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Uncertainty and Coverage With Evidence Development: Does Practice Meet Theory?
Xavier G L V Pouwels1, Janneke P C Grutters2, Jill Bindels3
1Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands; Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.
Summary
Coverage with Evidence Development (CED) schemes often fail to systematically address uncertainties. Research plans should better integrate identified uncertainties to improve evidence generation and decision-making in healthcare.
Area of Science:
- Health policy research
- Evidence-based medicine
- Health technology assessment
Background:
- Coverage with Evidence Development (CED) aims to resolve uncertainties in healthcare assessments.
- Systematic identification and integration of uncertainties are crucial for effective CED.
Purpose of the Study:
- To investigate uncertainties in Dutch CED cases.
- To assess how uncertainties were handled in initial assessments and research plans.
- To identify challenges and solutions for managing uncertainty in CED.
Main Methods:
- Analysis of three CED initial assessment dossiers.
- Interviews with 16 stakeholders involved in CED processes.
- Categorization of uncertainties based on cause (unavailability, indirectness, imprecision).
Main Results:
- Forty-two uncertainties were identified, primarily due to indirectness and unavailability of evidence.
- Most uncertainties were only mentioned or described, with limited exploration of their impact.
- Only 40% of identified uncertainties were included in CED research plans, with stakeholders noting a lack of focus on these.
Conclusions:
- CED schemes in practice do not systematically or completely identify uncertainties.
- A framework involving all stakeholders is needed for systematic uncertainty identification.
- Value of information analysis should guide CED research design, including unaddressed uncertainties.
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