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This chapter examines how international relations (IR) scholarship has approached two central questions concerning international law and legalisation: why do states create international law, and what makes a particular norm ‘legal’ in nature? It then outlines the concept of legalisation as described in Abbott et al.’s well-known article of the same name. Under the classic legalisation framework, legalisation has three components: obligation, precision and delegation. The chapter argues that the classic OPD framework cannot fully capture the expanding role of non-state actors or conceptualise law as a process. It therefore proposes an adapted model for the transnational legal system that incorporates a crucial omitted dimension – implementation. Implementation refers to the concrete actions taken by agents to translate legal or law-like principles into practical, workable instructions for courts, governments, companies, and other non-state actors.
This introductory chapter sets out the book’s key findings, methodology and structure. It also introduces the principal questions the book seeks to address. How have agents, operating at national, international and transnational levels, attempted to institutionalise the norm of corporate accountability for human rights violations linked to transnational corporate activity? What do these initiatives reveal about the nature of transnational legalisation, and how legalisation should be framed or conceptualised in the twenty-first century? Finally, could a revised framework of legalisation help explain when transnational litigation and soft law initiatives are more likely to succeed in the future?
This chapter analyses efforts within the United Nations to develop legal and normative frameworks for transnational corporations (TNCs) and human rights, beginning in the 1970s. It first considers the UN Code of Conduct for Transnational Corporations and explains why this initiative failed to materialise despite many years of negotiation. It then examines the Global Compact, which reflects emerging trends in legalisation through its emphasis on implementation, participation by non-state actors, and reliance on consensus-building and norm promotion. The chapter next reviews the rise and fall of the Draft Norms, before turning to the development of the UN Guiding Principles on Business and Human Rights. This section highlights the innovative nature of Ruggie’s constructivist approach to generating new legal and social norms. A new treaty process, initiated in 2014, remains ongoing and suggests that traditional legalisation strategies continue to retain relevance in certain contexts.
This chapter develops a theory of singular compositional explanation. The core idea is that a singular compositional explanation is a representation of an ontological dependence relation between entities mentioned in a representation of an explanans and entities mentioned in a representation of an explanandum. The account is realist in the sense that it postulates a real relation among entities in the world that would have been rejected by logical empiricists. Explanations are singular in the sense that the explanandum entity is a single spatiotemporal particular and the explanans entities are individual spatiotemporal particulars. The explanations are compositional in the sense that the explanandum entity is an individual, an individual property instance, or an individual activity instance that is explained by sets of lower level individuals, lower level property instances, or lower level activity instances.
Children’s Advocacy Centers (CACs) use multidisciplinary teams to respond to child abuse allegations. These fluid teams can benefit from team training to enhance team functioning and performance and strengthen the workforce, but they need guidance and resources to support the implementation of team training.
Methods:
We conducted a cluster-randomized hybrid effectiveness-implementation trial to test the effectiveness of team training and evaluate a self-guided implementation process. Six rural CACs (N = 172 team members) were randomized to TeamTRACS (Team Training in Roles, Awareness, Communication, & Support; n = 4) or a waitlist comparison (n = 2). Simultaneous mixed methods evaluated the effectiveness of TeamTRACS (QUAN + qual) and the implementation process (quan + QUAL).
Results:
Reactions to TeamTRACS were positive (mean ratings > 4.5 on 1–5 scale), and TeamTRACS significantly increased teamwork knowledge (estimated marginal means = 80% vs. 75% [intent-to-treat]; 85% vs. 76% [training attendance]). There were no effects on skill use or work-related outcomes. Changes in team-level outcomes were small and inconsistent; one TeamTRACS team made substantial improvements. Reactions to self-guided implementation were positive (mean ratings > 4 on 1–5 scale). However, only one team completed the implementation process. Challenges included difficulty forming and maintaining a change team, turnover and understaffing, and competing priorities and a short timeframe.
Conclusions:
Overall, TeamTRACS and its self-guided implementation process were positively received. Incomplete implementation may have limited TeamTRACS’ effectiveness. Longer timeframes and external support may improve the implementation of team training in low-resource settings.
Chapter 10 provides a comprehensive overview of the challenges posed by rapid urbanisation in China and its impact on urban stormwater management. The chapter introduces the “Sponge City” initiative, whose implementation started by the Chinese government in 2013, as a strategic response to address these challenges. Drawing inspiration from low impact development (LID) and best management practices (BMPs), the Sponge City concept represents a paradigm shift from conventional rapid draining to a more sustainable and flexible stormwater management approach. The authors discuss the key concepts, implementation strategies and technical guidelines for Sponge City construction, supported by case studies from pilot cities such as Shenzhen, Tianjin and Xi’an. The Sponge City initiative reflects a harmonious blend of ancient Chinese wisdom and modern Western stormwater management concepts, offering a promising solution for sustainable urban development in the face of rapid urbanisation in China.
Psychosocial interventions are vital in treating severe mental illness, yet their use remains limited, and patients often lack adequate information about them. Patient-focused versions of clinical guidelines are designed to enhance mental health literacy and inform patients about available treatments, but these resources are underutilized. This study evaluated the impact of implementing a patient-focused psychosocial intervention guideline on empowerment, knowledge, and use of psychosocial interventions among individuals with severe mental illness.
Methods
Multicentre, cluster-randomised trial. The study population comprised adult patients with a severe mental disorder. The intervention group received a multimodal, structured, and protocol-led patient-focused guideline implementation, whereas the control group received treatment as usual. Data were analysed using hierarchical linear models. The primary outcome was the change in patients’ empowerment.
Results
There was no significant intervention effect on empowerment (effect size=0.13, p=0.605), which increased slightly in both groups. The number of psychosocial interventions familiar to patients increased significantly more in the intervention group. Exploratory analyses suggest that patient empowerment could have been influenced by COVID-19-related stress, patient age, the severity of functional impairment, and migration background. The improvement in the utilisation of psychosocial interventions did not differ significantly between the intervention group (M=1.1, SD=2.5) and the control group (M=1.3, SD=2.4).
Conclusions
The implementation of a patient-focused psychosocial intervention guideline failed to enhance empowerment among service users. However, our analyses indicate that the intervention led to an improvement in patient knowledge with respect to guideline content. The availability of psychosocial interventions may have been significantly constrained by the COVID-19 pandemic.
There is growing consensus on essential components of care for hospital-presenting self-harm and suicidal ideation, yet these are often inconsistently implemented. This qualitative study aimed to explore the implementation of components of care across hospitals. Interviews were conducted with health professionals providing care for self-harm and suicidal ideation in hospital emergency departments. Participants (N = 30) represented 15 hospitals and various professional roles. A framework analysis was used, where factors affecting each care component were mapped by hospital and hospital grouping.
Results
A timely, compassionate response was facilitated by collaboration between liaison psychiatry and emergency-department staff and the availability of designated space. Other factors affecting the implementation of care components included patient preferences for, and staff encouragement of, family involvement, time taken to complete written care plans and handover and availability of next care impacting follow-up of patients.
Clinical implications
The findings suggest a need for further integration of all clinical professionals on the liaison psychiatry team in implementing care for self-harm; improved systems of handover; further training and awareness on the benefits and optimal processes of family involvement; as well as enhanced access to aftercare.
Safety planning is a commonly used, evidence-based intervention for suicide prevention. There is a need for continuous engagement with safety plans post-discharge, and the improvement of safety plan portability has been discussed within our mental health organisation. This has led to the development of an app, called the Hope App. This study aims to implement this app into routine practice in a Canadian psychiatric emergency department.
Aims
We aimed to describe a collaborative, theoretically driven approach to co-design implementation strategies to elicit behaviour change among emergency department clinicians; co-develop a set of tailored, theory-informed, multifaceted implementation strategies for embedding an app into a psychiatric emergency department; and describe engagement evaluation received by the co-design team.
Method
Co-design approaches and the Behaviour Change Wheel were used to develop implementation strategies with clinicians, patients and care partners. The co-design team consisted of 12 members, and we held four design sessions. Design sessions were iterative in nature and organised such that the findings of each session fed into the next session.
Results
We identified 11 implementation strategies encompassing different combinations of intervention functions and behaviour change techniques, targeting barriers and leveraging facilitators identified in our previous work.
Conclusions
The tailored implementation strategies developed in this study have the potential to fill existing gaps in integrating digital technology. A key strength of this study is its use of behaviour change theories and a collaborative approach. The strategies are designed to align with the needs and preferences of clinicians, patients and care partners.
Lean is one of the most widely used improvement approaches in healthcare. With origins in manufacturing, it focuses on improving efficiency, eliminating waste, and streamlining processes. This Element provides an overview of the evidence for the use of Lean in healthcare, summarises the supporting tools and techniques, and emphasises the importance of developing an organisational culture committed to continuous improvement. The authors offer two case studies of attempts to implement Lean at scale, noting that, despite its popularity, implementation is not straightforward. Challenges include terminology that isn't always easy to grasp, perceived dissonances between the manufacturing origins of Lean based on repetitive, standardised, automated production and the human-centred world of healthcare, and problems with fidelity. The authors make the case that there is a lack of a robust evidence base for Lean and call for well-designed studies to advance the implementation of Lean and associated process improvement techniques in healthcare. This title is also available as open access on Cambridge Core.
Theories, models, and frameworks (TMFs) are essential tools in dissemination and implementation (D&I) research, yet selecting and applying the most appropriate TMF is routinely a challenge, particularly for those new to the field. To address this need, we developed the Dissemination and Implementation Models in Health webtool (www.dissemination-implementation.org) a free, interactive, and evolving online resource designed to support the thoughtful use of D&I TMFs across all phases of research and practice – from planning through assessment. Created through a multi-institutional collaboration and refined using human-centered design, the webtool includes features such as logic model development, D&I TMF selection and comparison, guidance on combining and adapting models, strategies for application, and linkages to measurement tools. Since its initial release in 2014, the webtool has expanded to include over 110 D&I TMFs and new thematic content areas, including a section dedicated to health equity. It can be used in D&I trainings, proposal development, consultations, and academic coursework. Usage analytics and community feedback reflect ongoing relevance, utility, and evolving needs. The webtool continues to address a significant gap in D&I infrastructure by guiding users in selecting and operationalizing D&I TMFs, ultimately supporting more rigorous, context-sensitive translational research and practice.
Consistent uptake and implementation of evidence-based CBT (EB-CBT) in clinical practice remains challenging. Understanding key barriers and facilitators experienced by CBT therapists is essential for developing effective implementation strategies to enhance adoption of EB-CBT practices. This study applies the Capability, Opportunity, Motivation-Behaviour (COM-B) and Theoretical Domains Framework (TDF) to provide a theoretically driven exploration of perceived barriers and facilitators to implementing EB-CBT reported by CBT therapists. A cross-sectional survey design incorporating qualitative open-ended questions was used to gather in-depth insights from 228 UK-based CBT therapists. Data were analysed using reflexive thematic analysis. Inductive analysis identified ten barriers and eight facilitators, which were deductively mapped onto the COM-B and TDF to identify key determinants affecting practice at the individual therapist or broader organisational level. At the therapist level, barriers identified were understanding of evidence-based decision making, scepticism about EB-CBT as being rigid, based on flawed evidence, and lacking client centredness, and a preference for intuitive eclecticism. Therapist facilitators included skills in research literacy and formulation, guided self-reflection as a behaviour regulation strategy, and reinforcement through positive outcomes. Organisational barriers were limited or complex research/guidelines, difficulty accessing knowledge, lack of training/supervision, and service constraints. Organisational facilitators consisted of external monitoring as a behavioural regulation strategy, fostering communities of practice, gaining knowledge through resources, and access to training/supervision. Key perceptions as well as misconceptions around using EB-CBT in practice were identified, highlighting the need for multi-level strategies addressing both individual and organisational factors to enhance therapists’ capability, motivation, and opportunity to adopt EB-CBT practices.
Key learning aims
As a result of reading this paper, readers should:
(1) Understand the key barriers UK therapists perceive as hindering the implementation of evidence-based CBT practices.
(2) Understand the key factors UK therapists perceive as facilitating and enhancing the implementation evidence-based CBT practices.
(3) Be able to use the COM-B and TDF model to map key determinants affecting adoption of evidence-based CBT practice at both the individual therapist and broader organisational level.
(4) Consider theoretically driven implementation interventions which could be used to target identified individual and organisational factors to improve sustained adoption of EB-CBT.
Implementing changes to digital health systems in real-life contexts poses many challenges. Design as a field has the potential to tackle some of these. This article illustrates how design knowledge, through published literature, is currently referenced in relation to the implementation of digital health. To map design literature’s contribution to this field, we conducted a scoping review on digital health implementation publications and their use of references from nine prominent design journals. The search in Scopus and Web of Science yielded 382 digital health implementation publications, of which 70 were included for analysis. From those, we extracted data on publication characteristics and how they cited the design literature. The 70 publications cited 58 design articles, whose characteristics were also extracted. The results show that design is mainly cited to provide information about specific design methods and approaches, guidelines for using them and evidence of their benefits. Examples of referenced methods and approaches were co-design, prototyping, human-centered design, service design, understanding user needs and design thinking. The results thus show that design knowledge primarily contributed to digital health implementation with insights into methods and approaches. In addition, our method showcases a new way for understanding how design literature influences other fields.
Chapter 20 reflects on the evolving landscape of climate litigation, circling back to some of the insights emerging from the Handbook’s various chapters, and speculates on its future trajectory. The editors begin by underscoring the remarkable progress that has been made in climate litigation, highlighting the significant role it has played in shaping legal responses to the climate crisis. They emphasise that the journey of climate litigation is far from over and that the field is poised for continued advancements and innovations. In particular, the editors shine a light on new frontiers for strategic litigation, including loss and damage cases that promote climate justice and considerations of ethics, fairness, and equity; claims against private polluters, particularly major corporate greenhouse gas emitters; more diverse litigation against governments that target the insufficient ambition, inadequate implementation, and lack of transparency in climate policies; litigation defending biodiversity through a climate lens; and inter-State climate lawsuits.
While the international law frameworks regulating the relations between States are relatively well developed, the role of international law at a municipal level is equally important. This can be illustrated in various ways. This chapter assesses the role of international law in municipal law; this includes a review of theoretical perspectives as reflected in the so-called monism-dualism debate, and a consideration of how the 'transformation' and 'incorporation' approaches have been dealt with by the courts. The chapter then examines the relationship between Australian law and international law, starting with an assessment of Australia's international personality; this is followed by a review of treaty-making in Australia, and the position taken by Australian courts on some of these matters. We then consider the impact of customary international law upon the common law, with particular reference to Australia. Following is a discussion of the relationship between treaties and municipal law, taking account of basic principles, implementation of treaties and the role of the courts. The chapter concludes with a review of constitutional and legislative options.
Evaluate the extent to which delivery constraints were considered during the health technology assessment (HTA) of cell and gene therapies.
Methods
Constraints on delivering cell and gene therapies were identified from guidance documents by the National Institute for Health and Care Excellence Technology Appraisal and Highly Specialised Technologies streams until October 2024. Inductive coding was performed to identify delivery constraints reported within the guidance documents. A quantitative analysis established the proportion of guidance documents that reported delivery constraints, and the distribution of these constraints across the guidance documents (frequency, mean range).
Results
Sixteen guidance documents for cell and gene therapies were identified. Thirteen guidance documents (81.3 percent of the sample) reported constraints on delivering cell and gene therapies. Thirty-one examples of delivery constraints were reported. The mean number of constraints per guidance document was 1.9 (range: 0–6 constraints). The reported constraints were grouped by six different themes: provider experience (n = 8); testing constraints (n = 7); geographical constraints (n = 5); payment constraints (n = 5); maturity of developments in care (n = 4); and infrastructure constraints (n = 2).
Conclusion
Formal HTA processes are one effective way to identify constraints on delivering cell and gene therapies. Proactive identification of potential delivery constraints will help decision-makers, providers, and manufacturers generate strategies that improve the implementation of cell and gene therapies. Overcoming delivery constraints will strengthen the likelihood of realizing the expected incremental net health benefit of cost-effective cell and gene therapies for patients across a healthcare system.
This article uses the Sargasso Sea as a case study to provide an analysis of the provisions of Part III of the Agreement under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable Use of Marine Biological Diversity of Areas Beyond National Jurisdiction (BBNJ Agreement) on measures such as area-based management tools (ABMTs), including marine protected areas. The ability of the BBNJ Conference of the Parties (COP) to establish internationally legally binding ABMTs in areas beyond national jurisdiction (ABNJ) presents a new opportunity for the conservation of the Sargasso Sea. Existing work of the Sargasso Sea Commission, as well as the preparations it could make to support a proposal by one or more States Parties to the new COP for an ABMT in the Sargasso Sea are discussed, as is the comprehensive process the BBNJ Agreement establishes for stakeholder engagement as part of the submission of proposals. The Sargasso Sea Commission has a long history of collaboration with international organisations, governments, scientists and others to strengthen the stewardship of the Sargasso Sea. More recent activities to engage directly with the shipping industry stakeholder group specifically are discussed. Finally, the article discusses the work being undertaken in collecting the best available science, collaboration with other international frameworks and bodies and other stakeholders, and the preliminary work on the development of an outline management plan particularly in relation to ongoing monitoring using remote sensing capacity.
Quality improvement programmes (QIPs) are designed to enhance patient outcomes by systematically introducing evidence-based clinical practices. The CONQUEST QIP focuses on improving the identification and management of patients with COPD in primary care. The process of developing CONQUEST, recruiting, preparing systems for participation, and implementing the QIP across three integrated healthcare systems (IHSs) is examined to identify and share lessons learned.
Approach and development:
This review is organized into three stages: 1) development, 2) preparing IHSs for implementation, and 3) implementation. In each stage, key steps are described with the lessons learned and how they can inform others interested in developing QIPs designed to improve the care of patients with chronic conditions in primary care.
Stage 1 was establishing and working with steering committees to develop the QIP Quality Standards, define the target patient population, assess current management practices, and create a global operational protocol. Additionally, potential IHSs were assessed for feasibility of QIP integration into primary care practices. Factors assessed included a review of technological infrastructure, QI experience, and capacity for effective implementation.
Stage 2 was preparation for implementation. Key was enlisting clinical champions to advocate for the QIP, secure participation in primary care, and establish effective communication channels. Preparation for implementation required obtaining IHS approvals, ensuring Health Insurance Portability and Accountability Act compliance, and devising operational strategies for patient outreach and clinical decision support delivery.
Stage 3 was developing three IHS implementation models. With insight into the local context from local clinicians, implementation models were adapted to work with the resources and capacity of the IHSs while ensuring the delivery of essential elements of the programme.
Conclusion:
Developing and launching a QIP programme across primary care practices requires extensive groundwork, preparation, and committed local champions to assist in building an adaptable environment that encourages open communication and is receptive to feedback.
This chapter introduces curriculum in schools and the relationship between ideology and ideas as factors shaping education curriculum development. This approach stresses that curriculum is both dynamic and contested, and focuses on the development and implementation of the Australian Curriculum to illustrate how curriculum is shaped at the Commonwealth, state/territory and jurisdictional school levels. The chapter also discusses the key learning areas, cross-curriculum priorities and general capabilities. The intention is to examine how curriculum can be an empowering vehicle to frame content areas, and inform teaching, learning programs and assessment instruments. Concepts such as the overt and hidden curriculum are examined to better understand the nature of school curriculum. Further, there is a recognition that curriculum must be interpreted and contextualised so that it meets the needs of learners at different levels and in different ways. Finally, the notion of teachers as curriculum builders and enactors is a central concept in this chapter.
User engagement is recognised as a critical and pervasive challenge that has limited the potential evidence base being developed for mental health apps.
Aim
To understand young people’s motivations for participating in a randomised controlled trial for a mental health app and the role of intrinsic (e.g. improving well-being) and extrinsic (e.g. financial incentives) drivers in engagement.
Method
Emotional Competence for Well-Being (ECoWeB) was a superiority parallel three-arm randomised cohort trial recruiting a cohort of 16–22 year-olds across the UK, Germany, Spain and Belgium, who, depending on risk, were allocated respectively to the PREVENT (n = 1262) versus PROMOTE (n = 2532) trials. We conducted in-depth semi-structured interviews in the UK (n = 18, mean age = 17.7, s.d. = 1.5) and Spain (n = 11, mean age 20.6, s.d. = 1.7) to explore participants’ self-reported motivations and engagement. The trial was registered at ClinicalTrials.gov: NCT04148508.
Results
Across arms, 21% of participants never set up an account to access the app and approximately 50% did not complete the 3-month follow-up assessment. Engagement was not significantly higher in the intervention arm compared to the control arms across metrics. Qualitative findings demonstrated that although extrinsic factors alone may be enough to prompt someone to sign up to research, intrinsic drivers (e.g. finding the app useful) are needed to ensure longer-term engagement.
Conclusions
Incentivising participation in clinical trials needs to be consistent with incentives that might be utilised at the point of dissemination and implementation to ensure that findings are replicated if that intervention is adopted at scale.