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…patient reported outcome (PRO) measure for your clinical study

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

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…patient reported outcome (PRO) measure for your clinical study

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

  2. Introduction 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. Our workshop equips you with key insights into required concepts, strategies and instruments for capturing PRO data. Recognise the benefits of understanding the patients’ perspective to you and the patient in the evaluation of treatment outcomes 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 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 The patient’s perspective: As an introduction to PROswe provide a comprehensive overview of the benefits to you and the patient by understanding the perspective of the patient and how this can be achievedusing PROs. PROsare often selected on the basis of their popularity.To ensure your data is not misinterpreted and conclusions flawed through inappropriate selection,wehelp 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. Concepts: 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. Identifying key concepts: 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. Selecting the appropriate PRO: 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. Key stakeholders:

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

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