Learn more in this webinar on best practices for integrating Patient-Reported Outcomes in Clinical Trials developed by the International Society for Quality of Life Research and the National Cancer Institute.
Considerations for Research Protocols
HealthMeasures can be integrated in a wide range of research protocols. When doing so, consider the following factors:
Identify the Research Context
- What are the goals (research questions) of the study?
- Who is included in the target population?
- What are the patient-centered domains to be measured?
- Will the patient-reported data serve as a primary, secondary, or exploratory endpoint?
Design the Research Study
- What are the characteristics of the patients eligible for this study?
- Which measure should be used and has it been evaluated (validated) in the target population?
- Will the patient-reported data be collected on computer, tablet, by phone, or on paper? Is it self-report, proxy-report, or interviewer administered?
- When and how often should patient-reported data be collected?
- Where should the patient data be collected (e.g., in clinic, at home)?
Plan Quality Control for Data Collection
- Is the schedule of assessments feasible for the patient population?
- Is adequate time set aside for research staff to program the questionnaire, track patient enrollment, monitor data completion quality and rates, and follow up on problems?
- Are incentives provided for patients, interviewers, or sites?
- Is the proposed analytic plan appropriate for the endpoint?
- Is the sample size adequate based on power calculations?
- How will missing patient-reported data be handled?
- Is adequate time set aside for the statistician to analyze the data?
Presentation of Data and Dissemination of Results
- Who is the audience (e.g., researchers, clinicians, patients, administrators, policy makers)?
- Are the patient-reported data presented in a way that is easy to understand?
- Are the study results and clinical data disseminated in a high impact journal?