TABLE 3.
Suggested Features for PROMS Assessing Symptoms, Side Effects, and HRQoL Related to PLD Treatment
Feature | Need to Have | Nice to Have |
---|---|---|
Validation | Validated | — |
Symptoms | Assesses PLD-specific symptoms (yes/no) | Includes threshold to select patients for treatment |
HRQoL | Provides an overall indication of HRQoL Can detect clinically relevant changes in HRQoL | Includes specific HRQoL subdomains (ie, emotional health, health perception) |
Complications and side effects | Includes most frequent complications and side-effects associated with the treatment | Includes options to report unexpected side effects or complications |
Time needed | ≤30 minutes | ≤15 minutes |
Language | Language use understandable for the entire population | Available in multiple languages to enable cross-country comparability |
Frequency of administration (medical therapy) | At baseline and after stopping the treatment | During treatment with an appropriate interval depending on the therapy During follow-up period after stop treatment Treatment-specific effects on symptom burden, HRQoL and complications should be taken into account when administering the PROM during follow-up |
Frequency of administration (radiologic and surgical) | Baseline and at the end of follow-up | Treatment-specific effects on symptom burden, HRQoL and complications should be taken into account when administering the PROM during follow-up |