Health Care Analysis最新文献_第5页

Balancing Intelectual Property Protection and Legal Risk Assessment in Registration of Covid-19 Vaccines in Malaysia. 在马来西亚Covid-19疫苗注册中平衡知识产权保护和法律风险评估。

IF 1.9 3区哲学

Health Care Analysis Pub Date : 2023-12-01 Epub Date: 2023-07-21 DOI: 10.1007/s10728-023-00465-9

Haniff Ahamat, Hairanie Sa'ban, Nazura Abdul Manap

{"title":"Balancing Intelectual Property Protection and Legal Risk Assessment in Registration of Covid-19 Vaccines in Malaysia.","authors":"Haniff Ahamat, Hairanie Sa'ban, Nazura Abdul Manap","doi":"10.1007/s10728-023-00465-9","DOIUrl":"10.1007/s10728-023-00465-9","url":null,"abstract":"The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area.","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":"196-207"},"PeriodicalIF":1.9,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10223220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Should Severity Assessments in Healthcare Priority Setting be Risk- and Time-Sensitive? 医疗保健优先级设置中的严重程度评估是否应具有风险和时间敏感性?

IF 1.9 3区哲学

Health Care Analysis Pub Date : 2023-12-01 Epub Date: 2023-08-01 DOI: 10.1007/s10728-023-00460-0

Lars Sandman, Jan Liliemark

{"title":"Should Severity Assessments in Healthcare Priority Setting be Risk- and Time-Sensitive?","authors":"Lars Sandman, Jan Liliemark","doi":"10.1007/s10728-023-00460-0","DOIUrl":"10.1007/s10728-023-00460-0","url":null,"abstract":"Background: Severity plays an essential role in healthcare priority setting. Still, severity is an under-theorised concept. One controversy concerns whether severity should be risk- and/or time-sensitive. The aim of this article is to provide a normative analysis of this question.Methods: A reflective equilibrium approach is used, where judgements and arguments concerning severity in preventive situations are related to overall normative judgements and background theories in priority-setting, aiming for consistency. Analysis, discussion, and conclusions: There is an argument for taking the risk of developing a condition into account, and we do this when we consider the risk of dying in the severity assessment. If severity is discounted according to risk, this will 'dilute' severity, depending on how well we are able to delineate the population, which is dependent on the current level of knowledge. This will potentially have a more far-reaching effect when considering primary prevention, potentially the de-prioritisation of effective preventive treatments in relation to acute, less-effective treatments. The risk arguments are dependent on which population is being assessed. If we focus on the whole population at risk, with T0 as the relevant population, this supports the risk argument. If we instead focus on the population of as-yet (at T0) unidentified individuals who will develop the condition at T1, risk will become irrelevant, and severity will not be risk sensitive. The strongest argument for time-sensitive severity (or for discounting future severity) is the future development of technology. On a short timescale, this will differ between different diagnoses, supporting individualised discounting. On a large timescale, a more general discounting might be acceptable. However, we need to also consider the systemic effects of allowing severity to be risk- and time-sensitive.","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":"169-185"},"PeriodicalIF":1.9,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10693510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10287438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Exploring the Decision-Making Process of People Living with HIV Enrolled in Antiretroviral Clinical Trials: A Qualitative Study of Decisions Guided by Trust and Emotions. 艾滋病毒感染者参与抗逆转录病毒临床试验的决策过程探索:信任和情绪引导下的决策定性研究

IF 1.9 3区哲学

Health Care Analysis Pub Date : 2023-12-01 Epub Date: 2023-07-21 DOI: 10.1007/s10728-023-00461-z

Maria Feijoo-Cid, Antonia Arreciado Marañón, Ariadna Huertas, Amado Rivero-Santana, Carina Cesar, Valeria Fink, María Isabel Fernández-Cano, Omar Sued

{"title":"Exploring the Decision-Making Process of People Living with HIV Enrolled in Antiretroviral Clinical Trials: A Qualitative Study of Decisions Guided by Trust and Emotions.","authors":"Maria Feijoo-Cid, Antonia Arreciado Marañón, Ariadna Huertas, Amado Rivero-Santana, Carina Cesar, Valeria Fink, María Isabel Fernández-Cano, Omar Sued","doi":"10.1007/s10728-023-00461-z","DOIUrl":"10.1007/s10728-023-00461-z","url":null,"abstract":"The informed consent is an ethical and legal requirement for potential participants to enroll in a study. There is ample of evidence that understanding consent information and enrollment is challenging for participants in clinical trials. On the other hand, the reasoning process behind decision-making in HIV clinical trials remains mostly unexplored. This study aims to examine the decision-making process of people living with HIV currently participating in antiretroviral clinical trials and their understanding of informed consent. We conducted a qualitative socio-constructivist study using semi-structured interviews. Eleven participants were selected by purposive sampling in Argentina until data saturation was reached. A content analysis was performed. The findings highlight the fact that some participants decided to enroll on the spot, while others made the decision a few days later. In all cases, the decision was based on different aspects of trust (in doctors, in the clinical research site, in the clinical trials system) but also on emotions associated with HIV and/or treatment. Moreover, while people living with HIV felt truly informed after the consent dialogue with a researcher, consent forms were unintelligible and unfriendly. The immediacy of patient decision-making has rarely been described before. Enrollment in an HIV clinical trial is mainly a trust-based decision but this does not contradict the ethical values of autonomy, voluntariness, non-manipulation, and non-exploitation. Thus, trust is a key issue to be included in reshaping professional practices to ensure the integrity of the informed consent process.","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":" ","pages":"135-155"},"PeriodicalIF":1.9,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10693520/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9851393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Improvidence, Precaution, and the Logical-Empirical Disconnect in UK Health Policy. 英国卫生政策中的疏忽、预防和逻辑-经验脱节。

IF 1.9 3区哲学

Health Care Analysis Pub Date : 2023-06-01 DOI: 10.1007/s10728-022-00450-8

Jordan A Parsons

{"title":"Improvidence, Precaution, and the Logical-Empirical Disconnect in UK Health Policy.","authors":"Jordan A Parsons","doi":"10.1007/s10728-022-00450-8","DOIUrl":"https://doi.org/10.1007/s10728-022-00450-8","url":null,"abstract":"The last decade has seen significant developments in UK health policy, with are largely claimed to be evidence based. However, such a characterisation ought, in many cases, to be questioned. Policies can be broadly understood as based primarily on either a logical or empirical case. In the absence of relevant empirical evidence, policymakers understandably appeal to logical cases. Once such evidence is available, however, it can inform policy and enable the logical case to be set aside. Such a linear policy process is not always the reality, and logical cases often continue to guide policy decisions in direct opposition to empirical evidence. In this paper, I discuss two recent examples of this disconnect between logical and empirical cases in UK health policy. The first-organ donation-illustrates an example of a significant policy change being made in opposition to the evidence. I refer to this as the improvidence approach. The second-abortion-provides an example of policymakers not making a change that has extensive supporting data. I refer to this using the more recognisable language of the precautionary approach. Ultimately, I argue that both the improvidence and precautionary approaches are examples of problematic public policy where policymakers provide no explicit justification for going against the evidence.","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":"31 2","pages":"114-133"},"PeriodicalIF":1.9,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9791148/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9339523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development of the Inclination Toward Conscientious Objection Scale for Physicians. 医师良心拒服兵役倾向量表的编制。

IF 1.9 3区哲学

Health Care Analysis Pub Date : 2023-06-01 DOI: 10.1007/s10728-022-00452-6

Şükrü Keleş, Osman Dağ, Murat Aksu, Gizem Gülpinar, Neyyire Yasemin Yalım

{"title":"Development of the Inclination Toward Conscientious Objection Scale for Physicians.","authors":"Şükrü Keleş, Osman Dağ, Murat Aksu, Gizem Gülpinar, Neyyire Yasemin Yalım","doi":"10.1007/s10728-022-00452-6","DOIUrl":"https://doi.org/10.1007/s10728-022-00452-6","url":null,"abstract":"This study aims to develop a valid and reliable scale to assess whether a physician is inclined to take conscientious objection when asked to perform medical services that clash with his/her personal beliefs. The scale, named the Inclination toward Conscientious Objection Scale, was developed for physicians in Turkey. Face validity, content validity, criterion-related validity, and construct validity of the scale were evaluated in the development process. While measuring criterion-related validity, Student's t-test was used to identify the groups that did and did not show inclination toward conscientious objection. There were 126 items in the initial item pool, which reduced to 42 after content validity evaluation by five experts. After necessary adjustments, the scale was administered to 224 participants. Both exploratory and confirmatory factor analyses were performed to investigate factor structure. The split-half method was employed to assess scale reliability, and the Spearman-Brown coefficient was calculated. Cronbach's alpha reliability coefficient was used to estimate the internal consistency of the scale items. The distinctiveness of the items was evaluated using Student's t-test. The lower and upper 27% groups were compared to assess the distinctiveness of the scale. The items were loaded on four factors that explained 85.46% of the variance: \"Conscientious Objection - Medical Profession Relationship,\" \"Conscientious Objection in Medical Education and Medical Practice,\" \"Conscientious Objection with regard to the Concept of Rights\" and \"Conscientious Objection - Physician's Professional Identity and Role.\" The final scale has 40 items, and was found to be valid and reliable with high internal consistency.","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":"31 2","pages":"81-98"},"PeriodicalIF":1.9,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9402383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Correction to: Regulating the Global Antimicrobial Commons: Climate Agreements and Beyond. 更正:调节全球抗微生物公域:气候协议及其他。

IF 1.9 3区哲学

Health Care Analysis Pub Date : 2023-06-01 DOI: 10.1007/s10728-023-00457-9

Philippe Cullet

引用次数: 0

Policy Narratives on Palliative Care in Sweden 1974-2018. 1974-2018年瑞典姑息治疗政策叙述。

IF 1.9 3区哲学

Health Care Analysis Pub Date : 2023-06-01 DOI: 10.1007/s10728-022-00449-1

Axel Ågren, Barbro Krevers, Elisabet Cedersund, Ann-Charlotte Nedlund

{"title":"Policy Narratives on Palliative Care in Sweden 1974-2018.","authors":"Axel Ågren, Barbro Krevers, Elisabet Cedersund, Ann-Charlotte Nedlund","doi":"10.1007/s10728-022-00449-1","DOIUrl":"https://doi.org/10.1007/s10728-022-00449-1","url":null,"abstract":"In Sweden, efforts to govern end-of-life care through policies have been ongoing since the 1970s. The aim of this study is to analyse how policy narratives on palliative care in Sweden have been formulated and have changed over time since the 1970s up to 2018. We have analysed 65 different policy-documents. After having analysed the empirical material, three policy episodes were identified. In Episode 1, focus was on the need for norms, standards and a psychological end-of-life care with the main goal of solving the alleged deficiencies within end-of-life care in hospital settings. Episode 2 was characterised by an emphasis on prioritising end-of-life care and dying at home, and on the fact that the hospice care philosophy should serve as inspiration. In Episode 3, the need for a palliative care philosophy that transcended all palliative care and the importance of systematic follow-ups and indicators was endorsed. Furthermore, human value and freedom of choice were emphasised. In conclusion, the increase of policy-documents produced by the welfare-state illustrate that death and dying have become matters of public concern and responsibility. Furthermore, significant shifts in policy narratives display how notions of good palliative care change, which in turn may affect both the practice and the content of care at the end of life.","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":"31 2","pages":"99-113"},"PeriodicalIF":1.9,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10126030/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9356183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Shared Decision Making in Psychiatry: Dissolving the Responsibility Problem. 精神病学中的共同决策:解决责任问题。

IF 1.9 3区哲学

Health Care Analysis Pub Date : 2023-06-01 DOI: 10.1007/s10728-022-00451-7

Leila El-Alti

引用次数: 0

Governing the Global Antimicrobial Commons: Introduction to Special Issue. 管理全球共同抗微生物药物:特刊导论。

IF 1.9 3区哲学

Health Care Analysis Pub Date : 2023-03-01 DOI: 10.1007/s10728-019-00388-4

Steven J Hoffman, Julian Savulescu, Alberto Giubilini, Claas Kirchhelle, Susan Rogers Van Katwyk, Isaac Weldon, Brooke Campus, Mark Harrison, Hannah Maslen, Angela McLean

引用次数: 3

Exploring Models for an International Legal Agreement on the Global Antimicrobial Commons: Lessons from Climate Agreements. 探索全球抗菌药物共享国际法律协议的模式：气候协议的经验教训。

IF 1.9 3区哲学

Health Care Analysis Pub Date : 2023-03-01 DOI: 10.1007/s10728-019-00389-3

Susan Rogers Van Katwyk, Alberto Giubilini, Claas Kirchhelle, Isaac Weldon, Mark Harrison, Angela McLean, Julian Savulescu, Steven J Hoffman

{"title":"Exploring Models for an International Legal Agreement on the Global Antimicrobial Commons: Lessons from Climate Agreements.","authors":"Susan Rogers Van Katwyk, Alberto Giubilini, Claas Kirchhelle, Isaac Weldon, Mark Harrison, Angela McLean, Julian Savulescu, Steven J Hoffman","doi":"10.1007/s10728-019-00389-3","DOIUrl":"10.1007/s10728-019-00389-3","url":null,"abstract":"An international legal agreement governing the global antimicrobial commons would represent the strongest commitment mechanism for achieving collective action on antimicrobial resistance (AMR). Since AMR has important similarities to climate change-both are common pool resource challenges that require massive, long-term political commitments-the first article in this special issue draws lessons from various climate agreements that could be applicable for developing a grand bargain on AMR. We consider the similarities and differences between the Paris Climate Agreement and current governance structures for AMR, and identify the merits and challenges associated with different international forums for developing a long-term international agreement on AMR. To be effective, fair, and feasible, an enduring legal agreement on AMR will require a combination of universal, differentiated, and individualized requirements, nationally determined contributions that are regularly reviewed and ratcheted up in level of ambition, a regular independent scientific stocktake to support evidence informed policymaking, and a concrete global goal to rally support.","PeriodicalId":46740,"journal":{"name":"Health Care Analysis","volume":"31 1","pages":"25-46"},"PeriodicalIF":1.9,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/s10728-019-00389-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9198731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 31