Consideration of ethical, legal, and social issues plus patient values (ELSI+) in health technology assessment (HTA) is challenging because of a lack of conceptual clarity and the multi-disciplinary nature of ELSI+. We used concept mapping to identify key concepts and inter-relationships in the ELSI+ domain and provide a conceptual framework for consideration of ELSI+ in HTA.

We conducted a scoping review (Medline and EMBASE, 2000–2016) to identify ELSI+ issues in the HTA literature. Items from the scoping review and an expert brainstorming session were consolidated into eighty ELSI+-related statements, which were entered into Concept Systems® Global MAX™ software. Participants (N = 38; 36 percent worked as researchers, 21 percent as academics; 42 percent self-identified as HTA experts) sorted the statements into thematic groups, and rated them on importance in making decisions about adopting technologies in Canada, from 1 (not at all important) to 5 (extremely important). We used Concept Systems® Global MAX™ software to create and analyze concept maps with four to sixteen clusters.

Our final ELSI+ map consisted of five clusters, with each cluster representing a different concept and the statements within each cluster representing the same concept. Based on the concepts, we named these clusters: patient preferences/experiences, patient quality of life/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 ELSI+, based on conceptual coherence rather than academic disciplines. This will provide a foundation for incorporating ELSI+ into HTA.

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.

Individuals experiencing homelessness are particularly vulnerable to food insecurity. The At Home/Chez Soi study provides a unique opportunity to first examine baseline levels of food security among homeless individuals with mental illness and second to evaluate the effect of a Housing First (HF) intervention on food security in this population.

At Home/Chez Soi was a 2-year randomized controlled trial comparing the effectiveness of HF compared with usual care among homeless adults with mental illness, stratified by level of need for mental health services (high or moderate). Logistic regressions tested baseline associations between food security (US Food Security Survey Module), study site, sociodemographic variables, duration of homelessness, alcohol/substance use, physical health and service utilization. Negative binomial regression determined the impact of the HF intervention on achieving levels of high or marginal food security over an 18-month follow-up period (6 to 24 months).

Community settings at five Canadian sites (Moncton, Montreal, Toronto, Winnipeg and Vancouver).

Homeless adults with mental illness (n 2148).

Approximately 41 % of our sample reported high or marginal food security at baseline, but this figure varied with gender, age, mental health issues and substance use problems. High need participants who received HF were more likely to achieve marginal or high food security than those receiving usual care, but only at the Toronto and Moncton sites.

Our large multi-site study demonstrated low levels of food security among homeless experiencing mental illness. HF showed promise for improving food security among participants with high levels of need for mental health services, with notable site differences.