Back to Search
Start Over
Constructing a Conceptual Framework of Patient-Reported Outcomes for Metastatic Hormone-Refractory Prostate Cancer
- Source :
- Value in Health. 13(5):613-623
- Publication Year :
- 2010
- Publisher :
- Elsevier BV, 2010.
-
Abstract
- Objective A conceptual framework for patient-reported outcomes (PROs) is a structured representation of outcome concepts and issues. Our aim was to develop a conceptual framework of PROs for hormone-refractory prostate cancer (HRPC) to support measurement clarity. Methods Relevant outcome issues were identified from review of recent clinical trials. This provided content for an interview with 15 metastatic HRPC patients and a survey of 10 practitioners. All participants were asked about the relevance and importance of 26 outcomes and were allowed to nominate new outcomes. Practitioners were also asked to determine which outcomes endorsed by patients were attributable to the disease (symptoms) versus treatment (side effects). Analyses of archived clinical trial data were used to verify and augment the interview and survey results. Results Patients endorsed 11 concerns as relevant and important to HRPC including general pain, bone pain, urinary problems, fatigue, appetite loss, constipation, erectile dysfunction, peripheral neuropathy, diarrhea, PSA anxiety, and changes in self image. Practitioner judgments helped classify each concern into one of four categories, disease symptom, treatment side effect, both symptom and side effect, or psychological concern. Additionally, patients endorsed (and practitioners confirmed) the relevance and importance of several general domains of quality of life. Analyses of archived data confirmed the importance of these issues and suggested two additional concerns. Conclusion Findings were used to propose a conceptual framework of PROs for metastatic HRPC. Such frameworks can be used to help specify targets for assessment in clinical studies such as treatment trials.
- Subjects :
- Male
medicine.medical_specialty
Psychometrics
Antineoplastic Agents, Hormonal
MEDLINE
Antineoplastic Agents
Disease
Anxiety
Interviews as Topic
Quality of life (healthcare)
Outcome Assessment, Health Care
medicine
Confidence Intervals
Health Status Indicators
Humans
Neoplasm Metastasis
Bone pain
hormone-refractory
Aged
Pain Measurement
Aged, 80 and over
business.industry
Data Collection
Health Policy
Public Health, Environmental and Occupational Health
Prostatic Neoplasms
Middle Aged
Prostate-Specific Antigen
prostate cancer
Self Concept
Clinical trial
Conceptual framework
patient-reported outcomes
Drug Resistance, Neoplasm
Area Under Curve
Physical therapy
Quality of Life
Prednisone
conceptual framework
medicine.symptom
Mitoxantrone
business
Clinical psychology
Subjects
Details
- ISSN :
- 10983015
- Volume :
- 13
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Value in Health
- Accession number :
- edsair.doi.dedup.....902c0326439287099f16f43aa2ee0018
- Full Text :
- https://doi.org/10.1111/j.1524-4733.2010.00702.x