The politics of valuation and payment for regenerative medicine products in the UK

The field of regenerative medicine (RM) faces many challenges, including funding. Framing the analysis in terms of institutional politics, valuation studies and ‘technologies of knowledge’, the paper highlights growing debates about payment for RM in the UK, setting this alongside escalating policy debates about ‘value’. We draw on interviews and publicly available material to identify the interacting and conflicting positions of institutional stakeholders. It is concluded that while there is some common ground between institutional stakeholders such as industry and health system gatekeepers, there is significant conflict about reward systems, technology assessment methodologies and payment scenarios; a range of mostly conditional payment schemes and non-mainstream routes are being experimented with. We argue that current developments highlight a fundamental conflict between a concern for the societal value of medical technologies in a resource-limited system and a concern for engineering new reward and payment models to accommodate RM innovations

How should we set consumption thresholds for low risk drinking guidelines? Achieving objectivity and transparency using evidence, expert judgement and pragmatism

Most high-income nations issue guidelines on low-risk drinking to inform individuals' decisions about alcohol consumption. However, leading scientists have criticized the processes for setting the consumption thresholds within these guidelines for a lack of objectivity and transparency. This paper examines how guideline developers should respond to such criticisms and focuses particularly on the balance between epidemiological evidence, expert judgement and pragmatic considerations. Although concerned primarily with alcohol, our discussion is also relevant to those developing guidelines for other health-related behaviours. We make eight recommendations across three areas. First, recommendations on the use of epidemiological evidence: (1) guideline developers should assess whether the available epidemiological evidence is communicated most appropriately as population-level messages (e.g. suggesting reduced drinking benefits populations rather than individuals); (2) research funders should prioritize commissioning studies on the acceptability of different alcohol-related risks (e.g. mortality, morbidity, harms to others) to the public and other stakeholders; and (3) guideline developers should request and consider statistical analyses of epidemiological uncertainty. Secondly, recommendations to improve objectivity and transparency when translating epidemiological evidence into guidelines: (4) guideline developers should specify and publish their analytical framework to promote clear, consistent and coherent judgements; and (5) guideline developers' decision-making should be supported by numerical and visual techniques which also increase the transparency of judgements to stakeholders. Thirdly, recommendations relating to the diverse use of guidelines: (6) guideline developers and their commissioners should give meaningful attention to how guidelines are used in settings such as advocacy, health promotion, clinical practice and wider health debates, as well as in risk communication; (7) guideline developers should make evidence-based judgements that balance epidemiological and pragmatic concerns to maximize the communicability, credibility and general effectiveness of guidelines; and (8) as with scientific judgements, pragmatic judgements should be reported transparently

Evaluating quality of obstetric care in low-resource settings: Building on the literature to design tailor-made evaluation instruments - an illustration in Burkina Faso

<p>Abstract</p> <p>Background</p> <p>There are many instruments available freely for evaluating obstetric care quality in low-resource settings. However, this profusion can be confusing; moreover, evaluation instruments need to be adapted to local issues. In this article, we present tools we developed to guide the choice of instruments and describe how we used them in Burkina Faso to facilitate the participative development of a locally adapted instrument.</p> <p>Methods</p> <p>Based on a literature review, we developed two tools: a conceptual framework and an analysis grid of existing evaluation instruments. Subsequently, we facilitated several sessions with evaluation stakeholders in Burkina Faso. They used the tools to develop a locally adapted evaluation instrument that was subsequently tested in six healthcare facilities.</p> <p>Results</p> <p>Three outputs emerged from this process:</p> <p>1) A comprehensive conceptual framework for the quality of obstetric care, each component of which is a potential criterion for evaluation.</p> <p>2) A grid analyzing 37 instruments for evaluating the quality of obstetric care in low-resource settings. We highlight their key characteristics and describe how the grid can be used to prepare a new evaluation.</p> <p>3) An evaluation instrument adapted to Burkina Faso. We describe the experience of the Burkinabé stakeholders in developing this instrument using the conceptual framework and the analysis grid, while taking into account local realities.</p> <p>Conclusions</p> <p>This experience demonstrates how drawing upon existing instruments can inspire and rationalize the process of developing a new, tailor-made instrument. Two tools that came out of this experience can be useful to other teams: a conceptual framework for the quality of obstetric care and an analysis grid of existing evaluation instruments. These provide an easily accessible synthesis of the literature and are useful in integrating it with the context-specific knowledge of local actors, resulting in evaluation instruments that have both scientific and local legitimacy.</p

Determinants of exclusive breastfeeding in Nigeria

<p>Abstract</p> <p>Background</p> <p>Exclusive breast feeding (EBF) has important protective effects on the survival of infants and decreases risk for many early-life diseases. The purpose of this study was to assess the factors associated with EBF in Nigeria.</p> <p>Methods</p> <p>Data on 658 children less than 6 months of age were obtained from the Nigeria Demographic and Health Survey (NDHS) 2003. The 2003 NDHS was a multi-stage cluster sample survey of 7864 households. EBF rates were examined against a set of individual, household and community level variables using a backward stepwise multilevel logistic regression method.</p> <p>Results</p> <p>The average EBF rate among infants younger than 6 months of age was 16.4% (95%CI: 12.6%-21.1%) but was only 7.1% in infants in their fifth month of age. After adjusting for potential confounders, multivariate analyses revealed that the odds of EBF were higher in rich (Adjusted Odds Ratios (AOR) = 1.15, CI = 0.28-6.69) and middle level (AOR = 2.45, CI = 1.06-5.68) households than poor households. Increasing infant age was associated with significantly less EBF (AOR = 0.65, 95%CI: 0.51-0.82). Mothers who had four or more antenatal visits were significantly more likely to engage in EBF (AOR = 2.70, 95%CI = 1.04-7.01). Female infants were more likely to be exclusively breastfed than male infants (AOR = 2.13, 95%CI = 1.03-4.39). Mothers who lived in the North Central geopolitical region were significantly more likely to exclusively breastfeed their babies than those mothers who lived in other geopolitical regions.</p> <p>Conclusions</p> <p>The EBF rate in Nigeria is low and falls well short of the expected levels needed to achieve a substantial reduction in child mortality. Antenatal care was strongly associated with an increased rate of EBF. Appropriate infant feeding practises are needed if Nigeria is to reach the child survival Millennium Development Goal of reducing infant mortality from about 100 deaths per 1000 live births to a target of 35 deaths per 1000 live births by the year 2015.</p

Controlling occupational cancers in Australia

Lin Fritschi, Renae C Fernandez, Deborah A Vallance, Terry J Slevin, Alison Reid, Timothy R Driscoll, Deborah C Glas

Comparing two service delivery models for the prevention of mother-to-child transmission (PMTCT) of HIV during transition from single-dose nevirapine to multi-drug antiretroviral regimens

<p>Abstract</p> <p>Background</p> <p>Mother-to-child transmission (MTCT) of HIV has been eliminated from the developed world with the introduction of multi-drug antiretroviral (md-ARV) regimens for the prevention of MTCT (PMTCT); but remains the major cause of HIV infection among sub-Saharan African children. This study compares two service delivery models of PMTCT interventions and documents the lessons learned and the challenges encountered during the transition from single-dose nevirapine (sd-nvp) to md-ARV regimens in a resource-limited setting.</p> <p>Methods</p> <p>Program data collected from 32 clinical sites was used to describe trends and compare the performance (uptake of HIV testing, CD4 screening and ARV regimens initiated during pregnancy) of sites providing PMTCT as a stand-alone service (<it>stand-alone site</it>) versus sites providing PMTCT as well as antiretroviral therapy (ART) (<it>full package site</it>). CD4 cell count screening, enrolment into ART services and the initiation of md-ARV regimens during pregnancy, including dual (zidovudine [AZT] +sd-nvp) prophylaxis and highly active antiretroviral therapy (HAART) were analysed.</p> <p>Results</p> <p>From July 2006 to December 2008, 1,622 pregnant women tested HIV positive (HIV+) during antenatal care (ANC). CD4 cell count screening during pregnancy increased from 60% to 70%, and the initiation of md-ARV regimens increased from 35.5% to 97% during this period. In 2008, women attending ANC at <it>full package </it>sites were 30% more likely to undergo CD4 cell count assessment during pregnancy than women attending <it>stand-alone </it>sites (relative risk (RR) = 1.3; 95% confidence interval (CI): 1.1-1.4). Enrolment of HIV+ pregnant women in ART services was almost twice as likely at <it>full package </it>sites than at <it>stand-alone </it>sites (RR = 1.9; 95% CI: 1.5-2.3). However, no significant differences were detected between the two models of care in providing md-ARV (RR = 0.9; 95% CI: 0.9-1.0).</p> <p>Conclusions</p> <p>All sites successfully transitioned from sd-nvp to md-ARV regimens for PMTCT. <it>Full package </it>sites offer the most efficient model for providing immunological assessment and enrolment into care and treatment of HIV+ pregnant women. Strengthening the capacity of <it>stand-alone </it>PMTCT sites to achieve the same objectives is paramount.</p

Couple-oriented prenatal HIV counseling for HIV primary prevention: an acceptability study

<p>Abstract</p> <p>Background</p> <p>A large proportion of the 2.5 million new adult HIV infections that occurred worldwide in 2007 were in stable couples. Feasible and acceptable strategies to improve HIV prevention in a conjugal context are scarce. In the preparatory phase of the ANRS 12127 Prenahtest multi-site HIV prevention trial, we assessed the acceptability of couple-oriented post-test HIV counseling (COC) and men's involvement within prenatal care services, among pregnant women, male partners and health care workers in Cameroon, Dominican Republic, Georgia and India.</p> <p>Methods</p> <p>Quantitative and qualitative research methods were used: direct observations of health services; in-depth interviews with women, men and health care workers; monitoring of the COC intervention and exit interviews with COC participants.</p> <p>Results</p> <p>In-depth interviews conducted with 92 key informants across the four sites indicated that men rarely participated in antenatal care (ANC) services, mainly because these are traditionally and programmatically a woman's domain. However men's involvement was reported to be acceptable and needed in order to improve ANC and HIV prevention services. COC was considered by the respondents to be a feasible and acceptable strategy to actively encourage men to participate in prenatal HIV counseling and testing and overall in reproductive health services.</p> <p>Conclusions</p> <p>One of the keys to men's involvement within prenatal HIV counseling and testing is the better understanding of couple relationships, attitudes and communication patterns between men and women, in terms of HIV and sexual and reproductive health; this conjugal context should be taken into account in the provision of quality prenatal HIV counseling, which aims at integrated PMTCT and primary prevention of HIV.</p

Measuring and modelling concurrency

This article explores three critical topics discussed in the recent debate over concurrency (overlapping sexual partnerships): measurement of the prevalence of concurrency, mathematical modelling of concurrency and HIV epidemic dynamics, and measuring the correlation between HIV and concurrency. The focus of the article is the concurrency hypothesis &#x2013; the proposition that presumed high prevalence of concurrency explains sub-Saharan Africa&#x0027;s exceptionally high HIV prevalence. Recent surveys using improved questionnaire design show reported concurrency ranging from 0.8% to 7.6% in the region. Even after adjusting for plausible levels of reporting errors, appropriately parameterized sexual network models of HIV epidemics do not generate sustainable epidemic trajectories (avoid epidemic extinction) at levels of concurrency found in recent surveys in sub-Saharan Africa. Efforts to support the concurrency hypothesis with a statistical correlation between HIV incidence and concurrency prevalence are not yet successful. Two decades of efforts to find evidence in support of the concurrency hypothesis have failed to build a convincing case

Convergence, divergence and hybridity: a regulatory governance perspective on health technology assessment HTA) in England and Germany

Countries adopt different methods and processes to evaluate the benefits and costs of health technologies. It is important to identify and analyse the factors that influence the uptake and use of these methods and processes across countries. In this paper, we introduce a regulatory governance approach to the analysis of convergence, divergence and hybridity in HTA methods, discussing and critically analysing national processes for HTA in two major European Union (EU) Member States: England and Germany. We argue that any reasonably sophisticated account of national approaches to HTA must recognise that globalisation and the emergence of advanced industrial society involves the potential for widely varying processes, methods and evidential requirements. We suggest that this potentiality also confronts health policy analysts with the challenge of constructing analytical frameworks capable of identifying the diverse institutional, domestic and other factors that shape national approaches to HTA

Differences in allergen-induced T cell activation between allergic asthma and rhinitis: Role of CD28, ICOS and CTLA-4

<p>Abstract</p> <p>Background</p> <p>Th2 cell activation and T regulatory cell (Treg) deficiency are key features of allergy. This applies for asthma and rhinitis. However with a same atopic background, some patients will develop rhinitis and asthma, whereas others will display rhinitis only. Co-receptors are pivotal in determining the type of T cell activation, but their role in allergic asthma and rhinitis has not been explored. Our objective was to assess whether allergen-induced T cell activation differs from allergic rhinitis to allergic rhinitis with asthma, and explore the role of ICOS, CD28 and CTLA-4.</p> <p>Methods</p> <p>T cell co-receptor and cytokine expressions were assessed by flow cytometry in PBMC from 18 house dust mite (HDM) allergic rhinitics (R), 18 HDM allergic rhinitics and asthmatics (AR), 13 non allergic asthmatics (A) and 20 controls, with or without anti-co-receptors antibodies.</p> <p>Results</p> <p>In asthmatics (A+AR), a constitutive decrease of CTLA-4+ and of CD4+CD25+Foxp3+ cells was found, with an increase of IFN-γ+ cells. In allergic subjects (R + AR), allergen stimulation induced CD28 together with IL-4 and IL-13, and decreased the proportion of CTLA-4+, IL-10+ and CD4+CD25+Foxp3+ cells. Anti-ICOS and anti-CD28 antibodies blocked allergen-induced IL-4 and IL-13. IL-13 production also involved CTLA-4.</p> <p>Conclusions</p> <p>T cell activation differs between allergic rhinitis and asthma. In asthma, a constitutive, co-receptor independent, Th1 activation and Treg deficiency is found. In allergic rhinitis, an allergen-induced Treg cell deficiency is seen, as well as an ICOS-, CD28- and CTLA-4-dependent Th2 activation. Allergic asthmatics display both characteristics.</p