D. Chase

Growth hormone replacement in adults and bone mineral density: a systematic review and meta-analysis

background  The effect of GH replacement on bone mineral density (BMD) in adults with GH deficiency (GHD) is uncertain. We carried out a systematic review of randomized trials that compared GH to no active treatment, with BMD as an outcome.

Practical tools and methods for health technology assessment in Europe: Structures, methodologies, and tools developed by the European network for Health Technology Assessment, EUnetHTA

OBJECTIVES This article presents an overview of the practical methods and tools to support transnational Health Technology Assessment (HTA) that were developed and pilot tested by the European network for HTA (EUnetHTA), which involved a total of sixty-four Partner organizations. METHODS The methods differ according to scope and purpose of each of the tools developed. They included, for example, literature reviews, surveys, Delphi and consensus methods, workshops, pilot tests, and internal/public consultation. RESULTS Practical results include an HTA Core Model and a Handbook on the use of the model, two pilot examples of HTA core information, an HTA Adaptation Toolkit for taking existing reports into new settings, a book about HTA and health policy making in Europe, a newsletter providing structured information about emerging/new technologies, an interactive Web-based tool to share information about monitoring activities for emerging/new technologies, and a Handbook on HTA capacity building for Member States with limited institutionalization of HTA. CONCLUSIONS The tools provide high-quality information and methodological frameworks for HTA that facilitate preparation of HTA documentation, and sharing of information in and across national or regional systems. The tools will be used and further tested by partners in the EUnetHTA Collaboration aiming to (i) help reduce unnecessary duplication of HTA activities, (ii) develop and promote good practice in HTA methods and processes, (iii) share what can be shared, (iv) facilitate local adaptation of HTA information, (v) improve the links between health policy and HTA.

The health technology assessment adaptation toolkit: Description and use

OBJECTIVES Adapting health technology assessment (HTA) reports for different contexts could reduce the need for multiple reports on the same health technology with resultant saving of time and resources. This article describes an instrument, the adaptation toolkit, which has been developed to aid in the process of adaptation of HTA reports. METHODS The toolkit was developed by a partnership of HTA agencies and networks from across Europe. The role of the toolkit is to guide the user through the process of selecting possible relevant material from these report(s), assessing the relevance, reliability, and transferability of the material, and adapting it for the desired context. RESULTS The adaptation toolkit has been developed, it comprises a collection of resources that help the user assess whether data and information in existing HTA reports should and could be adapted for their own setting. The toolkit contains two sections: a preliminary speedy sifting section and the main toolkit. The main toolkit includes five domains: (i) technology use and development, (ii) safety, (iii) effectiveness (including efficacy), (iv) economic evaluation, and (v) organizational aspects. Legal, ethical, and social aspects are beyond the scope of the toolkit. The toolkit is designed for the adaptation of evidence synthesis rather than primary research. CONCLUSIONS The completed current version of the toolkit contains checklists and resources to aid in the adaptation of HTA reports. This collection of resources is available for use by all HTA agencies and can be accessed at: http://www.eunethta.net/upload/WP5/EUnetHTA_HTA_Adaptation_Toolkit_October08.pdf..

rhDNase therapy for the treatment of cystic fibrosis patients with mild to moderate lung disease

Objective: To assess the cost‐effectiveness of rhDNase (Pulmozyme®) for patients with cystic fibrosis (CF) aged 5 years or more, with mild to moderate lung disease. The review addresses four questions: a) does rhDNase therapy work in the short term?, b) does rhDNase therapy work more effectively in certain groups of patients?, c) does rhDNase therapy work in the long term? and d) what is the cost‐effectiveness of rhDNase therapy?

Inequity of use of implantable cardioverter defibrillators in England: retrospective analysis

Sudden cardiac death occurs in approximately 100 000 people annually in the United Kingdom and can be prevented by implantable cardioverter defibrillators (ICDs).1 Rates of implantation of ICDs in England have been increasing but lag behind those in other western European countries and North America. The National Institute for Clinical Excellence has recommended indications for use in patients with ventricular arrhythmias and proposed an annual implantation rate of 50 per million population.2 We present data on current use, geographical and social equity, and barriers to care in the provision of ICDs in England.

What are the relative merits of the sources used to identify potential research priorities for the NHS HTA programme

The NHS Health Technology Assessment (HTA) Programme runs an annual process of identifying suggestions for health technology assessment. The objective of this paper is to describe and evaluate the relative importance of the different sources used by the program in 1998 to identify potential priorities. There were four different sources: a) a widespread consultation of healthcare commissioners, providers and consumers; b) research recommendations from systematic reviews; c) reconsidering previous research priorities which had not been taken forward for funding; and d) horizon scanning. Collectively, the four sources generated just over 1,100 HTA suggestions. By far the largest source of suggestions and priorities was the widespread consultation. However, the success rate of this source, in terms of being commissioned, was low. Research recommendations from systematic reviews provided the second largest source of priorities and the best success rate of all sources. Value was found from different sources for different healthcare areas.

The adaptation of health technology assessment reports: Identification of the need for, and development of, a toolkit to aid the process

OBJECTIVES Europe has many health technology assessment (HTA) agencies, each producing their own HTA reports. Adapting HTA reports for different contexts could reduce the need for multiple reports on the same health technology with resultant saving of time and resources. This study aims to examine and understand the process of adaptation, and to develop a toolkit that would help the adaptation of reports produced by other countries. METHODS The methods used were a review of the literature; a survey of twenty-nine European HTA organizations, two rounds of a Delphi survey, a face-to-face meeting of twenty-one European network for Health Technology Assessment (EUnetHTA) representatives, iterative rounds of review, and two rounds of quality assurance testing (termed applicability testing). RESULTS Descriptions of previous examples of adaptation in the literature are sparse. Most respondents had previous experience in adapting reports, and all believed that adaptation was useful, and there was the ability to benefit from the use of a toolkit to aid in the process. EUnetHTA Partners developed and tested an adaptation toolkit. The toolkit is composed of a series of checklists and resources that identify or clarify the relevance, reliability, and transferability of data and information from existing reports. CONCLUSIONS Consensus of opinion from twenty-nine European organizations/networks has indicated that the adaptation of HTA reports would be desirable and beneficial. A toolkit was developed to help with the adaptation of HTA reports produced in other settings. This collection of resources is available for use by all HTA agencies and can be accessed at: http://www.eunethta.net/upload/WP5/EUnetHTA_HTA_Adaptation_Toolkit_October08.pdf.

Enhancing understanding: the development of a glossary of health technology assessment adaptation terms

BACKGROUND The way people use health technology assessment (HTA) terms varies considerably across Europe. Such variation can lead to misunderstandings when reading HTA reports from different contexts. This work is one of the outputs of the EUnetHTA Project and was undertaken between 2006 and 2008. OBJECTIVES The aim of this study was to develop a glossary of HTA adaptation terms to help reduce the misunderstandings of terms used in HTA reports from contexts other than the readers own. METHODS Several HTA glossaries were examined to identify ways in which an additional glossary could offer readers something new and to identify adaptation terms for inclusion. Twenty-eight European HTA organizations provided terms for the glossary and drafted descriptions and examples of how each specific term was used in their particular setting. The organizations then commented on the descriptions provided by the other groups and worked together to draft a single description for certain terms. RESULTS A glossary of HTA adaptation terms was developed. It provides a comprehensive range of descriptions, examples, and comments for forty-two potentially confusing HTA terms related to adaptation. CONCLUSIONS This glossary will be a valuable resource for European HTA agencies when reading HTA reports produced in different contexts and for adapting HTA reports produced in other countries. The glossary will help improve understanding and help facilitate the adaptation process.

Development of a toolkit and glossary to aid in the adaptation of health technology assessment (HTA) reports for use in different contexts.

OBJECTIVES To develop a health technology assessment (HTA) adaptation toolkit and glossary of adaptation terms for use by HTA agencies within EU member states to support them in adapting HTA reports written for other contexts. METHODS The toolkit and glossary were developed by a partnership of 28 HTA agencies and networks across Europe (EUnetHTA work package 5), led by the UK National Coordinating Centre for Health Technology Assessment (NCCHTA). Methods employed for the two resources were literature searching, a survey of adaptation experience, two rounds of a Delphi survey, meetings of the partnership and drawing on the expertise and experience of the partnership, two rounds of review, and two rounds of quality assurance testing. All partners were requested to provide input into each stage of development. RESULTS The resulting toolkit is a collection of resources, in the form of checklists of questions on relevance, reliability and transferability of data and information, and links to useful websites, that help the user assess whether data and information in existing HTA reports can be adapted for a different setting. The toolkit is designed for the adaptation of evidence synthesis rather than primary research. The accompanying glossary provides descriptions of meanings for HTA adaptation terms from HTA agencies across Europe. It seeks to highlight differences in the use and understanding of each word by HTA agencies. The toolkit and glossary are available for use by all HTA agencies and can be accessed via www.eunethta.net/. CONCLUSIONS These resources have been developed to help HTA agencies make better use of HTA reports produced elsewhere. They can be used by policy-makers and clinicians to aid in understanding HTA reports written for other contexts. The main implication of this work is that there is the potential for the adaptation of HTA reports and, if utilised, this should release resources to enable the development of further HTA reports. Recommendations for the further development of the toolkit include the potential to develop an interactive web-based version and to extend the toolkit to facilitate the adaptation of HTA reports on diagnostic testing and screening.

Is there unmet need for implantable cardioverter defibrillators? Findings from a post-mortem series of sudden cardiac death

AIMS To establish whether sudden cardiac death (SCD) victims could have been identified prior to their event and considered for an implantable cardioverter defibrillators (ICDs). METHODS AND RESULTS Consecutive post-mortem cases of adult SCDs presumed to be caused by a ventricular arrhythmia over 12 months (2002-03) from a defined catchment population, Southampton, UK (n = 443 824 adults aged >or=16 years). Pathological data were extracted from the post-mortem reports. Hospital and general practice (GP) notes provided data on previous symptoms, investigations, and cardiac disease history. Two electrophysiologists judged the appropriateness of each case for an ICD against National Guidance. Two hundred and fifteen cases met the inclusion criteria and lived within the catchment area. Agreement between experts on appropriateness for an ICD in those aged <80 years was good (kappa score of 0.64). Only one case (<1%) was considered appropriate for an ICD without requirement for further investigation. Forty-nine per cent of cases were considered to have required further cardiac investigations to determine appropriateness; these were mainly heart failure patients who had suffered a myocardial infarction (MI). Forty per cent of cases had no previous clinical evidence of confirmed or suspected heart disease. However, pathological data showed that 51% of cases had suffered a previous MI. CONCLUSION Two-fifths of SCD victims had no recorded health service contact that would indicate increased risk of SCD within their lifetime. A large number of patients suffered previous cardiac events or symptoms suggestive of increased SCD risk but were not referred for further investigations. There is a need for better care pathways for patients post-MI to identify those requiring an ICD. The impact on the ICD rate of undertaking these extra investigations is uncertain.