NICE enhances RWE framework with new guidance on qualitative research

NICE has updated its real-world evidence (RWE) framework, introducing guidance on qualitative research to better capture patient experiences and support healthcare decision-making.

The UK’s health technology assessment body, the National Institute for Health and Care Excellence (NICE) has revised its RWE framework, incorporating new guidance on the planning, conducting, and reporting qualitative research. The revised framework features an appendix of advice on leveraging qualitative data, such as insights into people's experiences, beliefs, preferences, attitudes, behaviors, and social contexts, to inform NICE’s decision-making processes. This latest update ensures the framework reflects the latest advancements in the field and continues to support healthcare decision-making.

Qualitative research methods, including interviews, focus groups, and free-text questionnaire surveys, offer valuable insights into patient experiences that are not captured through quantitative data. As explained by Páll Jónsson (Programme Director – Data and Real World Evidence, NICE) on LinkedIn, “Qualitative evidence can provide unique insights into patient, practitioner, and carer experiences. This real-world context can support better decision-making.”

NICE’s latest update to their RWE framework emphasizes thematic analysis as the primary method for interpreting qualitative data in evidence submissions. The guidance highlights the importance of a pre-specified study protocol that justifies the qualitative approach as the most appropriate for the research aims while ensuring ethical conduct and governance. Study reports should detail the data collection methods and settings, with clear justifications for the chosen approaches.

NICE also recommends involving stakeholders, including target populations and subject matter experts, in developing and piloting interview questions, survey tools, and discussion guides. Transparency in reporting is critical, requiring clear documentation of sampling strategies, data handling, and analysis methods, along with rationales for key decisions. To enhance credibility, NICE highlights practices such as researcher reflexivity, exploring negative cases, independent coding, and triangulating findings with other data sources.

First introduced in June 2022, NICE’s RWE framework is widely acknowledged as a global benchmark for guiding the use of real-world data (RWD) and ensuring rigorous standards in RWE study design and reporting. This latest update marks the third revision, reflecting NICE’s commitment to maintaining a "living" framework that evolves to meet the needs of decision-makers and stakeholders, and incorporates the latest best-practice guidance and research.

Additional enhancements in the update include background literature on best practices for code list development and sharing (page 49) and reference to the PRINCIPLED framework (page 63), which offers a structured, step-by-step process for systematically planning, conducting, and analyzing RWE studies that use the target trial approach.