Table 4.
A new common sense for patient-reported outcome assessmenta
| Do not rely on instrument databases for PRO identification and selection. |
| HRQL consists of symptoms, functions and limited aspects of the impact of these. |
| HRQL is very different from QoL. |
| The needs-based model of QoL is the most widely employed in medical research. |
| True QoL has rarely been measured in clinical studies and trials. |
| The content of QoL measures must be derived from relevant patients. |
| PROMs must be simple to administer, complete and score. |
| Simple two-point response formats are preferable to multiple response formats [43]. |
| All PROMs used in clinical trials should be disease-specific. |
| Generic PROMs do not allow the impact of different diseases on patients to be compared. |
| Population norms for PROMs are invalid. |
| Think twice before selecting generic measures such as the EQ-5D to determine utility estimates, as they have limited psychometric quality. |
| QoL is a unidimensional construct. |
| Data collected using PROMs must be shown to be unidimensional. |
| Scores on subscales can rarely be added together to give a total score. |
| High reliability (reproducibility) is crucial to the accuracy of PROMs. |
| Forward-backward translation is a flawed methodology, creating unnecessary work. |
| Think carefully before using PROMs developed in the Western world in Asia and Africa. |
| Evidence is required of the scalability, reproducibility and construct validity of all language versions of PROMs used in a clinical trial. |
aPRO, patient-reported outcome; PROM, patient-reported outcome measure; HRQL, health-related quality of life; QoL, quality of life.