Patient Involvement in the Design of a Patient-Centered Clinical Trial to Promote Adherence to Supplemental Oxygen Therapy in COPD
| Autor: | Jerry A. Krishnan, Linda J. Walsh, Janos Porszasz, Julian Husbands, Jamie L. Sullivan, Hélène A. Gussin, Kristen E. Holm, Valentin Prieto-Centurion, Robert A. Sandhaus, Scott Cerreta, Richard Casaburi |
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| Rok vydání: | 2015 |
| Předmět: |
Research design
medicine.medical_specialty Patients Health Status medicine.medical_treatment law.invention Pulmonary Disease Chronic Obstructive 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law medicine Humans Pulmonary rehabilitation 030212 general & internal medicine Patient participation Aged business.industry 030503 health policy & services Oxygen Inhalation Therapy Middle Aged Patient Outcome Assessment Clinical trial Mental Health Clinical research Caregivers Research Design Physical therapy Patient Compliance Anxiety Patient Participation Outcomes research medicine.symptom 0305 other medical science business |
| Zdroj: | The Patient - Patient-Centered Outcomes Research. 9:271-279 |
| ISSN: | 1178-1661 1178-1653 |
| DOI: | 10.1007/s40271-015-0150-z |
| Popis: | Patients are increasingly viewed as key stakeholders who can contribute in meaningful ways to clinical research and are emphasized in research funded by the Patient-Centered Outcomes Research Institute (PCORI). We are not aware of other peer-reviewed publications that report methods and outcomes of patient engagement to refine study design for a PCORI-sponsored clinical effectiveness trial. The aim of this report was to describe the process and outcomes of involving patients in the design of a clinical trial to promote adherence to supplemental oxygen therapy among patients with chronic obstructive pulmonary disease. In-person focus groups and individual discussions via telephone and email were used to elicit feedback to refine the intervention and clarify outcomes of highest importance to patients. A total of 25 patients and five caregivers provided feedback. Their feedback has informed decisions regarding the length of intervention sessions (20 min and in some cases longer was acceptable), the importance of including caregivers, and discussion topics (e.g., social discomfort about using oxygen in public, identifying personally relevant reasons to use oxygen, pulmonary rehabilitation). Multiple outcomes were rated as highly important to patients (physical function, fatigue, sleep, anxiety, depression, and ability to participate in social roles and activities), and the outcome that was ranked as most important varied by individual. Therefore, multiple patient-reported outcomes will be used as endpoints for the clinical trial. Patient involvement led to refinements of the intervention and clinical trial endpoints to better address the expressed needs and concerns of patients and caregivers. |
| Databáze: | OpenAIRE |
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