Demonstrating the influence of HTA: INAHTA member stories of HTA impact.

A central function of health technology assessment (HTA) agencies is the production of HTA reports to support evidence-informed policy and decision making. HTA agencies are interested in understanding the mechanisms of HTA impact, which can be understood as the influence or impact of HTA report findings on decision making at various levels of the health system. The members of the International Network of Agencies for HTA (INAHTA) meet at their annual Congress where impact story sharing is one important activity. This paper summarizes four stories of HTA impact that were finalists for the David Hailey Award for Best Impact Story.The methods to measure impact include: document review; claims analysis and review of reimbursement status; citation analysis; qualitative evaluation of stakeholders' views; and review of media response. HTA agency staff also observed changes in government activities and priorities based on the HTA. Impact assessment can provide information to improve the HTA process, for example, the value of patient and clinician engagement in the HTA process to better define the assessment question and literature reviews in a more holistic and balanced way.HTA reports produced by publicly funded HTA agencies are valued by health systems around the globe as they support decision making regarding the appropriate use, pricing, reimbursement, and disinvestment of health technologies. HTAs can also have a positive impact on information sharing between different levels of government and across stakeholder groups. These stories show how HTA can have a significant impact, irrespective of the health system and health technology being assessed.

The South African Guidelines for Pharmacoeconomic Submissions' Evidence Requirements Compared with Other African Countries and The National Institute for Health and Care Excellence in England.

Objectives: The South African Guidelines for Pharmacoeconomic Submissions (SAGPS) were compared with other African pharmacoeconomic guidelines and the National Institute of Health and Care Excellence Methods Guide (NICE MG) to make recommendations for evidence generation and further development thereof.Methods: The European Network for HTA Core Model (version 3.0) (the Model) provided the comparative framework, using three criteria: completely, partly, or not completely requiring the same/similar information.Results: Of 45 African countries reviewed, only Egypt had a publicly accessible pharmacoeconomic guideline (EPG). The guidelines were different in respect to their intended audience, size, and content but for all the main focus are the economic evaluation, and health problem and current treatment domains. The SAGPS and EPG had few requirements for a medicine's safety, organizational, ethical, and legal aspects. The SAGPS completely or partly required the same/similar information as the Model for 41.2% of total issues, the EPG 33.3%, and the NICE MG 63.2%.Conclusions: The SAGPS was similar to the EPG, but not as comprehensive as the NICE MG and could be strengthened for decision-making and priority setting. Evidence generation should focus on describing the medicine's targeted disease and current treatment options, and associated cost and outcomes data.

ENVIRONMENTAL IMPACT ASSESSMENT OF A HEALTH TECHNOLOGY: A SCOPING REVIEW.

INTRODUCTION: The Health Technology Expert Review Panel is an advisory body to Canadian Agency for Drugs and Technologies in Health (CADTH) that develops recommendations on health technology assessments (HTAs) for nondrug health technologies using a deliberative framework. The framework spans several domains, including the environmental impact of the health technology(ies). Our research objective was to identify articles on frameworks, methods or case studies on the environmental impact assessment of health technologies. METHODS: A literature search in major databases and a focused gray literature search were conducted. The main search concepts were HTA and environmental impact/sustainability. Eligible articles were those that described a conceptual framework or methods used to conduct an environmental assessment of health technologies, and case studies on the application of an environmental assessment. RESULTS: From the 1,710 citations identified, thirteen publications were included. Two articles presented a framework to incorporate environmental assessment in HTAs. Other approaches described weight of evidence practices and comprehensive and integrated environmental impact assessments. Central themes derived include transparency and repeatability, integration of components in a framework or of evidence into a single outcome, data availability to ensure the accuracy of findings, and familiarity with the approach used. CONCLUSIONS: Each framework and methods presented have different foci related to the ecosystem, health economics, or engineering practices. Their descriptions suggested transparency, repeatability, and the integration of components or of evidence into a single outcome as their main strengths. Our review is an initial step of a larger initiative by CADTH to develop the methods and processes to address the environmental impact question in an HTA.

Drug Policy in Estonia.

The aim of this article was to present a general overview of the health care system as well as pricing and reimbursement environment in Estonia. In Estonia the main stakeholders in the pharmaceutical sector are the Ministry of Social Affairs, the State Agency of Medicine, and the Estonian Health Insurance Fund. The national health insurance scheme is public, and approximately 95% of the population is covered by it. It is a social insurance, and universal and equal access to health care based on national health insurance is granted. The Estonian Health Insurance Fund is financed from social taxes and state budget and is responsible for the reimbursement of pharmaceuticals in the hospital setting. It acts as an advisory body to the Ministry of Social Affairs on the process of reimbursement regarding cost effectiveness. Pharmaceutical products' reimbursement dossiers submission and decisions are dealt with on the state level. Health technology assessment analyses are required by the authorities and the Baltic Guidelines for Economic Evaluations of Pharmaceuticals have to be followed. The reimbursement lists are positive lists only, and the criteria upon which reimbursement decisions are based are officially defined. Revisions of reimbursement are performed depending on the need and they are based on the prices of reference countries.

Building inclusive health innovation systems: lessons from India.

This article presents an overview of the changes that are taking place within the public and private health innovation systems in India including delivery of medical care, pharmaceutical products, medical devices, and Indian traditional medicine. The nature of the flaws that exist in the health innovation system is pinpointed. The response by the government, the health, technology and medical institutions, and the evolving industry is addressed on a national level. The article also discusses how the alignment of policies and institutions was developed within the scope of national health innovation systems, and how the government and the industry are dealing with the challenges to integrate health system, industry, and social policy development processes. Resumo: O artigo apresenta um panorama das mudanças atualmente em curso dentro dos sistemas público e privado de inovação em saúde na Índia, incluindo a prestação de serviços médicos, produtos farmacêuticos, dispositivos médicos e medicina tradicional indiana. É destacada a natureza das falhas que existem nos sistemas de inovação em saúde. As respostas do governo, das instituições médicas, de saúde e tecnologia e indústrias envolvidas, são abordadas em nível nacional. O artigo também discute como foi desenvolvido o alinhamento de políticas e instituições no escopo dos sistemas nacionais de inovação em saúde, e como governo e indústria estão lidando com os desafios para integrar o sistema de saúde, a indústria e o desenvolvimento de políticas sociais.

Integration of new technology into clinical practice after FDA approval.

Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

New technology in electrophysiology: FDA process and perspective.

The Food and Drug Administration (FDA) is a large regulatory agency that monitors everything from food, tobacco, and veterinary medicine to pharmaceutical drugs and medical devices. The Mission statement of the CDRH, one of the Centers of the FDA, in its most succinct form is to protect and promote public health. This is accomplished through timely and continued access to safe, effective, and high quality medical devices. This paper aims to review the overarching principles of the Agency's review process for cardiac devices as well as highlight some of the newer programs that FDA has engaged in to facilitate innovation, device development, research, and timely market approval.

Building inclusive health innovation systems: lessons from India / Creación de sistemas inclusivos de innovación en salud: lecciones desde la India / A criação de sistemas inclusivos de inovação em saúde: lições da Índia

Abstract: This article presents an overview of the changes that are taking place within the public and private health innovation systems in India including delivery of medical care, pharmaceutical products, medical devices, and Indian traditional medicine. The nature of the flaws that exist in the health innovation system is pinpointed. The response by the government, the health, technology and medical institutions, and the evolving industry is addressed on a national level. The article also discusses how the alignment of policies and institutions was developed within the scope of national health innovation systems, and how the government and the industry are dealing with the challenges to integrate health system, industry, and social policy development processes.

Resumen: El artículo presenta el panorama de los cambios actualmente en curso dentro de los sistemas públicos y privados de innovación en salud en la India, incluyendo la prestación de servicios médicos, productos farmacéuticos, dispositivos médicos y medicina tradicional india. Se destaca la naturaleza de las carencias que existen en los sistemas de innovación en salud. Los autores abordan la respuesta existente, a nivel nacional, por parte del gobierno, instituciones médicas y de salud y tecnología, y por la industria en este proceso de evolución. El artículo también discute cómo se desarrolló la alineación de políticas e instituciones en el alcance de los sistemas nacionales de innovación en salud, y cómo el gobierno, así como la industria, están enfrentando los desafíos que se presentan, con el fin de integrar sistema de salud, industria y desarrollo de políticas sociales.

Resumo: O artigo apresenta um panorama das mudanças atualmente em curso dentro dos sistemas público e privado de inovação em saúde na Índia, incluindo a prestação de serviços médicos, produtos farmacêuticos, dispositivos médicos e medicina tradicional indiana. É destacada a natureza das falhas que existem nos sistemas de inovação em saúde. As respostas do governo, das instituições médicas, de saúde e tecnologia e indústrias envolvidas, são abordadas em nível nacional. O artigo também discute como foi desenvolvido o alinhamento de políticas e instituições no escopo dos sistemas nacionais de inovação em saúde, e como governo e indústria estão lidando com os desafios para integrar o sistema de saúde, a indústria e o desenvolvimento de políticas sociais.

Assessment and non-clinical impact of medical devices.

Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.

Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold.

BACKGROUND: Cost-effectiveness analysis involves the comparison of the incremental cost-effectiveness ratio of a new technology, which is more costly than existing alternatives, with the cost-effectiveness threshold. This indicates whether or not the health expected to be gained from its use exceeds the health expected to be lost elsewhere as other health-care activities are displaced. The threshold therefore represents the additional cost that has to be imposed on the system to forgo 1 quality-adjusted life-year (QALY) of health through displacement. There are no empirical estimates of the cost-effectiveness threshold used by the National Institute for Health and Care Excellence. OBJECTIVES: (1) To provide a conceptual framework to define the cost-effectiveness threshold and to provide the basis for its empirical estimation. (2) Using programme budgeting data for the English NHS, to estimate the relationship between changes in overall NHS expenditure and changes in mortality. (3) To extend this mortality measure of the health effects of a change in expenditure to life-years and to QALYs by estimating the quality-of-life (QoL) associated with effects on years of life and the additional direct impact on QoL itself. (4) To present the best estimate of the cost-effectiveness threshold for policy purposes. METHODS: Earlier econometric analysis estimated the relationship between differences in primary care trust (PCT) spending, across programme budget categories (PBCs), and associated disease-specific mortality. This research is extended in several ways including estimating the impact of marginal increases or decreases in overall NHS expenditure on spending in each of the 23 PBCs. Further stages of work link the econometrics to broader health effects in terms of QALYs. RESULTS: The most relevant 'central' threshold is estimated to be £12,936 per QALY (2008 expenditure, 2008-10 mortality). Uncertainty analysis indicates that the probability that the threshold is < £20,000 per QALY is 0.89 and the probability that it is < £30,000 per QALY is 0.97. Additional 'structural' uncertainty suggests, on balance, that the central or best estimate is, if anything, likely to be an overestimate. The health effects of changes in expenditure are greater when PCTs are under more financial pressure and are more likely to be disinvesting than investing. This indicates that the central estimate of the threshold is likely to be an overestimate for all technologies which impose net costs on the NHS and the appropriate threshold to apply should be lower for technologies which have a greater impact on NHS costs. LIMITATIONS: The central estimate is based on identifying a preferred analysis at each stage based on the analysis that made the best use of available information, whether or not the assumptions required appeared more reasonable than the other alternatives available, and which provided a more complete picture of the likely health effects of a change in expenditure. However, the limitation of currently available data means that there is substantial uncertainty associated with the estimate of the overall threshold. CONCLUSIONS: The methods go some way to providing an empirical estimate of the scale of opportunity costs the NHS faces when considering whether or not the health benefits associated with new technologies are greater than the health that is likely to be lost elsewhere in the NHS. Priorities for future research include estimating the threshold for subsequent waves of expenditure and outcome data, for example by utilising expenditure and outcomes available at the level of Clinical Commissioning Groups as well as additional data collected on QoL and updated estimates of incidence (by age and gender) and duration of disease. Nonetheless, the study also starts to make the other NHS patients, who ultimately bear the opportunity costs of such decisions, less abstract and more 'known' in social decisions. FUNDING: The National Institute for Health Research-Medical Research Council Methodology Research Programme.

Medicina de sistemas: una nueva visión de la práctica clínica / Systems Medicine: A New Approach to Clinical Practice

La gran mayoría de las enfermedades respiratorias son consideradas patologías complejas puesto que su susceptibilidad o desenlace están influidos por la interacción entre factores dependientes del huésped (genéticos, comorbilidad, edad, etc.) y del ambiente (exposición a microorganismos y alérgenos, tratamiento administrado, etc.).El enfoque reduccionista ha sido muy importante para la comprensión de los diversos componentes de un sistema. La biología o medicina de sistemas es una aproximación complementaria cuyo objetivo es el análisis de las interacciones entre los componentes dentro de un nivel de organización (genoma, transcriptoma, proteoma) y posteriormente entre los distintos niveles. Las actuales aplicaciones de la medicina de sistemas incluyen la interpretación de la patogénesis y fisiopatología de las enfermedades, el descubrimiento de biomarcadores, el diseño de nuevas estrategias terapéuticas y la elaboración de modelos computacionales para los distintos procesos biológicos. En la presente revisión se exponen las principales nociones sobre la teoría que subyace a la medicina de sistemas así como sus aplicaciones en algunos procesos biológicos del ser humano

Most respiratory diseases are considered complex diseases as their susceptibility and outcomes are determined by the interaction between host-dependent factors (genetic factors, comorbidities, etc.) and environmental factors (exposure to microorganisms or allergens, treatments received, etc.).The reductionist approach in the study of diseases has been of fundamental importance for the understanding of the different components of a system. Systems biology or systems medicine is a complementary approach aimed at analyzing the interactions between the different components within one organizational level (genome, transcriptome, proteome), and then between the different levels. Systems medicine is currently used for the interpretation and understanding of the pathogenesis and pathophysiology of different diseases, biomarker discovery, design of innovative therapeutic targets, and the drawing up of computational models for different biological processes. In this review we discuss the most relevant concepts of the theory underlying systems medicine, as well as its applications in the various biological processes in humans

The Health Technology Assessment of companion diagnostics: experience of NICE.

Companion diagnostics are used to aid clinical decision making to identify patients who are most likely to respond to treatment. They are becoming increasingly important as more new pharmaceuticals receive licensed indications that require the use of a companion diagnostic to identify the appropriate patient subgroup for treatment. These pharmaceuticals have proven benefit in the treatment of some cancers and other diseases, and also have potential to precisely tailor treatments to the individual in the future. However, the increasing use of companion diagnostics could place a substantial burden on health system resources to provide potentially high volumes of testing. This situation, in part, has led policy makers and Health Technology Assessment (HTA) bodies to review the policies and methods used to make reimbursement decisions for pharmaceuticals requiring companion diagnostics. The assessment of a pharmaceutical alongside the companion diagnostic used in the clinical trials may be relatively straightforward, although there are a number of challenges associated with assessing pharmaceuticals where a range of alternative companion diagnostics are available for use in routine clinical practice. The UK HTA body, the National Institute for Health and Care Excellence (NICE), has developed policy for considering companion diagnostics using its Technology Appraisal and Diagnostics Assessment Programs. Some HTA bodies in other countries have also adapted their policies and methods to accommodate the assessment of companion diagnostics. Here, we provide insight into the HTA of companion diagnostics for reimbursement decisions and how the associated challenges are being addressed, in particular by NICE. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development."

Design principles for achieving integrated healthcare information systems.

Achieving integrated healthcare information systems has become a common goal for many countries in their pursuit of obtaining coordinated and comprehensive healthcare services. This article focuses on how a small local project termed 'Standardized pull of patient data' expanded and is now used on a large scale providing a majority of hospitals, general practitioners and citizens across Denmark with the possibility of accessing healthcare data from different electronic patient record systems and other systems. I build on design theory for information infrastructures, as presented by Hanseth and Lyytinen, to examine the design principles that facilitated this smallscale project to expand and become widespread. As a result of my findings, I outline three lessons learned that emphasize: (i) principles of flexibility, (ii) expansion from the installed base through modular strategies and (iii) identification of key healthcare actors to provide them with immediate benefits.

Total selenium and selenomethionine in pharmaceutical yeast tablets: assessment of the state of the art of measurement capabilities through international intercomparison CCQM-P86.

Results of an international intercomparison study (CCQM-P86) to assess the analytical capabilities of national metrology institutes (NMIs) and selected expert laboratories worldwide to accurately quantitate the mass fraction of selenomethionine (SeMet) and total Se in pharmaceutical tablets of selenised-yeast supplements (produced by Pharma Nord, Denmark) are presented. The study, jointly coordinated by LGC Ltd., UK, and the Institute for National Measurement Standards, National Research Council of Canada (NRCC), was conducted under the auspices of the Comité Consultatif pour la Quantité de Matière (CCQM) Inorganic Analysis Working Group and involved 15 laboratories (from 12 countries), of which ten were NMIs. Apart from a protocol for determination of moisture content and the provision of the certified reference material (CRM) SELM-1 to be used as the quality control sample, no sample preparation/extraction method was prescribed. A variety of approaches was thus used, including single-step and multiple-step enzymatic hydrolysis, enzymatic probe sonication and hydrolysis with methanesulfonic acid for SeMet, as well as microwave-assisted acid digestion and enzymatic probe sonication for total Se. For total Se, detection techniques included inductively coupled plasma (ICP) mass spectrometry (MS) with external calibration, standard additions or isotope dilution MS (IDMS), inductively coupled plasma optical emission spectrometry , flame atomic absorption spectrometry and instrumental neutron activation analysis. For determination of SeMet in the tablets, five NMIs and three academic/institute laboratories (of a total of five) relied upon measurements using IDMS. For species-specific IDMS measurements, an isotopically enriched standard of SeMet (76Se-enriched SeMet) was made available. A novel aspect of this study relies on the approach used to distinguish any errors which arise during analysis of a SeMet calibration solution from those which occur during analysis of the matrix. To help those participants undertaking SeMet analysis to do this, a blind sample in the form of a standard solution of natural abundance SeMet in 0.1 M HCl (with an expected value of 956 mg kg(-1) SeMet) was provided. Both high-performance liquid chromatography (HPLC)-ICP-MS or gas chromatography (GC)-ICP-MS and GC-MS techniques were used for quantitation of SeMet. Several advances in analytical methods for determination of SeMet were identified, including the combined use of double IDMS with HPLC-ICP-MS following extraction with methanesulfonic acid and simplified two-step enzymatic hydrolysis with protease/lipase/driselase followed by HPLC-ICP-IDMS, both using a species-specific IDMS approach. Overall, satisfactory agreement amongst participants was achieved; results averaged 337.6 mg kg(-1) (n = 13, with a standard deviation of 9.7 mg kg(-1)) and 561.5 mg kg(-1) (n = 11, with a standard deviation of 44.3 mg kg(-1)) with median values of 337.6 and 575.0 mg kg(-1) for total Se and SeMet, respectively. Recovery of SeMet from SELM-1 averaged 95.0% (n = 9). The ability of NMIs and expert laboratories worldwide to deliver accurate results for total Se and SeMet in such materials (selensied-yeast tablets containing approximately 300 mg kg(-1) Se) with 10% expanded uncertainty was demonstrated. The problems addressed in achieving accurate quantitation of SeMet in this product are representative of those encountered with a wide range of organometallic species in a number of common matrices.

Summary: use of class 3b and class 4 lasers and intense pulsed light sources for cosmetic procedures in non-medical settings

INTRODUCTION: Body image has always preoccupied people across time and cultures. Today, the search for beauty can be fulfilled with high-power technologies that are relatively easy to use, such as Class 3b and Class 4 lasers and intense pulsed light (IPL) sources. Lasers are devices that amplify light, emitting it in a narrow, coherent optical beam; the beam produced is near-monochromatic, the particles all move in the same direction, and the waves are in phase with one another. Intense pulsed light is based on different physical and technological principles. Unlike lasers, IPL sources emit polychromatic light (non-coherent, between 500 and 1,200 nm), and selected wavelengths are obtained by means of filters. These technologies are used for various cosmetic purposes and applications, including some that clearly come under activities reserved to physicians, while others fall into the grey areas surrounding medicine. Based on the definitions of the different fields of medical activity and on the laws and regulations governing the practice of medicine, this report has limited its scope to examining laser and IPL procedures that do not require medical diagnosis and that may be performed in Québec by operators other than physicians or health professionals, without medical supervision. This report does not purport to determine what does and does not lie within the scope of medicine. Rather, it focuses on the risks inherent in these technologies and on the qualifications required to use them, by taking hair removal as a base case and by dealing more briefly with skin resurfacing and tattoo removal, without ruling on the field of activity to which these practices belong. RESEARCH METHODS: Medline (National Library of Medicine) via PubMed and the Cochrane Library were searched. The grey literature was also examined to take into account the contextual aspects that prompted the request for this report, especially the legal and regulatory provisions framing the use of lasers and IPL by non-physician operators in various countries and regions. In addition, local experts were consulted to validate the contextual evidence and the applicability of the ensuing recommendations. These experts are key actors in the following organizations: Association des dermatologistes du Québec; Collège des médecins du Québec; Comité sectoriel de la main-d'œuvre des services de soins personnels [sector committee on personal services workers]; Ministère de l'Éducation, du Loisir et du Sport; Ministère de l'Emploi et de la Solidarité sociale; and Ministère de la Santé et des Services sociaux. CONCLUSION: Analysis of the scientific and contextual evidence leads to these findings: Class 3b and Class 4 lasers and IPL sources are high-power technologies entailing risks for operators and their customers. The use of these technologies leads to adverse effects that, although minor and transient for the most part, may in some cases be serious; however, scientific evidence does not allow us to determine their frequency or severity, or to link them with the types of professionals using them. Some cosmetic procedures may overlap with activities reserved to physicians when these. procedures are applied to areas of the skin with an underlying medical condition or with the risk of complications requiring medical expertise. Current Canadian safety standards regulate the sale and importation of these devices and their use in health-care facilities, and the safe use of lasers is governed by laws and regulations intended to protect workers' health and safety in all work settings. However, Québec has no law or regulation to protect the health and safety of the public undergoing laser or IPL procedures in non-medical settings. The use of Class 3b and Class 4 lasers and IPL sources is widespread in beauty care centres, but the specific types of devices used are not known. There is no professional order regulating the practice of estheticians or other types of personnel working in the personal services sector and likely to use laser or IPL devices, and the Office des professions du Québec has already denied the application by the Association des électrolystes du Québec to establish a professional order. The Comité sectoriel de la main-d'œuvre des services de soins personnels and the Ministère de l'Éducation, du Loisir et du Sport have already developed their own non-mandatory vocational training programs in laser hair removal, but these programs do not cover other cosmetic laser applications or the use of IPL. The Act respecting Workforce Vocational Training and Qualification (R.S.Q., c. F-5) could fill this regulatory gap in part by standardizing the required occupational skills, establishing vocational training and qualification programs, and determining occupational eligibility requirements for laser or IPL operators working in non-medical settings. In light of these findings, this report is not able to rule either on the safety of laser or IPL procedures by non-physician operators working without medical supervision or on the scope of activities that could be authorized to them in the Québec context. However, given that these technologies present hazards and may lead to adverse effects that are potentially serious when used for cosmetic procedures, and given that there is a serious possibility of interference with the field of medicine, AETMIS has reached the following conclusions, which define the major issues to be dealt with: The boundary between the procedures restricted to the field of medicine and the cosmetic procedures that may be performed by non-physician operators must be clearly established.

An evaluation of methods used in health technology assessments produced for the Medical Services Advisory Committee.

OBJECTIVE: To examine the methods used in health technology assessments (HTAs) produced for the Medical Services Advisory Committee (MSAC) reviewing the effectiveness of a technology or procedure. DESIGN AND SETTING: Data were extracted from the effectiveness section of HTA application assessment reports published between 1 January 1998 and 17 July 2006 and available on the MSAC website. Only HTAs of effectiveness interventions were examined, as the methods used to undertake such reviews are well established. MAIN OUTCOME MEASURES: Variables reflecting methods used in the HTAs to evaluate the effectiveness of health technologies or procedures. RESULTS: Of 56 MSAC HTA reports available, 31 met the inclusion criteria. Considerable variability was shown to exist between the various indicators of quality and the methodology used within the HTAs. Reports did not describe potential conflicts of interest of participants. The majority of reports (19/31) did not formally state the research question that the assessment was attempting to answer. Just over half of the reports (18/31) provided details of validity assessment of the included studies. CONCLUSIONS: Minimum and consistent standards of methodology and reporting are required in Australian HTAs, using international recommendations of best practice to increase the transparency and applicability of these reports.

Etica del diagnóstico / Ethic of diagnostic

Actas de la sesión ralizada por la Fundación Alberto J. Roemmers el día 14 de noviembre de 1996 en la Academia Nacional de Medicina para la disertación del profesor Francisco Vilardell