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Table 4 Promising PROs for patients with CKD: strengths and weaknesses

From: Development of a preliminary conceptual model of the patient experience of chronic kidney disease: a targeted literature review and analysis

PRO Type/coverage of PRO Strengthsa Weaknesses/gapsa
SF-36 [35,36,37] Generic HRQOL • Coverage of life impacts high
• Presence in trials and labels
• Content and psychometric validity
FACT-An [38,39,40] 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 [43,44,45] Generic concept-specific • Coverage of relevant specific concepts; depression
• Presence in trials and labels
• Content and psychometric validity
KDQOL-36 [46,47,48] 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 [50,51,52] 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
  1. aDescribed presence in labels is not CKD-specific
  2. 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