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Year: 2008 Publisher: Oslo : Norwegian Knowledge Centre for the Health Services,
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Background Since the heyday of HTA it has been claimed that ethics is an integral part of HTA. However, few HTA reports have addressed moral issues, and there has been little agreement on methods for implementing ethics in HTA. Therefore, there is a need to develop a standard methodology for addressing ethical issues in HTA in the same manner as there is a methodology for systematic reviews and economic analysis. Accordingly, the purpose of this report is to present a practical method for addressing moral issues in HTA. The method has to be applicable without special knowledge in ethics, and when applied, the method shall result in a broad basis for an open and transparent decision process. Accordingly, it shall only highlight the moral issues, and not lead to specific recommendations. Method On the basis of analyses and assessments of existing methods in ethics in general and in HTA in particular, a practical procedure for addressing moral issues in HTA is to be developed and presented. Results A practical method for addressing moral issues in HTA is presented. The method consists of a procedure in six steps:1. Identify and analyze the moral challenges with the health technology2. Identify involved persons, groups, and stakeholders3. Identify relevant moral questions (from a list of questions) and justify the selection4. Perform literature search in accordance with the identified moral questions5. Analyze and discuss the moral questions identified (in step 3) on the basis of1.1. The literature search1.2. Hearings of involved parties or qualitative studies6. Wrap up and summarize the process. The core set of moral questions in step 3 belong to the following main groups: 1. General moral issues. 2. Moral issues related to stakeholders 3. Moral issues related to the health technology. 4. Moral issues related to methodological choices in HTA. 5. Moral issues related to HTA itself. Addressing the moral issues shall result in a broad basis for an open and transparent decision process. Conclusion A practical procedure has been developed for ethical analysis in HTA, based on an analysis of existing methods. The procedure is based on six steps and a selection of 32 moral issues to be addressed.
Book
Year: 2008 Publisher: Oslo : Norwegian Knowledge Centre for the Health Services,
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Background About 300 women get cervical cancer and about 100 die from cervical cancer every year in Norway. Cervical cancer is primarily caused by continuous infection with human papilloma virus (HPV), and over 120 strains of HPV have been identified. About 14 of these are are oncogenic. HPV-16 and HPV-18 can be found in about 70% of of the women with cervical cancer. Most HPV infections will cease by themselves, but where the infections persist, there is an increased risk for cellular changes. There exist vaccines against HPV 16/18, but there is yet no evidence that the vaccine is effective against cervical cancer. This has incited fierce debates on whether to introduce the HPV vaccine in national or statewide vaccination programs. This report aims at highlighting and discussing the moral aspects that are relevant for the decision making process with regards to HPV vaccine. Method The report uses a method developed for addressing ethical issues in health technology assessments (HTAs) that discusses central moral questions related to health interventions. The aim is not to give unequivocal answers to the questions, but rather to elucidate arguments and aspects that are important for decision makers and stake holders. Results The potential utility of HPV-16/18 vaccination is considerable, but morally challenging, as the real impact of HPV vaccination on cervical cancer is not known, and the vaccine is costly. Vaccination is an intervention towards healthy people, calling for special attention, especially as there is considerable uncertainty about its effects and side effects. It is challenging to assess future utility of potential prophylactic interventions against the utility of health interventions today. HPV vaccine of children is also challenging with respect to informed consent. Informing the public and potential persons to receive the vaccine appears to be a considerable challenge. Conclusion HPV vaccination can potentially save 40 women from getting cervical cancer every year and 13 from dying, but there is no evidence for this, and vaccination is costly. That raises a series of morally challenging issues that are important to address when deciding whether to implement the vaccine or not (and how to implement it).
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