Table 4.
PRO | Type/coverage of PRO | Strengthsa | Weaknesses/gapsa |
---|---|---|---|
SF-36 [35–37] | Generic HRQOL |
• Coverage of life impacts high • Presence in trials and labels |
• Content and psychometric validity |
FACT-An [38–40] | Generic concept- specific |
• Psychometric validity (CKD-anaemia) • Presence in trials and labels |
• Coverage of concepts mainly from FACT-G section • Content validity |
FAACT [41, 42] | Generic concept- specific | • Presence in trials |
• Coverage of concepts mainly from FACT-G section • No presence in labels |
BDI-II [43–45] | Generic concept-specific |
• Coverage of relevant specific concepts; depression • Presence in trials and labels |
• Content and psychometric validity |
KDQOL-36 [46–48] | 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 |
DSI [50–52] | 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 |
POS-S Renal [53, 54] | 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 |
CKD-SBI [55, 56] | 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 |
ESRD-SI [57, 58] | 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 |
HSS [59, 60] | 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 |
aDescribed presence in labels is not CKD-specific
BDI-II Beck Depression Inventory-II, CKD chronic kidney disease, CKD-SBI Chronic Kidney Disease-Symptom Burden Index, DSI Dialysis Symptom Index, ESRD-SI End-Stage Renal Disease Severity Index, FAACT Functional Assessment of Anorexia/Cachexia Therapy, FACT-An Functional Assessment of Cancer Therapy-Anemia, FACT-G Functional Assessment of Cancer Therapy-General, HRQOL health-related quality of life, HSS Hemodialysis Stressor Scale, KDQOL Kidney Disease Quality of Life, KDQOL-36 Kidney Disease Quality of Life-36, POS-S Renal Palliative Care Outcome Scale-Symptoms (Renal), PRO patient-reported outcomes, SF-36 36-Item Short-Form Survey