Health technology assessment (HTA) is value-laden. Consideration of ethical, legal, and social issues (ELSI), and patient values (ELSI+), is challenged by lack of conceptual clarity and the multi-disciplinary nature of ELSI + . This study used concept mapping to identify key concepts in the ELSI+ domain and their interrelationships.
We conducted a scoping review using Medline and EMBASE (2000-2016, English language) with search terms related to ethics, legal/law, social/society/patient, “ELSI”, and HTA/technology/assessment. Items from the review and additional items from an expert brainstorming session were consolidated into 80 ELSI+-related statements which were entered into Concept Systems® Global MAX software. Participants (N = 38; 36 percent researchers, 21 percent academics; 42 percent self-identified as HTA experts) sorted the statements into thematic groups that made sense to them, and rated the statements on their importance in decision-making about adoption of technologies in Canada: 1 (not at all important), 5 (extremely important), 2, 3, and 4 (unlabeled). We used Concept Systems® Global MAX software to create and analyze concept maps with four to 16 clusters, which were reviewed by the study team.
We selected the map with five clusters because its clusters represented different concepts and the statements within each cluster represented the same concept. Based on the concepts, we named these clusters: patient preferences and experiences, patient quality of life and function, patient burden/harm, fairness, and organizational. The highest mean importance ratings were for the statements in the patient burden/harm (3.82) and organizational (3.92) clusters.
This study suggests an alternative approach to conceptualize the domains originally described as “ELSI+”. We identified clusters of relevant concepts that focus on patient perspectives (preferences, experiences, quality of life, function), burden and harm, fairness (individual and societal), and organizational issues. Basing ELSI+ on conceptual consonance, rather than academic disciplines or traditions, provides a framework for coherent consideration of ELSI+ in HTA.