…patient reported outcome (PRO) measure for your clinical studyDr Keith Meadows, DHP Research & Consultancy Ltd

Selecting the appropriate…

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.

Introduction

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.

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

An interactive training session

Review of key principles and concepts

Comprehensivetake 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?