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?

Statistical Analyses

• 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?