The huge increase in the number of medical imaging examinations being carried out has meant a corresponding increase in imaging costs in health- care budgets. In this article the authors argue that the current perspective of costs should be broadened to include negative collateral and external effects in order to assess the true cost of medical imaging.

Congenital hearing loss is the most frequent birth defect. The American Academy of Pediatrics and the Joint Committee on Infant Hearing established quality of care process indicators for Universal Newborn Hearing Screening starting from 1999. In a previous systematic review of Universal Newborn Hearing Screening studies we highlighted substantial variability in program design and in reported performance data. In order to overcome these heterogeneous findings we think it is necessary to optimize the implementation of Universal Newborn Hearing Screening programs with an appropriate application of the planning, executing, and monitoring, verifications and reporting phases. For this reason we propose a conceptual framework that logically integrates these three phases and, consequently, a tool (a check-list) for their rationalization and standardization.Our paper intends to stimulate debate on how to ameliorate the routine application of high quality Universal Newborn Hearing Screening programs. The conceptual framework is proposed to optimize, rationalise and standardise their implementation. The checklist is intended to allow an inter-program comparison by removing heterogeneity in processes description and assessment.

To summarize the results of all original cost-utility analyses (CUAs) in diagnostic cardiovascular imaging (CVI) and characterize those technologies by estimates of their cost-effectiveness. We systematically searched the literature for original CVI CUAs published between 2000 and 2008. Studies were classified according to several variables including anatomy of interest (e.g. cerebrovascular, aorta, peripheral) and imaging modality under study (e.g. angiography, ultrasound). The results of each study, expressed as cost of the intervention to number of quality-adjusted life years saved ratio (cost/QALY) were additionally classified as favorable or not using $20,000, $50,000, and $100,000 per QALY thresholds. The distribution of results was assessed with Chi Square or Fisher exact test, as indicated. Sixty-nine percent of all cardiovascular imaging CUAs were published between 2000 and 2008. Thirty-two studies reporting 82 cost/QALY ratios were included in the final sample. The most common vascular areas studied were cerebrovascular (n = 9) and cardiac (n = 8). Sixty-six percent (21/32) of studies focused on sonography, followed by conventional angiography and CT (25%, n = 8, each). Twenty-nine (35.4%), 42 (51.2%), and 53 (64.6%) ratios were favorable at WTP $20,000/QALY, $50,000/QALY, and $100,000/QALY, respectively. Thirty (36.6%) ratios compared one imaging test versus medical or surgical interventions; 26 (31.7%) ratios compared imaging to a different imaging test and another 26 (31.7%) to no intervention. Imaging interventions were more likely (P 0.01) to be favorable when compared to observation, medical treatment or non-intervention than when compared to a different imaging test at WTP $100,000/QALY. The diagnostic cardiovascular imaging literature has growth substantially. The studies available have, in general, favorable cost-effectiveness profiles with major determinants relating to being compared against observation, medical or no intervention instead of ot

Rare diseases are a global public health priority; they can cause significant morbidity and mortality, can gravely affect quality of life, and can confer a social and economic burden on families and communities. These conditions are, by their nature, encountered very infrequently by clinicians. Thus, clinical practice guidelines are potentially very helpful in supporting clinical decisions, health policy and resource allocation. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system is a structured and transparent approach to developing and presenting summaries of evidence, grading its quality, and then transparently interpreting the available evidence to make recommendations in health care. GRADE has been adopted widely. However, its use in creating guidelines for rare diseases - which are often plagued by a paucity of high quality evidence - has not yet been explored. RARE- Bestpractices is a project to create and populate a platform for sharing best practices for management of rare diseases. A major aim of this project is to ensure that European Union countries have the capacity to produce high quality clinical practice guidelines for rare diseases. On February 12, 2013 at the Istituto Superiore di Sanita, in Rome, Italy, the RARE-Bestpractices group held the first of a series of 2 workshops to discuss methodology for creating clinical practice guidelines, and explore issues specific to rare diseases. This paper summarizes key results of the first workshop, and explores how the current GRADE approach might (or might not) work for rare diseases. Avenues for future research are also identified.

Congenital hearing loss is one of the most frequent birth defects, and Early Detection and Intervention has been found to improve language outcomes. The American Academy of Pediatrics (AAP) and the Joint Committee on Infant Hearing (JCIH) established quality of care process indicators and benchmarks for Universal Newborn Hearing Screening (UNHS). We have aggregated some of these indicators/benchmarks according to the three pillars of universality, timely detection and overreferral. When dealing with inter-comparison, relying on complete and standardised literature data becomes crucial.The purpose of this paper is to verify whether literature data on UNHS programmes have included sufficient information to allow inter-programme comparisons according to the indicators considered.MethodsWe performed a systematic search identifying UNHS studies and assessing the quality of programmes.ResultsThe identified 12 studies demonstrated heterogeneity in criteria for referring to further examinations during the screening phase and in identifying high-risk neonates, protocols, tests, staff, and testing environments. Our systematic review also highlighted substantial variability in reported performance data. In order to optimise the reporting of screening protocols and process performance, we propose a checklist. Another result is the difficulty in guaranteeing full respect for the criteria of universality, timely detection and overreferral.ConclusionsStandardisation in reporting UNHS experiences may also have a positive impact on inter-program comparisons, hence favouring the emergence of recognised best practices.

The life expectancy improvement and the increasing incidence of chronic diseases in the population in rich countries make evident the problem of managing the process of care at home and in residential structures. This article proposed a system based on sensors data to identify the most appropriate solution to be activated when a health problem arises. In particular the proposed system allows identifying anomalies, their assessment and their management.

La riabilitazione respiratoria riveste un ruolo fondamentale nei pazienti con BPCO (evidenza A Linee Guida Gold 2010). La valutazione di programmi riabilitativi richiede attenzione alla dimensione clinica ed alla qualita? della vita del paziente anche attraverso la continuita? assistenziale territoriale. In tale ottica l'ASL Brindisi coordina un progetto CCM finanziato nel 2010 dal Ministero della Salute.

Nel documento "La sostenibilità dell'ambiente abitato" viene sottolineato come l'urbanizzazione rappresenti una delle principali cause del cambiamento climatico globale. Il suolo edificato, infatti, copre attualmente circa il 3 % di quello disponibile in totale sulla superficie terrestre, ma con una ben più rilevante impronta ecologica. Se il consumo di suolo per lo sviluppo continua ad espandersi ad un ritmo maggiore rispetto alla crescita demografica e la densità urbana diminuisce - come sta avvenendo nei paesi occidentali - le aree urbanizzate potrebbero occupare fino al 7% della superficie disponibile terrestre nei prossimi vent'anni.

Best practice guidelines for clinical management have increasingly become useful tools for patients and health care professionals in several disease areas. This is the case not least in the area of rare diseases, where scarcity of expertise is a well known and far too common cause of late or wrong diagnosis and care. However, in order for clinical guidelines to be useful and trustworthy, they must adhere to principles of how they are developed and updated, including a basis of best available evidence. Because of the potential great importance of well made best practice guidelines for rare diseases, we here describe work within the RARE-bestpractices EU project aim to address this topic by i) delineate the current state of existing best practice guidelines, as well as processes and tools for developing, updating, and adapting guidelines in the field of rare diseases, ii) define and agree on methodological quality standards for best practice guidelines on rare diseases, iii) develop pilot best practice guidelines for a specific rare condition, implementing the agreed methodological quality standards and iv) to develop a graphical representation of the sequence of activities in best practice guidelines, which are useful for helping in understanding key steps, for allowing a faster development of information systems supporting the enactment of the modeled process, and for monitoring the effectiveness, efficiency and equity of the implemented guidelines.

Over the last decade the European Union (EU) has been coordinating actions addressing various aspects of rare diseases and has funded several cross-border research projects. Recently the EU has initiated the biggest rare disease interna- tional collaborative effort by launching the International Rare Diseases Research Consortium (IRDiRC).RARE-Bestpractices is one of the more than 100 collaborative research projects on rare diseases funded under the Seventh Framework Programme for Research and Technological Development (FP7/2007-2013) [1].As a wide, open and inclusive network, RARE-Bestpractices will build on the knowledge of the experts in rare disease

OBJECTIVES: The present work reviews current practices for the definition of the reimbursed price of orphan drugs, and proposes a conceptual framework for their value-based pricing along with a roadmap for its possible implementation. METHODS: Based on a literature analysis, we systematize the current discussions on the topic within a conceptual framework intended to support evaluations and decision-making for determining a value-based reimbursed price for orphan drugs. RESULTS: Our analysis points out the "black box" pricing mechanism of orphan drugs and the limited consistency of some of the constituent domains of Health Technology Assessment when applied to orphan medical products (safety, clinical effectiveness, costs and economic evaluation, ethical analysis, and organizational and social aspects). The proposed framework comprises: a) elements of societal value and methods for its assessment, b) exchanges of valuable and trustworthy information between relevant stakeholders from an early stage, c) innovative reimbursement approaches to balance the need for evidence- based decisions with timely access to innovative drugs for patients with rare diseases, d) societal participation in the risky entrepreneurship of producing orphan drugs. Considering the areas reported in the proposed framework, we identified a possible roadmap for its implementation via three critical phases: i) sharing available experiences, ii) integrating and systematizing methods for appropriate use, iii) identifying delegate agencies. CONCLUSIONS: Additional piloting of emerging experiences and sharing of implementations developed worldwide are needed, along with the identification of an internationally agreed-upon taxonomy and pan-national recognised subjects to be delegated part of the HTA activities currently spread over a multiplicity of subjects.

The pricing and reimbursement policies for pharmaceuticals are relevant to balance timely and equitable access for all patients, financial sustainability, and reward for valuable innovation. The proliferation of high-cost specialty medicines is particularly true in rare diseases (RDs) where the pricing mechanism is characterised by a lack of transparency. This work provides an overall picture of current strategies for the definition of the reimbursed prices of orphan drugs (ODs) and highlights some potential improvements. Current strategies and suggestions are presented along 4 dimensions: (1) comprehensive value assessment, (2) early dialogs among relevant stakeholders, (3) innovative reimbursement approaches, and (4) societal participation in producing ODs. Comprehensive value assessment could be achieved by clarifying the approach of distributive justice to adopt, ensuring a representative participation of stakeholders, and with a broad consideration of value-bearing factors. With respect to early dialogs, cross-border cooperation can be determinant to companies and agencies. The cost-benefit ratio of early dialogs needs to be demonstrated and the "regulatory capture" effect should be monitored. Innovative reimbursement approaches were developed to balance the need for evidence-based decisions with the timely access to innovative drugs. The societal participation in producing ODs needs to be recognised in a collaborating framework where adaptive agreements can be developed with mutual satisfaction. Such agreements could also impact on coverage and reimbursement decisions as additional elements for the determination of a comprehensive societal value of ODs. Further research is needed to investigate the highlighted open challenges so that RDs will not remain, in practical terms, orphan diseases.

Purpose: The importance of working toward quality improvement in healthcare implies an increasing interest in analysing, understanding and optimizing process logic and sequences of activities embedded in healthcare processes. Their graphical representation promotes faster learning, higher retention and better compliance. The study identifies standardized graphical languages and notations applied to patient care processes and investigates their usefulness in the healthcare setting.Data sources: Peer-reviewed literature up to 19 May 2016. Information complemented by a questionnaire sent to the authors of selected studies.Study selection: Systematic review conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.Data extraction: Five authors extracted results of selected studies.Results of data synthesis: Ten articles met the inclusion criteria. One notation and language for healthcare process modelling were identified with an application to patient care processes: Business Process Model and Notation and Unified Modeling LanguageTM. One of the authors of every selected study completed the questionnaire. Users' comprehensibility and facilitation of inter-professional analysis of processes have been recognized, in the filled in questionnaires, as major strengths for process modelling in healthcare.Conclusion: Both the notation and the language could increase the clarity of presentation thanks to their visual properties, the capacity of easily managing macro and micro scenarios, the possibility of clearly and precisely representing the process logic. Both could increase guidelines/path- ways applicability by representing complex scenarios through charts and algorithms hence contributing to reduce unjustified practice variations which negatively impact on quality of care and patient safety.

To develop a more realistic assessment of costs, herein named "true" costs, the extra-cancer from medical radiation, environmental damage from imaging paraphernalia and radioactive wastes must be included as long-term costs from imaging examinations. It is urgent to define the "true" costs across imaging modalities as it interferes on physicians' decision to request an exam and on research projects such as cost-effectiveness analysis. Cardiology is the specialty that most will benefit from the outcome as cardiovascular exams represent almost 30% of the total exams acquired annually worldwide. © 2013 Braga et al.; licensee BioMed Central Ltd.