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NICE has recently updated its real-world evidence framework to include guidance on qualitative research1. In this blog, we summarize the key recommendations from NICE and share a case study showing how Vitaccess is at the forefront in conducting qualitative research that meets the rigorous standards needed for health technology assessment.
What is qualitative research?
Qualitative research is that which analyzes non-numerical, or descriptive, information. This includes things like participants’ opinions, experiences, preferences, attitudes, and beliefs. Qualitative data collection techniques include interviews, focus groups, and field observations.
These methods enable researchers to collect detailed and context-rich data from a range of stakeholders, thereby gaining a deep understanding of phenomena of interest. Qualitative research is immensely valuable, particularly in understanding “why?”. However, it is inherently challenging to conduct and report in a rigorous and transparent manner. The publication of guidance by NICE is therefore useful in promoting a structured and consistent approach.
What does the NICE guidance say?
Key takeaways from the NICE guidance are as follows:
Use of qualitative data in health technology assessment
Qualitative data may be used in health technology assessment to understand people’s experiences, beliefs, preferences, attitudes, behavior, and interactions and social context.
Research question and protocol
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- The study protocol should provide a rationale for taking a qualitative approach and justification for the proposed methodology.
- Involve stakeholders, including members of the target population and subject matter experts.
- Describe the sampling strategy, including when sampling will stop (data saturation or otherwise).
Data collection
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- Describe the data collection method and setting in the protocol, e.g., interview, focus group, survey with open-ended questions and/or free-text comments.
- Consider the following to ensure participants are supported in openly expressing their own views: how the data collection method will affect ease of participation and completion; question tone, order, and phrasing; and researcher reflexivity – that is, how the researcher’s own values and preferences may impact the findings.
- Pilot questions with a subset of the target population prior to data collection.
Analysis and reporting
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- Describe the approaches taken to ensure credibility of data collection and analysis.
- Thematic analysis is commonly used in qualitative evidence presented at NICE. Coding of transcribed data by multiple researchers can enhance credibility. Software can support transparent and systematic handling of data.
- Similarities and differences in the coded data can be noted to develop summaries, which can then be presented as a general descriptive analysis or used to inform further data collection and analysis.
- To reduce the risk of bias, analysis should consider both the impact of researcher reflexivity and the potential inclusion of “negative” cases that challenge the majority or conflict with previous findings.
- Identified themes should be substantiated with verbatim extracts or text excerpts, while ensuring participant anonymity.
How is Vitaccess leading the way in qualitative research?
At Vitaccess, we are leaders in conducting qualitative research that adheres to the high standards of rigor and reporting transparency required by NICE.
We have recently completed a qualitative interview study with informal unpaid family caregivers of patients who have a rare neuromuscular disease.
The study aimed to understand the impact of caregiving, including how caregivers’ experiences changed as the disease progressed, with findings to be used in market access activities to support our client’s product.
UK-based caregivers were recruited through patient advocacy groups. They participated in one-to-one semi-structured interviews with trained Vitaccess researchers, using a discussion guide co-created with patient advocacy group representatives. The interviews discussed the health state of the person being cared for and the caregiver’s past and current experiences of caregiving. Caregivers were also able to raise and discuss areas of importance to them.
Data were assessed using thematic analysis. Each interview transcript was reviewed by trained analysts, and themes within the information (e.g., impact of caregiving on daily routine, impact on education) were assigned codes. Codes were also documented in a codebook, which was refined as new themes emerged and existing ones were consolidated or separated. Data saturation was assessed over successive interviews and sampling stopped once saturation was reached.
The findings of the study emphasized the substantial impact of caregiving on overall wellbeing, including on physical and mental health, as well as on daily routine, finances, and work life. The interview data produced novel insights into the nature of the impacts experienced by caregivers as the patient’s condition progressed.
Conclusions
NICE’s new guidance lays out recommendations for conducting and reporting qualitative research in a rigorous and transparent manner. The guidance should encourage the inclusion of robust qualitative data in health technology assessments and its consideration by NICE, thus helping to provide a rich, well-rounded understanding of unmet needs and potential product value.
To speak to one of our team about how qualitative research could strengthen your product’s evidence base, please get in touch at info@vitaccess.com.
References
1. National Institute for Health and Care Excellence. Real-world evidence framework. Updated Jan 2025. Available at: https://www.nice.org.uk/corporate/ecd9/chapter/overview
By Emma Bagshaw
