to parents and professionals. It may result in lifelong deficits not only in language function, but also in social, emotional/behavioural, academic and economic well-being. Such delays can lead to considerable costs to the individual, the family and to society more widely. The Language for Learning trial tests a population-based intervention in 4 year olds with measured language delay, to determine (1) if it improves language and associated outcomes at ages 5 and 6 years and (2) its cost-effectiveness for families and the health care system.

Methods/Design

A large-scale randomised trial of a year-long intervention targeting preschoolers with language delay, nested within a well-documented, prospective, population-based cohort of 1464 children in Melbourne, Australia. All children received a 1.25-1.5 hour formal language assessment at their 4th birthday. The 200 children with expressive and/or receptive language scores more than 1.25 standard deviations below the mean were randomised into intervention or ‘usual care’ control arms. The 20-session intervention program comprises 18 one-hour home-based therapeutic sessions in three 6-week blocks, an outcome assessment, and a final feed-back/forward planning session. The therapy utilises a ‘step up-step down’ therapeutic approach depending on the child’s language profile, severity and progress, with standardised, manualised activities covering the four language development domains of: vocabulary and grammar; narrative skills; comprehension monitoring; and phonological awareness/pre-literacy skills. Blinded follow-up assessments at ages 5 and 6 years measure the primary outcome of receptive and expressive language, and secondary outcomes of vocabulary, narrative, and phonological skills.

Discussion

A key strength of this robust study is the implementation of a therapeutic framework that provides a standardised yet tailored approach for each child, with a focus on specific language domains known to be associated with later language and literacy. The trial responds to identified evidence gaps, has outcomes of direct relevance to families and the community, includes a well-developed economic analysis, and has the potential to improve long-term consequences of early language delay within a public health framework.

Therapeutic equivalence and the generic competition paradox

Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does not guarantee therapeutic equivalence; in some instances the lack of therapeutic equivalence can lead to fatal consequences for patients switching to generic products. In this paper, we construct a simple model to analyze the implications of therapeutic non-equivalence between branded and generic drugs. We show, theoretically and empirically, that this distinction can provide a plausible explanation of the generic competition paradox.