Developing an Observer-Reported Outcomes Measure (ObsRO): Best Practices, Challenges, and Solutions

Using a case study approach, webinar participants will learn more about developing Observer-Reported Outcomes Measures and implementing them in clinical studies. We’ll discuss some of the key challenges faced in developing and using Observer-Reported Outcomes Measures, along with potential solutions.

While capturing treatment benefit from the patient’s perspective is often important in clinical research, it is not always possible to do so directly through a patient-reported outcomes measure (PRO). This may be due to the patient’s condition (e.g., severe mental impairment) or because of the patient’s age (e.g., young children). In these cases, an observer-reported outcomes measure (ObsRO) may be used to gain information about the patient from the observations of a caregiver.

This webinar will address these key questions:

• What is an ObsRO, and when is it appropriate to use one?
• What are best practices for developing an ObsRO?
• What are some of the key challenges in ObsRO development and possible solutions?
• What are some of the key considerations for implementing an ObsRO in a clinical study?

Speakers

Beverly Romero, MA, Senior Outcomes Researcher, ICON Clinical Outcomes Assessment

Beverly is a Senior Outcomes Researcher in ICON’s, Gaithersburg, Maryland office. She has been working in the field of Clinical Outcomes Assessments (COAs) since 2010, starting first with Oxford Outcomes, which was later acquired by ICON in 2011. Beverly is an experienced project manager and qualitative researcher whose experience includes developing ObsROs as well as adult and pediatric PROs. In addition to instrument development, she has also been involved in large, multinational conjoint, survey, and interview studies. She also has worked in a variety of disease areas and populations: pediatric and adult ADHD, pediatric and adult ulcerative colitis, multiple sclerosis, non-small cell lung cancer, type 2 diabetes mellitus, and pediatric and adult CSID. Beverly has a Master’s degree in English and a background in teaching and communication.

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Emuella Flood, Senior Principal, ICON Clinical Outcomes Assessment

Emuella Flood is a Senior Principal within ICON Clinical Outcomes Assessment (COA) and leads the US East Coast COA team in Gaithersburg, Maryland. She began her career in COA research consulting nearly 20 years ago and has been with the ICON team since 2011. Emuella has directed the development and/or validation of PROs, ObsROs and ClinROs, as well as patient preference/conjoint and satisfaction surveys and patient-reported burden of illness surveys for both adult and pediatric populations. She has extensive experience in qualitative research and has presented on best practices at industry conferences, including ISOQOL and ISPOR. She has attended FDA meetings on behalf of sponsors in support of COAs used as key trial endpoints and the basis for labeling. Emuella is on the editorial board of The Patient, leads the DIA Study Endpoints Educational Series Committee, is co-chair of the ISOQOL Industry Advisory Special Interest Group and is a member of the Patient Preference Methodology working group of the Medical Device Innovation Consortium (MDIC). She has contributed to over 80 peer-reviewed publications and abstracts.

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