Difference in method of administration did not significantly impact item response: an IRT-based analysis from the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative - By Bjorner, J., Rose, M, Gandek, B., Stone, A., Doerte, U., Ju

Description

Qualitative Life Research, 2013 - This study tested the impact of method of administration (MOA) on the measurement characteristics of items developed in the Patient-Reported Outcomes Measurement Information System (PROMIS), including structural invariance, equivalence of item responses, and measurement precision. It found no statistically or clinically significant differences in score levels in Interactive Voice Response (IVR), Paper Questionnaire, or handheld Personal Digital Assistant (PDA) administration as compared to Personal Computer.

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Patient Reported Outcome Data Collection via Bring Your Own Device (BYOD) Approach: Key Benefits and Considerations for Clinical Development - By Chad Gwaltney, PhD

Description

Copyright, January 2014 - This white paper addresses the role of a Bring Your Own Device (BYOD) approach to electronic patient reported outcome (ePRO) data collection in clinical development. It presents questions researchers should consider before using BYOD in pre-labeling research and reviews how different ePRO methods of administration may or may not deliver equivalent results.

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Electronic Clinical Outcome Assessments (eCOAs): Value of Site-Based Assessments

Description

Copyright, January 2014 - Electronic Clinical Outcome Assessments (eCOAs) are collected on a frequent basis in the context of the patient's daily life, or when the patient visits a clinic for a healthcare or clinical trial appointment. This paper discusses site-based clinical outcome assessments, and the considerations for successfully collecting patient data at the site.

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Predictive Value of eC-SSRS Suicide Risk Assessment Questions during Psychiatric and Non-Psychiatric Clinical Trials based on Lifetime Reports of Suicidal Ideation and Behavior at Baseline

Description

CNS Summit Presented Poster, November 2013 - This study analyses the records of psychiatric and non-psychiatric patients with lifetime baseline and prospective assessments of SIB during clinical trials to identify the short-term predictive value for suicidal behaviors. Lifetime suicidal ideation or behavior or both at baseline significantly increases risk of prospectively reporting suicidal behavior during remaining clinical trial participation.

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Comparing Clinician-rated C-SSRS with Computer-administered eC-SSRS (Ver 2.0): Replication and Extension of Prior Research Findings

Description

ISCTM Conference Presented Poster, October 2013 - This study replicates and extends prior validation results of the eC-SSRS (Ver 1.6). In general, this study found comparable agreement between the revised eC-SSRS (Ver 2.0) and both clinician-rated C-SSRS assessments as was evident between the two experienced, well-trained C-SSRS raters.

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