DEPARTMENT OF PUBLIC HEALTH MEDICINE

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ACADEMIC PROGRAMME: JOURNAL CLUB

2022

The ecosystem of health decision making: from

fragmentation to synergy

05 April 2022��Dr L Dubula MBChB (Stell) �

Panelists

• Chairperson: Mr Mlanden Poluta
• Presenter: Dr Luxolo Dubula
• Discussant: Mrs Debjani Mueller
• Closing Remarks: Prof Daniel Kocks

The ecosystem of health decision making: from fragmentation to synergy.

Journal

• Schünemann H, Reinap M, Piggott T, Laidmäe E, Köhler K, Pōld M et al. The ecosystem of health decision making: from fragmentation to synergy. The Lancet Public Health. 2022;7(4):e378-e390.

The ecosystem of health decision making: from fragmentation to synergy.

Introduction

• Many actors influence or make health decisions at various levels.�
• The criteria and methods that these actors use in their work differ, but these methods frequently overlap and we describe the overlap and differences in decision-making criteria between different actors in the health sector to provide bridging opportunities through a unifying broad framework called theory of everything.�
• Although decision-making activities respond to system needs, processes are often poorly coordinated, both globally and on a country level. A decision made in isolation from other decisions on the same topic could cause misleading, unnecessary, or conflicted inputs to the health system and, therefore, confusion and resource waste

The ecosystem of health decision making: from fragmentation to synergy

Aims

• Lay out all encompassing concepts of health decision using a theoretical frame work across all disciplines
• Describe the health decision-making disciplines, criteria used, the overlap, the differences and the implications for practise and research and suggestion for way forward.
• Reconcile how evidence that influence decisions is used across multiple health system decision levels.

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The ecosystem of health decision making: from fragmentation to synergy

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The different actors who influence or make health decisions

• Regulators: play an important role in the review of evidence in advance of approval for a medical treatment
• Systematic review authors and organisations coordinating these activities: decision criteria such as benefits and harms of an intervention, values associated with outcomes, and other factors inform decisions in guidelines, quality improvement, listing of essential medicines, and policy making.
• HTA agencies: uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system
• Guideline developers: systematically developed evidence-based statements that assist providers, patients, policy-makers and other stakeholders to make informed decisions on health care and public health policy.

The ecosystem of health decision making: from fragmentation to synergy

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Continue…

• Coverage decisions makers: decisions by competent authorities or third-party payers (public or private health insurers) about whether to reimburse, and how much to pay, for medicines, tests, devices, or services, and under what conditions.
• Essential medicines and diagnostics decision makers: medicines that “satisfy the priority health care needs of the population”.
• Quality improvement actors: Quality indicators are measurable items referring to structures, processes, and outcomes of care.
• Evidence-informed policy makers: an approach aiming to ensure that policy decision making is informed by the best available research evidence.

The ecosystem of health decision making: from fragmentation to synergy

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Health decision-making background

PICO approach used to formulate questions. Found to provide a clear structure and definition of what the question of interest is.� P- population/patient� I- intervention/interest� C- comparison� O- outcome

• Primary research and systematic reviews: �primary research as a basis for influencing recommendations or decisions.��primary research should be synthesised through transparent and impartial methods reflected in the tenet of systematic review.��synthesise what is known about any of the criteria in a decision process, the actual processes used to make decisions, improvement in methodology��a method to systematically identify research and other evidence, and as the main way to provide the least biased evidence to support all of the disciplines that we discuss here, as a source to support the processes applied to making decisions.

The ecosystem of health decision making: from fragmentation to synergy

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Features influencing a decision or recommendation

• Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence-to-decision (EtD) frameworks served as a starting point for different types of recommendations and decisions in clinical practice, public health, coverage decision, and health policies.

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The ecosystem of health decision making: from fragmentation to synergy

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The ecosystem of health decision making: from fragmentation to synergy

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EtD criteria across disciplines

A discipline is a specific branch of knowledge and practice of actors that make health decisions.

• Regulation:�Review of evidence in advance of approval for a medical treatment.�The regulatory approval process is highly monitored and stringent to protect the public against unsafe treatments. The evidence review process might vary on the basis of priority.�First form of evidence review for medicines, often based on one or two clinical trials funded by pharmaceutical companies.�Regulatory agencies have an active role in trial design.�Decision criteria primarily focus on harms, health benefits, and systems in place for pharmacovigilance for post marketing surveillance of drugs. �Cost might be considered for regulation regarding market authorization.

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The ecosystem of health decision making: from fragmentation to synergy

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Cont…

• Health Technology assessment�Use systematic review methods and also modelling to explore whether interventions are cost-effective.�Cost-effectiveness analysis, based on these models, is used to compare the costs and outcomes of alternative policy options and as an informative tool in assessing value for money.�Cost effectiveness ratios and thresholds could be used alongside affordability, budget impact, feasibility, and other important contextual criteria.�HTAs often consider societal, ethical, or legal contexts.

The ecosystem of health decision making: from fragmentation to synergy

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Cont…

• Guidelines�Input from systematic reviews or HTA reports is used in multidisciplinary group processes to find agreement through formal or informal consensus processes, including voting, about the interpretation of evidence according to criteria that could influence a decision.�Guidelines make recommendations with a focus on health benefits and harms, relying on formalized consensus judgments and contextual factors.�Considerations should be made to decide whether these recommendations are right for that setting and modifying or adding to the recommendations to optimize their implementation using structured and transparent processes.

The ecosystem of health decision making: from fragmentation to synergy

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Cont…

• Coverage decisions�Processes and criteria are often the result of an HTA or a guideline process by considering similar factors.�The conclusions are typically decisions and not recommendations.�These decisions often include the following alternatives: do not cover; cover with evidence development; cover with price reduction; restricted coverage (with conditions); or cover for all indications and populations.�Other alternatives: risk sharing agreements between industry and the payers and policy makers covering the intervention (volume-based or performance-based, or both), usually alongside prospective data collection of use, effectiveness, and safety of the intervention in the health-care system, outside the context of clinical trials.

The ecosystem of health decision making: from fragmentation to synergy

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Cont..

• Essential medicines and diagnostics�Principles that should be applied in the evidence-based selection of medicines and diagnostics: assessing benefits and harms; defining the therapeutic role through best available guidelines; considering resource implications, comparative costs, and cost-effectiveness; addressing potential conflicts of interest; and ensuring transparency in decision making. �WHO Essential Medicines List (WHO EML) selection criteria include: �public health relevance, review of benefits, review of harms and toxicity, summary of available data on comparative cost and cost-effectiveness of the medicine, summary of regulatory status and market availability of the medicine, and availability of pharmacopoeial standards.

The ecosystem of health decision making: from fragmentation to synergy

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Cont..

• Quality assurance and improvement�To manage and improve health, guidelines usually form the basis for the development of quality indicators, performance measures, and performance indicators.�Agency for Healthcare Research Quality suggests considering the following factors in quality improvement: making comparisons; databases and benchmarks; trends over time; service delivery systems; unit of analysis; staff experience and user support; and costs.�Selection and identification of quality indicators should be based on a systematic and transparent approach.�Work on the linkage between guideline development and quality indicators revealed a relation between the criteria that are used to make recommendations in guidelines and the criteria that can serve to develop quality indicators, and connects the PICO and guideline development process to the identification and selection of quality indicators, performance measures, and performance indicators.

The ecosystem of health decision making: from fragmentation to synergy

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Cont…

• Evidence-informed policy making.�The aim of evidence-informed policy (EIP) is to apply explicit, systematic methods, and to increase transparency of the decision-making process. Evidence that is summarised using systematic review methodology should be obtained to support the use of values and resources to overcome subjectivity.�Evidence syntheses for policy commonly assess questions related to complex interventions, focusing not only on the interventions’ intrinsic benefits and harms, but also how to ensure better results through adequate contextualisation with intervention adaptations (if needed) and effective implementation.�Criteria and considerations related to choosing among options are feasibility, the possible effects (eg, benefits and harms), equity, cost, cost-effectiveness, and implementation considerations, which describe the strategies to overcome barriers and assist facilitators in implementing the options.

The ecosystem of health decision making: from fragmentation to synergy

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Approaches to integrating evidence and judgements

• Multicriteria decision analysis and modelling to arrive at answers.�Models can be defined as a mathematical framework representing variables and their inter-relationships to describe observed phenomena or predict future events in health-related disciplines and are typically used in (MCDA).�MCDA is a varied methodology for assessing complex issues across disciplines with greater application in economics. �It primarily addresses the costs and benefits of options available to decision makers and could include stakeholder input. A systematic review of the use of MCDA suggested that between three and 15 criteria are used in benefit–cost evaluations with health outcomes and cost-effectiveness is commonly used.
• Laying out options without modelling�For some decision makers, modelling is beyond scope or not (politically) desirable or feasible. Laying out the alternative options, including their potential effects on desirable and undesirable consequences is an approach that is used particularly in EIP making, but also in guidelines.

The ecosystem of health decision making: from fragmentation to synergy

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Drawing conclusions: making recommendations and decisions.

• Recommendations�Defined as an actionable statement for the best course of action, put forward by an authoritative body.�A guideline development group or HTA body, draws conclusions about the strength of recommendation or type of decision assessing the extent to which one can be confident that the desirable consequences of an intervention outweigh the undesirable ones. �The assessment might be based on the criteria of the GRADE EtD framework in which the recommendation can be strong or conditional (sometimes called weak, discretionary, or qualified) and be issued for or against interventions or options. The overlap between recommendations and decisions by various bodies is vast.

The ecosystem of health decision making: from fragmentation to synergy

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Cont…

• Decisions.�Decisions differ from recommendations because decisions are binding in some form.�For example, a coverage decision or policy decision will be binding for a jurisdiction, as opposed to a recommendation by a guideline panel that will be implemented depending on the individual or public-health circumstances (although they can sometimes be used in the court of law).�Regulator decisions could provide market authorisation but this authorisation does not mean a guideline process will recommend the product strongly or even conditionally.

The ecosystem of health decision making: from fragmentation to synergy

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Cont…

• Influence of legal frameworks�National or regional legislation will inform how decisions are made. Systematic reviews, HTAs, and guidelines could, or could not, be influenced by legal considerations whereas other types of decisions will be made considering the legal framework that prescribes decision making, but in theory the criteria could be independent of legal frameworks. Guideline recommendations and HTAs could be used to change or alter legal constraints
• Perspective taken�Decision makers should specify the perspective they are taking. For example, a clinical practice guideline development group might take a patient perspective or a population perspective. Coverage decisions and other policy level decisions usually take a population perspective or systems perspective. The type of perspective taken will influence the approach to decision making, and type of decisions being made.

The ecosystem of health decision making: from fragmentation to synergy

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Cont…

• Implementation �Implementation of the recommendation or decision will differ on the basis of the context and type of stakeholder. For example, a systematic review might be used by a clinician to directly inform a decision based on net health benefits (eg, the use of aspirin in acute myocardial infarction). An HTA agency could have direct influence on coverage decisions, sometimes made by the same entity. A guideline recommendation might be used to inform a therapeutic decision with a single patient or a public-health decision on a population level. �Implementation considerations should specify key concerns about the feasibility and acceptability of the intervention, strategies to address those concerns, and any important information about how to implement the intervention.

The ecosystem of health decision making: from fragmentation to synergy

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Conclusion

• PICO questions, primary research evaluation, and methods of systematic reviews provide the common ground preceding frameworks for decision making.
• Criteria that are linked to context are often overlapping and could be prioritised depending on the decision-making actor and perspective: social, ethical, legal, feasibility, acceptability, standards, and equity should always be considered .
• Standardisation of the way in which the benefits and harms of interventions are described and presented in evidence synthesis will allow for use across actors.
• Process issues, such as conflict of interest declarations and management, is relevant for all disciplines but not considered appropriately by all.
• Transparency and impartiality, therefore, in all of these processes, is a requirement.

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The ecosystem of health decision making: from fragmentation to synergy

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Journal Topic and Date.

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