Use of qualitative and mixed methods research in diagnostic technology evaluation and implementation: insights from a systematic review.

Abstract

Background: Development of new diagnostic health technologies is increasing, alongside interest in how they can be implemented into health services. Evaluation of new diagnostic tests has typically consisted of technical and diagnostic accuracy, place in the clinical pathway, effectiveness and cost-effectiveness. However, there are other considerations which are important in determining their ultimate adoption. These include the usability and acceptability of new tests - how clinicians and patients respond to and interact with them - as well as how applicable they are to individual settings and contexts. Such issues are more likely to be explored and understood using qualitative and mixed methods research. The purpose of this systematic review was to discern in the literature which qualitative and mixed methods approaches have been used in evaluating and implementing diagnostic technologies and tests and to identify how future use of these methods can be supported in this rapidly developing field.

Methods: We searched Medline, Embase and CINAHL from inception to September 2025 for evaluations of diagnostic technology and tests including qualitative and mixed methods research. The content and quality of the retrieved studies was examined using critical appraisal frameworks appropriate for the type of study, Spencer et al (2003) for qualitative studies and Mixed Methods Appraisal Tool (MMAT) (2018) for mixed methods studies.

Results: Our search yielded 11331 results, with 28 studies included in the review. All the studies were evaluations of point of care technology or tests for diagnosis. The studies were relevant to seven different medical conditions, across 18 countries. Of the 28 studies, 18 used a qualitative research design only and 10 a mixed methods design. Most studies used semi-structured interviews with health care professionals as either the sole or principal data collection method. There were issues around quality and reporting, including engagement with the methodological literature especially with regard to data analysis, idiosyncratic use of terminology and guiding frameworks, and lack of exploration of patient perspectives.

Conclusions: The review suggests that guidance to support the use of qualitative and mixed methods approaches in this field would be timely and helpful.