Instrumentation & Special Populations SIB Sub-group

Instrumentation and Special Populations Bibliography

Working Group Goal:

Review status and develop consensus on key considerations regarding the detection and assessment of SIB across different patient populations

Possible Activities:

–Key considerations of instruments for assessing presence and severity of SIB

• Psychometric properties and validation considerations

–Suitability of a single measure to assess SIB in all studies and all populations

• Issue of special populations

– Pediatric patients

– Cognitively impaired patients

–Look back periods

• Establishing best approaches to improve lifetime recall

–Frequency and duration of data collection in clinical trials

–Training requirements for clinician-administered assessments

–Integration of information from various sources

• Clinician/rater administered assessments
• Patient reported assessments
• Use of third party informants

–Pros & cons of using technology to assess SIB

–Cross-cultural considerations

Sub-group members:

Mark Bangs, Lilly
Florence Butlen, EMA
Martin Cheatle, Univ of Pennsylvania
Wen-Hung Chen, FDA
John Greist, Healthcare Technology Systems
Jill Harkavy-Friedman, American Foundation for Suicide Prevention
Diane Hollman, Clinilabs
Lynne Johnson, Lilly
J. John Mann, Columbia University
Derrick McKinley, Pfizer
Joe Palumbo, Mitsubishi Tanabe
Donna Palumbo, Pfizer
Michael Ryan, Novartis
Barbara Stanley, Columbia University
Steve Targum, Clintara
Oleg Tcheremessine, Carolina Healthcare System
Lynn Webster, PRA Health Sciences
Janet Williams, MedAvante
Christian Yavorsky, CROnos

Instrumentation and Special Populations Working Group Internal Documents