Health system guidance appraisal-concept evaluation and usability testing

Background: Health system guidance (HSG) provides recommendations aimed to address health system challenges. However, there is a paucity of methods to direct, appraise, and report HSG. Earlier research identified 30 candidate criteria (concepts) that can be used to evaluate the quality of HSG and guide development and reporting requirements. The objective of this paper was to describe two studies aimed at evaluating the importance of these 30 criteria, design a draft HSG appraisal tool, and test its usability. Methods: This study involved a two-step survey process. In step 1, respondents rated the 30 concepts for appropriateness to, relevance to, and priority for health system decisions and HSG. This led to a draft tool. In step 2, respondents reviewed HSG documents, appraised them using the tool, and answered a series of questions. Descriptive analyses were computed. Results: Fifty participants were invited in step 1, and we had a response rate of 82 %. The mean response rates for each concept within each survey question were universally favorable. There was also an overall agreement about the need for a high-quality tool to systematically direct the development, appraisal, and reporting of HSG. Qualitative feedback and a consensus process by the team led to refinements to some of the concepts and the creation of a beta (draft) version of the HSG tool. In step 2, 35 participants were invited and we had a response rate of 74 %. Exploratory analyses showed that the quality of the HSGs reviewed varied as a function of the HSG item and the specific document assessed. A favorable consensus was reached with participants agreeing that the HSG items were easy to understand and easy to apply. Moreover, the overall agreement was high for the usability of the tool to systematically direct the development (85 %), appraisal (92 %), and reporting (81 %) of HSG. From this process, version 1.0 of the HSG appraisal tool was generated complete with 32 items (and their descriptions) and 4 domains. Conclusions: The final tool, named the Appraisal of Guidelines for Research and Evaluation for Health Systems (AGREE-HS) (version 1), defines expectations of HSG and facilitates informed decisions among policymakers on health system delivery, financial, and governance arrangements. © 2016 Ako-Arrey et al

The EU's new paediatric medicines legislation: serving children's needs?

In new legislation for paediatric medicines which came into effect on 26 January 2007, the European Union (EU) has attempted to address several unresolved issues relating to children's needs for medicines in Europe. This article reviews the legislation's main proposals and makes some comparisons with equivalent legislation in the USA. We argue that the legislation suffers from several gaps and uncertainties in relation to the specific proposals and their intended aims. As the establishment of new legislation in this area offered the EU an opportunity to set some clear guidelines and objectives, and had the potential to go beyond the equivalent American rules, we thus see the proposals as something of a disappointment

Management of a mandibular molar with C-shape root canal using spiral computed tomography as a diagnostic aid

The aim of this article is to present the use of spiral computed tomography (CT) in endodontic management of a mandibular molar with an unusual morphology of C-shape canal. An accurate assessment of this unusual morphology was made with the help of spiral CT. This report extends the range of known possible anatomical variations to include teeth with an abnormal number of roots and canals. This report also highlights the role of spiral CT, over conventional intra-oral periapical radiographs, as an objective method to confirm the three-dimensional anatomy of teeth

Fundamental Rights and Health Care

There is a fundamental contradiction at the core of health policy in the EU that makes it difficult to draw a line between EU and Member State responsibilities. This raises a number of difficult questions for policy makers and practitioners as they struggle to interpret both 'hard' and 'soft' laws at EU and Member State level and to reconcile tensions between economic and social imperatives in health care. The book addresses these complex questions by combining analysis of the underlying issues with carefully chosen case studies that illustrate how broader principles are played out in practice. Each chapter addresses a topical area in which there is considerable debate and potential uncertainty. The book thus offers a comprehensive discussion of a number of current and emerging governance issues in EU health policy, including regulatory, legal, 'new governance' and policy-making dynamics, and the application of the legal framework in these areas

The politics of EU health policy and the case of direct-to-consumer advertising for prescription drugs

Direct-to-consumer advertising for prescription drugs (DTCA-PD) is currently banned in the EU, but the pharmaceutical industry (supported by key member states and DG Enterprise) made two major attempts to overturn it in the 2000s at the EU level and failed. What does this failure imply for the debates surrounding this policy area and EU health policy in general? To explore this question, this article will define DTCA-PD, examine its pros and cons, provide a brief overview of EU health policy and present a detailed review of the two recent attempts to overturn the ban. Following this, it will examine the five key elements of EU health policy, evaluate their relevance to the development of the EU's policy towards DTCA-PD and briefly speculate on the future of the ban