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  • Writer's pictureAdam Della Maggiora

Using Patient-Reported Outcomes in Clinical Research: A Guide for Healthcare Professionals

As clinical researchers, we often rely on clinician-reported outcomes to assess the effectiveness of interventions and treatments. However, patient-reported outcomes (PROs) are gaining traction as a valuable tool in clinical research, offering a more patient-centered approach to measuring outcomes. Here are some key points to consider:

What are Patient-Reported Outcomes?

Patient-reported outcomes are defined as any report of the status of a patient's health condition that comes directly from the patient, without interpretation by a clinician or anyone else. PROs can be collected through a variety of methods, including questionnaires, surveys, and interviews.

The Benefits of Using PROs in Clinical Research

PROs offer several benefits over clinician-reported outcomes, including:

  • Providing a more patient-centered approach to measuring outcomes

  • Offering insights into patient experiences, such as symptoms and quality of life, that may not be captured through traditional clinical measures

  • Enhancing patient engagement and communication

  • Improving patient satisfaction and quality of care

Incorporating PROs into Clinical Research

There are several key steps to incorporating PROs into clinical research, including:

  1. Identifying the most relevant PROs for your study: Depending on the specific research question, there may be a wide range of PROs to choose from. Consider the type of condition, the population being studied, and the outcomes of interest when selecting PROs.

  2. Developing or selecting appropriate PRO measures: Once you have identified the PROs, you will need to select or develop measures that are valid, reliable, and responsive to change.

  3. Administering PRO measures: PROs can be collected through a variety of methods, such as paper or electronic questionnaires, phone or video interviews, or in-person visits.

  4. Analyzing and interpreting PRO data: Once you have collected PRO data, you will need to analyze and interpret the results. This may involve using statistical methods to compare groups or to assess the impact of an intervention.

Challenges and Considerations

There are several challenges and considerations associated with using PROs in clinical research, including:

  • Ensuring that PRO measures are valid, reliable, and responsive to change

  • Addressing language and cultural barriers that may impact PRO data collection

  • Managing the burden of data collection on patients and healthcare providers

  • Addressing missing data or non-response to PRO measures


Patient-reported outcomes offer a valuable tool for clinical researchers looking to improve patient-centeredness and engagement in research studies. By selecting appropriate measures, administering PROs effectively, and addressing the challenges and considerations associated with their use, healthcare professionals can leverage the power of PROs to enhance clinical research and improve patient outcomes.

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