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Chapter 8 examines regulatory rules, beginning with an examination of written rules. It underlines the inescapability of interpretive uncertainty and considers ways in which that uncertainty can be addressed, including varying the precision of rules, how they are specified, the publication of interpretive ‘guidance’ (sometimes called ‘soft law’) and the delegation of detailed standard-setting to ‘technical experts’.
An introduction and overview of intellectual disability. The American Psychiatric Association (APA) diagnostic criteria for intellectual disability (DSM-5 criteria) are covered: Deficits in general mental abilities; Impairment in adaptive functioning for individual’s age and sociocultural background which may include communication, social skills, person independence, and school or work functioning; All symptoms must have an onset during the developmental period; The condition may be subcategorised according to severity based on adaptive functioning as mild, moderate, or severe. The chapter also covers the role and evidence base for medication and key issues when prescribing for people with intellectual disability.
People with intellectual disability are more likely to experience mental health difficulties, and their treatment responses may differ from those in the general population. This book, written by leading clinical practitioners from around the world, provides comprehensive guidance on prescribing for people with intellectual disability, as well as general information on their clinical care. The guidelines have been conceived and developed by clinicians working in intellectual disability services. Combining the latest evidence and expert opinion, they provide a consensus approach to prescribing as part of a holistic package of care, and include numerous case examples and scenarios. Now in its fourth edition, this update reflects the changes in prescribing practice; it places emphasis on clinical scenarios and case examples and includes input from service users and their families. This is a practical guide for busy clinicians, and a valuable reference for all primary and secondary healthcare professionals.
This chapter is a guide to taking on a first consultant post in forensic psychiatry, a guide to supervising trainee doctors in forensic psychiatry and an overview of advice from a group of senior clinical directors in forensic psychiatry across multiple jurisdictions. It is designed to offer informal advice to consultant forensic psychiatrists on a wide range of issues that pertain to clinical practice and management that is rarely contained in textbooks.
Operationalization guidance is needed to support health technology assessment (HTA) bodies considering implementing lifecycle HTA (LC-HTA) approaches. The 2022 Health Technology Assessment International (HTAi) Global Policy Forum (GPF) established a Task Force to develop a position paper on LC-HTA. In its first paper, the Task Force established a definition and framework for LC-HTA in order to tailor it to specific decision problems. This second paper focused on the provision of practical operational guidance to implement LC-HTA. Detailed descriptions of the three LC-HTA operational steps are provided (defining the decision problem, sequencing of HTA activities, and developing optimization criteria) and accompanied by worked examples and an operationalization checklist with 20 different questions for HTA bodies to consider when developing an LC-HTA approach. The questions were designed to be applicable across different types of HTA and scenarios, and require adaptation to local jurisdictions, remits, and context.
The Old Testament book of Samuel is an intriguing narrative that offers an account of the origin of the monarchy in Israel. It also deals at length with the fascinating stories of Saul and David. In this volume, John Goldingay works through the book, exploring the main theological ideas as they emerge in the narratives about Samuel, Saul, and David, as well as in the stories of characters such as Hannah, Michal, Bathsheba, and Tamar. Goldingay brings out the key ideas about God and God's involvement in the lives of people, and their involvement with him through prayer and worship. He also delves into the mystery and complexity of human persons and their roles in events. Goldingay's study traces how God pursues his purpose for Israel and, ultimately, for the world in these narratives. It shows how this pursuit is interwoven with the realities of family, monarchy, war, love, ambition, loss, failure, and politics.
Since the first edition was published in 2009, there have been significant advances in diagnostics and management of viral infections, as well as newly discovered viruses such as SARS-CoV-2 and Zika virus. This new edition provides up-to-date information on the key developments in clinical and diagnostic virology, especially molecular diagnosis, with guidance on new molecular and bedside tests. Effective antiviral treatments and novel combinations of treatments recently introduced are covered in depth. Infection control precautions and pandemic preparedness are discussed, with a focus on recent outbreaks. As with the first edition, coverage is succinct and practical with easily accessible information in algorithms and tables, and standardised chapter layouts organised from A to Z. This is an ideal introduction to complex topics for healthcare trainees, as well as a handy and easily accessible reference for more experienced hospital clinicians and primary care physicians.
Edited by
Roland Dix, Gloucestershire Health and Care NHS Foundation Trust, Gloucester,Stephen Dye, Norfolk and Suffolk Foundation Trust, Ipswich,Stephen M. Pereira, Keats House, London
Psychiatric intensive care units (PICUs) treat patients with an acute episode of a major mental illness who present with additional risk of harm to themselves or others that cannot be managed on an acute psychiatric ward. This chapter outlines standards of care that are expected upon such units, what they are and how the standards were developed with clinical rationale. It also gives examples of other guidelines and standards that impact practice within a PICU setting. It also describes the process of quality improvement in such units and how this relates to continual positive progress within a PICU setting. It alludes to how the principles of psychiatric intensive care can be incorporated within other settings and the need for clear definition of subspecialities within psychiatry.
In his treatment of the Wittgensteinian paradox about rule-following, Saul Kripke represents the non-reductionist approach, according to which meaning something by an expression is a sui generis state that cannot be elucidated in more basic terms, as brushing philosophical questions under the rug. This representation of non-reductionism aligns with the conception of some of its proponents. Meaning is viewed by these philosophers as an explanatory primitive that provides the basic materials for philosophical inquiry, and whose nature cannot serve as an object for that inquiry. There is, however, an alternative way of conceiving of non-reductionism, which makes it possible to tackle philosophical questions about the nature of meaning head-on, and thus to respond to Kripke’s challenge in an illuminating manner.
This chapter begins by exploring the causes of the uneasy relationship between cultural heritage and law and the relationship that has developed between law and other non-law initiatives to care for cultural heritage in the UK. In developing an integrated approach to the care of cultural heritage, by considering both legal and non-legal instruments, the terminology of ‘nested practices of care’ (drawn from the work of Joan Tronto) is adopted. These different practices of care form the corpus of study for this book and demonstrate the varied way in which care is provided in the UK. In addition to cultural heritage frameworks consisting of multiple nested practices, other sources of law and non-law dealing with general principles provide care and are therefore treated as nested practices of care. The analysis adopted in this book does not lose sight of the hierarchy of norms and enforceability of the different legal and non-legal instruments, but nevertheless does treat these different elements as contributing to the communities of care across the UK.
Interim analyses in clinical trials can take on a multitude of forms. They are often used to guide Data and Safety Monitoring Board (DSMB) recommendations to study teams regarding recruitment targets for large, later-phase clinical trials. As collaborative biostatisticians working and teaching in multiple fields of research and across a broad array of trial phases, we note the large heterogeneity and confusion surrounding interim analyses in clinical trials. Thus, in this paper, we aim to provide a general overview and guidance on interim analyses for a nonstatistical audience. We explain each of the following types of interim analyses: efficacy, futility, safety, and sample size re-estimation, and we provide the reader with reasoning, examples, and implications for each. We emphasize that while the types of interim analyses employed may differ depending on the nature of the study, we would always recommend prespecification of the interim analytic plan to the extent possible with risk mitigation and trial integrity remaining a priority. Finally, we posit that interim analyses should be used as tools to help the DSMB make informed decisions in the context of the overarching study. They should generally not be deemed binding, and they should not be reviewed in isolation.
Advances in the digitization of health systems and expedited regulatory approvals of innovative treatments have led to increased potential for the use of real-world data (RWD) to generate real-world evidence (RWE) to complement evidence from clinical trials. However, health technology assessment (HTA) bodies and payers have concerns about the ability to generate RWE of sufficient quality to be pivotal evidence of relative treatment effectiveness. Consequently, there is a growing need for HTA bodies and payers to develop guidance for the industry and other stakeholders about the use of RWD/RWE to support access, reimbursement, and pricing. We therefore sought to (i) understand barriers to the use of RWD/RWE by HTA bodies and payers; (ii) review potential solutions in the form of published guidance; and (iii) review findings with selected HTA/payer bodies. Four themes considered key to shaping the generation of robust RWE for HTA bodies and payers were identified as: (i) data (availability, governance, and quality); (ii) methodology (design and analytics); (iii) trust (transparency and reproducibility); and (iv) policy and partnerships. A range of guidance documents were found from trusted sources that could address these themes. These were discussed with HTA experts. This commentary summarizes the potential guidance solutions available to help resolve issues faced by HTA decision-makers in the adoption of RWD/RWE. It shows that there is alignment among stakeholders about the areas that need improvement in the development of RWE and that the key priority to move forward is better collaboration to make data usable for multiple purposes.
Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR—The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap.
Methods
The joint Task Force consisted of fifteen members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to two rounds of peer review.
Results
A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation.
Conclusions
The guidance and the checklist contain a series of questions, grouped by six phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.
Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc.). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals, as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.
Evidence-informed deliberative processes (EDPs) were introduced to guide health technology assessment (HTA) agencies to improve their processes toward more legitimate decision making. A survey among members of the International Network of Agencies for HTA (INAHTA) showed that EDPs can also be relevant for countries that have not (yet) established such an agency. Therefore, we explored to what extent low- and middle-income countries (LMIC) applied the steps and elements stipulated in the EDP framework and their need for guidance.
Methods
The survey among INAHTA members was slightly adapted to address LMIC context and sent to 416 experts identified through several HTA sources. The questions focused on contextual factors and the EDP steps (installation of an appraisal committee, selecting technologies and criteria, assessment, appraisal, communication and appeal). Data collection took place between 21 May and 1 September 2019. Descriptive statistics and qualitative analyses were used to summarize the findings.
Results
We received sixty-six meaningful responses from experts in thirty-two LMIC. We found that contextual factors to support HTA development are overall not present or only present to some extent. Respondents indicated that guidance was needed for specific elements related to selecting technologies and criteria, assessment, appraisal, as well as communication and appeal.
Conclusions
EDPs have the potential to provide steps for improving HTA processes. The results of this study can serve as a baseline measurement for future monitoring and evaluation of EDP application in the responding LMIC. This could support the countries in improving their processes and enhancing legitimate decision making when using HTA.
As the COVID-19 pandemic escalates worldwide, it is apparent that many patients with more severe illness will also experience delirium. These patients pose a particular challenge in the application of optimal care due to issues with infectious risk, respiratory compromise and potential interactions between medications that can be used to manage delirium with antiviral and other treatments used for COVID-19. We describe a guidance resource adapted from existing guidelines for delirium management that has been tailored to the specific challenge of managing delirium in patients with COVID-19 infection. Issues around the assessment and treatment of these patients are examined and distilled into a simple (one-paged guidance resource that can assist clinicians in managing suspected delirium.
If emotions have a rational role in action, then one challenge for accounting for how we can act rationally when acting emotionally is to show how we can guide our actions by our emotional considerations, seen as reasons. In this paper, I put forward a novel proposal for how this can be so. Drawing on the interconnection between emotions, cares and caring, I argue that, as the emotional agent is a caring agent, she can be aware of the emotional consideration as a pro tanto reason favouring an action choice and, even, as the reason for which she should act.
Outpatient interventions for adult anorexia nervosa typically have a modest impact on weight and eating disorder symptomatology. This study examined whether adding a brief online intervention focused on enhancing motivation to change and the development of a recovery identity (RecoveryMANTRA) would improve outcomes in adults with anorexia nervosa.
Methods
Participants with anorexia nervosa (n = 187) were recruited from 22 eating disorder outpatient services throughout the UK. They were randomised to receiving RecoveryMANTRA in addition to treatment as usual (TAU) (n = 99; experimental group) or TAU only (n = 88; control group). Outcomes were measured at end-of-intervention (6 weeks), 6 and 12 months.
Results
Adherence rates to RecoveryMANTRA were 83% for the online guidance sessions and 77% for the use of self-help materials (workbook and/or short video clips). Group differences in body mass index at 6 weeks (primary outcome) were not significant. Group differences in eating disorder symptoms, psychological wellbeing and work and social adjustment (at 6 weeks and at follow-up) were not significant, except for a trend-level greater reduction in anxiety at 6 weeks in the RecoveryMANTRA group (p = 0.06). However, the RecoveryMANTRA group had significantly higher levels of confidence in own ability to change (p = 0.02) and alliance with the therapist at the outpatient service (p = 0.005) compared to the control group at 6 weeks.
Conclusions
Augmenting outpatient treatment for adult anorexia nervosa with a focus on recovery and motivation produced short-term reductions in anxiety and increased confidence to change and therapeutic alliance.