Table 4 Promising PROs for patients with CKD: strengths and weaknesses
PRO | Type/coverage of PRO | Strengthsa | Weaknesses/gapsa |
|---|---|---|---|
Generic HRQOL | • Coverage of life impacts high • Presence in trials and labels | • Content and psychometric validity | |
Generic concept- specific | • Psychometric validity (CKD-anaemia) • Presence in trials and labels | • Coverage of concepts mainly from FACT-G section • Content validity | |
Generic concept- specific | • Presence in trials | • Coverage of concepts mainly from FACT-G section • No presence in labels | |
Generic concept-specific | • Coverage of relevant specific concepts; depression • Presence in trials and labels | • Content and psychometric validity | |
Kidney disease-specific HRQOL | • Coverage of CKD-specific concepts high • Presence in trials • Content and psychometric validity (moderate) | • No presence in labels • Some psychometric validation and content validity data needed | |
KDQOL [49] | Kidney disease-specific HRQOL | • Presence in trials • Coverage of life impacts high | • Coverage of signs and symptoms low (for 134-item version) • Content and psychometric validity • No presence in labels |
Kidney disease-specific HRQOL | • Content and psychometric validity (moderate) • Coverage of CKD-specific signs and symptoms high • Presence in trials | • Coverage of CKD-specific life impacts low • No presence in labels • Some psychometric validation needed | |
Kidney disease-specific HRQOL | • Content and psychometric validity (moderate) • Coverage of CKD-specific concepts high • Presence in trials | • No presence in labels • Some psychometric validation needed • As a check list, it might be questionable from a regulatory perspective | |
Kidney disease-specific HRQOL | • Content and psychometric validity (moderate) • Coverage of CKD-specific signs and symptoms high | • Coverage of CKD-specific signs and symptoms low • No presence in trials and labels • Some psychometric validation needed | |
Kidney disease-specific concept-specific | • Content and psychometric validity (moderate) • Coverage of CKD-specific signs and symptoms high | • No presence in trials and labels • Coverage of CKD-specific life impacts low • Lack of information found | |
Kidney disease-specific concept-specific | • Content and psychometric validity (moderate) • Coverage of CKD-specific concepts high | • No presence in trials and labels • Lack of information found |