 Subjects -> DISABILITY (Total: 100 journals)
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- THC volume 36 issue 6 Cover and Front matter
- PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320002184
Issue No: Vol. 36, No. 6 (2020)
- THC volume 36 issue 6 Cover and Back matter
- PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320002196
Issue No: Vol. 36, No. 6 (2020)
- Moving on from 2020 and looking forward to 2021 with a new and continuous
publication model- Authors: Wendy Babidge
Pages: 533 - 533
PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320002172
Issue No: Vol. 36, No. 6 (2020)
- Core competencies for ethics experts in health technology assessment
- Authors: Pietro Refolo; Kenneth Bond, Bart Bloemen, Ilona Autti-Rämö, Bjørn Hofmann, Claudia Mischke, Debjani Mueller, Sylvia Nabukenya, Wija Oortwijn, Lars Sandman, Michal Stanak, Duncan Steele, Gert Jan van der Wilt, Dario Sacchini
Pages: 534 - 539
Abstract: ObjectivesThere is no consensus on who might be qualified to conduct ethical analysis in the field of health technology assessment (HTA). Is there a specific expertise or skill set for doing this work' The aim of this article is to (i) clarify the concept of ethics expertise and, based on this, (ii) describe and specify the characteristics of ethics expertise in HTA.MethodsBased on the current literature and experiences in conducting ethical analysis in HTA, a group of members of the Health Technology Assessment International (HTAi) Interest Group on Ethical Issues in HTA critically analyzed the collected information during two face-to-face workshops. On the basis of the analysis, working definitions of “ethics expertise” and “core competencies” of ethics experts in HTA were developed. This paper reports the output of the workshop and subsequent revisions and discussions online among the authors.ResultsExpertise in a domain consists of both explicit and tacit knowledge and is acquired by formal training and social learning. There is a ubiquitous ethical expertise shared by most people in society; nevertheless, some people acquire specialist ethical expertise. To become an ethics expert in the field of HTA, one needs to acquire general knowledge about ethical issues as well as specific knowledge of the ethical domain in HTA. The core competencies of ethics experts in HTA consist of three fundamental elements: knowledge, skills, and attitudes.ConclusionsThe competencies described here can be used by HTA agencies and others involved in HTA to call attention to and strengthen ethical analysis in HTA.
PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320001968
Issue No: Vol. 36, No. 6 (2020)
- Prioritizing critical-care resources in response to COVID-19: lessons from
the development of Thailand's Triage protocol- Authors: Rachel A. Archer; Aniqa I. Marshall, Kanchanok Sirison, Woranan Witthayapipopsakul, Pisit Sriakkpokin, Somtanuek Chotchoungchatchai, Orapan Srisookwatana, Yot Teerawattananon, Viroj Tangcharoensathien
Pages: 540 - 544
Abstract: As COVID-19 ravages the world, many countries are faced with the grim reality of not having enough critical-care resources to go around. Knowing what could be in store, the Thai Ministry of Public Health called for the creation of an explicit protocol to determine how these resources are to be rationed in the situation of demand exceeding supply. This paper shares the experience of developing triage criteria and a mechanism for prioritizing intensive care unit resources in a middle-income country with the potential to be applied to other low- and middle-income countries (LMICs) faced with a similar (if not more of a) challenge when responding to the global pandemic. To the best of our knowledge, this locally developed guideline would be among the first of its kind from an LMIC setting. In summary, the experience from the Thai protocol development highlights three important lessons. First, stakeholder consultation and public engagement are crucial steps to ensure the protocol reflects the priorities of society and to maintain public trust in the health system. Second, all bodies and actions proposed in the protocol must not conflict with existing laws to ensure smooth implementation and adherence by professionals. Last, all components of the protocol must be compatible with the local context including medical culture, physician–patient relationship, and religious and societal norms.
PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320001890
Issue No: Vol. 36, No. 6 (2020)
- Telemedicine experience between two hospitals from Angola and Spain
- Authors: Eva Gil-Olivas; Fernando Salvador, Milagros Moreno, Cristina Bocanegra, María Luisa Aznar, Alberto Filipe, Agostinho Pessela, Raquel Mª Mateus, Adriano Zacarias, Teresa López, Yolima Cossio, Adrián Sánchez-Montalvá, Pau Bosch-Nicolau, Israel Molina
Pages: 545 - 548
Abstract: ObjectiveTelemedicine uses information and communication technologies to provide services in the field where the distance is a critical factor. The aim of the present study is to describe the experience of a synchronous telemedicine between two hospitals in Spain and Angola.MethodsThis is a retrospective observational study of all synchronous telemedicine sessions conducted between the Hospital Nossa Senhora da Paz in Angola and the Vall d'Hebron University Hospital in Spain from January 2011 to December 2014.ResultsSeventy-two cases were discussed in the telemedicine sessions. The average age of patients was 18.02 (SD 13.75) years and mostly women (54.38 percent). Reasons to discuss the cases were 46.47 percent doubts in the diagnosis and therapeutic management, 15.47 percent were purely formative cases, and only 8.45 percent treatment doubt. At the time of presentation, 29 percent of the patients were already diagnosed, 95 percent of whom with infectious disease diagnostic, and from the undiagnosed patients 36 percent presented a febrile syndrome.ConclusionThis study shows the viability of synchronous telemedicine between European and African countries without an excessively sophisticated technology.
PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320000847
Issue No: Vol. 36, No. 6 (2020)
- Ethics analysis of light and vitamin D therapies for seasonal affective
disorder- Authors: Michal Stanak; Christoph Strohmaier
Pages: 549 - 559
Abstract: ObjectiveThe aim of this ethics analysis was to highlight the overt and covert value issues with regard to two health technologies (light therapy and vitamin D therapy), the health technology assessment (HTA) and the disease of seasonal affective disorder (SAD). The present ethics analysis served as a chapter of a full HTA report that aimed to assist decision makers concerning the two technologies.MethodFirst, we used the revised Socratic approach of Hofmann et al. to build overarching topics of ethical issues, and then, we conducted a hand search and a comprehensive systematic literature search on between 12 and 14 February 2019 in seven databases.ResultsThe concrete ethical issues found concerned vulnerability of the target population and the imperative to treat depressive symptoms for the sake of preventing future harm. Further disease-related ethical issues concerned the questionable nature of SAD as a disease, autonomy, authenticity, and capacity for decision making of SAD patients, and the potential stigma related to the underdiagnosis of SAD, which is contrasted with the concern over unnecessary medicalization. Regarding the interventions and comparators, the ethical issues found concerned their benefit-harm ratios and the question of social inequality. The ethical issues related to the assessment process relate to the choice of comparators and the input data for the selected health economic studies.ConclusionsThe concrete ethical issues related to the interventions, the disease, and the assessment process itself were made overt in this ethics analysis. The ethics analysis provided an (additional) value context for making future decisions regarding light and vitamin D therapies.
PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320000884
Issue No: Vol. 36, No. 6 (2020)
- Quality of health economic evaluations submitted to the Italian Medicines
Agency: current state and future actions- Authors: Angelica Carletto; Matteo Zanuzzi, Annalisa Sammarco, Pierluigi Russo
Pages: 560 - 568
Abstract: ObjectivesThe purpose of this study was to evaluate the current state of health economic evaluations (HEEs) submitted by pharmaceutical companies to the Italian Medicines Agency (AIFA) as part of their pricing and reimbursement (P&R) dossiers, and to explore potential future actions in order to enhance their quality.MethodsAll company dossiers submitted from October 2016 to December 2018 were reviewed to select those containing pharmacoeconomic studies. The general characteristics of HEEs were described and their quality assessed based on a checklist adapted from Philips et al. (Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess. 2004;8: 1–158).ResultsOf the 299 dossiers submitted to AIFA, 105 included one or more pharmacoeconomic studies, of which fifty-three were cost-effectiveness analyses. Overall, the compliance of the HEEs with the quality checklist was highly variable: some studies reached high methodological standards whereas others had serious flaws (mean 59.22 percent, range 19.35–90.32 percent). The main weaknesses were the unjustified exclusion of relevant alternatives, poor description and justification of model data and assumptions, and insufficient exploration of uncertainty and study validity. Non-homogeneity across studies was found in study perspectives, discount rates, methods for costing, estimating quality-adjusted life-years and conducting sensitivity analyses.ConclusionsBased on the results of this study, the recommended actions for increasing the quality of HEEs within reimbursement submissions in Italy are twofold: first, to set methodological standards for conducting and reporting HEEs; second, to strengthen the internal assessment process, also through the acquisition of companies' models and re-evaluation of results. These actions will hopefully provide greater contribution to the evidence-based P&R decision making.
PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320000641
Issue No: Vol. 36, No. 6 (2020)
- Developing an agency's position with respect to patient involvement in
health technology assessment: the importance of the organizational culture
- Authors: Irina Cleemput; Marie Dauvrin, Laurence Kohn, Patriek Mistiaen, Wendy Christiaens, Christian Léonard
Pages: 569 - 578
Abstract: The Belgian Health Care Knowledge Centre (KCE) formally involves stakeholders in HTA since 2012. Patients are treated as one stakeholder amongst others, but it is recognized that patient involvement (PI) requires a different approach. The success of implementing PI depends, however, on the organizational culture toward PI.ObjectivesThe objective of this study was to map the PI culture at KCE in the context of the development of organization-wide supported position statements about PI.MethodsA nominal group technique was used to measure the PI culture at KCE. Arguments for and against PI and conditions for PI in different phases of the HTA process were collected. A literature review and interviews fed the draft position statements, for which support was assessed by means of a two-round Delphi process.ResultsArguments in favor of PI in HTA related to the relevance of the scope, expertise with data collection, bringing in fresh ideas for study design, access to survey participants, validation of data analyses, adherence to recommendations. Disadvantages and risks included the lack of scientific knowledge of involved patients, resources requirements, conflicts of interest, and heterogeneity within patient populations. Conditions for meaningful PI referred to measures mitigating the identified disadvantages. Eighteen position statements supported by KCE could be formulated.ConclusionThe KCE culture seems predominantly positive toward PI, although attitudes vary between HTA researchers. KCE recognizes the potential value of PI in HTA, but considers the level of involvement to be contingent on the topic and phase in the HTA process.
PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320000513
Issue No: Vol. 36, No. 6 (2020)
- Use of real-world data and evidence for medical devices: a qualitative
study of key informant interviews- Authors: Julie Polisena; Gayatri Jayaraman
Pages: 579 - 584
Abstract: IntroductionHealth Canada is committed to the modernization of the use of real-world data (RWD) and evidence (RWE) to support regulatory decisions. As such, telephone interviews with stakeholders, including government decision makers, health technology assessment (HTA) producers, industry, and patients, to understand their experiences with and perspectives on how to enhance RWE use for medical devices were performed.MethodsThirty-four semi-structured telephone interviews with forty key informants were conducted. Transcripts were reviewed independently by one individual to identify, define, and categorize key concepts and were verified by a second reviewer.Key FindingsThere are expectations for Health Canada to provide a framework and guidance on RWE use, identify relevant outcomes for data collection and criteria for data quality, conduct post-market surveillance more systematically, and partner with HTA organizations to develop methods for RWE generation. Stakeholders interviewed support the RWE use for regulatory decisions and HTA recommendations. Moreover, robust scientific methods for RWE generation will be critical to ensure that relevant questions are asked and rigorous statistical analyses are done to answer them. Patients are likely to consent to share their anonymized or de-identified medical information for nonprofit purposes.ConclusionsKey concepts from the interviews centered on the current and future RWE use for medical devices, considerations for the organizational, medical, scientific, and legal aspects and privacy issues of RWD collection or RWE generation, and options to implement the use of RWD and RWE. Our study findings will help inform the development of an RWE framework for regulatory decisions and HTA recommendations.
PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320000859
Issue No: Vol. 36, No. 6 (2020)
- Access to medicines in Turkey: Evaluation of the process of medicines
brought from abroad- Authors: Enver Kağan Atikeler; H.G.M. (Bert) Leufkens, Wim Goettsch
Pages: 585 - 591
Abstract: ObjectiveTurkey's health reforms started in 2003 with providing changes in regulatory, financing, and healthcare services. Access to health care and pharmaceuticals increased rapidly, and this resulted with an increase in public pharmaceutical expenditures. Our study aims to quantify and to evaluate the impact of a specific process within the Turkish system called “Medicines Brought From Abroad" (MBFA).MethodsWe reviewed the general reimbursement legislations of Social Security Institution (SSI), the guideline on MBFA, the SSI reimbursement list, the list of MBFA published by the Ministry of Health to describe the current supply mechanism of medicines and, in particular, the role of MBFA.ResultsTotal costs of the of MBFA medicines over the period 2011–17 went up to more than $520 million, which takes 7.5 percent of total public pharmaceutical expenditure for 2017. Our results showed that MBFA provides access to many orphan drugs and in total, forty-two orphan drugs listed in MBFA accounted for 83 percent of all MBFA budget in the year 2017. Nine of the top ten MBFA medicines were orphan drugs and total costs were $408 million. The highest budget impact was for eculizumab for “paroxysmal nocturnal hemoglobinuria” (PNH), covering 31 percent of total MBFA costs and 2.3 percent of overall drug costs in 2017.ConclusionsTurkey faced significant challenges for creating an access pathway for innovative medicines while continuing the sustainability of the public pharmaceutical budget like many other countries. Therefore, it may be argued that Turkey needs to create an independent health technology assessment organization to provide sustainable access to medicines in the future.
PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320000872
Issue No: Vol. 36, No. 6 (2020)
- The rationale and design of public involvement in health-funding decision
making: focus groups with the Canadian public- Authors: Edilene Lopes; Jackie Street, Tania Stafinski, Tracy Merlin, Drew Carter
Pages: 592 - 598
Abstract: BackgroundWorldwide, governments employ health technology assessment (HTA) in healthcare funding decision making. Requests to include public perspectives in this are increasing, with the idea being that the public can identify social values to guide policy development, increasing the transparency and accountability of government decision making.ObjectiveTo understand the perspectives of the Canadian public on the rationale and design of public involvement in HTA.DesignA demographically representative sample of residents of a Canadian province was selected to take part in two sets of two focus groups (sixteen people for the first set and twenty for the second set).ResultsParticipants were suspicious of the interests driving various stakeholders involved in HTA. They saw the public as uniquely impartial though also lacking knowledge about health technologies. Participants were also suspicious of personal biases and commended mechanisms to reduce their impact. Participants suggested various involvement methods, such as focus groups, citizens' juries and surveys, noting advantages and disadvantages belonging to each and commending a combination.Discussion and conclusionsWe identified a lack of public understanding of how decisions are made and distrust concerning whose interests and values are being considered. Public involvement was seen as a way of providing information to the public and ascertaining their views and values. Participants suggested that public involvement should employ a mixed-methods strategy to support informed debate and participation of a large number of people.
PubDate: 2020-12-01T00:00:00.000Z
DOI: 10.1017/S0266462320000537
Issue No: Vol. 36, No. 6 (2020)
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