Health System Decision Makers Research Articles

HAS Should Not Be NICE: Rejecting Imaginary Worlds in the French Technology Assessment Guidelines

Pricing decisions and access to pharmaceuticals should be evidence based. Unfortunately, the French guidelines for technology assessment, in their adoption of the National Institute for Health and Clinical Excellence (NICE) reference case modeling standard ensure that this is not the case. Rather than requiring the submission of claims that are credible, evaluable and replicable, the Haute Autorité de Sante (HAS) mandates the creation of imaginary worlds to support comparative effectiveness and cost-outcome claims. The purpose of this commentary is to make the case that HAS should reconsider this commitment to standards for health technology assessment that are more appropriately seen as pseudoscience. The recommendation is that HAS should put to one side mandating lifetime cost-per-quality adjusted life year (QALY) or life years saved claims in favor of short-term claims that can be evaluated and reported to health system decision makers as part of a provisional assessment of new products as well as supporting ongoing disease area and therapeutic class reviews.
 
 Type: Commentary

Dreamtime: Version 5.0 of the Australian Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC)

In September 2016 the Australian Department of Health published Version 5.0 of the Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC). These guidelines, which were first published for comment in 1990, set out how to prepare a submission to list a new medicine or medicinal product on the Pharmaceutical Benefits Schedule (PBS). The guidelines give instructions on the information required by the PBAC and the Economic Sub-Committee (ESC), the most appropriate form for presenting clinical evidence and the standards for an economic evaluation. The purpose of this commentary is to consider whether or not the evidence standards proposed and the consequent modeled claims for economic effectiveness meet the standards of normal science: are the claims presented to support PBS listing credible, evaluable and replicable. The review concludes that the PBAC guidelines do not meet the standards expected in normal science. The absence of empirically evaluable claims means there is no way of judging whether they are right or even if they are wrong. If the Guidelines were never intended to support experimentation and systematic observation to generate feedback to health system decision makers, then this should be made clear by the PBAC. If not, then consideration should be given to redrafting the guidelines to ensure they conform to these standards. Hopefully, future versions of the guidelines will address this issue and focus on a rigorous research program of claims assessment and feedback.
 
 Type: Commentary

HAS Should Not Be NICE: Rejecting Imaginary Worlds in the French Technology Assessment Guidelines

Pricing decisions and access to pharmaceuticals should be evidence based. Unfortunately, the French guidelines for technology assessment, in their adoption of the National Institute for Health and Clinical Excellence (NICE) reference case modeling standard ensure that this is not the case. Rather than requiring the submission of claims that are credible, evaluable and replicable, the Haute Autorite de Sante (HAS) mandates the creation of imaginary worlds to support comparative effectiveness and cost-outcome claims. The purpose of this commentary is to make the case that HAS should reconsider this commitment to standards for health technology assessment that are more appropriately seen as pseudoscience. The recommendation is that HAS should put to one side mandating lifetime cost-per-quality adjusted life year (QALY) or life years saved claims in favor of short-term claims that can be evaluated and reported to health system decision makers as part of a provisional assessment of new products as well as supporting ongoing disease area and therapeutic class reviews. Type: Commentary

Dreamtime: Version 5.0 of the Australian Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC)

In September 2016 the Australian Department of Health published Version 5.0 of the Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC). These guidelines, which were first published for comment in 1990, set out how to prepare a submission to list a new medicine or medicinal product on the Pharmaceutical Benefits Schedule (PBS). The guidelines give instructions on the information required by the PBAC and the Economic Sub-Committee (ESC), the most appropriate form for presenting clinical evidence and the standards for an economic evaluation. The purpose of this commentary is to consider whether or not the evidence standards proposed and the consequent modeled claims for economic effectiveness meet the standards of normal science: are the claims presented to support PBS listing credible, evaluable and replicable. The review concludes that the PBAC guidelines do not meet the standards expected in normal science. The absence of empirically evaluable claims means there is no way of judging whether they are right or even if they are wrong. If the Guidelines were never intended to support experimentation and systematic observation to generate feedback to health system decision makers, then this should be made clear by the PBAC. If not, then consideration should be given to redrafting the guidelines to ensure they conform to these standards. Hopefully, future versions of the guidelines will address this issue and focus on a rigorous research program of claims assessment and feedback. Type: Commentary

Primary oral health care: a missing link in public health in Pakistan

In Pakistan, the limited availability of oral health care and the high level of unmet oral health care needs are well documented. The recorded prevalence of dental caries is 50-70% and that of oral cancer is among the highest in the world. Although oral health care has been declared to be part of the primary health care system, oral health disparities between rich and poor, and emerging problems of access to and use of appropriate care have never been addressed, reflecting a lack of awareness among both patients and health system decisionmakers. Oral cancer screening and atraumatic restorative treatment for tooth decay could be included in a basic package of oral care that does not require qualified dental surgeons. This article develops an argument, based on literature review and an analysis of the health system in Pakistan, for how a basic oral health programme could be an accessible, affordable and acceptable component of the primary health care system.

User survey finds rapid evidence reviews increased uptake of evidence by Veterans Health Administration leadership to inform fast-paced health-system decision-making.

BackgroundTo provide evidence synthesis for faster-paced healthcare decision-making, rapid reviews have emerged as a streamlined alternative to standard systematic reviews. In 2012, the Veterans Affairs Evidence-based Synthesis Program (VA ESP) added rapid reviews to support Veterans Health Administration (VHA) operational partners’ more urgent decision-making needs. VHA operational partners play a substantial role in dissemination of ESP rapid reviews through a variety of routes, including posting on the VA ESP’s public website (http://www.hsrd.research.va.gov/publications/esp/). As demand for rapid reviews rises, much progress has been made in characterizing methods and practices. However, evidence synthesis organizations still seek to better understand how and when rapid reviews are being used.MethodsThe VA ESP administered an online survey to rapid review operational partners. The survey assessed the nature of decision-making needs, overall perception of review content, resulting actions, and implementation timeframe. We use descriptive statistics and narrative methods to summarize findings.ResultsBetween October 2011 and April 2015, we completed 12 rapid reviews for 35 operational partners. Operational partners were primarily non-academic subject matter experts with VA operations’ decision-making authority. The most common topic categories reviewed were policy or system (50 %) or process of care (42 %) initiatives. Median report completion time was 14.5 weeks. Survey response rate was 46 %, with at least one operational partner responding for 92 % of reports. Reviews served multiple purposes including policy directive or regulation (72 %), supporting program development and evaluation (55 %), identifying future research needs (45 %), and determining implementation strategy (45 %). Overall, operational partners’ perception of report content was positive. A majority of rapid reviews were used immediately and informed actions ranking high on the Institute of Medicine’s Degrees of Impact framework: 45.4 % effected change, 18.2 % inspired action, 18.2 % informed the field, 9.1 % received recognition, and 9.1 % spread a message.ConclusionsVA ESP rapid reviews have increased the VHA’s uptake of evidence to inform time-sensitive system-level decision-making. Key areas of interest for future evaluation include assessing user perception of our streamlined methods and the quality of our efforts to inform users of these methods, as well as comparing the usability and impact of our rapid and standard systematic reviews.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-016-0306-5) contains supplementary material, which is available to authorized users.

He Ao Pohewa: The PHARMAC Prescription for Pharmacoeconomic Analysis in New Zealand and the Standards of Normal Science

In common with a number of other single payer health systems, New Zealand has, through the Pharmaceutical Management Agency (PHARMAC), established guidelines for formulary submissions by pharmaceutical manufacturers. A question that is important to health system decision makers is to whether or not guidelines for economic evaluations in countries like New Zealand are consistent with the standards of normal science. Do the guidelines require those making the submission to put their claims in the form of testable hypotheses that can support falsification and replication? Are post-listing evaluations of these claims ever carried out? The purpose of this review is to consider whether the 2012 PHARMAC guidelines meet these standards. The assessment argues that the guidelines do not meet the standards of normal science. Instead, from this perspective, they are best characterized as supporting the creation of he ao pohewa (an imaginary world). There is no requirement in the guidelines for claims to be expressed as testable propositions; as hypotheses for expected impact that can be evaluated and the outcomes reported as part of ongoing disease area and therapeutic class reviews. There is no commitment to the discovery of new facts though falsification and replication. Our review concludes with suggestions for a reworking of the guidelines to meet the standards of normal science.
 
 Type: Commentary

Imaginary Worlds: The Status of Simulation Modeling in Claims for Cost-Effectiveness In Diabetes Mellitus

Over the past 20 years a number of simulations or models have been developed as a basis for tracking and evaluating the impact of pharmacological and other interventions in type 1 and type 2 diabetes mellitus. These models have typically tracked the natural course of these diseases generating long-term composite claims for cost-effectiveness. These claims can extend over the lifetime of the modeled patient cohort. Set against the standards of normal science, however, these claims lack credibility. The claims presented are all too often either immune to failure or are presented in a form that is non-testable. As such they fail to meet the key experimental requirements of falsification and replication. Unfortunately, there is a continuing belief that long-term or lifetime models are essential to decision-making. This is misplaced. The purpose of this review is to argue that there is a pressing need to reconsider the needs of health system decision makers and focus on modeled or simulated claims that are meaningful, testable, reportable and replicable in evaluating interventions in diabetes mellitus.
 
 Type: Commentary

PHP187 - Marketing Authorization of Medicines Approved In Eu Via “Adaptive Pathway”: Consequences on The Egyptian Public Health

This paper aims to discuss the consequences of the broadened use of the “adaptive pathways” in the EU countries, the availability of adequate measures in the current regulatory framework and healthcare system to ensure public health benefit and reduce hazards. Finally, this paper will draw policy recommendations on how to manage the entrance of these kind of products to the Egyptian Market. Literature review is done to set a list of measurements and prerequisites in the regulatory and healthcare system to ensure and monitor the benefit-risk balance across the product life cycle. A focus group of medicines regulators and healthcare system experts was established to discuss the existence of these measurements within the Egyptian regulatory framework and healthcare system context. Finally a list of policy recommendations will be set for the safe introduction of medicines approved by “adaptive pathway” to the Egyptian market. Health system decision makers and the Egyptian Drug Authority should ensure that the following measurements will be in place before starting the introduction of “Adaptive licensing” medicines: Vigilance regulation is fulfilled; Regulatory bodies closely monitor the promotion practice and prescribing practice to prevent off-label use; The Egyptian Drug Authority should revisit the definition of unmet medical need; Payers and health insurance organization should reconsider their reimbursement mechanisms and shift to payment-for- performance scheme; The MOH should ensure the availability of unbiased clear information for patients; Patient Registry systems in MOH and University tertiary hospitals should be strengthened and there should be a mechanism in place to compensate patients for any resulted harms from the therapy. Medicines approved by “adaptive pathway” should get a market authorization in Egypt only if there is an unmet medical need.

P063: Is triage score a valid measure of emergency department case mix?

Introduction: In the Canadian province of Alberta, (pop. 4,227,879), the publicly-funded health care system uses the five level Canadian Triage and Acuity Scale (CTAS), to prioritize emergency department (ED) patients. Health system decision makers and policy makers currently use CTAS as an isolated metric to describe ED patient case-mix and to compare EDs. Methods: Using the National Ambulatory Care Reporting System dataset, we reviewed the distribution of patient CTAS scores and the proportion of inpatient admissions by CTAS level for the 16 highest volume Alberta hospital EDs during FY 2013/2014. Results: Collectively, the EDs received 1,027,976 patients, with 1%, 18%, 44%, 30% and 7% classified as CTAS 1-5, respectively. The proportions by CTAS level ranged from 0.2% to 2.8% in CTAS 1; 3.3% to 33.3% in CTAS 2; 29.1% to 54.1% in CTAS 3; 16.7% to 49.0% in CTAS 4; and 3.1% to 12.3% in CTAS 5. Admission proportions by CTAS level ranged from 43.9% to 75.2% in CTAS 1; 18.9% to 42.1% in CTAS 2; 5.4% to 24.7% in CTAS 3; 0.8% to 9.3% in CTAS 4; and 0.1% to 9.1% in CTAS 5. Conclusion: Inter-hospital differences in CTAS acuity distributions reflect triage variability and real differences in case-mix. Wide variation in admission proportions by CTAS level reflects differing admission thresholds between sites, but also suggest intra-level differences in patient severity, comorbidity and complexity. Triage levels cannot be used as an isolated metric to describe and compare ED case-mix. Further work is required to accurately characterize ED patient case-mix.

Patient narratives representing patient voices to inform research: a pilot qualitative study.

We are investigating the feasibility and effectiveness of establishing a library of patient narratives to inform patient-centered research in the U.S. Veterans Affairs organization. Using qualitative methods, we conducted a needs assessment of 15 researchers and then interviewed and videotaped 11 veterans with traumatic brain injury or diabetes. We developed a method for displaying the narratives to researchers modeled after a UK initiative called DIPEx and then performed preliminary usability testing. We found that it is not only feasible to provide researchers with patient narratives that could help guide their research, but that similar narratives might be useful to practitioners, health system decision makers, and other patients as well.

Stochastic multi-objective auto-optimization for resource allocation decision-making in fixed-input health systems.

The management of hospitals within fixed-input health systems such as the U.S. Military Health System (MHS) can be challenging due to the large number of hospitals, as well as the uncertainty in input resources and achievable outputs. This paper introduces a stochastic multi-objective auto-optimization model (SMAOM) for resource allocation decision-making in fixed-input health systems. The model can automatically identify where to re-allocate system input resources at the hospital level in order to optimize overall system performance, while considering uncertainty in the model parameters. The model is applied to 128 hospitals in the three services (Air Force, Army, and Navy) in the MHS using hospital-level data from 2009 - 2013. The results are compared to the traditional input-oriented variable returns-to-scale Data Envelopment Analysis (DEA) model. The application of SMAOM to the MHS increases the expected system-wide technical efficiency by 18 % over the DEA model while also accounting for uncertainty of health system inputs and outputs. The developed method is useful for decision-makers in the Defense Health Agency (DHA), who have a strategic level objective of integrating clinical and business processes through better sharing of resources across the MHS and through system-wide standardization across the services. It is also less sensitive to data outliers or sampling errors than traditional DEA methods.

The determinants of efficiency in the Canadian health care system.

In spite of the vast number of studies measuring economic efficiency in health care, there has been little take-up of this evidence by policy-makers to date. This study provides an illustration of how a system-level study drawing on best practice in empirical measurement of efficiency may be of practical use to health system decision makers and managers. We make use of the rich data available in Canada to undertake a robust two-stage data envelopment analysis to calculate efficiency at the regional (sub-provincial) level. Decisions about what the health system produces (the outcome to measure efficiency against) and what are the resources it has to produce that outcome were based on interviews and consultation with health system decision makers. Overall, we find large inefficiencies in the Canadian health care system, which could improve outcomes (here, measured as a reduction in treatable causes of death) by between 18 and 35% across our analyses. Also, we find that inefficiencies are the result of three main sets of factors that policy makers could pay attention to: management factors, such as hospital re-admissions; public health factors, such as obesity and smoking rates; and environmental factors such as the population's average income.

Medicines and universal health coverage: challenges and opportunities.

Medicines and universal health coverage: challenges and opportunities.

Supporting chronic pain management across provincial and territorial health systems in Canada: Findings from two stakeholder dialogues.

Chronic pain is a serious health problem given its prevalence, associated disability, impact on quality of life and the costs associated with the extensive use of health care services by individuals living with it. To summarize the research evidence and elicit health system policymakers', stakeholders' and researchers' tacit knowledge and views about improving chronic pain management in Canada and engaging provincial and territorial health system decision makers in supporting comprehensive chronic pain management in Canada. For these two topics, the global and local research evidence regarding each of the two problems were synthesized in evidence briefs. Three options were generated for addressing each problem, and implementation considerations were assessed. A stakeholder dialogue regarding each topic was convened (with 29 participants in total) and the deliberations were synthesized. To inform the first stakeholder dialogue, the authors found that systematic reviews supported the use of evidence-based tools for strengthening chronic pain management, including patient education, self-management supports, interventions to implement guidelines and multidisciplinary approaches to pain management. While research evidence about patient registries/treatment-monitoring systems is limited, many dialogue participants argued that a registrysystem is needed. Many saw a registry as a precondition for moving forward with other options, including creating a national network of chronic pain centres with a coordinating 'hub' to provide chronic pain-related decision support and a cross-payer, cross-discipline model of patient-centred primary health care-based chronic pain management. For the second dialogue, systematic reviews indicated that traditional media can be used to positively influence individual health-related behaviours, and that multistakeholder partnerships can contribute to increasing attention devoted to issues on policy agendas. Dialogue participants emphasized the need to mobilize behind an effort to build a national network that would bring together existing organizations and committed individuals. Developing a national network and, thereafter, a national pain strategy are important initiatives that garnered broad-based support during the dialogues. Efforts toward achieving this goal have been made since convening the dialogues.

Barriers, facilitators and views about next steps to implementing supports for evidence-informed decision-making in health systems: a qualitative study.

BackgroundMobilizing research evidence for daily decision-making is challenging for health system decision-makers. In a previous qualitative paper, we showed the current mix of supports that Canadian health-care organizations have in place and the ones that are perceived to be helpful to facilitate the use of research evidence in health system decision-making. Factors influencing the implementation of such supports remain poorly described in the literature. Identifying the barriers to and facilitators of different interventions is essential for implementation of effective, context-specific, supports for evidence-informed decision-making (EIDM) in health systems. The purpose of this study was to identify (a) barriers and facilitators to implementing supports for EIDM in Canadian health-care organizations, (b) views about emerging development of supports for EIDM, and (c) views about the priorities to bridge the gaps in the current mix of supports that these organizations have in place.MethodsThis qualitative study was conducted in three types of health-care organizations (regional health authorities, hospitals, and primary care practices) in two Canadian provinces (Ontario and Quebec). Fifty-seven in-depth semi-structured telephone interviews were conducted with senior managers, library managers, and knowledge brokers from health-care organizations that have already undertaken strategic initiatives in knowledge translation. The interviews were taped, transcribed, and then analyzed thematically using NVivo 9 qualitative data analysis software.ResultsLimited resources (i.e., money or staff), time constraints, and negative attitudes (or resistance) toward change were the most frequently identified barriers to implementing supports for EIDM. Genuine interest from health system decision-makers, notably their willingness to invest money and resources and to create a knowledge translation culture over time in health-care organizations, was the most frequently identified facilitator to implementing supports for EIDM. The most frequently cited views about emerging development of supports for EIDM were implementing accessible and efficient systems to support the use of research in decision-making (e.g., documentation and reporting tools, communication tools, and decision support tools) and developing and implementing an infrastructure or position where the accountability for encouraging knowledge use lies. The most frequently stated priorities for bridging the gaps in the current mix of supports that these organizations have in place were implementing technical infrastructures to support research use and to ensure access to research evidence and establishing formal or informal ties to researchers and knowledge brokers outside the organization who can assist in EIDM.ConclusionsThese results provide insights on the type of practical implementation imperatives involved in supporting EIDM.

Seeing the forests and the trees--innovative approaches to exploring heterogeneity in systematic reviews of complex interventions to enhance health system decision-making: a protocol.

BackgroundTo improve quality of care and patient outcomes, health system decision-makers need to identify and implement effective interventions. An increasing number of systematic reviews document the effects of quality improvement programs to assist decision-makers in developing new initiatives. However, limitations in the reporting of primary studies and current meta-analysis methods (including approaches for exploring heterogeneity) reduce the utility of existing syntheses for health system decision-makers. This study will explore the role of innovative meta-analysis approaches and the added value of enriched and updated data for increasing the utility of systematic reviews of complex interventions.Methods/DesignWe will use the dataset from our recent systematic review of 142 randomized trials of diabetes quality improvement programs to evaluate novel approaches for exploring heterogeneity. These will include exploratory methods, such as multivariate meta-regression analyses and all-subsets combinatorial meta-analysis. We will then update our systematic review to include new trials and enrich the dataset by surveying authors of all included trials. In doing so, we will explore the impact of variables not, reported in previous publications, such as details of study context, on the effectiveness of the intervention. We will use innovative analytical methods on the enriched and updated dataset to identify key success factors in the implementation of quality improvement interventions for diabetes. Decision-makers will be involved throughout to help identify and prioritize variables to be explored and to aid in the interpretation and dissemination of results.DiscussionThis study will inform future systematic reviews of complex interventions and describe the value of enriching and updating data for exploring heterogeneity in meta-analysis. It will also result in an updated comprehensive systematic review of diabetes quality improvement interventions that will be useful to health system decision-makers in developing interventions to improve outcomes for people with diabetes.Systematic review registrationPROSPERO registration no. CRD42013005165

Health system decision makers’ feedback on summaries and tools supporting the use of systematic reviews: a qualitative study

Health system managers and policy makers need timely access to high quality, policy-relevant systematic reviews. Our objectives were to obtain managers’ and policy makers’ feedback about user-friendly summaries of systematic reviews and about tools related to supporting or assessing their use. Our interviews identified that participants prefer key messages up front, such as details regarding background, methods, and applicability, appreciate quality ratings, and prefer bullets and tables to paragraphs. There were mixed views about the relevance-assessment tool and positive views about the use-assessment tool. The findings can be used to support evidence-informed decision making among managers and policy makers.

Using the Delphi Method for Qualitative, Participatory Action Research in Health Leadership

Current pressures on public health systems have led to increased emphasis on restructuring, which is seen as a potential solution to crises of accessibility, quality, and funding. Leadership is an important factor in the success or failure of these initiatives. Despite its importance, health leadership evades easy articulation, and its study requires a thoughtful methodological approach. We used a modified Delphi method in a Participatory Action Research (PAR) project on health leadership in Canada. Little has been written about the combination of Delphi method with PAR. We offer a rationale for the combination and describe its usefulness in researching the role of leadership in a restructuring initiative in “real time” with the participation of health system decision makers. Recommendations are provided to researchers wishing to use the Delphi method qualitatively (i.e., without statistical consensus) in a PAR framework while protecting the confidentiality of participants who work at different levels of authority. We propose a modification of Kaiser's (2009) post-interview confidentiality form to address power differentials between participants and to enhance confidentiality in the PAR process.

How to Implement Clinical Practice Guidelines in Iran

Background:Evidence-based medicine would come to the result by evidence-based implementation. Clinical Practice Guidelines (CPG) as one of the evidence-based knowledge products requires appropriate interventions after being produced to be applied.Objectives:The aim of this qualitative study was to identify the strategies for application of CPGs produced in Iran.Materials and Methods:The purposive snowball sampling was performed and it continued until reaching the theoretical saturation. In-depth semistructured individual interviews and Focus Group Discussion (FGD) were performed aiming at triangulation. The thematic framework approach was used for the analysis.Results:Twelve interviews were conducted with three health system policy makers and decision makers, four experienced in the production or adaptation of clinical practices, and five experts in evidence-based medicine development and education. In addition, 11 policy makers, managers, and decision makers of the health system took part in FGD. The proposed interventions were classified in the following themes: Health professionals-oriented, Financial, Organizational, Regulatory, and Multifaceted interventions.Conclusions:Along with adaptation and development process of CPGs, their utilization should also be planned; otherwise spent time and money would be in vain. Certainly, imposing above-mentioned interventions with the ultimate goal of sustainable behavior change in health system service providers is beyond the capacity of specific groups or few academic centers. It requires the participation of all practitioners under the monitoring and support of the Ministry of Health and Medical Education. Deployment of the family physician plan and referral system is an opportunity which must be considered a trophy.