Alan Lyles | University of Baltimore (original) (raw)

Papers by Alan Lyles

Clin Ther, 2008

The dream of reason did not take power into account. paul Start 1 Existing comparative informatio... more The dream of reason did not take power into account. paul Start 1 Existing comparative information on pharmaceutical products is insufficient for the choices required. The marketingauthorization standards of the US Food and Drug Administration are, in many ways, more suggestive than confirmatory in terms of both relative safety and relative effectiveness in usual community practice. More is known about a product's performance against placebo than against the relevant alternative therapies. In the absence of head-to-head studies, models imply relative effectiveness but are actually structured guesses at the answers to empirically testable questions. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) 2 exemplifies postmarketing research that clarifies the standing of therapies introduced at different times and possibly against different sets of competing products. However, its scale was daunting in terms of both complexity and cost-how many such trials can be funded on a regular basis? What are the alternatives? S 3408, the Comparative Effectiveness Research Act of 2008, 3 was introduced by Senators Kent Conrad (D-ND, Budget Committee Chair) and Max Baucus (D-MT, Finance Committee Chair) as a remedy. This Act would establish a nonprofit Health Care Comparative Effectiveness Research Institute whose research agenda would include "evaluating and comparing the clinical effectiveness, risks, and benefits of two or more medical treatments, services, ...health care interventions, protocols for treatment, procedures, medical devices, diagnostic tools, pharmaceuticals (including drugs and biologicals), and any other processes or items being used in the treatment and diagnosis of, or prevention of illness or injury in, patients. "3 S 3408 comes late in the current congressional session, and, with November elections pending, it is unlikely to pass in this session. However, this bill clearly reflects lessons learned from prior legislative, regulatory, and private comparative and translational initiatives. For example, the practice guideline for low back pain issued in 19944 by the Agency for Health Care Programs and Research (AHCPR) represented only one aspect of the agency's larger outcomes-research portfolio. Although this was not the first guideline the agency had disseminated, it did elicit the strongest response, leading to a brief period in which the AHCPR budget was reduced to zero. The politics of the early nineties, with changing majority parties in Congress, put the agency and its mission at risk. 5 This experience led legislators to embed in subsequent legislation prohibitions against the inclusion of wording that might be interpreted as allowing practice guidelines.

Clin Ther, 2011

The international implications of even rigorous cost-effectiveness analyses (CEAs) are limited by... more The international implications of even rigorous cost-effectiveness analyses (CEAs) are limited by factors beyond a product's pharmacological properties. Unlike physiological parameters, economic modeling studies incorporate national values, political determinations and heterogeneity in medical services' organization, financing and delivery. Collectively, these influence the external validity and the possibility for direct extrapolation of economic modeling results from one national setting to another. The primary aim of pharmacoeconomic analyses is to determine the value of a product when it is used for its intended purpose. Economic modeling builds on the product's clinical profile, but even decisions about the adequacy of clinical evidence for marketing authorization differs between nations. Mason, et al. (2010) 1 quantified the discordance among the USA's Food and Drug Administration (FDA), the European Medicines Agency (EMA), the National Institute for Health and Clinical Excellence (NICE) and the Scottish Medicines Consortium (SMC) decisions on the 59 antineoplastics authorized by FDA during 2004-2008. EMA licensed 46 (78%) of those products; NICE had appraised just 50% of EMA's licensed products by December 31, 2009, accepting 8 (17%), restricting 10 (22%) and not approving 5 (11%) for routine use; while the SMC had appraised 42 (91%), accepting 7 (15%), restricting 13 (28%) and not approving 22 (48%) for routine use. Despite differences in whether a national marketing authorization decision had been made, and, if so, precisely what that decision was regarding the clinical evidence, CEA permits modeling the clinical and economic outcomes without distinction to approval or specific marketed indications. The CEA by Wu, et al., of rh-endostatin as a first line therapy for advanced non-small-cell lung cancer in China exemplifies the caution for international audiences of such studies. Approved for this indication in China, rh-endostatin is not universally so authorized, for example, it is still experimental in the USA and in Europe. Consequently, national marketing decisions determine the context within which the results of an economic model apply and how those results should be interpreted elsewhere. Recent Clinical Therapeutics editorials have further identified the threats to external validity posed by national differences in the organization, financing, and delivery of health care 2 , noting that pharmacoeconomic research. .. should contain [at least] a brief description of the pertinent health sector and specify whether the findings appear to be unique to that system, culture or economy, or are likely to be generalizable to other settings 2 and that authors must place their work in the context of the major incentives, constraints, and economic forces acting on key domestic stakeholders at the time it was conducted. 3 Despite these restrictions, CEA occupies an important position in the international pharmaceutical economics and health policy literature. The interconnected global pharmaceutical market requires a contemporaneous and granular understanding of national circumstances from within as well as across boundaries. Dr. Wu's pharmacoeconomic analysis had at the start the possibility of a positive or a negative finding. In neither case, however, should its findings have been an argument for or pressure on national licensing authorities in a different nation. For that, clinical evidence development must follow the standards and procedures of the intended authority.

Clin Ther, 2009

The Pharmaceutical Economics & Health Policy section of this journal features empiric articles, e... more The Pharmaceutical Economics & Health Policy section of this journal features empiric articles, editorials, and occasional commentaries to support evidence-based communications, all of them peer reviewed for relevance, technical accuracy, clarity, and objectivity. However, despite the availability of objective information both here and elsewhere, objectivity does not seem to figure in much of the media coverage of the current health care reform debate. It is clearly not the cumulative objective evidence that has generated the extreme passions surrounding health care reform. National health expenditures per capita increased 123% between 1990 and 2004, 1 but it was not this that evoked such intensity. The numbers of the uninsured are substantial and have been increasing for years without arousing anything like the present turmoil. So, why is health care reform so contentious, and what is the role for evidence-based pharmaceutical economics and health policy? Rates of unemployment in the United States increased from 4.8% in February 2008 2 to 7.2% in December 2008 3 and 9.7% in August 2009, 4 a 102% increase in 18 months. Under a system of employment-based health insurance, this magnitude of unemployment threatens or eliminates health insurance for millions. However, the fact of employment no longer guarantees health benefits: the percentage of firms offering health benefits declined from a high of 69% in 2000 to 63% in 2008. 5 Americans' domestic concerns are now dominated by the economy (33%), health care (25%), unemployment and jobs (14%), and the federal debt (7%). 6 The Kaiser Family Foundation has estimated that each 1-point increase in the national unemployment rate produces an additional 1.1 million uninsured and an additional 1 million Medicaid and State Children's Health Insurance Program enrollees. 7 Trends in health care costs also pose a substantial threat to employers. From 16% of the gross domestic product in 2007, health care costs are projected to reach 25% by 2025, threatening the competitiveness of US businesses and the fiscal soundness of federal, state, and local governments. 8 Financial crises, declines in employmentbased health insurance for those still employed, and the loss of health insurance by those in the growing ranks of the unemployed have converged to make the health care status quo unacceptable to many citizens. Public Opinion Strategies, LLC, the firm whose research contributed to the "Harry and Louise" campaign that helped defeat the Clinton Administration's Health Security Act of 1993, reported that by June 2007, 36% of voters endorsed "the need for radical change in the U.S. health care system," and about half supported reform. 9 Support for radical change came from 45% of Democrats, 43% of Independents, and 20% of Republicans. In the 2008 presidential election, voters elected a candidate whose central campaign theme was change; however, the details of that change have been slower to emerge than the opposition to it. The clarity of the election results are in stark contrast to the melee that took place during the congressional recess, when McCarthy et al, 10 writing in the Congressional Quarterly, observed that "as politicians and interest groups try to shape the outcome of the healthcare overhaul, they've offered interpretations that are so wildly different that truth sometimes seems to be taking a vacation." Examining a dozen major talking points in the media coverage of health care reform, the authors concluded that 5 were demonstrably false, 6 were misleading, and 1 was true. An article in Newsweek magazine was more blunt, referring to "the five biggest lies in the health care debate." 11 When so much valid information is available from unbiased and peer-reviewed sources, why is the debate dominated by highamplitude but demonstrably false claims? Given the current approach to health policy and reform, the question posed by a 2004 editorial in this journal-"Evidence-or Opinion-Based Pharmaceutical Policy?" 12-remains relevant today. Paul Grenier, writing in The Baltimore Sun, has asserted that "what we need…are not labels, but analysis." 13 Political theater is taking the place of the genuine work of crisis resolution. Only incomplete health care reform legislation had been drafted by the end of July 2009. Separate House committees had issued 3 marked-up bills, and only 1 Senate committee had completed its work. 14 The remaining committee with jurisdiction, the Senate Finance Committee, was still negotiating as the August recess began. Plotted over time, health care costs form an

The American Journal of Managed Care, May 1, 2002

To learn whether the healthcare costs for patients of various care delivery systems are associate... more To learn whether the healthcare costs for patients of various care delivery systems are associated with the quality of ambulatory care received. Despite intense interest in the cost and quality of healthcare delivery in the United States, there have been relatively few studies of the relationship between those measures, and none have addressed the relationship for integrated care delivery systems. Study Design: Results of a retrospective analysis of claims records for overall costs of care for enrollees of 18 care delivery systems were compared with a variety of quality measures for each system. Patients and Methods: We analyzed the yearly (1996-1998) claims records of 110,000 to 150,000 employees and dependents of member companies of an employer coalition in Minnesota that received all of their medical services from 18 care systems that had at least 1000 employees and dependents. Overall case-mix and inflation-adjusted costs of care for enrollees of each care system were compared with 21 ambulatory care process-oriented quality indicators covering 3 chronic diseases and 5 preventive services. Results: Regardless of whether the unit of analysis was the care system or the individual enrollee, there was no evidence of a consistent relationship between overall cost of care and quality on any measures. The little association there was tended to suggest that higher quality was provided by the lowestcost care systems. Conclusion: Although additional confirmatory research is needed, this analysis of the quality-cost relationship provides some reassurance for those who question whether selecting lower-cost sources of medical care might have a negative effect on quality of care.

Clinical Therapeutics, Apr 1, 2008

The State Child Health Insurance Program (SCHIP) provides health care access for low-income child... more The State Child Health Insurance Program (SCHIP) provides health care access for low-income children not covered by Medicaid. Established under Title XXI of the Social Security Act (PL 105-33), SCHIP initially provided 40billionover10yearstostatesthatchosetoenrolllow−incomechildren.1,2Theprogramisacollaborativefederal−statepartnership:thestatesareresponsibleforadministeringtheprogram,andthefederalgovernmentprovidesanaveragestatefundingmatchof7040 billion over 10 years to states that chose to enroll low-income children. 1,2 The program is a collaborative federal-state partnership: the states are responsible for administering the program, and the federal government provides an average state funding match of 70%. 3 States are given flexibility in terms of program design. They may use the funding either to expand Medicaid or to create new child health programs. 4 The intent of the program was to expand health insurance coverage for "uninsured children living in families with income that is modest but too high to qualify for Medicaid." 2 According to statute, this means that children living in families with incomes below 200% of the federal poverty level (FPL) (40billionover10yearstostatesthatchosetoenrolllow−incomechildren.1,2Theprogramisacollaborativefederal−statepartnership:thestatesareresponsibleforadministeringtheprogram,andthefederalgovernmentprovidesanaveragestatefundingmatchof7033,200 annual income for a family of 3 in 2006 5) or 50% of the Medicaid threshold are eligible for SCHIP. 2 Covered health services include inpatient and outpatient hospital services, physician visits, prescription drugs, immunizations, dental and hearing services, and rehabilitative, therapeutic, and preventive services. 1 SCHIP has increased health insurance coverage and access. The rate of uninsured children living in families between 100% and 200% of the FPL dropped from 22.5% in 1996 (before SCHIP) to 16.9% in 2005, a 25% decrease. 2 The number of children with health benefits increased from 660,000 in fiscal year 1998 to 6.6 million in fiscal year 2006. 6 However, according to the Congressional Budget Office, "the uninsured rate among higherincome children [ie, those who did not qualify for SCHIP] remained relatively stable" 2 between 1996 and 2005. Insurance coverage influences access to and utilization of health services, both of which are critical factors in the prevention and management of childhood diseases. In 1997-1998, the mean percentage of children aged ≤18 years who did not have a clinic or doctor's office visit within the previous 12 months was 10.1% for those covered under Medicaid and 28.8% for the uninsured; the corresponding rates were 10.3% and 31.9% in 2001-2002, and 9.7% and 30.9% in 2004-2005. 7 Moreover, approximately 90% of children enrolled through SCHIP report having a usual source of medical care, 8 a correlate of reduced crisis-oriented care such as emergency department visits and inpatient hospitalizations. 9 Despite a decade of success, SCHIP was scheduled to sunset on September 30, 2007. Although President Bush's stated position was to "put poorer children first," 10 he vetoed 2 versions of the Children's Health Insurance Program Reauthorization Act of 2007 (HR 976 11 and HR 3963 12). Both versions, which received bipartisan support, would have extended health care benefits to 4 million previously uninsured low-income children. The vetoes reflected 4 main areas of ideological difference between the Bush Administration and legislators. 3 First, opponents maintained that the program would be too costly. Under the proposed legislation, income eligibility limits for children living in low-income families would have increased from 200% to 300% of the FPL ($51,510 annual income for a family of 3 in 2007), which would account for 17.2% of the population under the age of 18 years. 13 Opponents asserted that this income level was too high, edging into the middle-class range. Second, some feared that raising the threshold income level would lead some families to drop their private insurance and replace it with public insurance, thus "crowding out" private coverage. Third, the expansion of coverage would have been funded by additional tobacco taxes, an option opposed by tobacco companies. Finally, opposition to the program was generated by the eligibility of US adults with and without children and the enrollment of illegal immigrants. However, according to a recent assessment by Sarah Rosenbaum in The New England Journal of Medicine, 14 the main consideration in the presidential vetoes was not enrollment expansion or crowd-out but political ideology. The President, she noted, has argued for a limited government role in overseeing the private health care market:

Clinical Therapeutics, 2009

It may be a political truth that perception is reality (an observation attributed to political st... more It may be a political truth that perception is reality (an observation attributed to political strategist Lee Atwater 1), but in economics and medicine, objective reality is both the impetus and the goal. Construction of mathematically tractable and internally consistent economic theory does not ensure that the observed outcomes will match the theoretical predictions. For example, in finance, the efficient-market hypothesis theorizes that asset prices fully reflect all available information, and in economics, rational choice theory asserts that individuals have all necessary information and make reasoned choices based on the compatibility of that information with their preferences. Recent economic events indicate that neither theory is correct in practice. Medicine also requires the correcting influence of empiric observation. As Alvan R. Feinstein, founder of the Journal of Clinical Epidemiology, described the situation, "In medical science, almost every plausible concept that has been held throughout the centuries about the causes, mechanisms, and treatment of diseases has been either wholly wrong or so deficient that it was later overthrown and supplanted by other concepts." 2 Peer review is the strongest, if imperfect, method of consistently serving the role of validating scientific observations. It ensures that the published literature contains empiric and methodologic research that is transparent, timely, rigorous, credible, unbiased, and accessible. To meet the information needs of decision-makers and other stakeholders, pharmaceutical economics and health policy research must include the perspectives of the patient, provider, manufacturer, payer, and regulator. The methodologies continue to evolve. Constrained by the limited opportunities for randomized research trials, investigators in this field have had to make creative use of diverse data sources and mixed analytic methods. Nations vary in terms of the organization, financing, and delivery of health services, and these variations affect the net assessment of economic costs and gains for similar clinical results. The increasingly global environment in which pharmaceuticals are discovered, developed, manufactured, and used requires peer-reviewed reports of both domestic and international applied research. Articles in the current issue of Clinical Therapeutics reflect the breadth of the information needs and a diversity of methodologies. Two of the papers originate from the Asia-Pacific region. Wong et al 3 employ a cohort design to study short-term adherence to β-blocker pharmacotherapy for hypertension among ethnic Chinese living in Hong Kong. Liew et al 4 use the 2005 Korea National Health and Nutrition Examination Survey to develop a Markov model of pharmacotherapy for the primary prevention of cardiovascular disease. Yang et al 5 use a retrospective design to evaluate nonadherence to 3 therapeutic drug classes among Medicare Part D enrollees with diabetes in 6 states. The availability of peer-reviewed empiric research expands opportunities for informed decisions in the private sector and comparisons of policy outcomes against intentions in the public sector. However, the relevant therapeutic comparisons and the policies they support are in constant flux, and this research may become dated unless revised to reflect new realities. The articles in the current issue attest to the breadth and depth of information needed for rational decisions and policies, and the richly varied opportunities for researchers to make substantial contributions.

Schizophr Res, 1997

The Schizophrenia PORT literature review provides the basis for the following recommendation on f... more The Schizophrenia PORT literature review provides the basis for the following recommendation on family interventions:Patients who have ongoing contact with their families should be offered a family psychosocial intervention which provides a combination of education about the ...

Learning Objectives Describe the impetus and goals of an initiative to introduce pharmaceutical m... more Learning Objectives Describe the impetus and goals of an initiative to introduce pharmaceutical management for underserved populations into U.S. health care education. Contrast the site-specific strategies that the University of Iowa and the Johns Hopkins University have developed. Discuss how these two models, one from a college of pharmacy and the other from a school of public health can be adapted by other institutions.

Clin Ther, 2004

In the field of public policy, as in calculus, solutions are approached by making successively cl... more In the field of public policy, as in calculus, solutions are approached by making successively closer approximations toward a goal-although, in the case of public policy, those goals are seldom stationary. On December 8, 2003, US President George W. Bush signed the Medicare Prescription Drug, Improvement and Modernization Act (commonly referred to as the Medicare Modernization Act [MMA] of 2003), providing a version of a prescription drug benefit to Medicare beneficiaries. 1 This is not the first drug benefit under Medicare; in June 1988, the Medicare Catastrophic Coverage Act (MCCA) established a drug benefit, but that act was repealed in October 1989. 2 Will the outcome be different this time? Will the MMA stand, or will it, too, be repealed as support for the legislation shifts? Any speculation on these matters must consider the prescription drug benefit's legislative history and timing. The MMA of 2003 was a compromise produced by a joint conference committee of the US House of Representatives and US Senate. Even so, the act passed by a narrow margin in the House after a 2-hour-51-minute roll-call vote-the longest in House history-and a similarly close vote in the Senate) Even as members of the House were voting, the outcome was uncertain: interim tallies counted 216 votes for the legislation versus 218 against it. Active lobbying continued during the roll call) Achieving the key compromises necessary to advance this legislation after it stalled in the conference committee required the intervention of House Speaker J. Dennis Hastert and Senate Majority Leader Bill Frist. Is it surprising, then, that the resulting MMA has proved to be an unstable mix of competing interests and divergent political philosophies? Given its background, the MMA could not be expected to be coherent, internally consistent, or even rational; and now that it has been passed, further legislation should be expected to resolve these aspects. With the Republican party currently holding the majority of seats in both the House and the Senate, and with a Republican president heading the executive branch of the US government, maintaining the party's policy of rejecting both reimportation and direct price negotiations was critical to obtaining sufficient votes to pass the MMA. In addition, AARPg support played a critical role in the passage of the MMA, yet AARP subsequently changed its position (partly due to a backlash in which-45,000 people canceled their AARP memberships). ~-6 Does all of the activity around, reconsideration of, and possible fundamental changes to the MMA indicate that it will meet the same fate as the MCCA? If the carefully cobbled-together congressional majority cannot be maintained, can the legislation? Total repeal of the MMA is unlikely. According to a recent, nationally representative survey] only 26% of Medicare beneficiaries aged >65 years have a favorable impression of the MMA, with just 2% of respondents reporting that they felt "enthusiastic about the new Medicare law." On the other hand, only 10% of respondents said that Congress should repeal the MMA; in fact, 66% said they believed that lawmakers should work to fix the law's problems] This contrasts sharply with Dr. Marilyn Moon's assessment that the MCCA's demise was the result of 2 forces: (1) vocal and visible Medicare beneficiaries who opposed the legislation and (2) legislators who had reached the limits of their willingness to compromise. 2 Therefore, it is probable that public support will be sufficient to retain the general structure of a Part D Medicare benefit, even if substantial modifications are required to address electoral demands and resolve unintended consequences. The MMA's passage did not settle these issues and, with elections assuring sharpened party differences, the strength of public sentiment-and the sway of potential voters-guarantees that they will be reconsidered. Because electoral politics will drive these issues to become even more partisan, it is crucial that the information underlying public-policy debates be rigorous and objective. Health-service research and pharmacoeconomic results can play important roles in doing so, even though they do not determine policy outcomes.

Clinical Therapeutics, Feb 1, 2003

Socioeconomic factors, inaccurate or incomplete information, and ineffective office-practice mana... more Socioeconomic factors, inaccurate or incomplete information, and ineffective office-practice management can result in missed opportunities to vaccinate patients. Socioeconomic factors include poverty and the attendant inability to afford the expense of the vaccine and/or the administration fee(s). Information factors include parents not knowing the child's vaccination status, clinicians believing the immunization rate in their practice is higher than it actually is, and fragmented immunization records that reveal incomplete or misleading information. Practicemanagement factors include inadequate clinical-decision support, such as assessment/feedback or reminder/recall systems, and not performing immunization assessments. Beyond the physician and patient factors, the fragility of vaccine supply may also pose a barrier to adhering to the recommended schedule, as does the increasing complexity of the recommended schedule of vaccinations. The Advisory Committee on Immunization Practices (ACIP) provides advice on vaccine-preventable disease to the Secretary of the US Department of Health and Human Services and to the Centers for Disease Control and Prevention (CDC).' The ACIP's functions, according to its charter, are: (1) to provide "advice and guidance regarding the most appropriate application of antigens and related agents for effective communicable disease control in the civilian population"; (2) to "review and report regularly on immunization practices and recommend improvements in the national immunization efforts"; and (3) to "establish and periodically review and revise a list of vaccines for administration to children eligible to receive vaccines through the Vaccines for Children program, along with schedules regarding the appropriate periodicity, dosage and contraindications." The National Immunization Program, established under Section 317 of the Public Health Service Act and organized under the CDC, provides national focus and leadership in immunization initiatives. Under its strategic plan for 2000-2005, goal 2 is to "achieve maximum coverage: raise and sustain vaccine coverage levels in all populations for all recommended vaccines."2 Through partnerships (eg, with the Women, Infants, and Children program) and promotion of strategies that have proved to be effective (eg, the Assessment, Feedback, Incentives, and exchange of Information [AFIX]) program), the National Immunization Program identifies opportunities to institutionalize quality vaccine care. Section 3 17 funds 'Material m the followmg sectmn IS based on a presentauon and subsequent

Clinical Therapeutics, 2010

The American Recovery and Reinvestment Act of 2009 made provisions for funding comparative effect... more The American Recovery and Reinvestment Act of 2009 made provisions for funding comparative effectiveness research (CER) that would fill information gaps in the practice of evidence-based medicine. This year, as the House and Senate leadership work to meld their health care reform bills into a single piece of legislation, they will have an opportunity to expand on the initial investment in securing sound, unbiased evidence for the comparative effectiveness of therapeutics and services. There are critical differences in the approach to the funding and oversight of CER in the 2 bills. The House bill would vest responsibility for CER in the Agency for Healthcare Research and Quality, whereas the Senate bill would create a nongovernmental Patient-Centered Outcomes Research Institute whose policy and procedures, including the management of conflict of interest, would have to be developed de novo. The Patient-Centered Outcomes Research Institute would have a governing board of 15 members, 3 of whom would be drawn from the pharmaceutical industry. It would be authorized to contract with federal agencies and appropriate private entities to conduct CER, and publication of the results would depend on the report being "within the bounds of and entirely consistent with the evidence and findings produced under the contract with the Institute." 1 This departure from peer review as the basis for deter-r r mining funding priorities and publication places the reception of the resulting work in doubt. 2 Not unexpectedly, the turmoil surrounding the current US health care reform debate has elicited international comparisons-although with little attention to the differences in national contexts or evidence for their relevance to the US context. To date, international comparisons have overlooked all but the biological and clinical results of published studies; however, differences in international approaches, costs, and population health profiles ensure that comparisons of this type will not be sufficient to meet the needs of decision-makers. Reports of pharmacoeconomic research conducted in other national settings should contain a brief description of the pertinent health sector and specify whether the findings appear to be unique to that system, culture, or economy, or are likely to be generalizable to other settings. To ensure that accepted papers have these qualities, the Pharmaceutical Economics & Health Policy section of Clinical Therapeutics has an international Editorial Advisory Board dedicated to the advancement of knowledge in the field and an extensive network of peer reviewers. The current issue of Clinical Therapeutics illustrates the international scope and focus of the journal. The paper by Ademi et al 3 takes an uncommon "bottom-up" approach to determining the direct medical costs associated with the treatment of atherothrombotic disease in Australia from the government perspective. Tu et al 4 present an analysis of practice variations, guidelines, and costs associated with the treatment of hepatitis B virus infection in the Netherlands, contributing empiric evidence to the policy debate. In another report from the Netherlands, Pechlivanoglou et al 5 examine the diffusion and utilization of risperidone long-acting injectable therapy since its introduction in 2003. These papers, which employ various methodologies, perspectives, and focuses, transcend national boundaries. Taken together, they are consistent with the Pharmaceutical Economics & Health Policy section's goal of contributing to informed decision-making. Peer-reviewed publications that examine policy-directed and natural experiments in other countries provide an opportunity for more robust insights as major health care reform is undertaken in the United States. Sound information that grounds the public debate in objective reality is needed more than ever as the House and Senate reconcile the differences between their bills. The outcome will determine whether the resulting legislation is capable of functioning in the transparent environment of peer-reviewed science. In the US health care crisis, the continuing availability of timely empiric evidence will be crucial to resisting the formulation of policy based on ideology.

Clinical Therapeutics, 2002

Health Services Research, Aug 1, 1993

Two theories--agency and managerialism--are compared with respect to their usefulness in explaini... more Two theories--agency and managerialism--are compared with respect to their usefulness in explaining the role of insiders on the hospital board: whether their participation enhances or impairs board financial decision making. The study used 1985 hospital financial and governing board data for a representative sample of acute care California hospitals. Relationships were examined cross-sectionally between the presence or absence of insiders on the board and measures of hospital financial viability while controlling for the organizational factors of system affiliation, ownership, size, region, and corporate restructuring. Multiple regression analysis found significant relationships between insider (CEO, medical staff) participation and hospital viability. These results support the managerial theory of governance by suggesting that the CEO and medical staff provide informational advantages to the hospital governing board. However, the cross-sectional design points to the need for future longitudinal studies in order to sequence these relationships between insider participation and improved hospital viability.

Clinical Therapeutics, Nov 1, 2009

The strengths and limitations of various mechanisms for scientific and policy communications are ... more The strengths and limitations of various mechanisms for scientific and policy communications are actively debated, but peer review and the associated publication process remain the best recognized and most trusted of these mechanisms. The main focus of the peer-review process is the vetting of empiric research. Clinical Therapeutics publishes articles that are reviewed by at least 2 independent researchers for clinical relevance, technical accuracy, methodologic rigor, clarity, and objectivity. 1 These goals are supported by the structure and process of peer review at the journal. In addition, the journal employs explicit requirements for authorship, financial disclosure, and manuscript components that are intended to promote transparency. 2 Over time, the types of manuscripts that appear in peer-reviewed journals have evolved to meet the needs of an expanding and diverse audience of practitioners, policy-makers, government and regulatory agencies, provider organizations, pharmaceutical research and manufacturing companies, and scholars. In addition to original empiric research, Clinical Therapeutics publishes review articles, consensus statements, pieces on contemporary issues, commentaries, brief reports, case reports, research letters, and letters to the editor. Each has a specific definition, structure, and role in achieving the overall objective of rigorously vetted communications. This month, the journal adds a new category to the type of manuscripts considered for publication: the Perspective. This category was designed for brief communications that advance an opinion or provide a perspective on a timely or high-priority topic. Commentaries serve this purpose for some journals, but in Clinical Therapeutics, that category is reserved for balanced articles rather than opinion pieces. The requirement that a Commentary be a 3000-to 3500-word paper containing a thorough, well-referenced, systematic or evidence-based treatment of an issue 2 is designed to elicit a more extensive and balanced analysis than is typical of a Perspective. Until now, some submissions that did not qualify as a Commentary and were not rejected as marketing communications have been excluded because of a focus on a particular view or opinion. This left a gap in the marketplace for ideas. When clearly identified as such and rigorously reviewed against the appropriate standard, a Perspective can stimulate useful exchanges among stakeholders with an interest in pharmaceutical economics and health policy. We do not expect there to be numerous Perspectives submissions. However, occasional high-quality papers in this section will add to our collective understanding of the implications and uses of the peer-reviewed evidence.