Can reflective multicriteria be the new paradigm for healthcare decision-making? The EVIDEM journey.

BACKGROUND: Multiple technologies, procedures and programs call for fairly-based decisions for prioritization of healthcare interventions. There is a diversity of perspectives of what constitutes a legitimate decision, which depends on both the process and the reasoning applied. Current approaches focus on technical aspects while methods to support alignment of decisions with the compassionate impetus of healthcare systems is lacking. METHODS: The framework was developed based on an analysis of the foundations of healthcare systems, the reasoning underlying decisions and fair processes. The concept of reflective multicriteria was created: it assumes that decisionmakers guided by a generic interpretative frame rooted in the compassionate impetus of healthcare systems, can sharpen their reasoning, raise awareness of their motivation and increase legitimacy of decisions. The initial framework was made available through a not for profit organization (the EVIDEM Collaboration, 2006-2017) to stimulate its development with thought leaders and stakeholders in an open source philosophy. Development was tailored to the real-life needs of decisionmakers and drew on several domains of knowledge including healthcare ethics, evidenced-based medicine, health economics, health technology assessment and multicriteria approaches. RESULTS: The 10th edition framework builds on four dimensions: (1) the universal impetus of healthcare systems, (2) reasoning, values and ethics, (3) evidence and knowledge on interventions, and (4) a transformative process. Mathematical aspects of the framework are designed to help clarify, express and share individual reasoning; this non-conventional use of numbers requires a cultural change and needs to be phased in slowly. The framework includes four tools for easy adaptation and operationalization: (a) concepts and operationalization, (b) adapt and pilot, (c) evidence matrix, (d) mathematical representation of reasoning. Application is useful throughout all types of healthcare interventions, for all levels of decision, and across the globe. CONCLUSION: By clarifying their reasoning while keeping decisionmakers aware of the impetus of healthcare systems, reflective multicriteria provides an effective approach to increase the legitimacy of decisions. Beyond a tool, reflective multicriteria pioneered by EVIDEM is geared to transform our vision of the value of healthcare interventions and how they might contribute to relevant, equitable and sustainable healthcare systems.

DRUG EVALUATION AND DECISION MAKING IN CATALONIA: DEVELOPMENT AND VALIDATION OF A METHODOLOGICAL FRAMEWORK BASED ON MULTI-CRITERIA DECISION ANALYSIS (MCDA) FOR ORPHAN DRUGS.

OBJECTIVES: The aim of this study was to adapt and assess the value of a Multi-Criteria Decision Analysis (MCDA) framework (EVIDEM) for the evaluation of Orphan drugs in Catalonia (Catalan Health Service). METHODS: The standard evaluation and decision-making procedures of CatSalut were compared with the EVIDEM methodology and contents. The EVIDEM framework was adapted to the Catalan context, focusing on the evaluation of Orphan drugs (PASFTAC program), during a Workshop with sixteen PASFTAC members. The criteria weighting was done using two different techniques (nonhierarchical and hierarchical). Reliability was assessed by re-test. RESULTS: The EVIDEM framework and methodology was found useful and feasible for Orphan drugs evaluation and decision making in Catalonia. All the criteria considered for the development of the CatSalut Technical Reports and decision making were considered in the framework. Nevertheless, the framework could improve the reporting of some of these criteria (i.e., "unmet needs" or "nonmedical costs"). Some Contextual criteria were removed (i.e., "Mandate and scope of healthcare system", "Environmental impact") or adapted ("population priorities and access") for CatSalut purposes. Independently of the weighting technique considered, the most important evaluation criteria identified for orphan drugs were: "disease severity", "unmet needs" and "comparative effectiveness", while the "size of the population" had the lowest relevance for decision making. Test-retest analysis showed weight consistency among techniques, supporting reliability overtime. CONCLUSIONS: MCDA (EVIDEM framework) could be a useful tool to complement the current evaluation methods of CatSalut, contributing to standardization and pragmatism, providing a method to tackle ethical dilemmas and facilitating discussions related to decision making.

EXPLORING VALUES OF HEALTH TECHNOLOGY ASSESSMENT AGENCIES USING REFLECTIVE MULTICRITERIA AND RARE DISEASE CASE.

OBJECTIVES: Tackling ethical dilemmas faced by reimbursement decision makers requires deeper understanding of values on which health technology assessment (HTA) agencies are founded and how trade-offs are made. This was explored in this study including the case of rare disease. METHODS: Representatives from eight HTA explored values on which institutions are founded using a narrative approach and reflective multicriteria (developed from EVIDEM, criteria derived from ethical imperatives of health care). Trade-offs between criteria and the impact of incorporating defined priorities (including for rare diseases) were explored through a quantitative values elicitation exercise. RESULTS: Participants reported a diversity of substantive and procedural values with a common emphasis on scientific excellence, stakeholder involvement, independence, and transparency. Examining the ethical imperatives behind EVIDEM criteria was found to be useful to further explore substantive values. Most criteria were deemed to reflect institutions' values, while 70 percent of the criteria were reported by at least half of participants to be considered formally by their institutions. The quantitative values elicitation highlighted the difficulty to balance imperatives of "alleviating or preventing patient suffering," "serving the whole population equitably," "upholding healthcare system sustainability," and "making decisions informed by evidence and context" but may help share the ethical reasoning behind decisions. Incorporating "Priorities" (including for rare diseases) helped reveal trade-offs from other criteria and their underlying ethical imperatives. CONCLUSIONS: Reflective multicriteria are useful to explore substantive values of HTAs, reflect how these values and their ethical underpinnings can be operationalized into criteria, and explore the ethical reasoning at the heart of the healthcare debate.

Which criteria are considered in healthcare decisions? Insights from an international survey of policy and clinical decision makers.

OBJECTIVES: The aim of this study was to gather qualitative and quantitative data on criteria considered by healthcare decision makers. METHODS: Using snowball sampling and an online questionnaire with forty-three criteria organized into ten clusters, decision makers were invited by an international task force to report which criteria they consider when making decisions on healthcare interventions in their context. Respondents reported whether each criterion is "currently considered," "should be considered," and its relative weight (scale 0-5). Differences in proportions of respondents were explored with inferential statistics across levels of decision (micro, meso, macro), decision maker perspectives, and world regions. RESULTS: A total of 140 decision makers (1/3 clinical, 2/3 policy) from 23 countries in five continents completed the survey. The most relevant criteria (top ranked for "Currently considered," "Should be considered," and weights) were Clinical efficacy/effectiveness, Safety, Quality of evidence, Disease severity, and Impact on healthcare costs. Organizational and skill requirements were frequently considered but had relatively low weights. For almost all criteria, a higher proportion of decision makers reported that they "Should be considered" than that they are "Currently considered" (p < .05). For more than 74 percent of criteria, there were no statistical differences in proportions across levels of decision, perspectives and world regions. Statistically significant differences across several comparisons were found for: Population priorities, Stakeholder pressure/interests, Capacity to stimulate research, Impact on partnership and collaboration, and Environmental impact. CONCLUSIONS: Results suggest convergence among decision makers on the relevance of a core set of criteria and on the need to consider a wider range of criteria. Areas of divergence appear to be principally related to contextual factors.

HTA challenges for appraising rare disease interventions viewed through the lens of an institutional multidimensional value framework.

INTRODUCTION: Evaluating rare disease interventions poses challenges for HTA agencies, including uncertainties and ethical issues and tensions. INESSS has recently adopted a Statement of Principles and Ethical Foundations which proposes a multidimensional approach to value appraisal as well as five principles to frame the evaluation process. AREAS COVERED: Our aim was to identify and analyze HTA challenges for appraising interventions for rare diseases, using the Statement's approach to value appraisal as an analytical framework, and outline how the Statement's principles can help address these challenges. Challenges, covering a diversity of aspects, were identified by leveraging institutional experience in diverse domains of expertise and consolidated through narrative literature review. Challenges were categorized by value dimension (clinical, populational, economic, organizational, and sociocultural), which allowed to pinpoint how each challenge affects the ability to appraise the value of an intervention. Key ethical tensions across dimensions were also identified. Specific approaches to addressing these challenges - related to knowledge mobilization and integration, deliberation, and recommendation-making - were outlined on the basis of the principles promulgated in the Statement. EXPERT OPINION: A multidimensional approach can be fruitful for analyzing challenges for appraising the value of rare disease interventions and help guide approaches to tackle them.

Burden of community-acquired and nosocomial rotavirus gastroenteritis in the pediatric population of Western Europe: a scoping review.

BACKGROUND: Rotavirus affects 95% of children worldwide by age 5 years and is the leading cause of severe dehydrating diarrhea. The objective of this review was to estimate the burden of rotavirus gastroenteritis (RVGE) in the Western European pediatric population. METHODS: A comprehensive literature search (1999-2010) was conducted in PubMed and other sources (CDC; WHO, others). Data on the epidemiology and burden of RVGE among children < 5 years-old in Western Europe --including hospital-acquired disease--were extracted. RESULTS: 76 studies from 16 countries were identified. The mean percentage of acute gastroenteritis (AGE) cases caused by rotavirus ranged from 25.3%-63.5% in children < 5 years of age, peaking during winter. Incidence rates of RVGE ranged from 1.33-4.96 cases/100 person- years. Hospitalization rates for RVGE ranged from 7% to 81% among infected children, depending on the country. Nosocomial RVGE accounted for 47%-69% of all hospital-acquired AGE and prolonged hospital stays by 4-12 days. Each year, RVGE incurred $0.54- $53.6 million in direct medical costs and $1.7-$22.4 million in indirect costs in the 16 countries studied. Full serotyping data was available for 8 countries. G1P[8], G2P[4], G9P[8], and G3P[8] were the most prevalent serotypes (cumulative frequency: 57.2%- 98.7%). Serotype distribution in nosocomial RVGE was similar. CONCLUSIONS: This review confirms that RVGE is a common disease associated with significant morbidity and costs across Western Europe. A vaccine protecting against multiple serotypes may decrease the epidemiological and cost burden of RVGE in Western Europe.

Field testing of a multicriteria decision analysis (MCDA) framework for coverage of a screening test for cervical cancer in South Africa.

BACKGROUND: Systematic and transparent approaches to priority setting are needed, particularly in low-resource settings, to produce decisions that are sound and acceptable to stakeholders. The EVIDEM framework brings together Health Technology Assessment (HTA) and multi-criteria decision analysis (MCDA) by proposing a comprehensive set of decision criteria together with standardized processes to support decisionmaking. The objective of the study was to field test the framework for decisionmaking on a screening test by a private health plan in South Africa. METHODS: Liquid-based cytology (LBC) for cervical cancer screening was selected by the health plan for this field test. An HTA report structured by decision criterion (14 criteria organized in the MCDA matrix and 4 contextual criteria) was produced based on a literature review and input from the health plan. During workshop sessions, committee members 1) weighted each MCDA decision criterion to express their individual perspectives, and 2) to appraise LBC, assigned scores to each MCDA criterion on the basis of the by-criterion HTA report.Committee members then considered the potential impacts of four contextual criteria on the use of LBC in the context of their health plan. Feedback on the framework and process was collected through discussion and from a questionnaire. RESULTS: For 9 of the MCDA matrix decision criteria, 89% or more of committee members thought they should always be considered in decisionmaking. Greatest weights were given to the criteria "Budget impact", "Cost-effectiveness" and "Completeness and consistency of reporting evidence". When appraising LBC for cervical cancer screening, the committee assigned the highest scores to "Relevance and validity of evidence" and "Disease severity". Combination of weights and scores yielded a mean MCDA value estimate of 46% (SD 7%) of the potential maximum value. Overall, the committee felt the framework brought greater clarity to the decisionmaking process and was easily adaptable to different types of health interventions. CONCLUSIONS: The EVIDEM framework was easily adapted to evaluating a screening technology in South Africa, thereby broadening its applicability in healthcare decision making.

From efficacy to equity: Literature review of decision criteria for resource allocation and healthcare decisionmaking.

OBJECTIVES: Resource allocation is a challenging issue faced by health policy decisionmakers requiring careful consideration of many factors. Objectives of this study were to identify decision criteria and their frequency reported in the literature on healthcare decisionmaking. METHOD: An extensive literature search was performed in Medline and EMBASE to identify articles reporting healthcare decision criteria. Studies conducted with decisionmakers (e.g., focus groups, surveys, interviews), conceptual and review articles and articles describing multicriteria tools were included. Criteria were extracted, organized using a classification system derived from the EVIDEM framework and applying multicriteria decision analysis (MCDA) principles, and the frequency of their occurrence was measured. RESULTS: Out of 3146 records identified, 2790 were excluded. Out of 356 articles assessed for eligibility, 40 studies included. Criteria were identified from studies performed in several regions of the world involving decisionmakers at micro, meso and macro levels of decision and from studies reporting on multicriteria tools. Large variations in terminology used to define criteria were observed and 360 different terms were identified. These were assigned to 58 criteria which were classified in 9 different categories including: health outcomes; types of benefit; disease impact; therapeutic context; economic impact; quality of evidence; implementation complexity; priority, fairness and ethics; and overall context. The most frequently mentioned criteria were: equity/fairness (32 times), efficacy/effectiveness (29), stakeholder interests and pressures (28), cost-effectiveness (23), strength of evidence (20), safety (19), mission and mandate of health system (19), organizational requirements and capacity (17), patient-reported outcomes (17) and need (16). CONCLUSION: This study highlights the importance of considering both normative and feasibility criteria for fair allocation of resources and optimized decisionmaking for coverage and use of healthcare interventions. This analysis provides a foundation to develop a questionnaire for an international survey of decisionmakers on criteria and their relative importance. The ultimate objective is to develop sound multicriteria approaches to enlighten healthcare decisionmaking and priority-setting.

Burden of rotavirus gastroenteritis in the Middle Eastern and North African pediatric population.

BACKGROUND: Rotavirus gastroenteritis (RVGE) is the most common cause of severe childhood diarrhea worldwide. Objectives were to estimate the burden of RVGE among children less than five years old in the Middle East (Bahrain, Iran, Iraq, Israel, Jordan, Kuwait, Oman, Qatar, Saudi Arabia, Syria, UAE, Yemen), North Africa (Algeria, Egypt, Libya, Morocco, Tunisia) and Turkey. METHODS: A comprehensive literature search was conducted in major databases on the epidemiology and burden of rotavirus among children less than five years old between 1999 and 2009. Data from each country was extracted and compared. RESULTS: The search identified 43 studies. RVGE was identified in 16-61% of all cases of acute gastroenteritis, with a peak in the winter. RVGE-related hospitalization rates ranged from 14% to 45%, compared to 14%-28% for non-RVGE. Annually, RVGE caused up to 112 fatalities per 100,000 in certain countries in the region. Hospitalization costs ranged from $1.8 to $4.6 million annually, depending on the country. The most recent literature available showed that G1P[8] was the most prevalent genotype combination in 8 countries (range 23%-56%). G2P[4] was most prevalent in 4 countries (26%-48%). G9P[8] and G4P[8] were also frequently detected. CONCLUSIONS: RVGE is a common disease associated with significant morbidity, mortality, and economic burden. Given the variety and diverse rotavirus types in the region, use of a vaccine with broad and consistent serotype coverage would be important to help decrease the burden of RVGE in the Middle East and North Africa.

Burden of rotavirus gastroenteritis in the pediatric population in Central and Eastern Europe: serotype distribution and burden of illness.

BACKGROUND: Rotaviral gastroenteritis (RVGE) is the leading cause of severe diarrhea in children under five years of age worldwide. This comprehensive review aims to estimate the burden of RVGE among children in Central and Eastern Europe. METHODS: An extensive search of the biomedical literature (1999-2009) was conducted in major databases. Studies pertaining to the epidemiology and burden of rotavirus in Central and Eastern Europe were captured and data from each country was systematically extracted and compared. RESULTS: This literature search captured 38 studies pertaining to RVGE infection in the region. Among children under 15 years of age, RVGE accounted for between 22.0% and 55.3% of all cases of acute gastroenteritis per year. For most countries RVGE was most common in the winter months, although it was reported year round in Bulgaria. Geographical comparison of genotyping data revealed that three genotype combinations, G1P[8], G4P[8], and G2P[4] were present in all countries for which full genotyping data was available. Genotype predominance varied on a season to season basis within each country. Only limited data was available for healthcare resource utilization, and economic burden for this region. CONCLUSIONS: RVGE is a common disease associated with significant morbidity, and mortality. While three genotype combinations currently predominate in the region, the dominance of a certain serotype can change dramatically from year to year and from country to country. A vaccination program with broad serotype coverage may help to decrease the burden of RVGE in Central and Eastern Europe.

Bridging health technology assessment (HTA) with multicriteria decision analyses (MCDA): field testing of the EVIDEM framework for coverage decisions by a public payer in Canada.

BACKGROUND: Consistent healthcare decision making requires systematic consideration of decision criteria and evidence available to inform them. This can be tackled by combining multicriteria decision analysis (MCDA) and Health Technology Assessment (HTA). The objective of this study was to field-test a decision support framework (EVIDEM), explore its utility to a drug advisory committee and test its reliability over time. METHODS: Tramadol for chronic non-cancer pain was selected by the health plan as a case study relevant to their context. Based on extensive literature review, a by-criterion HTA report was developed to provide synthesized evidence for each criterion of the framework (14 criteria for the MCDA Core Model and 6 qualitative criteria for the Contextual Tool). During workshop sessions, committee members tested the framework in three steps by assigning: 1) weights to each criterion of the MCDA Core Model representing individual perspective; 2) scores for tramadol for each criterion of the MCDA Core Model using synthesized data; and 3) qualitative impacts of criteria of the Contextual Tool on the appraisal. Utility and reliability of the approach were explored through discussion, survey and test-retest. Agreement between test and retest data was analyzed by calculating intra-rater correlation coefficients (ICCs) for weights, scores and MCDA value estimates. RESULTS: The framework was found useful by the drug advisory committee in supporting systematic consideration of a broad range of criteria to promote a consistent approach to appraising healthcare interventions. Directly integrated in the framework as a "by-criterion" HTA report, synthesized evidence for each criterion facilitated its consideration, although this was sometimes limited by lack of relevant data. Test-retest analysis showed fair to good consistency of weights, scores and MCDA value estimates at the individual level (ICC ranging from 0.676 to 0.698), thus lending some support for the reliability of the approach. Overall, committee members endorsed the inclusion of most framework criteria and revealed important areas of discussion, clarification and adaptation of the framework to the needs of the committee. CONCLUSIONS: By promoting systematic consideration of all decision criteria and the underlying evidence, the framework allows a consistent approach to appraising healthcare interventions. Further testing and validation are needed to advance MCDA approaches in healthcare decisionmaking.

Combining multicriteria decision analysis, ethics and health technology assessment: applying the EVIDEM decision-making framework to growth hormone for Turner syndrome patients.

OBJECTIVES: To test and further develop a healthcare policy and clinical decision support framework using growth hormone (GH) for Turner syndrome (TS) as a complex case study. METHODS: The EVIDEM framework was further developed to complement the multicriteria decision analysis (MCDA) Value Matrix, that includes 15 quantifiable components of decision clustered in four domains (quality of evidence, disease, intervention and economics), with a qualitative tool including six ethical and health system-related components of decision. An extensive review of the literature was performed to develop a health technology assessment report (HTA) tailored to each component of decision, and content was validated by experts. A panel of representative stakeholders then estimated the MCDA value of GH for TS in Canada by assigning weights and scores to each MCDA component of decision and then considered the impact of non-quantifiable components of decision. RESULTS: Applying the framework revealed significant data gaps and the importance of aligning research questions with data needs to truly inform decision. Panelists estimated the value of GH for TS at 41% of maximum value on the MCDA scale, with good agreement at the individual level (retest value 40%; ICC: 0.687) and large variation across panelists. Main contributors to this panel specific value were "Improvement of efficacy", "Disease severity" and "Quality of evidence". Ethical considerations on utility, efficiency and fairness as well as potential misuse of GH had mixed effects on the perceived value of the treatment. CONCLUSIONS: This framework is proposed as a pragmatic step beyond the current cost-effectiveness model, combining HTA, MCDA, values and ethics. It supports systematic consideration of all components of decision and available evidence for greater transparency. Further testing and validation is needed to build up MCDA approaches combined with pragmatic HTA in healthcare decision-making.

Evidence and Value: Impact on DEcisionMaking--the EVIDEM framework and potential applications.

BACKGROUND: Healthcare decisionmaking is a complex process relying on disparate types of evidence and value judgments. Our objectives for this study were to develop a practical framework to facilitate decisionmaking in terms of supporting the deliberative process, providing access to evidence, and enhancing the communication of decisions. METHODS: Extensive analyses of the literature and of documented decisionmaking processes around the globe were performed to explore what steps are currently used to make decisions with respect to context (from evidence generation to communication of decision) and thought process (conceptual components of decisions). Needs and methodologies available to support decisionmaking were identified to lay the groundwork for the EVIDEM framework. RESULTS: A framework was developed consisting of seven modules that can evolve over the life cycle of a healthcare intervention. Components of decision that could be quantified, i.e., intrinsic value of a healthcare intervention and quality of evidence available, were organized into matrices. A multicriteria decision analysis (MCDA) Value Matrix (VM) was developed to include the 15 quantifiable components that are currently considered in decisionmaking. A methodology to synthesize the evidence needed for each component of the VM was developed including electronic access to full text source documents. A Quality Matrix was designed to quantify three criteria of quality for the 12 types of evidence usually required by decisionmakers. An integrated system was developed to optimize data analysis, synthesis and validation by experts, compatible with a collaborative structure. CONCLUSION: The EVIDEM framework promotes transparent and efficient healthcare decisionmaking through systematic assessment and dissemination of the evidence and values on which decisions are based. It provides a collaborative framework that could connect all stakeholders and serve the healthcare community at local, national and international levels by allowing sharing of data, resources and values. Validation and further development is needed to explore the full potential of this approach.

Pragmatic Multicriteria Decision Analysis (MCDA) Combined With Advanced Pharmacoepidemiology for Benefit-Risk Assessments of Medicines Adapted to the Real-Life Constraints of Regulators: Development and Case Study.

BACKGROUND: Multicriteria decision analysis (MCDA) represents a promising method for benefit-risk assessment. Our goal was to develop features of pragmatic MCDA (EVIDEM [Evidence and Value: Impact on DEcisionMaking]) addressing real-life regulatory decision-making needs, incorporate advanced pharmacoepidemiology, and test the resulting benefit-risk framework using a case study. METHODS: The Intervention Outcomes domain of EVIDEM was transformed into a generic benefit-risk framework including clinical efficacy, patient-reported outcomes, and adverse event (AE) criteria. The concept of relative benefit-risk balance (RBRB) was developed for comparability across products and therapeutic areas and over time. Evidence matrix was designed to include most relevant data from trials, observational studies, and models, including Bayesian and longitudinal modeling. The framework was tested with a panel of stakeholders using efalizumab for psoriasis as retrospective case study. Uncertainty was explored. RESULTS: The MCDA benefit-risk tree was adapted with psoriasis-specific subcriteria. Panelists assigned similar weights to benefits (0.48; SD, 0.20-0.70) and risks (0.52; SD, 0.10-0.60), with large variations reflecting diverse perspectives. Panelist scores reflected higher efficacy versus placebo, lower efficacy versus active comparators, and serious and fatal AEs identified postlicensing. Efalizumab's RBRB was positive at licensing in 2004 (0.29, scale -1 to +1) and ranged from -0.41 (vs active comparators) to 0.01 (vs placebo) in 2009, when its market authorization was withdrawn. Retesting indicated good reproducibility. Panelists acknowledged good face validity and the importance of criteria beyond benefit-risk in real-life assessments. CONCLUSIONS: The approach allows quantification and visualization of benefit-risk over time and across comparators. Combination of pragmatic MCDA designed to integrate criteria beyond benefit-risk and advanced statistics supports application of MCDA to further accountable benefit-risk assessments for real-life decision making.

Medicare coverage and reimbursement of outpatient prescription drugs in the US: history, recent changes and outlook for the future.

US Medicare provides health insurance to 41.5 million disabled and elderly Americans. Outpatient coverage, including a limited pharmacy benefit, is provided by Medicare Part B. Even with very restrictive criteria, Part B incurs 8.5 billion US dollars annually for outpatient prescription medications. Prior to passage of the Medicare Prescription Drug and Improvement Modernization Act (MMA) 2003, the Part B pharmacy benefit was criticised for its limited coverage criteria and flawed reimbursement practices. Despite the changes made under the MMA, these two issues continue to be concerns for the Medicare Part B outpatient prescription drug programme because (a) the criteria for selection of drugs for coverage do not necessarily reflect valuable advances in medicine, and the extent to which the new private-sector style 2006 Medicare Part D drug benefit will correct this is unknown; and (b) although pre-MMA average wholesale price-based reimbursement practices were clearly flawed, MMA changes such as use of the average sales price and providing increased reimbursement to physicians for drug administration may or may not be successful, and could lead to new problems. The extent to which the MMA and its associated Part D drug benefit address concerns and advance towards better, more cost-effective healthcare is reviewed and recommendations made.

Understanding the underlying drivers of inpatient cost growth: a literature review.

BACKGROUND: After the declining growth in inpatient hospital spending that occurred from 1994 through 1998, the recent trend in increased spending has been of concern to many. Understanding the underlying reasons for this new growth will aid decision makers in finding best means to manage inpatient costs. OBJECTIVE: To identify potential contributors to recent growth in inpatient spending. STUDY DESIGN: Literature review. METHODS: Healthcare and economic databases, prominent Web sites, and key journals were searched to identify potential drivers for the 1999-2001 rise in inpatient spending. Initial literature review and state-level regression analyses published in a companion paper were used to identify key explanatory factors, which were further explored. RESULTS: Although many of the contributors to the rise in inpatient costs overlap and are interrelated, the major cost drivers were identified as (1) workforce shortage; (2) new technology; (3) less tightly managed care; and (4) shifting hospital business directions. Underlying factors such as legislation, quality of care, limited access to noninpatient care, pressures on the safety net, population aging, and increasing chronic illness prevalence were found to influence the contributors and healthcare spending in general. CONCLUSIONS: Future trends in inpatient spending will depend on the response of the healthcare system to these cost drivers and underlying factors. Potential avenues to control inpatient spending include expanding access to primary care, encouraging cost-effective technology and more efficient hospital market structures, and developing incentives for the healthcare workforce.

Bridging health technology assessment (HTA) and efficient health care decision making with multicriteria decision analysis (MCDA): applying the EVIDEM framework to medicines appraisal.

BACKGROUND: Health care decision making is complex and requires efficient and explicit processes to ensure transparency and consistency of factors considered. OBJECTIVES: To pilot an adaptable decision-making framework incorporating multicriteria decision analysis (MCDA) in health technology assessment (HTA) with a pan-Canadian group of policy and clinical decision makers and researchers appraising 10 medicines covering 6 therapeutic areas. METHODS: An appraisal group was convened and participants were asked to express their individual perspectives, independently of the medicines, by assigning weights to each criterion of the MCDA core model: disease severity, size of population, current practice and unmet needs, intervention outcomes (efficacy, safety, patient reported), type of health benefit, economics, and quality of evidence. Participants then assigned performance scores for each medicine using available evidence synthesized in a "by-criterion" HTA report covering each of the MCDA CORE model criteria. MCDA estimates of perceived value were calculated by combining normalized weights and scores. Feedback on the approach was collected through structured discussion. RESULTS: Relative weights on criteria varied widely, reflecting the diverse perspectives of participants. Scores for each criterion provided a performance measure, highlighting strengths and weaknesses of each medicine. MCDA estimates of perceived value ranged from 0.42 to 0.64 across medicines, providing comprehensive measures incorporating a large spectrum of criteria. Participants reported that the framework provided an efficient approach to systematic consideration in a pragmatic format of the multiple elements guiding decision, including criteria and values (MCDA core model) and evidence (HTA "by-criterion" report). CONCLUSIONS: This proof-of-concept study demonstrated the usefulness of incorporating MCDA in HTA to support transparent and systematic appraisal of health care interventions. Further research is needed to advance MCDA-based approaches to more effective healthcare decision making.

The societal value of universal childhood vaccination.

Availability of new vaccines preventing infectious diseases in healthy children populations is increasing worldwide. In Canada, despite the current recommendation of the National Advisory Committee on Immunization to include recent vaccines in routine schedule, only a few provinces have incorporated some of the newer vaccines in routine vaccination programs. A review was undertaken of economic evaluations of childhood vaccination strategies performed from the societal point of view in industrialized countries, to gain perspective on their global benefits. The general trend supports most universal vaccination programs as cost-saving or cost-effective for society. Comparison of vaccination programs with other health care interventions indicates that vaccines are often one of society's best healthcare investments. Current data suggest that the Canadian society would benefit from a more complete immunization program.