Leading beyond the bottom line, Part 4. The questions it has raised

The Leading Beyond the Bottom Line article series has received an overwhelming response from ACPE members, mostly in enthusiastic support of this new leadership concept. Some of the important questions raised by members are presented with answers from the authors. This article also explores the moral challenge of leadership and why health care is more than a business. In recent years, there's been confusion about the role of the health care enterprise, its leadership and its management. We have lost our way about the "moral" thing, the "right" thing, because we have no philosophy to guide us. To manage or lead in this "business" of health care, a philosophy is required that recognizes the multiple elements to which the leader has responsibility and obligations: the customers, community, employees, and, certainly, the financial assets.     

Reproductive and Developmental Risks from Ethylene Oxide: A Probabilistic Characterization of Possible Regulatory Thresholds

Ethylene oxide is a gas produced in large quantities in the United States that is used primarily as a chemical intermediate in the production of ethylene glycol, propylene glycol, non-ionic surfactants, ethanolamines, glycol ethers, and other chemicals. It has been well established that ethylene oxide can induce cancer, genetic, reproductive and developmental, and acute health effects in animals. The U.S. Environmental Protection Agency is currently developing both a cancer potency factor and a reference concentration (RfC) for ethylene oxide. This study used the rich database on the reproductive and developmental effects of ethylene oxide to develop a probabilistic characterization of possible regulatory thresholds for ethylene oxide. This analysis was based on the standard regulatory approach for noncancer risk assessment, but involved several innovative elements, such as: (1) the use of advanced statistical methods to account for correlations in developmental outcomes among littermates and allow for simultaneous control of covariates (such as litter size); (2) the application of a probabilistic approach for characterizing the uncertainty in extrapolating the animal results to humans; and (3) the use of a quantitative approach to account for the variation in heterogeneity among the human population. This article presents several classes of results, including: (1) probabilistic characterizations of ED10s for two quantal reproductive outcomes-resorption and fetal death, (2) probabilistic characterizations of one developmental outcome-the dose expected to yield a 5% reduction in fetal (or pup) weight, (3) estimates of the RfCs that would result from using these values in the standard regulatory approach for noncancer risk assessment, and (4) a probabilistic characterization of the level of ethylene oxide exposure that would be expected to yield a 1/1,000 increase in the risk of reproductive or developmental outcomes in exposed human populations.     

Customized clinical case management for chronically ill patients. Health system sees remarkable results with teams of case managers,physicians, patients

Securing excellent care and positive outcomes for seriously ill, high-risk patients requires extraordinary measures. A health system in Georgia is experiencing strong results by taking a team approach to health care with case managers, physicians and patients working together.     

Role of Negative Emotion in Communication about CO2 Risks

This article describes how the effectiveness of risk communication is determined by the interaction between emotional and informative elements. An experiment is described that examined the role of negative emotion in communication about CO₂ risks. This experiment was based on the elaboration likelihood model and the related heuristic systematic model of attitude formation. The results indicated that inducing fear of CO₂ risks leads to systematic processing of information about energy conservation as a risk-reducing strategy. In turn, this results in more favorable attitudes toward energy conservation if strong arguments are provided. Individual differences in concern seem to have similar effects.     

Are Economic Development and Education Improvement Associated with Participation in Transnational Terrorism?

Using transnational terrorism data from 1980 to 2000, this study empirically examines the relationships between frequency of participation in transnational terrorism acts and economic development and education improvement. We find an inverse U‐shaped association between the frequency of various nationals acting as perpetrators in transnational terrorism acts and per capita income in their respective home countries. As per capita incomes increase from relatively low levels, frequencies of participation in transnational terrorism increase. However, at sufficiently higher levels of per capita income, further increase in per capita income is negatively associated with the rate of participation in transnational terrorism. Education improvement from elementary to secondary is positively correlated with frequency of participation in transnational terrorism events, whereas further improvement from secondary to tertiary level is negatively correlated with participation in transnational terrorism. We also find that citizens of countries with greater openness to international trade, lower degree of income inequality, greater economic freedom, larger proportion of population with tertiary education, and less religious prevalence participate in transnational terrorism events less frequently.     

Transparency in Europe: A Quantitative Study

In recent years, European pharmaceutical regulators have increasingly committed to heightening access to raw safety‐related data as part of a wave of transparency initiatives (e.g., providing public Internet‐mediated access to clinical trials data). Yet, the regulators—who are under significant pressure—have not yet benefited from a systematic review of this new policy. In seeking to inject much needed evidence, this article explores the effects of new transparency policies designed to promote meaningful communication of risks and benefits to patients. Results of a cross‐national European survey with respondents from Great Britain, the Netherlands, Spain, France, Germany, and Sweden (N = 5,648) shed light on how patients and the public are likely to react to the regulators’ new transparency policies. The findings demonstrate clear national variations in how European citizens are likely to react and emphasize the need to develop evidence‐based, reasoned transparency policies that integrate benefit‐risk communication. The authors conclude by providing six specific recommendations, informed by the study, that seek to improve the European transparency model both within the medical field and across health, safety, and environmental policy domains.     

Decisions,Science, and Values: Crafting Regulatory Alternatives Analysis

Emerging “prevention‐based” approaches to chemical regulation seek to minimize the use of toxic chemicals by mandating or directly incentivizing the adoption of viable safer alternative chemicals or processes. California and Maine are beginning to implement such programs, requiring manufacturers of consumer products containing certain chemicals of concern to identify and evaluate potential safer alternatives. In the European Union, the REACH program imposes similar obligations on manufacturers of certain substances of very high concern. Effective prevention‐based regulation requires regulatory alternatives analysis (RAA), a methodology for comparing and evaluating the regulated chemical or process and its alternatives across a range of relevant criteria. RAA has both public and private dimensions. To a significant degree, alternatives analysis is an aspect of product design; that is, the process by which private industry designs the goods it sells. Accordingly, an RAA method should reflect the attributes of well‐crafted product design tools used by businesses. But RAA adds health and environmental objectives to the mix of concerns taken into account by the product designer. Moreover, as part of a prevention‐based regulatory regime, it implicates important public values such as legitimacy, equity, public engagement, and accountability. Thus, an RAA should reflect both private standards and public values, and be evaluated against them. This article adopts that perspective, identifying an integrated set of design principles for RAA, and illustrating the application of those principles.     

Entry and Exit in OTC Derivatives Markets

We develop a parsimonious model to study the equilibrium and socially optimal decisions of banks to enter, trade in, and possibly exit, an OTC market. Although we endow all banks with the same trading technology, banks' optimal entry and trading decisions endogenously lead to a realistic market structure composed of dealers and customers with distinct trading patterns. We decompose banks' entry incentives into incentives to hedge risk and incentives to make intermediation profits. We show that dealer banks enter more than is socially optimal. In the face of large negative shocks, they may also exit more than is socially optimal when markets are not perfectly resilient.     

Estimation of Nonparametric Models With Simultaneity

We introduce methods for estimating nonparametric, nonadditive models with simultaneity. The methods are developed by directly connecting the elements of the structural system to be estimated with features of the density of the observable variables, such as ratios of derivatives or averages of products of derivatives of this density. The estimators are therefore easily computed functionals of a nonparametric estimator of the density of the observable variables. We consider in detail a model where to each structural equation there corresponds an exclusive regressor and a model with one equation of interest and one instrument that is included in a second equation. For both models, we provide new characterizations of observational equivalence on a set, in terms of the density of the observable variables and derivatives of the structural functions. Based on those characterizations, we develop two estimation methods. In the first method, the estimators of the structural derivatives are calculated by a simple matrix inversion and matrix multiplication, analogous to a standard least squares estimator, but with the elements of the matrices being averages of products of derivatives of nonparametric density estimators. In the second method, the estimators of the structural derivatives are calculated in two steps. In a first step, values of the instrument are found at which the density of the observable variables satisfies some properties. In the second step, the estimators are calculated directly from the values of derivatives of the density of the observable variables evaluated at the found values of the instrument. We show that both pointwise estimators are consistent and asymptotically normal.