Development of Clinical Outcome Assessment (COA) measures is a complex and iterative process. 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.

1. A Snap Shot of Our
Approach to COA
Development
Discover our five stage
research-based methodology
for COA development
1

2. Clinical Outcome Assessment
(COA) Development
Development of Clinical Outcome Assessment (COA) measures is a complex
and iterative process. 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
Establishing primary and secondary endpoints
The first step is to work with you to establish the primary and secondary endpoints that
will be statistically compared among treatment groups to assess the effect of
treatment and corresponds with the clinical trial’s objectives, design, and data analysis
plan.
Conceptual Framework Development 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
identifying relevant concepts and item generation in support of your labelling claim.
Conceptual Framework development
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. 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.

3. Clinical Outcome Assessment
(COA) Development
Item generation
Here our focus is on the development of items, selecting appropriate response options,
appropriate format/layout, length and readability that represent the conceptual
framework, 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
• The 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 in which each method results in the
improvement of different aspects of the questionnaire.
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
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4. Health Outcomes Insights helps healthcare
agencies and pharmaceutical companies
across a range of conditions including
diabetes, get targeted answers to patient
behaviour whenever health outcomes are
part of your programme.
Email: info@healthoutinsights.com
Tel: +44 (0) 1367 615 052