Decision criteria of the framework

The EVIDEM framework is designed to evaluate interventions and facilitate their prioritization using a comprehensive set of decision criteria organized into pragmatic tools. Based on ongoing discussions with stakeholders, analyses of the literature and decisionmaking processes currently in place in several regions of the world, the framework and its tools are maintained and updated by active members of the collaboration.

A framework rooted in the triple aim of healthcare combined with practical wisdom

Care that matters for patients

Imperative to help and prevent/alleviate suffering (an aspect of deontology)

Serving the population at best

Prioritize those who are worse off (an aspect of Distributive justice & fairness) and benefit the greatest number (an aspect of utilitarianism)

Optimizing healthcare systems

Sustainable and efficient (an aspect of utitarianism)

PRACTICAL WISDOM

These aims which are often conflicting were transformed into operionalizable criteria, allowing  therefore allowing to tackle the  ethical dilemmas faced by healthcare decisionmakers at all levels.

Making explicit the complexity of decisionmaking

Decision criteria included in the EVIDEM framework were defined to explicitly reflect the complex process underlying the appraisal/prioritization of healthcare interventions. This process includes normative (i.e., what should we do?) and feasibility (what can be done?) considerations that are made explicit by the criteria and design of the framework.

In addition, the criteria of the framework were defined to fulfill the MCDA requirements of completeness, non-redundancy and mutual independence. Universal criteria, defined as those for which low and high ends of the scales can be defined a priori (i.e., they are universally agreed upon), in addition fulfill the fourth MCDA requirement of “operationality”. These criteria constitute the MCDA Core Model (normative universal criteria).

MCDA CORE MODEL – Normative universal criteria

The framework assumes that highest rank (or priority) should be given to healthcare interventions:

  • For severe disease
  • For common disease
  • For disease with many unmet needs
  • Either conferring major risk reduction or major alleviation of suffering; this design allows to consider both preventive and therapeutic interventions, without giving a priori priority to either one
  • Conferring major improvement in efficacy/effectiveness over standard of care
  • Conferring major improvement in safety & tolerability over standard of care
  • Conferring major improvement of patient-reported outcomes/patient-perceived health over standard of care
  • That result in savings in treatment expenditures as well as other medical and non-medical expenditures
  • For which there is sufficient data, that is fully reported and valid and relevant
  • Recommended in consensus guidelines by experts

These criteria constitute the MCDA Core Model. Most of these criteria include sub-criteria that can be added by end-users to the MCDA Core Model (see section below for details on definition, sub-criteria, ethical implications and rationale for each criterion).

Note: Cost-effectiveness is a composite of some elements of other criteria and does not comply with the non-redundancy design requirement of MCDA.

CONTEXTUAL TOOL – Contextual criteria

The Contextual Tool is used as a guide to tailor the framework to the context of decisionmaking. It includes seven generic criteria/themes, with a number of sub-criteria from which end-users can select those most relevant to their setting. Contextual criteria and sub-criteria, once identified, can remain in the Contextual Tool for qualitative consideration, or be moved to the MCDA Core Model if they can be operationalized (i.e., the low and high ends of the scale are clearly defined and stable across interventions). The Contextual Tool includes normative and feasibility contextual criteria.

 

Normative contextual criteria

  • Mandate and scope of healthcare system: the mandate and scope of the healthcare system/plan need to be defined explicitly; once defined, this criterion can be included in the MCDA Core Model to assign more value to interventions that are fully aligned with the scope and mission of the healthcare system.
  • Population priorities and access: priorities of decisionmakers/ society need to be identified explicitly (e.g., priority to children, population in remote communities); once defined, this criterion can be included in the MCDA Core Model to assign more value to interventions that are fully aligned with the identified priorities.
  • Common goal and specific interests: usually not quantifiable but important to realize and to address to ensure that the decision is fair-minded and driven by the common goal and not unduly influenced by specific interests.
  • Environmental impact of the intervention: Extent to which the production, use, or implementation of the intervention causes environmental damages; if clearly operationalized in a given context, this criterion can be included in the MCDA Core Model to assign more value to interventions that do not cause environmental damage.

Feasibility contextual criteria

  • Opportunity costs and affordability: the actual financial impact of an intervention and the available budget need to be aligned using budgeting tools; considerations of opportunity costs and silo budgeting should be part of this financial exercise (note: the normative aspects of economic considerations [i.e., encouraging savings] are included in the MCDA Core Model).
  • System capacity and appropriate use of intervention: a number of aspects may need to be considered under this umbrella (e.g., skill requirements, organizational requirements – see section below for other specific criteria); criteria identified as critical by end users can either be kept in the Contextual Tool for qualitative considerations or, if operationalizable, can be included in the MCDA Core Model.
  • Political, historical and cultural context: a number of aspects need to be considered under this umbrella (e.g., cultural acceptability, precedence, current political priorities, impact on healthcare research – see section below for other specific criteria); criteria identified as critical by end-users can either remain in the Contextual Tool for qualitative consideration or, if operationalizable, be included in the MCDA Core Model.
Decision Criteria of the framework