The National Institute for Health and Care Excellence (NICE) has recently updated its Real-World Evidence (RWE) Framework, formally recognising qualitative research as an important contributor to health technology assessment (HTA) in England. This update offers long-awaited structure for researchers seeking to ensure that descriptive, experience-based insights are gathered and presented to HTA bodies in a transparent and rigorous manner.
Qualitative research refers to the study of non-numerical data, capturing the richness of human experience through methods such as interviews, focus groups and observations. These approaches are particularly valuable for uncovering patients’ and caregivers’ beliefs, preferences, behaviours and lived experiences—dimensions that are often overlooked in traditional clinical or quantitative economic evaluations.
When conducted properly, qualitative methods help answer essential questions such as “Why do people behave in certain ways?” or “How do individuals perceive and navigate healthcare challenges?” However, they also present unique challenges in standardisation, credibility and reproducibility, hence the relevance of NICE’s latest guidance.
NICE’s framework outlines a structured process for incorporating qualitative evidence into HTA submissions. Some of the key takeaways include:
1. Use of qualitative data in HTA
Qualitative data is recognised as a valuable source of information to:
- Understand stakeholder preferences and beliefs;
- Explore real-world behaviours and decision-making;
- Investigate unmet needs and contextual factors that affect intervention uptake and outcomes.
2. Formulating the research question and protocol
- Clearly justify the choice of a qualitative approach.
- Include a detailed methodology in the study protocol, covering the rationale, objectives and relevance to the health technology under review.
- Engage with stakeholders, especially the target population and domain experts, during the design phase.
- Define a sampling strategy, including criteria for stopping data collection (e.g. when data saturation is reached).
3. Data collection
- Describe the planned mode of data collection (e.g. semi-structured interviews, focus groups or open-ended survey responses).
- Consider how the research setting and interaction style will support open and honest dialogue.
- Use pilot testing to refine questions for clarity, tone and sensitivity.
- Acknowledge researcher reflexivity, i.e. how a researcher’s personal biases and positioning may affect the data collection process.
4. Analysis and reporting
- Outline steps taken to ensure credibility and transparency in data analysis.
- Thematic analysis is a commonly used method. Coding by multiple researchers is encouraged to reduce bias.
- Use qualitative analysis software to support systematic handling and traceability of data.
- Report findings using verbatim excerpts that substantiate themes while maintaining participant anonymity.
- Actively consider negative cases—i.e. participant views that diverge from the main narrative, to strengthen robustness.
- Reflect on how the researcher’s perspective may have shaped both data interpretation and final conclusions.
Case study: Understanding caregiver burden in rare disease
To illustrate how NICE-compliant qualitative research can support HTA, consider a recent study focused on the experiences of informal caregivers supporting patients with a progressive rare disease. The objective was to capture the full scope of caregiving burden to inform market access planning for an emerging therapy.
Caregivers were recruited through national patient organisations and participated in one-to-one semi-structured interviews. A discussion guide, developed in consultation with patient advocates, explored how caregiving responsibilities evolved as the disease progressed and what emotional, physical, social and financial impacts were experienced.
Thematic analysis was used to code the transcripts. A detailed codebook was iteratively refined as new themes emerged. Saturation was monitored and sampling ceased when no new codes were being generated.
Key findings revealed substantial disruptions to caregivers’ professional lives, sleep patterns, social relationships and mental health. These insights helped contextualise existing burden-of-illness data and were used as supporting evidence in a value dossier aimed at NICE and other European HTA agencies.
The new NICE guidance represents a significant milestone in recognising the value of real-world, experience-based data in healthcare decision-making. Researchers and sponsors now have a clear pathway for incorporating qualitative insights into submissions, aligning with NICE’s broader commitment to transparency, inclusivity and relevance in HTA. As the landscape of evidence generation evolves, incorporating well-conducted qualitative research will be essential to ensure health technologies are not only clinically effective and cost-efficient, but also responsive to the needs, concerns and priorities of the people they are designed to serve.
Reference
- National Institute for Health and Care Excellence. Real-world evidence framework. Updated January 2025. https://www.nice.org.uk/corporate/ecd9/chapter/overview