Clinical Outcome Assessment experts to deliver ClinRO workshop at ISOQOL 2013

On Wednesday October 9th 2013 Rob Arbuckle and Sophi Tatlock from the Adelphi Values Endpoint Development & Outcomes Assessment practice, will be in Miami to deliver a workshop at the ISOQOL 20th annual conference.

Titled “The development and validation of clinician-reported outcome instruments: the application of methods from patient-reported outcomes”, the workshop has been designed to give attendees a sound understanding of the application of Patient-Reported Outcome (PRO) development and validation methods to the development and validation of Clinician-Reported Outcomes (ClinRO) to regulatory standards.

Attendees will:

  1. Develop an understanding of the methods for developing ClinRO measures to FDA standards and the overlap and differences with developing PRO measures.
  2. Learn how to tailor interview guides for patients and clinicians to explore the same therapy area.
  3. Develop an understanding of the key psychometric properties of a ClinRO and how these may be assessed

The value of observing or recording clinician-patient interactions and associated ethical issues will be discussed, and specific considerations for psychometric validation of ClinROs, including inter-rater reliability and developing cut-points through Receiver Operating Characteristic (ROC) analysis will be explored. In addition, specific considerations for implementing ClinROs in clinical trials and other large scale studies will be discussed alongside the challenges of using measures developed for use in clinical practice as trial endpoints, and vice versa.

“Adelphi Values has been developing COA methods since 1993, so it is great to be a part of the ISOQOL 20th birthday celebrations, in the year we will also reach this significant milestone” said Rob Arbuckle, Director Endpoint Development & Outcomes Assessment. “Like Adelphi Values, ISOQOL remains at the forefront of driving forward the science of patient-centered outcomes.  As such, we’re excited to be presenting this workshop with its focus on taking established PRO methods and extending and tailoring them for use in evaluating ClinROs”.

The International Society for Quality of Life Research (ISOQOL) focuses on promotion of high quality research in the science of health-related quality of life (HRQOL) measurement. The annual conference will be held in Miami, Florida 9-12 October 2013.

For more information on the workshop, or other solutions provided by Adelphi Values, please email info@adelphivalues.com or visit www.adelphivalues.com

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