Lack of timely access to effective mental health and addiction treatment services is a major issue worldwide. Individuals, families, workplaces, and societies all suffer as a result. Using digital therapeutic tools can help expand services at a low cost.


But these must be appropriately evaluated to ensure they are effective, secure, and safe before they are used with confidence. Currently, many digital health technologies are promoted in an unregulated environment based on unsubstantiated claims. Effectiveness, privacy, and safety cannot be assumed.


Before recommending an app to a patient, healthcare providers need to ensure it is safe and effective and consider legal liabilities. Many app review websites do not base recommendations on the evidence of effectiveness, privacy assurance, etc. This may cause harm by promoting the use of unsafe or ineffective apps –resulting in delays to receiving effective therapy. It also will erode the trust of the public and healthcare providers.

There is an urgent need for the sound evaluation of apps and high integrity websites that recommend apps based on rigorous, unbiased, and transparent processes.



Leading change


Homewood Research Institute (HRI) is bringing stakeholders together to create such an environment that will promote the development, evaluation, and use of digital therapy tools that can be used with confidence within healthcare settings and community agencies. 

HRI is a Canadian charity created to advance its vision of “no life held back or cut short by mental illness or addiction.” HRI’s mission is to achieve this by working with leading scientists across Canada and beyond in alignment with like-minded organizations to promote excellence and system change.


Dr. Yuri Quintana, an HRI Collaborating Scientist, leads HRI’s digital innovations program. He is Chief of the Division of Clinical Informatics at Beth Israel Deaconess Medical Center. HRI recruited him because he is an international leader bringing together diverse stakeholders to achieve high-impact system change. For instance, he pioneered the creation of a global network that improved pediatric cancer survival rates in low- and middle-income nations using evidence-based approaches.


Dr. Quintana led a 2019 HRI review, supported by the RBC Foundation, which discovered an absence of credible app assessments and underscored the need for rigorous methodologies to evaluate digital therapy tools. This study focused on apps claiming to relieve anxiety and depression in youth. The lack of objective evidence was stunning. Weak designs, small sample sizes, and limited follow-ups were the norm.


In 2020 Dr. Quintana worked with an international team to develop a Framework that for the first time defines processes for comprehensively and systematically evaluating digital therapies with respect to efficacy, privacy, data security, and app design technique. HRI’s Framework is intended to guide those who create apps for medical practitioners, scientists, and others who evaluate apps as medical interventions (e.g., governments, healthcare organizations, regulators, investors).


In 2021 HRI created a protocol for co-designing apps with users to enhance user engagement, as called for by the Framework. Apps that don’t engage users are often abandoned before they can benefit the user. Most health apps lose users within the first week. This project presents a paradigm for engaging users in app design to identify critical features and establish meaningful engagement techniques.


A second 2021 project, funded by the McConnell Foundation, recommended regulations related to efficacy, safety, privacy, and security pertaining to digital therapy tools recommended for professional use. Dr. Quintana led a national panel of experts to recommend improving privacy and security in digital mental health. A well-designed regulatory environment would guide developers, assure users, and allow meaningful oversight.


A third 2021 project, supported by RBC Foundation and Frayme, aimed to improve app efficacy research. HRI and Frayme co-led a two-stage project.  In the first stage, an international panel defined criteria for identifying reliable and valid measures for assessing outcomes in evaluating digital therapy tools.  Then the group identified outcome measures that met these criteria. The focus was on outcomes of digital therapy for depression and anxiety in youth. This project lays out a generic process for finding sound measures and promotes specific recommended outcome measures for studying the digital treatment of depression and anxiety among youth.



What lies ahead?


These HRI projects engaged scientists, health professionals, technological leaders, government representatives, NGOs, service providers, and many others, including persons with lived experience. Future collaborations can focus on integrating recommended measures with youth services to assess and improve “real world” outcomes. HRI envisions a collaborative environment in which service providers, evaluators, scientists, service funders, and service users work together to improve digital platforms that enhance access to effective services continuously.


This overview illustrates how HRI seeks to facilitate international collaboration to boost our collective impact in using digital tools to enhance mental health and addiction services. The work involves a programmatic approach to improving practices through digital innovations that meet high ethical, professional, and scientific standards.


By working together, we achieve better and more scalable results.


For more information on HRI and its programs, visit https://hriresearch.com/research/digital-innovations/ or contact us at info@hriresearch.com.



Authors


Yuri Quintana, PhD, Collaborating Scientist, Homewood Research Institute (HRI), Assistant Professor of Medicine, Harvard Medical School, Chief Division of Clinical Informatics, Beth Israel Deaconess Medical Center, Boston, MA, USA.

Sidney Kennedy, MD, FRCPC, FRCPsych, Executive Director, Homewood Research Institute, Professor of Psychiatry and Arthur Sommer Rotenberg Chair in Depression and Suicide Studies at the University of Toronto, Director of the Centre for Suicide and Depression Research at St. Michael’s Hospital, and a Scientist at Li Ka Shing Knowledge Institute and Krembil Research Institute.

Roy Cameron, PhD, Past Executive Director, Homewood Research Institute