Objectives: Qualitative methods allow in-depth exploration of patient experiences and can provide context for healthcare decision making. Frameworks for patient-based evidence in health technology assessment (HTA) are expanding; yet, how extensively qualitative methods are currently used is unclear. This review characterized the extent and quality of qualitative data submitted to National Institute for Health and Care Excellence (NICE) and Canadian Agency for Drugs and Technologies in Health (CADTH) for HTA. Methods: NICE and CADTH submissions from September 2019 to August 2021 were reviewed. Submission characteristics and features of patient-based evidence included within submissions were extracted. The quality of qualitative reporting was assessed using the CASP checklist. Results: Patient-based evidence was included in 83/107 NICE and 119/124 CADTH submissions. A small proportion described qualitative data collection (NICE=14; CADTH=24) and analysis (NICE=6; CADTH=9) methods. One-to-one interviews were the most common data collection method, and thematic analysis was exclusively used. Thirty-three percent of NICE submissions scored >7 yes responses on CASP, versus 78 percent of CADTH submissions. Conclusions: Although patient-based evidence was common in the submissions reviewed, only 14/107 NICE and 24/124 CADTH submissions involved formal qualitative data collection. Use of formal analysis methods was even rarer and reporting tended to be brief. At present, there is little guidance about qualitative evidence most likely to be informative and therefore to potentially impact decision making. Ensuring, however, that qualitative data are collected and analyzed in a systematic, rigorous way will maximize their usefulness and ensure that patient voices are clearly heard.
BackgroundIn 2020, an international task force put forth a new consensus definition of health technology assessment (HTA) (1). HTA was defined as a multidisciplinary process using explicit methods to determine the value of a health technology to inform healthcare decision making, with a goal of promoting an equitable, efficient, and high-quality health system (1). Traditionally HTA has focused on the clinical and cost-effectiveness of the health technologies being evaluated (1). However, more recently the use of patient-based evidence in HTA, defined as "knowledge that originates directly from patients about their experiences of health, quality of life, health care, health services, and health research" (2), has been gaining attention. There are many features of patient-based evidence that make it well-suited to contributing to HTA. These types of data can speak to issues like which aspects of treatment value are important to consider from the patient's perspective and help ensure the relevance of the decision outcomes to those who will use the novel interventions under consideration. In addition, the inclusion of patient-based evidence reflects a commitment to partnership with an active role for patients within HTA (2). Patient-based evidence may...