Lecture 8: Patient Centricity Flashcards Preview

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Flashcards in Lecture 8: Patient Centricity Deck (7):

Concept, Outcome, Endpoint

Concept: The experience to be measured such as a feeling or function (pain)
Outcome: A variable that reflects how a patient feels, functions or survives (value on an 11 point NRS or 101 point VAS)
Endpoint: A variable (i.e., number) will be statistically compared among treatment groups to assess the effect of treatment


Understanding the disease or the condition

1) Natural history of the disease or condition
2) Patient subpopulations
3) Health care environment
4) Patient/caregiver perspectives


Conceptualizing treatment benefit

1) Identify concepts of interest (COI) for meaningful treatment benefit
2) Define context of use (COU) for clinical trial
3) Select clinical outcome assessment (COA) type


Selecting/Developing the outcome measure

1) Search for existing COA measuring COI in COU
2) Begin COA development
3) Complete COA development


Clinical outcome assessments

1) identify context of use and concept of interest
2) draft instrument and evaluate content validity
3) Cross sectional evaluation of other measurement properties
4) Longitudinal evaluation of measurement properties/interpretation methods
5) modify instrument



-Participants (know who your participants are so you can build a strategy around their unique needs and the context of use)
-Endpoints (consider specific endpoints that support the study objectives and timing needed to capture the right data
-Burden on participants (length of instrument and how difficult the questions are in the instrument)
-Mode and location of administration and selection of technology solution


Developing a neW Patient reported outcome (PRO)

-Start with published literature
-speak with physicians and the health workers that treat the condition
-speak to patients
-develop PRO