Health Care Analysis最新文献

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.

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.

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.

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.

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.

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.

Person centered care (PCC) invites ideas of shared responsibility as a direct result of its shared decision making (SDM) process. The intersection of PCC and psychiatric contexts brings about what I refer to as the responsibility problem, which seemingly arises when SDM is applied in psychiatric settings due to (1) patients' potentially diminished capacities for responsibility, (2) tension prompted by professional reasons for and against sharing responsibility with patients, as well as (3) the responsibility/blame dilemma. This paper aims to do away with the responsibility problem through arguing for a functional approach to mental illness, a blameless responsibility ascription to the person with mental illness, as well as a nuanced understanding of SDM as part of an emancipation-oriented PCC model.

Antimicrobial resistance is one of the greatest public health crises of our time. The natural biological process that causes microbes to become resistant to antimicrobial drugs presents a complex social challenge requiring more effective and sustainable management of the global antimicrobial commons-the common pool of effective antimicrobials. This special issue of Health Care Analysis explores the potential of two legal approaches-one long-term and one short-term-for managing the antimicrobial commons. The first article explores the lessons for antimicrobial resistance that can be learned from recent climate change agreements, and the second article explores how existing international laws can be adapted to better support global action in the short-term.

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.