In contrast to the validated scales for face-to-face assessment of negative symptoms, no widely accepted tools currently exist for remote monitoring of negative symptoms. Remote assessment of negative symptoms can be broadly divided into three categories: 1) remote administration of an existing negative symptom scale by a clinician, in real time, using videoconference technology to communicate with the patient; 2) direct inference of negative symptoms through detection and analysis of the patient’s voice, appearance or activity by way of the patient’s smartphone or other device; and 3) ecological momentary assessment (EMA), in which the patient self-reports their condition upon receipt of periodic prompts from a smartphone or other device during their daily routine. These modalities vary in cost, technological complexity, and
applicability to the different negative symptom domains. Each modality has unique strengths, weaknesses, and issues with validation. As a result, an optimal solution may be more likely to employ several techniques than to use a single tool.
For remote assessment of negative symptoms to be adopted as primary or secondary endpoints in regulated clinical trials, appropriate psychometric standards will need to be met. Standards for substituting one set of measures for another, as well as what constitutes a “gold” reference standard, will need to be precisely defined and a process for defining them developed. Despite over four decades of progress towards this goal, significant work remains to be done before clinical trials addressing negative symptoms can utilize remotely assessed secondary or primary outcome measures.
AUTHORS:
David G Daniel, MD 1 Alex S Cohen, PhD2, Dawn Velligan, PhD3, Phillip D Harvey, PhD,4, Larry Alphs, MD, PhD5, Michael Davidson, MD6, William Potter, MD, PhD7, Alan Kott, MD8, Nina Schooler, PhD9, Christopher R Brodie, PhD10, Raeanne C Moore, PhD11, Pierre Lindenmeyer, MD12, Stephen R Marder, MD13
1. Signant Health, Mclean, Virginia, USA
2. Louisiana State University, Baton Rouge, Louisiana, USA
3. University of Texas Health Science Center at San Antonio, San Antonio,TX, USA
4. University of Miami, Miami, FL, USA and Research Service, Bruce W. Carter VA Medical Center, Miami, FL
5. Denovo BioPharma, San Diego, CA, USA
6. Minerva Neurosciences, Inc, Burlington, MA, USA
7. Independent Expert, Philadelphia, PA, USA
8. Signant Health, Prague, Czech Republic
9. SUNY Downstate Medical Center, Brooklyn, NY, USA
10. Otsuka Pharmaceutical Development and Commercialization, Inc, Princeton, NJ, USA
11. University of California San Diego, San Diego, CA, USA
12. Nathan S Kline Institute for Psychiatric Research, Orangeburg, NY, USA
13. Semel Institute for Neuroscience at UCLA and the VA Desert Pacific Mental Illness Research, Education and Clinical Center, Los Angeles, CA, USA
LINK TO PUBLICATION:
Remote Assessment of Negative Symptoms of Schizophrenia