Clinical Outcome Assessment Development

Development of Clinical Outcome Assessment measures is a complex and iterative process and should be left to the expert.

At Health Outcomes Insights we apply the latest research and thinking in the development of your COA to ensure it is fit for purpose from a regulatory and or payer perspective.

Conceptualising treatment benefit

Step one in the development of clinical outcomes assessment measures is to work with you to establish the concept(s) of interest and define the context of use to enable us to develop the measure that corresponds with the clinical trial’s objectives, design, and data analysis plan.

Concept Elicitation and Item generation

The FDA (2009) places considerable importance on the development of the conceptual framework and the generation of items to represent it in the support of claims in approved medical product labelling. Because of this we at Health Outcomes Insights take this seriously by bringing the latest research, thinking and methodologies in concept elicitation and item generation in support of your labelling claim.

1. Concept Elicitation

In addition to a comprehensive review of the literature, our approach is to focus on using a range of techniques to encourage patients/carers to tell their story in their own words including in-depth interviews. We can also combine patient story telling with Experience sampling (ES) – using a

mobile research app to capture the in-the-moment experiences at times considered relevant to the participant.

From this information we are able to identify and develop the concepts and generate items to represent the conceptual framework.

2. Item generation

Here our focus is on the development of items, selecting appropriate response options, appropriate format/layout, length and readability that represent the concept of interest, based on patient stories and in-the-moment experiences.  In doing so we draw on the latest research and thinking in both off-line and on-line questionnaire design that will enhance the quality of data collected by your COA. For example, we draw on our knowledge of:

  • Differences between mobile, PC and paper respondent behaviour and how this can impact on response rates and survey breakoffs
  • Question formats to be avoided
  • How question layout can affect respondents’ answers

Item evaluation

At Health Outcomes Insights we are aware that different methodologies will identify different problems, so we again draw on the latest research and thinking in applying an iterative multimethod approach to item evaluation. With this approach each method results in the improvement of different aspects of the questionnaire.  All items will first be reviewed using our questionnaire evaluation platform QuestReview™ This will be followed by a series of cognitive interviews to identify issues around concept and item comprehension. There is a range of techniques in the application of cognitive interviews, each with their strengths and weaknesses. We select the most appropriate  methodology that aligns with the study objectives, availability of resources and time. 

Read more on our research-based approach to clinical outcome assessment item development which sets us apart from other developers.

Ongoing evaluation

Development of the COA continues with further evaluation including, refinement of the
conceptual framework and rigorous assessment of the psychometric properties such
as:
• Test-retest and internal consistency
• Item convergent and discriminant validity
• Construct and criterion-related validity

Find Out More Here (PDF)
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