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. Author manuscript; available in PMC: 2023 Jan 4.
Published in final edited form as: Health Technol Assess. 2021 Sep 1;25(57):1–132. doi: 10.3310/hta25570

Table 7. Core elements for the evaluation phase.

Core elements Issues to consider Risk of not considering them
Context

  1. Consider the wider contextual factors that may influence the evaluation in relation to influences on either the ‘intervention’or the ‘study processes’

  1. Questions related to external validity will not be answered
Programme theory

  1. Has the programme theory changed from the development and/or feasibility phase?

  2. What aspects of the wider system have influenced the desired outcomes?

  1. Lack of potential learning and understanding owing to either lack of programme theory or underdeveloped programme theory
Stakeholders

  1. Gather appropriate input from a range of relevant stakeholders to ensure that evaluation methods and outcomes meet their requirements

  1. Not collecting the correct data to inform changes in policy and practice could negatively impact the utility of the evaluation and future implementation of the intervention
Uncertainty

  1. The evaluation should respond to key uncertainties identified by engaging with stakeholders, existing evidence and relevant theory

  1. Answering research questions that do not address important areas of uncertainty, so that the utility of the evaluation will be limited
Intervention refinement

  1. Decide beforehand what type of refinement is appropriate to allow for a robust evaluation

  1. Not allowing for appropriate changes to the intervention or study processes may lead to outcomes that are not useful or meaningful. Validity of the evaluation may be compromised by failing to consider what kind of intervention refinement is acceptable
Economic considerations

  1. Importance of (broad) perspective

  2. Sensitivity analysis and subgroup analyses will be crucial

  3. Identify preferred economic evaluation framework (other frameworks can be embedded)

  4. Consider both a short-term and a long-term time horizon for economic analyses

  1. Too narrow a perspective will not reveal the full economic impact

  2. Cost-effectiveness of alternative scenarios will not be identified

  3. Incorrect frameworks may not identify all relevant costs and impacts

  4. Ignoring long-term costs and outcomes may result in an incorrect cost-effectiveness conclusion