Towards better health outcomes - What role for pharmaceutical innovation? EPC Policy Brief, 10 December 2015

From the current refugee crisis to ageing populations, and from rising healthcare prices to patients’ rising expectations: demands on European health systems continue to increase. Delivering health efficiently and ensuring the long-term sustainability of healthcare in the face of reduced public budgets requires new thinking – and there is a role for pharmaceuticals as well. Building on the series of discussions organised under Transformations, this Policy Brief focuses on the specific role of medicines and pharmaceutical innovation in improving health outcomes. It considers the state of play of drug innovation, from the development to the deployment of medicines, and the measures needed to make it deliver more for society and the economy, while ensuring that patients in Europe can have access to innovative and safe solutions.

Policy and administration.

Mode of access: Internet.

A non-linear discrete stochastic optimization model for Advanced Access patient appointment scheduling

Access to healthcare is a major problem in which patients are deprived of receiving timely admission to healthcare. Poor access has resulted in significant but avoidable healthcare cost, poor quality of healthcare, and deterioration in the general public health. Advanced Access is a simple and direct approach to appointment scheduling in which the majority of a clinic's appointments slots are kept open in order to provide access for immediate or same day healthcare needs and therefore, alleviate the problem of poor access the healthcare. This research formulates a non-linear discrete stochastic mathematical model of the Advanced Access appointment scheduling policy. The model objective is to maximize the expected profit of the clinic subject to constraints on minimum access to healthcare provided. Patient behavior is characterized with probabilities for no-show, balking, and related patient choices. Structural properties of the model are analyzed to determine whether Advanced Access patient scheduling is feasible. To solve the complex combinatorial optimization problem, a heuristic that combines greedy construction algorithm and neighborhood improvement search was developed. The model and the heuristic were used to evaluate the Advanced Access patient appointment policy compared to existing policies. Trade-off between profit and access to healthcare are established, and parameter analysis of input parameters was performed. The trade-off curve is a characteristic curve and was observed to be concave. This implies that there exists an access level at which at which the clinic can be operated at optimal profit that can be realized. The results also show that, in many scenarios by switching from existing scheduling policy to Advanced Access policy clinics can improve access without any decrease in profit. Further, the success of Advanced Access policy in providing improved access and/or profit depends on the expected value of demand, variation in demand, and the ratio of demand for same day and advanced appointments. The contributions of the dissertation are a model of Advanced Access patient scheduling, a heuristic to solve the model, and the use of the model to understand the scheduling policy trade-offs which healthcare clinic managers must make. ^

Teacher-child relationship quality for young children with parent reported language concerns

Previous research has demonstrated the importance of the qualities of the teacher-child relationship on children’s development. Close teacher-child relationships are especially important for children at risk. Positive relationships have been shown to have beneficial effects on children’s social and academic development (Birch & Ladd, 1997; Pianta & Stuhlman, 2004). Children with language difficulties are likely to face increased risks with regard to long term social and academic outcomes. The purpose of the current research was to gain greater understanding of the qualities of teacher-child relationships for young children with parent reported language concerns. The research analyses completed for this thesis involved the use of data from the public-access database of Growing Up in Australia: The Longitudinal Study of Australian Children (LSAC). LSAC is a longitudinal study involving a nationally representative sample of 10,000 Australian children. Data are being collected biennially from 2004 (Wave 1 data collection) until 2010 (Wave 4 data collection). LSAC has a cross-sequential research design involving two cohorts, an infant cohort (0-1 year at age of recruitment) and a kindergarten cohort (4-5 years at age of recruitment). Two studies are reported in this thesis using data for the LSAC Kindergarten Cohort which had 4983 child participants at recruitment. Study 1 used Wave 1 data to identify the differences between teacher-child relationship qualities for children with parent reported language concerns and their peers. Children identified by parents for whom concerns were held about their receptive and expressive language, as measured by items from the Parents’ Evaluation of Developmental Status (PEDS) (Glascoe, 2000) were the target (at risk) group in the study (n = 210). A matched case control group of peers (n = 210), matched on the child characteristics of sex, age, cultural and linguistic differences (CALD), and socio-economic positioning (SEP), were the comparison group for this analysis. Teacher-child relationship quality was measured by teacher reports on the Closeness and Conflict scales from the short version of the Student-Teacher Relationship Scale (STRS) (Pianta, 2001). There were statistically significant differences in the levels of closeness and conflict between the two groups. The target group had relationships with their teachers that had lower levels of closeness and higher levels of conflict than the control group. Study 2 reports analyses that examined the stability of the qualities of the teacher-child relationships at Wave 1 (4-5 years) and the qualities of the teacher-child relationships at Wave 2 (6-7 years). This time frame crosses the period of the children’s transition to school. The study examined whether early patterns in the qualities of the teacher-child relationship for children with parent reported language concerns at Wave 1 predicted the qualities of the teacher-child relationship outcomes in the early years of formal school. The sample for this study consisted of the group of children identified with PEDS language concerns at Wave 1 who also had teacher report data at Wave 2 (n = 145). Teacher-child relationship quality at Wave 1 and Wave 2 was again measured by the STRS scales of Closeness and Conflict. Results from multiple regression models indicated that teacher-child relationship quality at Wave 1 significantly contributed to the prediction of the quality of the teacher-child relationship at Wave 2, beyond other predictor variables included in the regression models. Specifically, Wave 1 STRS Closeness scores were the most significant predictor for STRS Closeness scores at Wave 2, while Wave 1 STRS Conflict scores were the only significant predictor for Wave 2 STRS Conflict outcomes. These results indicate that the qualities of the teacher-child relationship experienced prior to school by children with parent reported language concerns remained stable across transitions into formal schooling at which time the child had a different teacher. The results of these studies provide valuable insight into the nature of teacher-child relationship quality for young children with parent reported language concerns. These children experienced teacher-child relationships of a lower quality when compared with peers and, additionally, the qualities of these relationships prior to formal schooling were predictive of the qualities of the relationships in the early years of formal schooling. This raises concerns, given the increased risks of poorer social and academic outcomes already faced by children with language difficulties, that these early teacher-child relationships have an impact on future teacher-child relationships. Results of these studies are discussed with these considerations in mind and also discussed in terms of the implications for educational theory, policy and practice.

Public health and clinical dilemmas resulting from imprecise vitamin D tests

Objective: To determine whether there are clinical and public health dilemmas resulting from the reproducibility of routine vitamin D assays. Methods: Blinded agreement studies were conducted in eight clinical laboratories using two commonly used assays to measure serum 25-hydroxyvitamin D (25(OH)D) levels in Australasia and Canada (DiaSorin Radioimmunoassay (RIA) and DiaSorin LIAISON® one). Results: Only one laboratory measured 25(OH)D with excellent precision. Replicate 25(OH)D measurements varied by up to 97% and 15% of paired results differed by more than 50%. Thirteen percent of subjects received one result indicating insufficiency [25-50 nmol/l] and another suggesting adequacy [>50 nmol/l]). Agreement ranged from poor to excellent for laboratories using the manual RIA, while the precision of the semi-automated Liaison® system was consistently poor. Conclusions: Recent interest in the relevance of vitamin D to human health has increased demand for 25(OH)D testing and associated costs. Our results suggest clinicians and public health authorities are making decisions about treatment or changes to public health policy based on imprecise data. Clinicians, researchers and policy makers should be made aware of the imprecision of current 25(OH)D testing so that they exercise caution when using these assays for clinical practice, and when interpreting the findings of epidemiological studies based on vitamin D levels measured using these assays. Development of a rapid, reproducible, accurate and robust assay should be a priority due to interest in populationbased screening programs and research to inform public health policy about the amount of sun exposure required for human health. In the interim, 25(OH)D results should routinely include a statement of measurement uncertainty.

Constructing leadership in child care : epistemological beliefs and transformational leadership

Early childhood education and care (ECEC) in Australia are currently a focus of social and economic policy. However, early childhood leadership in Australia is yet to develop a clear identity that will enable the field to develop to its full potential. In this paper we investigate a unique theoretical framework for constructing leadership identity, based on transformational leadership and epistemological beliefs. Using semistructured interviews, 15 childcare directors from a large metropolitan area in Australia were asked to describe their beliefs about knowing in the context of their leadership practices. The findings showed that leaders (n = 5) who espoused predominantly evaluativist beliefs about knowing were more likely to describe transformational leadership behaviours in the context of childcare leadership. A number of leaders held mixed beliefs (n = 9) about knowing and described their leadership practice in ways that reflected both transactional and transformational leadership styles. Finally, one leader described predominantly objectivist epistemological beliefs and transactional beliefs about leadership. These preliminary findings show that there seems to be a relationship between core epistemological beliefs and beliefs about leadership practices and offers a new way to characterise leadership in ECEC in Australia.

Towards equity in the futures market : curriculum as a condition of access

This article provides a consideration of the problem of equity in education. In the first part of the discussion, the author draws on philosophical and sociological literatures to consider what equity means and its implications for education. Drawing on work by Burbules, Lord & Sherman, she looks to curriculum as a condition of access and the importance of learning support structures in bringing about equitable educational outcomes, conceived in terms of Amy Gutmanns’s democratic threshold. The paper offers a conceptual-theoretical model for thinking about the resourcing and curricular requirements for equity in contemporary liberal democratic societies, contrasting the social and economic policy mixes employed by governments situated at different points along a liberty/equality continuum.

Leadership of public education : an exploration of executive leaders in education Queensland

Education reform aimed at achieving improved student learning is a demanding challenge for leaders at all levels of education across the globe. In Queensland, Australia, Assistant Regional Directors, School Performance (ARD-SP) of public schools are executive leaders at the forefront of this challenge, working with groups, clusters, or networks of schools and one-on-one with principals, focusing on the performance of their schools. The ARD-SP role was recently established to positively impact student learning across the entire public school system in Queensland. The proposed study aimed to capture how ARDs-SP conceptualise and enact their leadership role. The study utilised a micropolitical perspective of leadership to understand the way in which these leaders talked about their leadership practices, their challenges, and the wider contextual factors impacting upon their work. A case study methodology guided the study and allowed ARDs-SP to share their understandings and enactment of executive leadership. A conceptual framework drawing upon the micropolitical leadership framework of Blase and Anderson (1995) was employed to analyse the research data gathered. Data were collected from Education Queensland (EQ) (i.e. that sector of the Department of Education and Training in Queensland responsible for public schools) policy material and reports and two rounds of semi-structured interviews with 18 ARD-SP participants and two senior EQ executives. The findings of this study were initially presented as four themes: performance, supervision, professional challenge, and system sustainability. They were then considered in the light of the literature and explored through the macro, meso, and micro layers within the conceptual framework. The key findings of this study found that ARDs-SP referred to using two different leadership approaches (i.e. an adversarial approach and/or a facilitative approach) when supervising school principals and the approach employed depended primarily upon the perceived performance of the principal. It was also found that the notion of supervision embedded within the role was perceived by ARDs-SP as problematic. These findings imply opportunities to refine the role and in doing so harness other system improvement strategies for EQ. An important contribution of this study was a reconceptualised conceptual framework that showed leadership approaches used by ARDs-SP as falling upon a continuum.

Forrest v ASIC : a ‘perfect storm’

The policy objectives of the continuous disclosure regime augmented by the misleading or deceptive conduct provisions in the Corporations Act are to enhance the integrity and efficiency of Australian capital markets by ensuring equality of opportunity for all investors through public access to accurate and material company information to enable them to make well-informed investment decisions. This article argues that there were failures by the regulators in the performance of their roles to protect the interests of investors in Forrest v ASIC; FMG v ASIC (2012) 247 CLR 486: ASX failed to enforce timely compliance with the continuous disclosure regime and ensure that the market was properly informed by seeking immediate clarification from FMG as to the agreed fixed price and/or seeking production of a copy of the CREC agreement; and ASIC failed to succeed in the High Court because of the way it pleaded its case. The article also examines the reasoning of the High Court in Forrest v ASIC and whether it might have changed previous understandings of the Campomar test for determining whether representations directed to the public generally are misleading.

The next publication revolution : open access and the post-2014 Research Excellence Framework

The world is increasingly moving towards more open models of publishing and communication. The UK government has demonstrated a firm commitment to ensuring that academic research outputs are made available to all who might benefit from access to them, and its open access policy attempts to make academic publications freely available to readers, rather than being locked behind pay walls or only available to researchers with access to well-funded university libraries. Open access policies have an important role to play in fostering an open innovation ecosystem and ensuring that maximum value is derived from investments in university-based research. But are we ready to embrace this change?

The rise of englightened shareholder primacy and its impact on US corporate self-regulation

Enlightened shareholder primacy (“ESP”) is a new approach in the corporate governance (“CG”) framework. The emergence of this approach is important owing to its role in answering a vital question: is the company really a private organisation to be seen only through the economic prism of contract? Or is it public and about a wider group of interests and underwritten by communitarian concern about social responsibility? Apart from answering this question, ESP explains the changes in corporate directors’ roles and self-regulation strategies of companies.

Supporting the needs of public health decision-makers and review authors in the UK

Introduction Systematic reviews, through the synthesis of multiple primary research studies, can be powerful tools in enabling evidence-informed public health policy debate, development and action. In seeking to optimize the utility of these reviews, it is important to understand the needs of those using them. Previous work has emphasized that researchers should adopt methods that are appropriate to the problems that public health decision-makers are grappling with, as well as to the policy context in which they operate.1,2 Meeting these demands poses significant methodological challenges for review authors and prompts a reconsideration of the resources, training and support structures available to facilitate the efficient and timely production of useful, comprehensive reviews. The Cochrane Public Health Group (CPHG) was formed in 2008 to support reviews of complex, upstream public health topics. The majority of CPHG authors are from the UK, which has historically been at the forefront of efforts to promote the production and use of systematic reviews of research relevant to public health decision-makers. The UK therefore provides a suitably mature national context in which to examine (i) the current and future demands of decision-makers to increase the use, value and impact of evidence syntheses; (ii) the implications this has for the scope and methods of reviews and (iii) the required action to build and support capacity to conduct such reviews.

Informing methods for preparing public health overviews of reviews: a comparison of public health overviews with Cochrane Overviews published between 1999 and 2014

Background: Overviews of systematic reviews (SRs) are useful for public health policy; however there is an absence of Cochrane Overviews covering public health (PH) topics. Objectives: We sought to analyze the methodological approaches used in existing Cochrane Overviews and Protocols for overviews (primarily clinical in nature), and compare these to the methods and approaches used in PH overviews (non-Cochrane). The intent was to identify issues that would be relevant for undertaking Cochrane overviews. Methods: We conducted a descriptive analysis of overviews published between 1999 and 2014. We searched the Cochrane Database of Systematic Reviews for Cochrane Protocols for overviews and Cochrane Overviews, and the HealthEvidence.org for PH overviews. The primary characteristics of the overviews and elements of the methodology were extracted and compared. Results: A total of 61 overviews of SRs were included in our analysis; specifically, this included 21 Cochrane Protocols for overviews, 15 Cochrane Overviews, and 27 non-Cochrane PH overviews. Amongst the overviews, the most significant differences are that PH overviews (non-Cochrane) tend to: include earlier and more reviews, greater number of participants, allow lower levels of evidence, use assessment tools other than AMSTAR (A Measurement Tool to Assess Systematic Reviews, i.e. a tool for assessing quality of SRs), not assess quality of evidence in reviews, search more databases overall, specify search limits including English-only reviews, and not consider recent primary studies for inclusion. Some of these differences clearly related to quality, however many relate to the nuances of PH interventions. Conclusions: The methodology in Cochrane overviews and PH overviews varies widely. Future PH overviews may benefit from the Cochrane methodology but the Cochrane approach requires modification to accommodate PH research methodology. Additionally, the use of databases that pre-screen and quality assess relevant PH systematic reviews may help expedite the search process.

Reinventing Nordic Openness : Transparency and State Information in Finland

The study explores new ideational changes in the information strategy of the Finnish state between 1998 and 2007, after a juncture in Finnish governing in the early 1990s. The study scrutinizes the economic reframing of institutional openness in Finland that comes with significant and often unintended institutional consequences of transparency. Most notably, the constitutional principle of publicity (julkisuusperiaate), a Nordic institutional peculiarity allowing public access to state information, is now becoming an instrument of economic performance and accountability through results. Finland has a long institutional history in the publicity of government information, acknowledged by law since 1951. Nevertheless, access to government information became a policy concern in the mid-1990s, involving a historical narrative of openness as a Nordic tradition of Finnish governing Nordic openness (pohjoismainen avoimuus). International interest in transparency of governance has also marked an opening for institutional re-descriptions in Nordic context. The essential added value, or contradictory term, that transparency has on the Finnish conceptualisation of governing is the innovation that public acts of governing can be economically efficient. This is most apparent in the new attempts at providing standardised information on government and expressing it in numbers. In Finland, the publicity of government information has been a concept of democratic connotations, but new internationally diffusing ideas of performance and national economic competitiveness are discussed under the notion of transparency and its peer concepts openness and public (sector) information, which are also newcomers to Finnish vocabulary of governing. The above concepts often conflict with one another, paving the way to unintended consequences for the reforms conducted in their name. Moreover, the study argues that the policy concerns over openness and public sector information are linked to the new drive for transparency. Drawing on theories of new institutionalism, political economy, and conceptual history, the study argues for a reinvention of Nordic openness in two senses. First, in referring to institutional history, the policy discourse of Nordic openness discovers an administrative tradition in response to new dilemmas of public governance. Moreover, this normatively appealing discourse also legitimizes the new ideational changes. Second, a former mechanism of democratic accountability is being reframed with market and performance ideas, mostly originating from the sphere of transnational governance and governance indices. Mobilizing different research techniques and data (public documents of the Finnish government and international organizations, some 30 interviews of Finnish civil servants, and statistical time series), the study asks how the above ideational changes have been possible, pointing to the importance of nationalistically appealing historical narratives and normative concepts of governing. Concerning institutional developments, the study analyses the ideational changes in central steering mechanisms (political, normative and financial steering) and the introduction of budget transparency and performance management in two cases: census data (Population Register Centre) and foreign political information (Ministry for Foreign Affairs). The new policy domain of governance indices is also explored as a type of transparency. The study further asks what institutional transformations are to be observed in the above cases and in the accountability system. The study concludes that while the information rights of citizens have been reinforced and recalibrated during the period under scrutiny, there has also been a conversion of institutional practices towards economic performance. As the discourse of Nordic openness has been rather unquestioned, the new internationally circulating ideas of transparency and the knowledge economy have entered this discourse without public notice. Since the mid 1990s, state registry data has been perceived as an exploitable economic resource in Finland and in the EU public sector information. This is a parallel development to the new drive for budget transparency in organisations as vital to the state as the Population Register Centre, which has led to marketization of census data in Finland, an international exceptionality. In the Finnish Ministry for Foreign Affairs, the post-Cold War rhetorical shift from secrecy to performance-driven openness marked a conversion in institutional practices that now see information services with high regards. But this has not necessarily led to the increased publicity of foreign political information. In this context, openness is also defined as sharing information with select actors, as a trust based non-public activity, deemed necessary amid the global economic competition. Regarding accountability system, deliberation and performance now overlap, making it increasingly difficult to identify to whom and for what the public administration is accountable. These evolving institutional practices are characterised by unintended consequences and paradoxes. History is a paradoxical component in the above institutional change, as long-term institutional developments now justify short-term reforms.

Child sexual abuse: Raising awareness and empathy is essential to promote new public health responses

Child sexual abuse is a major global public health concern, affecting one in eight children and causing massive costs including depression, unwanted pregnancy and HIV. The gravity of this global issue is reflected by the United Nations’ new effort to respond to sexual abuse in the 2015 Sustainable Development Goals. The fundamental policy aims are to improve prevention, identification and optimal responses to sexual abuse. However, as shown in our literature review, policymakers face difficult challenges because child sexual abuse is hidden, psychologically complex, and socially sensitive. This article contributes significant new ideas for international progress. Insights about required strategies are informed by an innovative multidisciplinary analysis of research from public health, medicine, social science, psychology, and neurology. Using an ecological model comprising individual, institutional and societal dimensions, we propose that two preconditions for progress are the enhancement of awareness of child sexual abuse, and of empathic responses towards its victims.