Patient-Reported Outcomes

6. Conclusion: Label What We Measure

Self-Reported Outcomes, referred to as Patient Reported Outcomes (PROs) in the context of healthcare, include any report coming directly from the person or persons affected by their life, health condition(s) and treatment (Patrick et al., 2007). PROs:

  • Address the source of the report rather than the content;
  • Include health status and quality of life; and
  • Report on satisfaction with treatment and care, adherence to prescribed regimens when directly related to end-result outcomes, and any other treatment or outcome evaluation obtained directly from patients through interviews, self-completed questionnaires, diaries, or other data collection.

Developers and users should specify and label the content and type of measure for every application of a PRO and provide evidence of its appropriateness to the intended use, for validity of the measure as used in a particular case, and how to interpret results.

Table 1 presents examples of validation of interpretation of PROs. A major challenge faces developers and users of these measures in establishing a testable theory of the expected and observed relationships among the different concepts and domains of quality of life.

Table 1

Validity and Interpretability of Patient-Reported Outcomes

Measure of dyspnea in patients with lung diseaseCorrelation with walk test distance, global ratings of dyspneaAn improvement of 4 points represents a small but important difference
Measure of fatigue in patients with heart failureCorrelations with other questionnaires that tap into fatigueAn improvement of 0.5 represents a small but important difference
Measure of vision-related quality of lifeCorrelation with traditional visual acuity measuresResponses in accord with logical expectations for ordered effects (respondents who can drive at night almost always have no other limitations due to vision; respondents unable to recognize others when they are close are severely limited by vision in all aspects of their lives

It is as important to establish a theory of how to link clinical variables with health-related quality of life as it is to link larger determinants of PROs such as political unrest, economic depression, inequalities, and sociocultural trends and processes (Wilson and Cleary, 1995; Patrick and Erickson, 1993; Patrick and Chiang, 2000).

Patrick D.L., Erickson P. (1993). Health status and health policy: Quality of life in health care evaluation and resource allocation. New York: Oxford University Press.