Collection and impact of patient reported outcomes

Abstract

SummaryThe efficacy assessment in clinical studies evaluating drug effects, or more generally disease management, is generally focused on the occurrence of objective clinical or economical outcomes, in line with regulatory guidelines. However, there is growing recognition of the value of capturing wider effects of treatments reported by patients in the form of patient-reported outcomes (PROs). A PRO is defined as any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. After examining the reasons explaining the development of these new clinical research outcomes, the main fields covered by PROs (such as quality of life) in chronic diseases will be described. We will develop PRO measurement issues, notably psychometric properties and cultural adaptations, and also differences between generic and disease-specific instruments, with quality of life instruments as an example. Then we will define the use of PROs data in the field of adherence research, with their advantages and limitations compared with other sources of data. Last, the actual or potential impact of PROs will also be examined in terms of quality of care for daily medical practice and research issues.Disclosure of InterestNone declared. SummaryThe efficacy assessment in clinical studies evaluating drug effects, or more generally disease management, is generally focused on the occurrence of objective clinical or economical outcomes, in line with regulatory guidelines. However, there is growing recognition of the value of capturing wider effects of treatments reported by patients in the form of patient-reported outcomes (PROs). A PRO is defined as any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. After examining the reasons explaining the development of these new clinical research outcomes, the main fields covered by PROs (such as quality of life) in chronic diseases will be described. We will develop PRO measurement issues, notably psychometric properties and cultural adaptations, and also differences between generic and disease-specific instruments, with quality of life instruments as an example. Then we will define the use of PROs data in the field of adherence research, with their advantages and limitations compared with other sources of data. Last, the actual or potential impact of PROs will also be examined in terms of quality of care for daily medical practice and research issues. The efficacy assessment in clinical studies evaluating drug effects, or more generally disease management, is generally focused on the occurrence of objective clinical or economical outcomes, in line with regulatory guidelines. However, there is growing recognition of the value of capturing wider effects of treatments reported by patients in the form of patient-reported outcomes (PROs). A PRO is defined as any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. After examining the reasons explaining the development of these new clinical research outcomes, the main fields covered by PROs (such as quality of life) in chronic diseases will be described. We will develop PRO measurement issues, notably psychometric properties and cultural adaptations, and also differences between generic and disease-specific instruments, with quality of life instruments as an example. Then we will define the use of PROs data in the field of adherence research, with their advantages and limitations compared with other sources of data. Last, the actual or potential impact of PROs will also be examined in terms of quality of care for daily medical practice and research issues. Disclosure of InterestNone declared. None declared.