From the perspectives of both researchers and clinicians, a combined "PRO" criterion for assessing success in multi-modal pain therapy is desirable.
It is unclear why our relative errors in VO2 and VCO2 are higher than other MM3B validation studies, as it is unlikely this was due to errors made in the Douglas bag assessments, as there was good agreement between the primary DBM and secondary Oxycon Pro criterions.
The other did not analyse the PRO data due to poor compliance, and did not address any other recommended CONSORT-PRO criteria, scoring 0/14.
An mCRPC symptom index meeting all FDA PRO guidance criteria, including content validity, likely has a greater chance of supporting both US label and EMA SmPC claims.
In conclusion, we developed a feasible, combined, PRO-success criterion for multimodal pain therapy.
Seventeen PROs met the criteria (Table 1).
All PROs fulfilled our criteria of an overall response rate of over 80% (Table 3).
All PROs fulfilled our criteria of a proportion of items missing of less than 5% (Table 3).
All PROs fulfilled our criteria of a proportion of items requiring manual validation of less than 5%.
The aim of the COSMIN study is to develop consensus-based standards for the assessment of evaluative HR-PROs, including explicit criteria for good measurement properties.
All PROs fulfilled our criteria of a floor effect of less than 15%; the floor effect was 0.5% or less for the disease-specific PROs (p < 0.001) and less than 0.3% for the generic PROs (p = 0.03).
