Self-assessment for clinical researchers: should our planned clinical study have a health economic component? (in development)


Some core activities in health economic evaluation

Context and aims

  • Defining the context of the economic evaluation: what is the jurisdiction of interest and intended purpose?

Methods and analytical approaches

  • Making key methodological choices: what type of health economic evaluation study should be performed?
  • Deciding on type of analysis: should it be predominantly within-trial or predominantly decision-analytic modelling-based?
  • Determining model structure (if applicable): which clinical patient paths should be covered by the evaluation?

Clinical effectiveness

  • Identifying required clinical parameters and judging their validity: on what types of evidence are these based and how are they elicited?
  • Characterizing clinical effectiveness: which effectiveness parameters should be considered?
  • Measuring patient reported outcome measures (PROMs): which ones are appropriate for my study population (e.g. Kansas City Cardiomyopathy Questionnaire, etc.)?
  • Measuring preference-based health-related quality of life: with what instrument (e.g. EQ-5D-5L), how and how often should utilities be assessed?
  • Estimating quality-adjusted life years (QALYs): how are these determined depending on sources and measurement approaches used?

Costs

  • Measuring healthcare resource use: where are differences between the compared healthcare strategies expected and how can measurements be implemented?
  • Determining the perspective of cost assessment and deciding which costs costs need to be considered (medication costs, cost of inpatient or outpatient treatment, cost of physiotherapy, cost of lost productivity due to illness, etc.)?
  • Assessing or estimating unit costs systematically: where can I obtain cost data? (e.g. TARDOC, TARMEDSpezialitätenliste, SwissDRG, etc.)

Analysis

  • Analyzing the data or model: what needs to be considered in terms of stratification, between-centre heterogeneity, (residual) confounding?
  • Dealing with missing values, censored data, and skewed data
  • Quantifying the effects of structural, parameter, and stochastic uncertainty

Reporting

  • Reporting: how should the results be written up, presented graphically, and interpreted?
  • Ensuring reporting quality: what guideline should be followed? The most important reporting guideline in the field is the Consolidated Health Economic Evaluation Reporting Standards (CHEERS)