DHPResearch&Consultancyprovidesboth bespokeandstandardone-dayworkshopsaimedataddressingtheseissuesandhelpingyouroutcomesteammakesounddecisionsregardingtheconcepts,strategiesandinstrumentsforcapturingPROdatainclinicaltrialsandobservationalstudies

1. …patient reported outcome (PRO) measure for
your clinical study
Dr Keith Meadows, DHP Research & Consultancy Ltd

2. Both nationally and internationally, the assessment of outcomes based on the
patient’s perspective using patient-reported outcome (PRO) measures, are
increasingly accompanying the traditional clinical ways of measuring health and
the effects of treatment on the patient.
Data derived from PROs provides added value in supporting key biomedical
endpoints, reimbursement, product differentiation and marketing. However, many
questions remain such as what is achievable using a PRO? How can we distinguish
between the different measured endpoints? How can we understand a PRO score
in relation to clinical endpoints? And most importantly, how do we get key
stakeholders to pay for their inclusion in clinical trials and observational studies?
DHP Research & Consultancy provides both bespoke and standard one-day
workshops aimed at addressing these issues and helping your outcomes team make
sound decisions regarding the concepts, strategies and instruments for capturing
PRO data in clinical trials and observational studies.

3. Understand what PROs are, what they measure and what is achievable
using PRO endpoints for your labelling claim
Distinguish between the different endpoints measured by PROs e.g. QoL
health status and the importance of matching the concept with the claim
Recognise the benefits of understanding the patients’ perspective to you
and the patient in the evaluation of treatment outcomes
Have a deeper insight into the key concepts and strategies for selecting
an appropriate PRO for your clinical trial or observational study
Demonstrate the benefits of patient-perceived effects as a valuable adjunct
to indicators of medical efficacy in clinical trials and observational studies
Our workshop equips you with key insights into required
concepts, strategies and instruments for capturing PRO data.

4. As an introduction to PROs we provide a comprehensive overview of the benefits to you and
the patient by understanding the perspective of the patient and how this can be achieved
using PROs.
PROs are often selected on the basis of their popularity. To ensure your data is not
misinterpreted and conclusions flawed through inappropriate selection, we help you to
distinguish between the different PRO endpoints e.g. does the EQ-5D and SF-36 measure QoL?
In addition to examining the different types of PRO - including, generic and disease-specific -
we also explore ways to increase the sensitivity of PROs in clinical studies and aid
interpretation of the relationships between clinical endpoints and PRO scores.
With emphasis on the importance of linking the concept with the claim, we examine what is
achievable with PROs as well as focusing on different approaches - including the development
of endpoint models - to enable you to identify key PRO concepts to demonstrate potential
treatment effects.
Ensuring a strong link between the item content of the PRO, its measured concept and study
objectives is essential for identifying potential treatment benefits. We explore evidence-based
approaches to help you select an appropriate PRO by evaluating its developmental history
including, examination of content validity and other properties of the instrument.
Stakeholders with an interest in PRO outcomes has over the past years broadened to include,
regulators, health technology assessment authorities, policy makers and physicians.
Nevertheless, demonstration of the cost/benefits for inclusion of PROs in clinical trials and
observational studies can be challenging. Through interactive sessions, we explore how the
benefits of potential patient-perceived effects can be shown as a valuable adjunct to
indicators of medical efficacy in clinical trials and observational studies.
Concepts:
Identifying
key concepts:
Selecting the
appropriate PRO:
Key stakeholders:
The patient’s
perspective:
An overview of our PRO workshop

5. An interactive training
session
Review of key principles
and concepts
Comprehensive
take away training pack
Opportunities for discussion
and debate
Follow-up training
To help you identify the
appropriate PRO to
demonstrate potential
treatment benefits
We will review any
particular issues that
have arisen as you embed
PROs into your research
A bibliography of further
reading material
A detailed guide to selecting
PROs
Detailed workshop notes
What is included in our PRO workshop?