A NARRATIVE REVIEW AND PATIENT-REPORTED OUTCOME (PRO) LANDSCAPE ASSESSMENT TO INFORM THE DEVELOPMENT OF THE NOVEL SUICIDAL AND SELF-INJURIOUS BEHAVIOR SCALE (SASIBS)
Author(s)
Tiago Maia, MPH1, Adam Gater, MSc2, Melissa Barclay, BSc, MSc2, Ruixue Ma, MBA3, Huda Shalhoub, PhD4.
1EuroServices Bayer, S.L.U., Barcelona, Spain, 2Adelphi Values – Patient-Centered Outcomes, Bollington, United Kingdom, 3Bayer China Ltd, Shanghai, China, 4Bayer AG, Berlin, Germany.
1EuroServices Bayer, S.L.U., Barcelona, Spain, 2Adelphi Values – Patient-Centered Outcomes, Bollington, United Kingdom, 3Bayer China Ltd, Shanghai, China, 4Bayer AG, Berlin, Germany.
OBJECTIVES: Routine assessment of suicidal and self-injurious ideation and behavior (SSIB) is increasingly necessary in clinical trials across several indications (e.g., central nervous system active interventions). This study aimed to review existing SSIB literature and PRO measures to inform the development of a novel PRO assessing SSIB in clinical trial populations.
METHODS: Targeted searches of qualitative and quantitative SSIB literature were conducted in PubMed and Google Scholar from January-March 2026 (no date restrictions were applied). Records were screened according to pre-defined inclusion/exclusion criteria. Additional searches were conducted in PROQOLIDTM and Google to identify existing SSIB-related PRO measures and relevant guidance, practice guidelines and recommendations. Evidence regarding concept dimensionality, patient terminology, design and administration considerations was synthesized to inform PRO development.
RESULTS: Fifteen peer-reviewed publications (10 qualitative, 5 quantitative) met the inclusion criteria. Qualitative evidence highlighted suicidal ideation, suicidal behavior, self-injurious ideation, and self-injurious behavior as relevant patient-reported constructs, underscoring the importance of distinguishing self-injury from suicidality. Evidence supported suicidality as a multidimensional construct best reported by patients (versus observers or clinicians). Such findings were consistent with FDA, NHS England guidance and APA practice guidelines. A total of 96 clinical outcome assessment instruments were identified. Based on preliminary evaluation of concepts of interest, context of use, developmental history and prior use, six PROs were selected for in-depth review; following which issues with patient burden, implementation and limited conceptual coverage were identified. Accordingly, a concise 8-item PRO measure was developed to assess passive ideation, active ideation (nonspecific, method, intent, plan), suicidal behavior, self-injurious ideation and self-injurious behavior. The measure utilizes frequency scales and binary responses, integrating a tiered scoring algorithm.
CONCLUSIONS: The Suicidal and Self-Injurious Behavior Scale (SASIBS) is a new PRO measure informed by existing patient-centered literature and aligned with patient-focused drug development recommendations. Further content validation research and psychometric evaluation are planned.
METHODS: Targeted searches of qualitative and quantitative SSIB literature were conducted in PubMed and Google Scholar from January-March 2026 (no date restrictions were applied). Records were screened according to pre-defined inclusion/exclusion criteria. Additional searches were conducted in PROQOLIDTM and Google to identify existing SSIB-related PRO measures and relevant guidance, practice guidelines and recommendations. Evidence regarding concept dimensionality, patient terminology, design and administration considerations was synthesized to inform PRO development.
RESULTS: Fifteen peer-reviewed publications (10 qualitative, 5 quantitative) met the inclusion criteria. Qualitative evidence highlighted suicidal ideation, suicidal behavior, self-injurious ideation, and self-injurious behavior as relevant patient-reported constructs, underscoring the importance of distinguishing self-injury from suicidality. Evidence supported suicidality as a multidimensional construct best reported by patients (versus observers or clinicians). Such findings were consistent with FDA, NHS England guidance and APA practice guidelines. A total of 96 clinical outcome assessment instruments were identified. Based on preliminary evaluation of concepts of interest, context of use, developmental history and prior use, six PROs were selected for in-depth review; following which issues with patient burden, implementation and limited conceptual coverage were identified. Accordingly, a concise 8-item PRO measure was developed to assess passive ideation, active ideation (nonspecific, method, intent, plan), suicidal behavior, self-injurious ideation and self-injurious behavior. The measure utilizes frequency scales and binary responses, integrating a tiered scoring algorithm.
CONCLUSIONS: The Suicidal and Self-Injurious Behavior Scale (SASIBS) is a new PRO measure informed by existing patient-centered literature and aligned with patient-focused drug development recommendations. Further content validation research and psychometric evaluation are planned.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR13
Topic
Epidemiology & Public Health, Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
Mental Health (including addiction), No Additional Disease & Conditions/Specialized Treatment Areas