Consumer directed care aged care reforms in Australia since 2009: A retrospective policy analysis

In 2009, the Australian federal government used the projected rise in aged care expenditure and changing societal attitudes to justify the decision to overhaul the funding for aged healthcare services. A major feature of the reforms was the introduction of a consumer directed care (CDC) model. This followed the UK, Sweden, Canada and the USA who had already implemented CDC to some degree. The CDC model transferred aged care decisions from providers to consumers. This promised to create a competitive market system, resulting in decreased costs, increased quality and increased consumer satisfaction of aged healthcare services. Advocacy services were also reformed to address market failures. These changes were achieved by engaging key actors throughout the policy cycle, giving perceived legitimacy and transparency; and commissioning reviews with restricted scope and at calculated times, limiting their ability to produce negative criticism. In July 2018, the federal government gained full funding and responsibility for aged care with the support of key stakeholders and multiple reviews, yet with little objective data on the benefit of the reforms. This analysis highlights the power of the policymaking process in creating policies.     

Making Good Decisions in Healthcare with Multi-Criteria Decision Analysis: The Use,Current Research and Future Development of MCDA

Healthcare decision making is usually characterized by a low degree of transparency. The demand for transparent decision processes can be fulfilled only when assessment, appraisal and decisions about health technologies are performed under a systematic construct of benefit assessment. The benefit of an intervention is often multidimensional and, thus, must be represented by several decision criteria. Complex decision problems require an assessment and appraisal of various criteria; therefore, a decision process that systematically identifies the best available alternative and enables an optimal and transparent decision is needed. For that reason, decision criteria must be weighted and goal achievement must be scored for all alternatives. Methods of multi-criteria decision analysis (MCDA) are available to analyse and appraise multiple clinical endpoints and structure complex decision problems in healthcare decision making. By means of MCDA, value judgments, priorities and preferences of patients, insurees and experts can be integrated systematically and transparently into the decision-making process. This article describes the MCDA framework and identifies potential areas where MCDA can be of use (e.g. approval, guidelines and reimbursement/pricing of health technologies). A literature search was performed to identify current research in healthcare. The results showed that healthcare decision making is addressing the problem of multiple decision criteria and is focusing on the future development and use of techniques to weight and score different decision criteria. This article emphasizes the use and future benefit of MCDA.     

Evaluation of new medicines in Spain and comparison with other European countries

ObjectiveTo compare the use of health technology assessment (HTA) as a tool to support pricing and reimbursement (P&R) of new medicines in Spain with England, Sweden, France and Germany.MethodFor each country, the literature is used to identify the purpose and timing of the P&R decision, the HTA and decision-making procedures used to generate evidence, and the criteria used to make decisions.ResultsResults are presented as a summary of the HTA landscape for P&R of new medicines in each country. Comparisons are made between Spain and other countries regarding the procedure and implementation of HTA.ConclusionsBased on these assessments, we made recommendations for how HTA might develop in Spain with the aim of improving governance and efficiency. Spain has made considerable progress in recent years, but still falls short of international standards in terms of independence of the HTA agencies and decision-making committees from political influence and industrial policy, the setting of prices of medicines in relation to health gain, improve the transparency of the process and results of the evaluation, and promote the participation of stakeholders. In common with other countries, Spain needs to clarify the role of cost-effectiveness criteria. Further progress needs to be made to coordinate effort across the various agencies, strengthen technical staff, and ensure equitable access to medicines between regions.     

Entscheidungsunterstützung durch gesundheits?konomische Evaluation in Deutschland aus Perspektive der Wissenschaft

For decades, economic evaluation studies, or cost-benefit analyses (CBA), have been a tool for decision support in the use of public funds. Despite this, in the last few years, debates on the inclusion of CBAs in the German health care system have paid little attention to the findings and practical experiences of scientific research. CBAs - especially the QALY - were instead represented a priori as "unfair" and "discriminatory." Today they have virtually no meaning when it comes to allocation and pricing decisions about publicly funded health services. Of course, CBAs are based on value judgments, which have to be communicated. They can lead to allocations that violate the minimum standards of justice. Here, distributive requirements and criteria are needed and must be developed in an interdisciplinary discourse. However, a general waiver of CBA does not make decisions about the allocation of resources easier, especially since its involvement can contribute to more openness and transparency in the system. Accordingly, for Germany a dual approach is recommended: an interdisciplinary exploration of the methodological foundations of economic evaluation and a consistent application of these in healthcare decision-making.     

Representation and legitimacy in health policy formulation at a national level: perspectives from a study of health technology eligibility procedures in the United Kingdom

Decisions about the availability of publicly funded new drugs, treatments and medical devices are of fundamental interest to patients, health technology manufacturers, clinicians and tax or insurance payers. The issue of who can claim to speak for whom in decisions made on behalf of significant proportions of the population may thus be central to the perceived legitimacy of decision-making procedures. This article focuses on the meaning of representation and legitimacy in relation to such decisions within the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom. Interviews with key informants (n=33) indicate potentially fluid and imprecise aspects of representation and legitimacy that are not necessarily addressed by formal structures for engaging and involving stakeholders in decision-making processes. The findings suggest that those charged with managing bodies such as NICE should adopt a flexible approach to engaging and involving stakeholders. The "representation" of relevant stakeholder constituencies in decision-making procedures is not, however, enough. The legitimacy of decision-making arrangements on behalf of wider society also depends upon transparent reasoned debate that affords different interests the opportunity to challenge, test or advance arguments about evidence in a manner that discounts preconceived ideas about the status and authority of protagonists.     

The Use of Multicriteria Decision Analysis to Support Decision Making in Healthcare: An Updated Systematic Literature Review

ObjectivesMulticriteria decision analysis (MCDA) is increasingly used for decision making in healthcare. However, its application in different decision-making contexts is still unclear. This study aimed to provide a comprehensive review of MCDA studies performed to inform decisions in healthcare and to summarize its application in different decision contexts.MethodsWe updated a systematic review conducted in 2013 by searching Embase, MEDLINE, and Google Scholar for MCDA studies in healthcare, published in English between August 2013 and November 2020. We also expanded the search by reviewing grey literature found via Trip Medical Database and Google, published between January 1990 and November 2020. A comprehensive template was developed to extract information about the decision context, criteria, methods, stakeholders involved, and sensitivity analyses conducted.ResultsFrom the 4295 identified studies, 473 studies were eligible for full-text review after assessing titles and abstracts. Of those, 228 studies met the inclusion criteria and underwent data extraction. The use of MCDA continues to grow in healthcare literature, with most of the studies (49%) informing priority-setting decisions. Safety, cost, and quality of care delivery are the most frequently used criteria, although there are considerable differences across decision contexts. Almost half of the MCDA studies used the linear additive model whereas scales and the analytical hierarchy process were the most used techniques for scoring and weighting, respectively. Not all studies report on each one of the MCDA steps, consider axiomatic properties, or justify the methods used.ConclusionsA guide on how to conduct and report MCDA that acknowledges the particularities of the different decision contexts and methods needs to be developed.     

What health care services does the public want and who should decide? Ask them!

Most of the parties involved in healthcare decisions – governments, politicians, healthcare professionals, pharmaceutical companies, special interest groups – actively work to make their desires known. In Israel the public is part of the decision committee; in Germany health care decision are made more or less without the public being involved. In a recently published IJHPR article, Giora Kaplan and Orna Baron-Epel raise the question of how well acquainted senior decision makers in the Israeli health system are with the public’s priorities regarding the services being considered for inclusion in the public funding list. This commentary speculates about the reasons for the discrepancies found in that article between the decision makers’ and the public’s view. Furthermore, it reports on survey results from Germany about who should be part of the decision making committee and briefly touches upon the situation in other OECD countries. While public opinion may not be the determining factor, all authors advocate a strengthening of the public’s contribution to the health care decision making process, including steps to make decision makers aware of public priorities on an ongoing basis.     

Decision Support Needs for Transgender and Gender-Diverse Youth and Families: A Patient-Centered Needs Assessment

PurposeDue to the intertwining of medical and social decision-making, new approaches to shared decision-making are likely needed for supporting decisions related to the care of transgender and gender-diverse (TGD) adolescents. Prior to developing decision support interventions for TGD youth, a decision support needs assessment must be completed.MethodsSelf-identified TGD youth, family members of TGD youth, clinicians caring for this population, and community advocates participated in one of six group level assessments (GLAs). GLA is a structured, participatory qualitative method that engages diverse groups of stakeholders in generating and evaluating ideas on the topic of interest. Upon completion of all GLAs, a survey was developed and distributed to GLA participants inviting them to rank ideas generated during the GLAs.ResultsSix major themes emerged from the GLAs regarding decision support needs, including: improving healthcare provider skills and education, increasing access to support outside the healthcare system, strengthening community and societal support, developing special information resources, supporting youth in leading decision-making about transition, and modifying the healthcare system. In the follow-up survey, improving healthcare provider skills and education was the most commonly chosen top priority.DiscussionParticipants identified decision support needs for TGD youth and their families that were mostly distinct from traditional decision support approaches. Participants' focus on the need to improve healthcare provider skills and education provides an opportunity to couple gender-focused education with shared decision-making skills, an approach that may be more sustainable than tools for specific decisions.     

Some Aspects of the Reform of the Health Care Systems in Austria, Germany and Switzerland

The health care systems in Austria, Germany and Switzerland owe theirinstitutional structure to different historical developments. While Austriaand Germany voted for the Bismarck-Model of social health insurance,Switzerland adopted a voluntary system of health insurance. In all threecountries, until very recently, the different challenges which the healthcare sector faced were met by piecemeal approaches and by stop and gopolicies, which, in the long run were not very successful either incontaining costs or in improving efficacy and efficiency. During the 1990 morefundamental reforms in the health care systems of all three countries tookplace. Germany and Switzerland chose the path of deregulation of thehealth insurance system, which consequently strengthened the competitionbetween the insurance companies, and, to some extent between thesuppliers of medical services. While this can be seen as an essential part ofthe reform process for these two countries, Austria favors a state-orientedand interventionist approach in order to meet the challenges.     

Substitute Decision-Making for Adults with Intellectual Disabilities Living in Residential Care: Learning Through Experience

In the UK, current policies and services for people with mental disorders, including those with intellectual disabilities (ID), presume that these men and women can, do, and should, make decisions for themselves. The new Mental Capacity Act (England and Wales) 2005 (MCA) sets this presumption into statute, and codifies how decisions relating to health and welfare should be made for those adults judged unable to make one or more such decisions autonomously. The MCA uses a procedural checklist to guide this process of substitute decision-making. The personal experiences of providing direct support to seven men and women with ID living in residential care, however, showed that substitute decision-making took two forms, depending on the type of decision to be made. The first process, 'strategic substitute decision-making', paralleled the MCA's legal and ethical framework, whilst the second process, 'relational substitute decision-making', was markedly different from these statutory procedures. In this setting, 'relational substitute decision-making' underpinned everyday personal and social interventions connected with residents' daily living, and was situated within a framework of interpersonal and interdependent care relationships. The implications of these findings for residential services and the implementation of the MCA are discussed.     

Nuclear waste transportation: case studies of identifying stakeholder risk information needs

The U.S. Department of Energy (DOE) is responsible for the cleanup of our nation's nuclear legacy, involving complex decisions about how and where to dispose of nuclear waste and how to transport it to its ultimate disposal site. It is widely recognized that a broad range of stakeholders and tribes should be involved in this kind of decision. All too frequently, however, stakeholders and tribes are only invited to participate by commenting on processes and activities that are near completion; they are not included in the problem formulation stages. Moreover, it is often assumed that high levels of complexity and uncertainty prevent meaningful participation by these groups. Considering the types of information that stakeholders and tribes need to be able to participate in the full life cycle of decision making is critical for improving participation and transparency of decision making. Toward this objective, the Consortium for Risk Evaluation with Stakeholder Participation (CRESP) participated in three public processes relating to nuclear waste transportation and disposal in 1997-1998. First, CRESP organized focus groups to identify concerns about nuclear waste transportation. Second, CRESP conducted exit surveys at regional public workshops held by DOE to get input from stakeholders on intersite waste transfer issues. Third, CRESP developed visual tools to synthesize technical information and allow stakeholders and tribes with varying levels of knowledge about nuclear waste to participate in meaningful discussion. In this article we share the results of the CRESP findings, discuss common themes arising from these interactions, and comment on special considerations needed to facilitate stakeholder and tribal participation in similar decision-making processes.     

Lessons from abroad on healthcare reform. Universal access and cost constraint work in Canada and in Germany

Neither the single-payer Canadian healthcare system nor the multipayer German healthcare system is a totally appropriate model for the United States. But we can learn something by studying both. Nations such as Canada and Germany use global budgetary target approaches, which have been shown to be more effective in controlling healthcare costs than the United States' micromanagement methodology of allocating resources. As Congress decides on a basic comprehensive benefit package, it must keep in mind that a universal, comprehensive plan results in a significant additional demand for healthcare services, as seen in Canada and in Germany. The Canadian and German healthcare systems encourage consumers to select their physicians and hospitals. Germany has a distinct separation of community-based, fee-for-service physicians and hospital-based salaried doctors. This arrangement causes difficulty in providing continuity of patient care.     

A spatial decision support tool for estimating population catchments to aid rural and remote health service allocation planning

There is mounting pressure on healthcare planners to manage and contain costs. In rural regions, there is a particular need to rationalize health service allocation to ensure the best possible coverage for a dispersed population. Rural health administrators need to be able to quantify the population affected by their allocation decisions and, therefore, need the capacity to incorporate spatial analyses into their decision-making process. Spatial decision support systems (SDSS) can provide this capability. In this article, we combine geographical information systems (GIS) with a web-based graphical user interface (webGUI) in a SDSS tool that enables rural decision-makers charged with service allocation, to estimate population catchments around specific health services in rural and remote areas. Using this tool, health-care planners can model multiple scenarios to determine the optimal location for health services, as well as the number of people served in each instance.     

Health technology assessment in Denmark

The Danish healthcare services are mainly provided by public sector institutions. The system is highly decentralized. The state has little direct influence on the provision of healthcare services. State influence is exercised through legislation and budget allocations. The main task of the state is to initiate, coordinate, and advise. Counties, which run the hospitals, also decide on the placement of services. The hospital sector is controlled within the framework of legislation and global budgets. General practitioners occupy a central position in the Danish healthcare sector, acting as gatekeepers to the rest of the system. The system works well, and its structure has resulted in steady costs of health care for a long period. There is no regulatory mechanism in the Danish health services requiring use of health technology assessment (HTA) as a basis for policy decisions, planning, or administrative procedures. However, since the late 1970s a number of comprehensive assessments of health technology have formed the basis for national health policy decisions. In 1997, after years of public criticism of the quality of hospital care and health technologies, and on the basis of a previously developed national HTA strategy, a national institute for HTA (DIHTA) was established. There seems to be a growing awareness of evidence-based healthcare among health professionals and a general acceptance of health economic analyses as a basis for health policy decision making. This progress is coupled with growing regional HTA activity in the health services. HTA seems to have a bright future in Denmark.     

Criteria for use in the evaluation of health impact assessments

This paper reports the conclusions of a recent workshop that was established to discuss how health impact assessments (HIAs) might be evaluated. The main purposes of HIA are: (a) to predict the consequences of different decisions; (b) to make the decision-making process more open by involving stakeholders; and (c) to inform the decision makers. 'Prediction', 'participation' and 'informing decision makers' are thus the three domains in which HIA should be evaluated. In the 'prediction' domain, process criteria scrutinize the methods used to see if it is likely that they would produce reliable predictions. Outcome criteria involve verifying the predictions, but this is frequently impractical and predictions for the counter factual (the option not chosen) can never be verified. In the 'participation' domain, process criteria examine the ways in which stakeholders were involved, while outcome criteria explore the degree to which the stakeholders felt included. In the 'informing decision makers' domain, process criteria are concerned with the communication between decision makers and those doing the HIA, and should reflect upon the relevance of the HIA content to the decision makers' agenda. Outcome criteria explore the degree to which the decision makers considered that they had been informed by the HIA. This paper concludes with suggestions for the types of information that should be included in HIA reports in order to permit the readers to make an assessment of the 'quality' of the HIA using the three domain criteria outlined above.     

HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force

ObjectivesAmbiguity in communication of key study parameters limits the utility of real-world evidence (RWE) studies in healthcare decision-making. Clear communication about data provenance, design, analysis, and implementation is needed. This would facilitate reproducibility, replication in independent data, and assessment of potential sources of bias.MethodsThe International Society for Pharmacoepidemiology (ISPE) and ISPOR–The Professional Society for Health Economics and Outcomes Research (ISPOR) convened a joint task force, including representation from key international stakeholders, to create a harmonized protocol template for RWE studies that evaluate a treatment effect and are intended to inform decision-making. The template builds on existing efforts to improve transparency and incorporates recent insights regarding the level of detail needed to enable RWE study reproducibility. The over-arching principle was to reach for sufficient clarity regarding data, design, analysis, and implementation to achieve 3 main goals. One, to help investigators thoroughly consider, then document their choices and rationale for key study parameters that define the causal question (e.g., target estimand), two, to facilitate decision-making by enabling reviewers to readily assess potential for biases related to these choices, and three, to facilitate reproducibility.Strategies to Disseminate and Facilitate UseRecognizing that the impact of this harmonized template relies on uptake, we have outlined a plan to introduce and pilot the template with key international stakeholders over the next 2 years.ConclusionThe HARmonized Protocol Template to Enhance Reproducibility (HARPER) helps to create a shared understanding of intended scientific decisions through a common text, tabular and visual structure. The template provides a set of core recommendations for clear and reproducible RWE study protocols and is intended to be used as a backbone throughout the research process from developing a valid study protocol, to registration, through implementation and reporting on those implementation decisions.     

Healthcare regulation as a tool for public accountability

The increasing costs of healthcare delivery led to different political and administrative approaches trying to preserve the core values of the welfare state. This approach has well documented weaknesses namely with regard to healthcare rationing. The objective of this paper is to evaluate if independent healthcare regulation is an important tool with regard to the construction of fair processes for setting limits to healthcare. Methodologically the authors depart from Norman Daniels’ and James Sabin’s theory of accountability for reasonableness and try to determine if new regulatory models—namely independent agencies—perform better with regard to the public disclosure of the reasons and rationales of healthcare rationing. In publicly financed healthcare systems independent regulation is an important tool to assure fair and reasonable procedures of prioritising services. In accordance with the principle of public accountability, independent regulatory agencies are particularly well suited to assure publicity of the decision-making processes, relevance of the rationale involved and particularly mechanisms for challenge and dispute resolution regarding limit setting decisions. It follows that independent healthcare regulation could be regarded not only as an instrument for performance improvement but also as a tool of social justice. The authors conclude by stating that accountability for reasonableness should be regarded as a landmark of any healthcare reform. And therefore regulators have the social task of assuring that the rationales for limit-setting decisions are clearly accessible to the public.