For the development and testing of COAs, mixed methods research allows us to examine the relevance,
understanding, validity and interpretability of an outcome measure in a way that is scientifically robust, but critically, is highly efficient and pragmatic in its approach.

Rather than collecting and analyzing different data types and sources sequentially, we develop and implement research designs that allow us to leverage insights from multiple sources in parallel.

Qualitative data collected via elicitation interviews, telephone-depth interviews, cognitive debriefing for instance, is used alongside quantitative data from clinical trials, chart reviews, diary studies and validation studies allowing us to examine the research question from every angle.

For example, in the development of a new symptom measure, concept elicitation and subsequent cognitive interviews to refine the content of the measure is a standard approach, however, incorporating a 2-week, real-world diary study to collect ‘naturalistic’ symptom data allows for preliminary, exploratory quantitative evaluation and interpretation prior to confirmatory psychometric testing.

This process is an efficient way of informing early measurement properties and reducing risk of late-stage measurement issues which otherwise may have only been observed during end of Phase 2 psychometric analysis of a measure.

Due to its pragmatic nature, mixed methods approaches are also useful when conducting research in rare
conditions where recruitment may be challenging due to small sample sizes. Quantitative methods such as bootstrapping may be used to perform psychometric testing i n these reduced samples. One example of a novel mixed methods approach we may use in our research is Group Concept

Mapping (GCM). GCM uses online technology to collect qualitative and quantitative data in a highly efficient and robust way. GCM can be used to understand what is most important to a group of individuals and is particularly useful in patient-centred research.

Mixed methods studies can be complex and operationally challenging but at COS we are leading the field in the strategic planning, design and implementation of mixed methods research.

Depending on the research question, timelines and funding requirements, COS can design and implement a mixed methods approach to meet our clients' needs.

Contact us to find out how mixed methods research may help you.