Abstract Objective Although regulatory authorities evaluate the risks and benefits of any new drug therapy during the new drug-approval process, quantitative risk–benefit assessment (RBA) is not ...typically performed, nor is it presented in a consistent and integrated framework when it is used. Our purpose is to identify and describe published quantitative RBA methods for pharmaceuticals. Methods Using MEDLINE and other Internet-based search engines, a systematic literature review was performed to identify quantitative methodologies for RBA. These distinct RBA approaches were summarized to highlight the implications of their differences for the pharmaceutical industry and regulatory agencies. Results Theoretical models, parameters, and key features were reviewed and compared for the 12 quantitative RBA methods identified in the literature, including the Quantitative Framework for Risk and Benefit Assessment, benefit-less-risk analysis, the quality-adjusted time without symptoms and toxicity, number needed to treat (NNT), and number needed to harm and their relative-value-adjusted versions, minimum clinical efficacy, incremental net health benefit, the risk–benefit plane (RBP), the probabilistic simulation method, multicriteria decision analysis (MCDA), the risk–benefit contour (RBC), and the stated preference method (SPM). Whereas some approaches (e.g., NNT) rely on subjective weighting schemes or nonstatistical assessments, other methods (e.g., RBP, MCDA, RBC, and SPM) assess joint distributions of benefit and risk. Conclusions Several quantitative RBA methods are available that could be used to help lessen concern over subjective drug assessments and to help guide authorities toward more objective and transparent decision-making. When evaluating a new drug therapy, we recommend the use of multiple RBA approaches across different therapeutic indications and treatment populations in order to bound the risk–benefit profile.
To improve the air quality in winter, clean heating policy was implemented in “2 + 26” cities of China in 2016, which mainly included replacing coal with gas or electricity. Tremendous financial ...subsidies have been provided by city and central governments. This new heating mode changed the heating fee-cost to residents. This paper estimates the economic costs to both governments and residents, and evaluates the environmental and public health benefits by combining a difference-in-differences model with an exposure-response function. Results show that the total costs of clean heating were up to 43.1 billion yuan. Governments and residents account for 44% and 56% of the total costs, respectively. In terms of benefits, the clean heating project is effective for air pollution control and brings health economic benefits of about 109.85 billion yuan (95% CI: 22.40–159.83). The clean heating policy was identified as a net-positive benefit program with environmental and public health improvements. However, the inequality in subsidies from different cities governments increases the heating burden on low-income households and leads to heating poverty for households in the less developed regions. We provide suggestions for implementation in future clean heating campaigns and in subsidy mechanism design in China and for other developing countries.
•Existing situation and problems of clean heating and its subsidy in China.•Economic costs of clean heating were up to 43.1 billion yuan.•Governments and residents account for 44% and 56% of the total costs.•Clean heating program brings health economic co-benefits of about 109.85 billion yuan.•Clean heating was a net positive benefit program.
Today, consumers expect companies to be socially responsible. However, the literature is undecided about the effects of communicating one's corporate social responsibility activities to consumers. ...This raises the question of how sustainability‐driven companies can best advertise their products to stimulate ethical consumption: using self‐benefit frames, where the main beneficiary is the consumer, or using other‐benefit frames, where the main beneficiary is a third party. Using three experiments, this study examines the effect of other‐benefit (vs. self‐benefit) advertising frames on consumers' impulse purchases from sustainability‐driven companies. Increasing impulse purchases can help such companies to strengthen their competitive positions. Additionally, it is studied to what extent two types of justification (moral versus deservingness) explain the proposed effect of advertising frames. The results show that only other‐benefit frames affect impulse buying behavior, both directly, as mediated by moral justification. This study's insights may help sustainability‐driven companies to decide on their advertising strategies by providing evidence that other‐benefit‐framed advertisements are more effective in enhancing impulse purchases than self‐benefit‐framed advertisements.
Coproduction, a collaborative model of research that includes stakeholders in the research process, has been widely advocated as a means of facilitating research use and impact. We summarise the ...arguments in favour of coproduction, the different approaches to establishing coproductive work and their costs, and offer some advice as to when and how to consider coproduction.
Despite the multiplicity of reasons and incentives to coproduce, there is little consensus about what coproduction is, why we do it, what effects we are trying to achieve, or the best coproduction techniques to achieve policy, practice or population health change. Furthermore, coproduction is not free risk or cost. Tensions can arise throughout coproduced research processes between the different interests involved. We identify five types of costs associated with coproduced research affecting the research itself, the research process, professional risks for researchers and stakeholders, personal risks for researchers and stakeholders, and risks to the wider cause of scholarship. Yet, these costs are rarely referred to in the literature, which generally calls for greater inclusion of stakeholders in research processes, focusing exclusively on potential positives. There are few tools to help researchers avoid or alleviate risks to themselves and their stakeholders.
First, we recommend identifying specific motivations for coproduction and clarifying exactly which outcomes are required for whom for any particular piece of research. Second, we suggest selecting strategies specifically designed to enable these outcomes to be achieved, and properly evaluated. Finally, in the absence of strong evidence about the impact and process of coproduction, we advise a cautious approach to coproduction. This would involve conscious and reflective research practice, evaluation of how coproduced research practices change outcomes, and exploration of the costs and benefits of coproduction. We propose some preliminary advice to help decide when coproduction is likely to be more or less useful.
The objective was to (i) assess the long-term cost-effectiveness of acceptance and commitment therapy (ACT), a workplace dialog intervention (WDI), and ACT+WDI compared to treatment as usual (TAU) ...for common mental disorders and (ii) investigate any differences in cost-effectiveness between diagnostic groups.
An economic evaluation from the healthcare and limited welfare perspectives was conducted alongside a randomized clinical trial with a two-year follow-up period. Persons with common mental disorders receiving sickness benefits were invited to the trial. We used registry data for cost analysis alongside participant data collected during the trial and the reduction in sickness absence days as treatment effect. A total of 264 participants with a diagnosis of depression, anxiety, or stress-induced exhaustion disorder participated in a two-year follow-up of a four-arm trial: ACT (N=74), WDI (N=60), ACT+WDI (N=70), and TAU (N=60).
For all patients in general, there were no statistically significant differences between interventions in terms of costs or effect. The subgroup analyses suggested that from a healthcare perspective, ACT was a cost-effective option for depression or anxiety disorders and ACT+WDI for stress-induced exhaustion disorder. With a two-year time horizon, the probability of WDI to be cost-saving in terms of sickness benefits costs was 80% compared with TAU.
ACT had a high probability of cost-effectiveness from a healthcare perspective for employees on sick leave due to depression or anxiety disorders. For participants with stress-induced exhaustion disorder, adding WDI to ACT seems to reduce healthcare costs, while WDI as a stand-alone intervention seems to reduce welfare costs.
ABSTRACT
To shed light on the role that academic research plays in Securities and Exchange Commission (SEC) rulemaking, this paper examines the SEC's patterns of consumption of academic research from ...2007 through 2017. We show how the Business Roundtable v. SEC ruling in 2011 increased consideration given to academic research during SEC rulemaking. We find that after the ruling, the SEC cites more papers in its proposed rules and, in particular, more papers that illustrate the costs of regulation. This change in academic citations results in fewer negative comment letters on proposed SEC regulations. We survey academics whose research was cited by the SEC, and the majority respond that the SEC's description of their work is completely or mostly accurate. When we survey general academics, their average rating of the SEC's accuracy is lower, although the rating improves regarding specific SEC quotes citing academic research. Although there is still room for a more substantive discussion of research, having a higher standard of cost‐benefit analysis leads to a more balanced discussion of academic research.
This study reviews the literature on the evaluation of the Olympic Games, within the broader framework of their significance as cultural assets and opportunities for endogenous growth and sustainable ...development of the host city. The study reviews the main approaches to the economic assessment of the Games, from the point of view of the underlying economic concepts and methodologies, as well as of the empirical results obtained. It focuses on the effects that are measured and on those, which even though important, are generally neglected. The methodologies utilized for the quantitative assessments of the Games are reviewed with special emphasis on impact and cost–benefit analysis, both on ex ante and ex post basis. The studies surveyed are analysed from the point of view of different sets of effects on the host city, and for a limited number of cases, on the host country. While the major focus is on hosting the Summer Olympics, some attention is also paid to the bidding cities, the Winter Olympics and the Paralympics. The general findings appear to be controversial with some hints of positive overall effects, but also with a well‐documented tendency to exaggerate the benefits and underestimate the costs of holding the Games in the ex ante versus the ex post studies. The survey finally suggests that ex post cross‐country econometric studies tend to catch sizable differential and persistent benefits ignored by individual studies, especially on macroeconomic and trade variables.
Managerial Epidemiology Cases and Concepts Fleming, Steven; Staff, Health Administration Press; Staff, Association of University Programs in Health Administration
2014
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