Valuing Health: Evolution, Revolution, Resistance, and Reform.

A number of methods have sought to determine the value of interventions and services that promote health, even when no agreement exists on the proper way to determine and define "value." Previous valuation efforts began simply by counting deaths or measuring life expectancy, slowly evolving to the widespread use of cost-effectiveness analysis (CEA) as the de facto normative standard for medical interventions. Users of CEA recognize that the method is incomplete. Further, no meaningful agreement exists on how best to apply CEA in decision settings because of either inadequacies in the CEA framework or lack of consensus on how to use it in a setting with budget constraints. Yet efforts to value health still predominantly use (and continue to recommend) this limited framework. Is this owing to a lack of new ideas and motivation, resistance to change, or an aversion to embrace more comprehensive systems approaches? We argue that tools of systems engineering can advance our capabilities, but they have had only limited use in health policy. We identify some reasons and specifically highlight the promise of systems-analytic platforms-such as multicriteria decision support systems-and the need to make them more accessible for different uses in real situations with real consequences. We also explore the need for comparative testing of different multicriteria approaches (including direct comparisons with CEA) to learn when and by how much the recommendations differ and what the consequences might be.

Vision for a systems architecture to integrate and transform population health.

Entities involved in population health often share a common mission while acting independently of one another and perhaps redundantly. Population health is in everybody's interest, but nobody is really in charge of promoting it. Across governments, corporations, and frontline operations, lack of coordination, lack of resources, and lack of reliable, current information have often impeded the development of situation-awareness models and thus a broad operational integration for population health. These deficiencies may also affect the technical, organizational, policy, and legal arrangements for information sharing, a desired practice of high potential value in population health. In this article, we articulate a vision for a next-generation modeling effort to create a systems architecture for broadly integrating and visualizing strategies for advancing population health. This multipurpose systems architecture would enable different views, alerts, and scenarios to better prepare for and respond to potential degradations in population health. We draw inspiration from systems engineering and visualization tools currently in other uses, including monitoring the state of the economy (market performance), security (classified intelligence), energy (power generation), transportation (global air traffic control), environment (weather monitoring), jobs (labor market dynamics), manufacturing and supply chain (tracking of components, parts, subassemblies, and products), and democratic processes (election analytics). We envision the basic ingredients for a population health systems architecture and its visualization dashboards to eventually support proactive planning and joint action among constituents. We intend our ambitious vision to encourage the work needed for progress that the population deserves.

Stakeholder involvement in Multi-Criteria Decision Analysis.

This brief perspective highlights the importance of decision maker buy-in and ownership through stakeholder engagement in the co-construction of the multi-criteria decision analysis (MCDA) model. A brief historical overview of MCDA is presented before outlining the importance of bridging the gap (and to gain trust) between the tool developers and users. The issues with the current MCDA tool development and testing efforts are highlighted, and the ownership and routine adoption of the MCDA process is discussed.

Resource allocation in decision support frameworks.

BACKGROUND: Cost-benefit and cost-effectiveness analysis place limits on the dimensions of value that the models can incorporate. Cost-benefit analysis requires monetization of all measures of value (including life), a task sometimes deemed either difficult to accomplish or even repugnant. Cost-effectiveness analyses include health care gains in natural units (e.g., quality-adjusted life years or QALYs) rather than purely monetizing them (e.g., in dollars) and offers an efficiency perspective based on the ratio of cost per QALYs or similar health measures. These two methods use different rules for investment. Cost-benefit analysis says to invest whenever benefits exceed costs. Cost-effectiveness analysis says to invest if the intervention has a cost per QALY that meets-or is below-a designated cutoff value. METHODS: Multi-criteria frameworks expand decision analyses by considering value tradeoffs from decision makers, and then producing a synthetic measure that summarizes the performance of investment options. This evaluation is done across all chosen dimensions of value, based on the weights provided by the decision makers, but this flexibility comes at a cost. To date, no approach is widely accepted to suggest how much to invest (how to determine a budget constraint) using multi-attribute models. Moreover, there is no agreed-upon method to measure willingness to pay for incremental multi-attribute value improvements. Our paper proposes a way forward. RESULTS: Based on existing dollar estimates of willingness to pay for QALYs, our concept creates a comparable cutoff for multi-criteria value measures. Our proposed method expands the acceptable cost per QALYs in proportion to how much of the total measure is accounted for by the QALY component. Agreed-upon values for cost per QALY are thus extrapolated to account for extra value created by non-QALY attributes of each intervention. CONCLUSION: Using our proposed methods, the cost per QALY cutoff can serve as a benchmark toward creating a resource allocation cutoff in multi-criteria frameworks.

Using Multicriteria Approaches to Assess the Value of Health Care.

Practitioners of cost-utility analysis know that their models omit several important factors that often affect real-world decisions about health care options. Furthermore, cost-utility analyses typically reflect only single perspectives (e.g., individual, business, and societal), further limiting the value for those with different perspectives (patients, providers, payers, producers, and planners-the 5Ps). We discuss how models based on multicriteria analyses, which look at problems from many perspectives, can fill this void. Each of the 5Ps can use multicriteria analyses in different ways to aid their decisions. Each perspective may lead to different value measures and outcomes, whereas no single-metric approach (such as cost-utility analysis) can satisfy all these stakeholders. All stakeholders have unique ways to measure value, even if assessing the same health intervention. We illustrate the benefits of this approach by comparing the value of five different hypothetical treatment choices for five hypothetical patients with cancer, each with different preference structures. Nine attributes describe each treatment option. We add a brief discussion regarding the use of these approaches in group-based decisions. We urge that methods to value health interventions embrace the multicriteria approaches that we discuss, because these approaches 1) increase transparency about the decision process, 2) allow flight simulator-type evaluation of alternative interventions before actual investment or deployment, 3) help focus efforts to improve data in an efficient manner, 4) at least in some cases help facilitate decision convergence among stakeholders with differing perspectives, and 5) help avoid potential cognitive errors known to impair intuitive judgments.

Beyond cost-effectiveness: Using systems analysis for infectious disease preparedness.

Until the recent outbreaks, Ebola vaccines ranked low in decision makers' priority lists based on cost-effectiveness analysis and (or) corporate profitability. Despite a relatively small number of Ebola-related cases and deaths (compared to other causes), Ebola vaccines suddenly leapt to highest priority among international health agencies and vaccine developers. Clearly, earlier cost-effectiveness analyses badly missed some factors affecting real world decisions. Multi-criteria systems analysis can improve evaluation and prioritization of vaccine development and also of many other health policy and investment decisions. Neither cost-effectiveness nor cost-benefit analysis can capture important aspects of problems such as Ebola or the emerging threat of Zika, especially issues of inequality and disparity-issues that dominate the planning of many global health and economic organizations. Cost-benefit analysis requires assumptions about the specific value of life-an idea objectionable to many analysts and policy makers. Additionally, standard cost-effectiveness calculations cannot generally capture effects on people uninfected with Ebola for example, but nevertheless affected through such factors as contagion, herd immunity, and fear of dread disease, reduction of travel and commerce, and even the hope of disease eradication. Using SMART Vaccines, we demonstrate how systems analysis can visibly include important "other factors" and more usefully guide decision making and beneficially alter priority setting processes.

Planning and priority setting for vaccine development and immunization.

We review a sequence of strategic planning efforts over time in the United States, all involving processes to prioritize new vaccine candidates. The Institute of Medicine of the National Academies of Sciences, Engineering, and Medicine has been involved in three priority setting processes, each using different metrics and methodologies: infant mortality equivalents (1985-1986), cost-effectiveness (2000), and more recently, the implementation of a software system based on a broader multi-criteria systems approach that can include either of the earlier metrics among other various considerations (2015). The systems approach offers users the flexibility to select, combine, rank, weigh and evaluate different attributes representing their perspectives, assumptions, and particular needs. This approach also overcomes concerns relating to the previous single-metric ranking approaches that yielded lists that, once published, were static, and could not readily accommodate new information about emerging pathogens, new scientific advances, or changes in the costs and performance features of interventions. We discuss the rationale and reasoning behind the design of this multi-criteria decision support approach, stakeholder feedback about the tool, and highlight the potential advantages from using this expanded approach to better inform and support vaccine policies.

Strategic Planning in Population Health and Public Health Practice: A Call to Action for Higher Education.

POLICY POINTS: Scarce resources, especially in population health and public health practice, underlie the importance of strategic planning. Public health agencies' current planning and priority setting efforts are often narrow, at times opaque, and focused on single metrics such as cost-effectiveness. As demonstrated by SMART Vaccines, a decision support software system developed by the Institute of Medicine and the National Academy of Engineering, new approaches to strategic planning allow the formal incorporation of multiple stakeholder views and multicriteria decision making that surpass even those sophisticated cost-effectiveness analyses widely recommended and used for public health planning. Institutions of higher education can and should respond by building on modern strategic planning tools as they teach their students how to improve population health and public health practice. CONTEXT: Strategic planning in population health and public health practice often uses single indicators of success or, when using multiple indicators, provides no mechanism for coherently combining the assessments. Cost-effectiveness analysis, the most complex strategic planning tool commonly applied in public health, uses only a single metric to evaluate programmatic choices, even though other factors often influence actual decisions. METHODS: Our work employed a multicriteria systems analysis approach--specifically, multiattribute utility theory--to assist in strategic planning and priority setting in a particular area of health care (vaccines), thereby moving beyond the traditional cost-effectiveness analysis approach. FINDINGS: (1) Multicriteria systems analysis provides more flexibility, transparency, and clarity in decision support for public health issues compared with cost-effectiveness analysis. (2) More sophisticated systems-level analyses will become increasingly important to public health as disease burdens increase and the resources to deal with them become scarcer. CONCLUSIONS: The teaching of strategic planning in public health must be expanded in order to fill a void in the profession's planning capabilities. Public health training should actively incorporate model building, promote the interactive use of software tools, and explore planning approaches that transcend restrictive assumptions of cost-effectiveness analysis. The Strategic Multi-Attribute Ranking Tool for Vaccines (SMART Vaccines), which was recently developed by the Institute of Medicine and the National Academy of Engineering to help prioritize new vaccine development, is a working example of systems analysis as a basis for decision support.

Bridging the gap: need for a data repository to support vaccine prioritization efforts.

As the mechanisms for discovery, development, and delivery of new vaccines become increasingly complex, strategic planning and priority setting have become ever more crucial. Traditional single value metrics such as disease burden or cost-effectiveness no longer suffice to rank vaccine candidates for development. The Institute of Medicine-in collaboration with the National Academy of Engineering-has developed a novel software system to support vaccine prioritization efforts. The Strategic Multi-Attribute Ranking Tool for Vaccines-SMART Vaccines-allows decision makers to specify their own value structure, selecting from among 28 pre-defined and up to 7 user-defined attributes relevant to the ranking of vaccine candidates. Widespread use of SMART Vaccines will require compilation of a comprehensive data repository for numerous relevant populations-including their demographics, disease burdens and associated treatment costs, as well as characterizing performance features of potential or existing vaccines that might be created, improved, or deployed. While the software contains preloaded data for a modest number of populations, a large gap exists between the existing data and a comprehensive data repository necessary to make full use of SMART Vaccines. While some of these data exist in disparate sources and forms, constructing a data repository will require much new coordination and focus. Finding strategies to bridge the gap to a comprehensive data repository remains the most important task in bringing SMART Vaccines to full fruition, and to support strategic vaccine prioritization efforts in general.

Vaccines: from valuation to resource allocation.

This review focuses on selected challenges and opportunities concerning broader valuation of vaccines and immunization. The challenges involve conceptualizing and measuring the value of vaccines, while the opportunities relate to the strategic and systematic use of that information in health policy decisions that range from the adoption of particular vaccines in national immunization plans to the allocation of resources to vaccine research, development, and delivery. Clarifying the demonstrable individual, family, and community-level benefits of vaccines will allow the public health community to make better-informed and more meaningful comparisons of the costs of vaccines in relation to their full benefits. Taking advantage of this opportunity will require enhanced data collection and the development of strategic planning tools for transparently assessing trade-offs among the myriad attributes of different vaccines in various social and economic contexts.

Enhancing hemodialysis efficacy through neuromuscular stimulation.

Beat-to-beat blood pressure monitoring was used to assess the efficacy of reflex-mediated, calf muscle pump stimulation to enhance cardiovascular refilling in subjects in the supine and seated positions, with extension of this stimulation technology to dialysis evaluated in 2 dialysis patients. Micromechanical stimulation (50 mum at 45 Hz) of the plantar surface was found to significantly increase both the rate and volume of cardiovascular refilling relative to that observed for subjects in the supine position. During hemodialysis, calf muscle pump stimulation permitted significantly increased ultrafiltrate removal, specifically from 78 to 96% of clinical goal, while serving to maintain both blood pressure and blood volume.

Prevalence and etiology of delayed orthostatic hypotension in adult women.

OBJECTIVE: To evaluate the contributing roles of venous status, microvascular filtration, and calf muscle pump activity in the etiology of delayed orthostatic hypotension (OH). DESIGN: Unblinded within-subjects trial. SETTING: Academic clinical research center. PARTICIPANTS: Convenience sample of healthy adult women (N=30) with an age range of 30 to 65 years. INTERVENTION: Plantar micromechanical stimulation applied at a 45-Hz frequency and a 50-microm amplitude for a duration of 30 minutes during upright sitting. MAIN OUTCOME MEASURE: Diastolic blood pressure (DBP). RESULTS: White women (mean age, 51.8+/-1.3 y) were recruited and screened for delayed OH. About one quarter (9/33) of the screened subjects showed delayed OH as determined by a significant decrease in blood pressure after at least 15 minutes of quiet sitting. Air plethysmographic assessment provided no evidence of venous insufficiency (venous filling index, >2.5 mL/s; venous volume, >80 mL) or excessive microvascular filtration in the affected subjects, whereas activation of the calf muscle pump (CMP) through plantar-based micromechanical stimulation consistently resulted in a significant increase in systolic blood pressure (SBP) (DeltaSBP=22.8+/-3.9 mmHg, P=.003) and DBP (DeltaDBP=20.9+/-3.3 mmHg, P=.002). CONCLUSIONS: About 25% of the adult women studied showed delayed OH during quiet sitting and the proximate cause appears to be neuromuscular in origin, specifically inadequate calf muscle tone, because venous and microvascular filtration status is normative in the delayed OH subpopulation and CMP stimulation reverses the hypotension.

Ultrasonometric profiling of incidence and risk of osteoporosis in rural women.

BACKGROUND: It is estimated that over 200 million people worldwide have osteoporosis. The prevalence of osteoporosis is continuing to escalate with the increasingly aging population. The major complication of osteoporosis is an increase in fragility fractures leading to morbidity, mortality, and decreased quality of life. This investigation profiled the incidence and risk of osteoporosis in adult women from a rural setting using ultrasonic bone scanning technology. METHODS: Between 2001 and 2005, adult female subjects (n = 323) in the age range of 40-87 were drawn from an independent, community dwelling, convenience sample. Bone mineral density T-scores were evaluated using heel ultrasonometry. Demographic and risk factor data, Merck Osteoporosis Evaluation SCORE questionnaire data, and the Osteoporosis Risk Assessment questionnaire data were analyzed. RESULTS: Results of these scans indicate that 25% of the total population had a T-score < or = -1.0, implying a 1.5- to 2.0-fold increase in risk ratio of hip or spinal fracture for each standard deviational decrease. Age at menopause and weight had a positive correlation with T-scores. While the overall scores on the Merck SCORE questionnaire were inversely correlated to T-scores, no significant correlation was found between the Osteoporosis Risk Assessment questionnaire and T-score data. Additionally, women who had taken estrogen had significantly higher T-scores (p = 0.038) than those who had not. CONCLUSION: That approximately 25% of this sample has low bone mass or osteoporosis underscores the importance of early screening in order to develop preventative awareness and provide education on bone health management. This finding has particularly important ramifications, since the sample was rural women, who typically have limited access to diagnostic bone density procedures.

Cardiovascular systemic regulation by plantar surface stimulation.

UNLABELLED: The decreased blood pressure and flow rates associated with orthostasis have been implicated in the etiology of numerous clinical conditions, including deep vein thrombosis, chronic fatigue syndrome, and more recently osteoporosis. Here, we investigate the potential of low-magnitude vibration, applied at the plantar surface, to inhibit the cardiovascular responses of adult women to the orthostatic stress associated with quiet sitting. METHODS: Thirty healthy women, aged 22-82 years, were exposed to a plantar-based vibration immediately after taking a seated position. Seven stimulus frequencies (0, 15, 22, 44, 60, 90, and 120 Hz, all at 0.2g) were tested on each subject, and cardiovascular responses were followed for 20 minutes. Each subject experienced only a single test frequency on any day. Pre- and poststimulus blood pressures and continuous electrocardiogram results were obtained, from which mean arterial pressure (MAP) and heart rate variability (HRV) were calculated. RESULTS: In the per-protocol study population (n = 25), 20 minutes of quiet sitting was associated with an average depression of 8.95 mm Hg in systolic pressure and of 1.9 mm Hg in diastolic blood pressure, corresponding to an average decrease in MAP of 5.15 mm Hg. These orthostasis-based changes in blood pressure were significantly reduced by exposure to plantar vibration, in a frequency-dependent manner, with essentially complete suppression of the drop in MAP achieved with plantar stimulation at 44 Hz (P < or = . 01). In the orthostatically hypotensive subpopulation (n = 15), both the 9.3-mm Hg depression in MAP and the decline in HRV were eliminated by exposure to plantar vibrations in the 40- to 60-Hz range (P = .01 and P = .03, respectively). These results are consistent with the hypothesis that the plantar vibration may be stimulating type IIA muscle fiber activity in the leg, which is critical for effective skeletal muscle pumping in the absence of locomotion. CONCLUSIONS: Our findings lead us to suggest that noninvasive, low-level, plantar-based vibration in the regime of 30-60 Hz can significantly inhibit the effects of the orthostatic stress of quiet sitting on the cardiovascular system.

Vibromyographic quantification of voluntary isometric contractile force in the brachioradialis.

This study investigated the ability of vibromyography (VMG) to accurately represent voluntary forearm muscle contractile force during attempted-isometric contraction of the brachioradialis. VMG signals were collected from the brachioradialis of healthy adult men (mean age, 26.6+/-9.8 years, N=24) during attempted-isometric contraction over a force range of 4.45 N to maximum sustained load. The VMG signals were decomposed using wavelet packet analysis techniques, and the corresponding wavelet packets were utilized in a multiple regression model for parameter reduction and identification of signal components which best correlated to muscle force. It was observed that just two wavelet components were sufficient to accurately predict muscle force (R2=0.984, P<0.0001). The signal force relationship observed is monotonic, though quadratic in form. More importantly, the wavelet data was able to predict absolute force output of the brachioradialis without normalization or prior knowledge of a subject's maximum voluntary force. These data show that VMG recordings are capable of providing a monotonic relationship between VMG signal and muscle force. Moreover, in contrast to EMG technology which can only provide relative force levels, VMG appears to be capable of reporting absolute force levels, an observation which is expected to lead to numerous applications in medicine and rehabilitation.