A Unified Set Of Patient Inspired Health Concepts For Chronic

Leo Migdal

-Dec 5, 2025, 4:31 PM

a unified set of patient inspired health concepts for chronic

A unified set of patient-inspired health concepts can provide a representative description of… The mechanistic model is a logical link among patient-inspired health concepts, a drug’s… Miami (December 4, 2024) - The perspectives and priorities of people living with chronic obstructive pulmonary disease (COPD) should be integrated into the development process of new therapies for COPD, according to a new... The article is published in the Annals of the American Thoracic Society. COPD comprises several conditions, including chronic bronchitis and emphysema, and can be caused by genetics and irritants like smoke or pollution. The disease affects more than 30 million Americans and is the fourth leading cause of death worldwide, yet awareness of the disease's symptoms, methods to reduce risk, and disease management remains poor.

The commentary discusses the COPD Foundation's PIVOT (Patient-Inspired Validation of Outcome Tools) initiative, a patient-centric framework to validate outcome measures for use in clinical trials in COPD. A foundational component of PIVOT is the creation of a unified set of patient-inspired health concepts in COPD. "The development of a unified set of patient-inspired health concepts in COPD is aligned with the U.S. Food and Drug Administration Patient-Focused Drug Development guidance series and establishes a patient-centric framework for identifying, testing and communicating treatment benefit," said Alan Hamilton, Ph.D., Senior Director of Research at the COPD Foundation and... "We have worked closely with people with COPD who want more involvement in health care decision making. They bring valuable first-hand insights based on their lived experience to the development of drugs and other interventions for the disease."

Dr. Hamilton and co-authors describe several advantages of a set of patient-inspired health concepts, including increased efficiencies in medical product development, earlier access to new treatments, improved research study design and more patient-centric language in... 1Patient-Centered Research, COPD Foundation, Miami, Florida; 2Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; 3Patient-Centered Research, Evidera, Thermo Fisher, Wilmington, North Carolina; and 4Patient-Centered Research, Evidera, Thermo Fisher, London, United Kingdom

Correspondence and requests for reprints should be addressed to Alan Hamilton, Ph.D., Patient-Centered Research, COPD Foundation, 3300 Ponce de Leon, Miami, FL 33134. E-mail: [email protected]. The perspectives and priorities of people living with chronic obstructive pulmonary disease (COPD) should be integrated into the development process of new therapies for COPD, according to a new commentary. The article is published in the Annals of the American Thoracic Society. COPD comprises several conditions, including chronic bronchitis and emphysema, and can be caused by genetics and irritants like smoke or pollution. The disease affects more than 15 million Americans and is the fourth leading cause of death worldwide, yet awareness of the disease’s symptoms, methods to reduce risk, and disease management remains poor.

The commentary discusses the COPD Foundation’s PIVOT (Patient-Inspired Validation of Outcome Tools) initiative, a patient-centric framework to validate outcome measures for use in clinical trials in COPD. A foundational component of PIVOT is the creation of a unified set of patient-inspired health concepts in COPD. “The development of a unified set of patient-inspired health concepts in COPD is aligned with the US Food and Drug Administration Patient-Focused Drug Development guidance series and establishes a patient-centric framework for identifying, testing,... “We have worked closely with people with COPD who want more involvement in health care decision-making. They bring valuable first-hand insights based on their lived experience to the development of drugs and other interventions for the disease.” Ashley Duenas, MSc1 Klaudia Kornalska, MSc1 Alan Hamilton, PhD2,3

Ashley Duenas, MSc PPD Evidera Patient-Centered Research Thermo Fisher Scientific The Ark, 201 Talgarth Rd, Hammersmith W6 8BJ United Kingdom Phone: +44-20-8576-5052 Email: ashley.duenas@thermofisher.com Objectives: A critical step in designing clinical trials to evaluate treatment efficacy in chronic obstructive pulmonary disease (COPD) is selecting fit-for-purpose outcome measures that reflect health concepts meaningful to people living with COPD. The purpose of this review was to summarize and synthesize qualitative literature addressing how patients with COPD describe aspects of their disease, to inform health concept selection and outcome measure selection. Methods: A literature review and metasynthesis of qualitative research published from 2013 to 2023 was performed. Studies meeting criteria underwent critical appraisal and data extraction. Studies were summarized and synthesized with constant comparative analysis to review author interpretations and direct patient quotes.

Results: Nineteen studies addressing the patient experience of COPD met screening criteria for full review and data synthesis. In total, 507 patients (range: 8–64 individuals per study) across 11 countries participated in these studies via interviews (63.2%), focus groups (15.8%), or online forums (5.3%). Prominent COPD symptoms included breathlessness, cough, mucus, wheezing, chest discomfort, difficulty sleeping, tiredness, and weakness. Patients described significant impacts on physical activity, emphasizing difficulties with activities of daily living. The symptoms experienced and the persistent limitation on physical activity had severe consequences on social and role functioning and psychological and emotional health.

A Unified Set Of Patient Inspired Health Concepts For Chronic

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