An overview of the DHP Research & Consultancy Workshop: Selecting the appropriate PRO for your clinical trial

1. Selecting the appropriate patient reported outcome (PRO) measure for your clinical study A one day workshop An overview DHP Research & Consultancy Ltd

3. Our workshop equips you with key insights into the required concepts, strategies and instruments for capturing PRO data. 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

4. An overview of our PRO workshop 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:

5. What is included in our PRO workshop 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

6. DHP Research & Consultancy Ltd 113 Lower Camden Chislehurst Kent BR7 5JD Tel: +44 (0)20 8467 3739 Email: kmeadows@dhpresearch.com Website: www.dhpresearch.com