A Framework to Measure the Value of Public Health Services

To develop a framework that public health practitioners could use to measure the value of public health services. Data Sources . Primary data were collected from August 2006 through March 2007. We interviewed ( n =46) public health practitioners in four states, leaders of national public health organizations, and academic researchers. Study Design . Using a semi-structured interview protocol, we conducted a series of qualitative interviews to define the component parts of value for public health services and identify methodologies used to measure value and data collected. Data Collection/Extraction Methods . The primary form of analysis is descriptive, synthesizing information across respondents as to how they measure the value of their services. Principal Findings . Our interviews did not reveal a consensus on how to measure value or a specific framework for doing so. Nonetheless, the interviews identified some potential strategies, such as cost accounting and performance-based contracting mechanisms. The interviews noted implementation barriers, including limits to staff capacity and data availability. Conclusions . We developed a framework that considers four component elements to measure value: external factors that must be taken into account (i.e., mandates); key internal actions that a local health department must take (i.e., staff assessment); using appropriate quantitative measures; and communicating value to elected officials and the public.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/74681/1/j.1475-6773.2009.01013.x.pd

FDA Actions Against Health Economic Promotions, 2002–2011

AbstractObjectiveTo investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading.MethodsWe reviewed all warning letters and notices of violation (“untitled letters”) issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to “health economic promotion,” defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act.ResultsOf 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114.ConclusionThe FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence

FDA Actions against Misleading or Unsubstantiated Economic and Quality-of-Life Promotional Claims: An Analysis of Warning Letters and Notices of Violation

AbstractObjectivesThe objective of this study was to understand the types of economic and quality-of-life promotional claims the FDA considers false or misleading.MethodsPublicly available FDA letters (n = 569) sent to pharmaceutical companies from 1997 through 2001 for inappropriate promotional claims were reviewed. A standard data collection form was developed, including six categories for economic violations and three for QOL violations. For QOL, only letters with explicit violations for false or misleading claims using the words “quality of life” or patient “well-being” were considered. Other information collected included type of regulatory letter and media in which violations were found.ResultsTwenty-eight (4.9%) letters cited false and/or misleading economic claims. The most common economic violation was “unsupported comparative claim of effectiveness, safety, or interchangeability” (n = 14). Twenty-eight (4.9%) letters cited QOL violations, of which four contained both economic and QOL violations. The most common QOL violation was “lack of substantial evidence for QOL claims” (n = 15). None of the FDA letters used the term “patient reported outcomes.” Violations were found most frequently in brochure and Web site-based promotions.ConclusionsThe body of evidence that is emerging illustrates how the FDA is regulating promotional material containing misleading or unsubstantiated economic and QOL claims. However, knowing what constitutes an appropriate claim remains challenging because there are no formal guidelines describing what constitutes a violation, nor what level of substantiating evidence is required. More guidance may be needed to ensure appropriate use of these claims in drug promotions

Impact of Electric Fields on Highly Excited Rovibrational States of Polar Dimers

We study the effect of a strong static homogeneous electric field on the highly excited rovibrational levels of the LiCs dimer in its electronic ground state. Our full rovibrational investigation of the system includes the interaction with the field due to the permanent electric dipole moment and the polarizability of the molecule. We explore the evolution of the states next to the dissociation threshold as the field strength is increased. The rotational and vibrational dynamics are influenced by the field; effects such as orientation, angular motion hybridization and squeezing of the vibrational motion are demonstrated and analyzed. The field also induces avoided crossings causing a strong mixing of the electrically dressed rovibrational states. Importantly, we show how some of these highly excited levels can be shifted to the continuum as the field strength is increased, and reversely how two atoms in the continuum can be brought into a bound state by lowering the electric field strength.Comment: 10 pages, 4 figure

Understanding the Medical and Nonmedical Value of Diagnostic Testing

ABSTRACTObjectivesTo develop a framework for defining the potential value of diagnostic testing, and discuss its implications for the health-care delivery system.MethodsWe reviewed the conceptual and empirical literature related to the valuing of diagnostic tests, and used this information to create a framework for characterizing their value. We then made inferences about the impact of this framework on health insurance coverage, health technology assessment, physician–patient relationships, and public health policy.ResultsThree dimensions can effectively classify the potential value created by diagnostic tests: 1) medical value (impact on treatment decisions); 2) planning value (affect on patients' ability to make better life decisions); and 3) psychic value (how test information affects patients' sense of self). This comprehensive framework for valuing diagnostics suggests that existing health technology assessments may systematically under- or overvalue diagnostics, leading to potentially incorrect conclusions about cost-effectiveness. Further, failure to account for all value dimensions may lead to distorted payments under a value-based health-care system.ConclusionsThe potential value created by medical diagnostics incorporates medical value as well as value associated with well-being and planning. Consideration of all three dimensions has important implications for technology assessment and value-based payment

Inferring the Ancient History of the Translation Machinery and Genetic Code via Recapitulation of Ribosomal Subunit Assembly Orders

Universally conserved positions in ribosomal proteins have significant biases in amino acid usage, likely indicating the expansion of the genetic code at the time leading up to the most recent common ancestor(s) (MRCA). Here, we apply this principle to the evolutionary history of the ribosome before the MRCA. It has been proposed that the experimentally determined order of assembly for ribosomal subunits recapitulates their evolutionary chronology. Given this model, we produce a probabilistic evolutionary ordering of the universally conserved small subunit (SSU) and large subunit (LSU) ribosomal proteins. Optimizing the relative ordering of SSU and LSU evolutionary chronologies with respect to minimizing differences in amino acid usage bias, we find strong compositional evidence for a more ancient origin for early LSU proteins. Furthermore, we find that this ordering produces several trends in specific amino acid usages compatible with models of genetic code evolution

Robotic bees for crop pollination: why drones cannot replace biodiversity

The notion that robotic crop pollination will solve the decline in pollinators has gained wide popularity recently (Fig. 1), and in March 2018 Walmart filed a patent for autonomous robot bees. However, w present six arguments showing that this is a technically and economically inviable 'solution' at present and poses substantial ecological and moral risks: (1) despite recent advances, robotic pollination is far from being able to replace bees to pollinate crops efficiently; (2) using robots is very unlikely to be economically viable; (3) there would be unacceptably high environmental costs; (4) wider ecosystems would be damaged; (5) it would erode the values of biodiversity; and, (6) relying on robotic pollination could actually lead to major food insecurity

Diffusion of published cost-utility analyses in the field of health policy and practice

OBJECTIVES: The diffusion of cost-utility analyses (CUAs) through the medical literature was examined, documenting visible patterns and determining how they correspond with expectations about the diffusion of process innovations. METHODS: This study used 539 CUAs from a registry. It includes data elements comprising year of publication, the research center in which the study was performed, the clinical area covered by the CUA, and the specific journal. Finally, each paper was assigned to a journal type that could be one of the three categories: health services research, general medicine, or clinical specialty. RESULTS: When the average number of publications is plotted against time, the plot reveals an S-shaped curve. It appears that, whereas CUAs initially were published more frequently in general medical or health services research journals, there was a clear increase in the diffusion of CUA into subspecialty journals over time. The concentration ratio for research centers as measured by the Herfindhal-Hirschman Index decreased over time. CONCLUSIONS: The spread of CUA through the medical literature follows patterns identified for the diffusion of other new technologies and processes. Future research should focus on what impact this spread has had on the practice of medicine and formulation of health policy

Cost-Utility Analysis of Cancer Prevention, Treatment, and Control

Substantial innovation related to cancer prevention and treatment has occurred in recent decades. However, these innovations have often come at a significant cost. Cost-utility analysis provides a useful framework to assess if the benefits from innovation are worth the additional cost. This systematic review on published cost-utility analyses related to cancer care is from 1988 through 2013. Analyses were conducted in 2013–2015