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Following acquired brain injury (ABI), individuals often experience anxiety and/or depressive symptoms. BrainACT is an adapted form of Acceptance and Commitment Therapy (ACT) tailored to this target group. The current study is a trial-based health-economic evaluation comparing BrainACT to a psychoeducation and relaxation control treatment.
Methods
An economic evaluation from a societal perspective was conducted in the Netherlands alongside a multicenter randomized controlled two-armed parallel trial including 72 participants. A cost-utility and cost-effectiveness analysis was conducted where incremental costs, quality-adjusted life-years (QALYs), and anxiety/depression (Hospital Anxiety and Depression Scale (HADS) score) were collected and presented over a 1-year follow-up period. Bootstrapping, scenario, and subgroup analyses were performed to test the robustness of the results.
Results
The BrainACT arm reported non-significant lower total costs (incremental difference of €−4,881; bootstrap interval €−12,139 to €2,330) combined with significantly decreased anxiety/depression (HADS) (3.2; bootstrap intervals 0.7–5.7). However, the total QALYs were non-significantly lower (−0.008; bootstrap interval −0.060 to 0.042) for BrainACT. The probability of the intervention being cost-effective was 86 percent at a willingness-to-accept threshold of €50,000/QALY. The scenario and subgroup analyses confirmed the robustness of the results.
Conclusion
BrainACT may be a more cost-effective alternative to a psychoeducation and relaxation intervention for anxiety and/or depressive symptoms following ABI. Despite limitations, BrainACT appears to be a promising addition to treatment options in the Netherlands. Further research is needed to validate these findings, and consideration should be given to implementing BrainACT in Dutch clinical settings with ongoing monitoring.
This manuscript addresses a critical topic: navigating complexities of conducting clinical trials during a pandemic. Central to this discussion is engaging communities to ensure diverse participation. The manuscript elucidates deliberate strategies employed to recruit minority communities with poor social drivers of health for participation in COVID-19 trials. The paper adopts a descriptive approach, eschewing analysis of data-driven efficacy of these efforts, and instead provides a comprehensive account of strategies utilized. The Accelerate COVID-19 Treatment Interventions and Vaccines (ACTIV) public–private partnership launched early in the COVID-19 pandemic to develop clinical trials to advance SARS-CoV-2 treatments. In this paper, ACTIV investigators share challenges in conducting research during an evolving pandemic and approaches selected to engage communities when traditional strategies were infeasible. Lessons from this experience include importance of community representatives’ involvement early in study design and implementation and integration of well-developed public outreach and communication strategies with trial launch. Centralization and coordination of outreach will allow for efficient use of resources and the sharing of best practices. Insights gleaned from the ACTIV program, as outlined in this paper, shed light on effective strategies for involving communities in treatment trials amidst rapidly evolving public health emergencies. This underscores critical importance of community engagement initiatives well in advance of the pandemic.
Less than a decade after the American Civil War, the United States signed the 1874 reciprocity treaty, imposing its first restrictions on Hawaiian sovereignty. Whereas most scholars take for granted US interests in controlling Hawaii, we ask how this interest emerged in 1874. We argue the answer lies with American entrepreneurs like Henry A.P. Carter. The rise of commodity prices - first in sandalwood, then in whale oil, and finally, in sugar - drove American entrepreneurs to Hawaii. When threats to their enterprises emerged, they formed a lobby to advocate for American imperialism, and shaped perceptions of the costs and benefits of imperialism within Hawaii and the United States.
Why did the United States establish an early American Empire in the Pacific (1856-1898)? This chapter summarizes the argument of this book, explaining why patterns of imperialism demonstrate the influence of commodity prices and entrepreneurs for distinctive patterns of American imperialism. It then addresses 1898. Scholars often suggest that 1898 was the moment when the United States became an empire. This chapter argues that this view is misplaced. Instead, 1898 marks a shift in the US approach to empire, when the US Navy replaced the small entrepreneur as the key figure in US expansion. It then addresses the lessons learned from this book, with an emphasis on the politics of race in the contemporary Pacific and struggles for recognition in the region.
Guano imperialism marked the first major commodity rush into the Pacific. Between 1850 and 1900, the United States claimed over a hundred islands across the world through the Guano Act of 1856. Why did the United States develop a guano empire? Most scholarly attention focuses on state-led explanations for guano imperialism, like the influence of American farmers and naval lobbies on Congress. By contrast, this chapter presents evidence that entrepreneurs led the way into the Pacific. A sudden rise in guano prices led US entrepreneurs to search for guano and threats to their interests from foreign competitors led them to search for government protection.
This chapter provides an entrepreneur-led theory of American early Pacific imperialism. The central argument is that changes in commodity prices provided incentives for American imperialism. It outlines how price changes encourage imperialism through a sequence of three mechanisms: price, threat, and lobbying. The price mechanism posits that commodity rushes led American entrepreneurs to relocate overseas. The threat mechanism describes the turn from entrepreneurs into lobbyists. The lobbying mechanism describes how entrepreneurs built support for their imperial schemes. In making these arguments, the chapter highlights the structural differences between American and European empires in the mid-nineteenth century by drawing comparisons to economic theories developed to explain European empires.
Why did the United States establish an early American Empire in the Pacific (1856-1898)? This chapter first discusses the conventional wisdom that focuses on the role of naval power, trade with China, and missionaries. It shows that these explanations are unable to explain patterns of American imperialism in the Pacific. It then introduces a theory of entrepreneurs and highlights the contributions that an entrepreneurial theory makes to International Relations scholarship, including to theories of empire, territorial expansion, and contemporary struggles for recognition for indigenous peoples in the Asia-Pacific.
Whereas most books emphasize cases of expansion, this chapter focuses on cases in which the United States does not expand. These cases - Fiji, Kiribati, Tahiti, Tokelau, and Tuvalu- challenge grand narratives of America’s path in the Pacific. The islands had strategic value, large markets, and souls to save. Yet, there was little if any interest from the US government in annexation. Using a structured, focused comparison, we attribute these instances of non-expansion to three causes: an island lacks commodities or labor for the entrepreneur to exploit; the entrepreneur dies or is arrested before the imperial lobby matures; or the entrepreneur establishes themselves in territories already controlled by foreign empires who can offer protection from local threats. These cases are interesting, brief stories about the American commercial experience abroad that have been ignored by scholars of American imperialism.
In 1889, almost a decade before the Spanish-American War, the United States, Germany, and Great Britain agreed to enter into an imperial condominium in Samoa. Conventional wisdom credits American imperialism in Samoa to security motives and major economic interest groups within the United States. This chapter argues that American entrepreneurs shaped American imperialism in Samoa. It presents novel evidence that American entrepreneurs - especially H.J. Moors - entered the islands in pursuit of high copra prices and turned to lobbyists after facing threats from German competitors. They pressured officials in Washington and naval captains who visited the islands for action.
The United States was an upside-down British Empire. It had an agrarian economy, few large investors, and no territorial holdings outside of North America. However, decades before the Spanish-American War, the United States quietly began to establish an empire across thousands of miles of Pacific Ocean. While conventional wisdom suggests that large interests – the military and major business interests – drove American imperialism, The Price of Empire argues that early American imperialism was driven by small entrepreneurs. When commodity prices boomed, these small entrepreneurs took risks, racing ahead of the American state. Yet when profits were threatened, they clamoured for the US government to follow them into the Pacific. Through novel, intriguing stories of American small businessmen, this book shows how American entrepreneurs manipulated the United States into pursuing imperial projects in the Pacific. It explores their travels abroad and highlights the consequences of contemporary struggles for justice in the Pacific.
To develop a consensus-based checklist that can be used as a minimum standard to appraise the comprehensiveness, transparency and consistency of cost-of-illness (COI) studies. This is important when, for instance, reviewing and assessing COI studies as part of a systematic review or when building an economic model.
Methods
The development process of the consensus-based checklist involved six steps: (i) a scoping review, (ii) an assessment and comparison of the different checklists and their questions, (iii) the development of a (preliminary) checklist, (iv) expert interviews, (v) the finalization of the checklist, and (vi) the development of guidance statements explaining each question.
Results
The result was a consensus-based checklist for the critical appraisal of COI studies, comprising seventeen main questions (and some additional subquestions) across three domains: (i) study characteristics; (ii) methodology and cost analysis; and (iii) results and reporting. Guidance statements were developed describing the purpose and meaning behind each question and listing examples of best practice. The following answer categories were suggested to be applied when answering the questions in the checklist: Yes, Partially, No, Not Applicable, or Unclear.
Conclusions
The consensus-based checklist for COI studies is a first step toward standardizing the critical appraisal of COI studies and is one that could be considered a minimum standard. The checklist can help to improve comprehensiveness, transparency and consistency in COI studies, to address heterogeneity, and to enable better comparability of methodological approaches across international studies.