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. 2021 Jun 23;22:233. doi: 10.1186/s12882-021-02440-9

Table 4.

Promising PROs for patients with CKD: strengths and weaknesses

PRO Type/coverage of PRO Strengthsa Weaknesses/gapsa
SF-36 [3537] Generic HRQOL

• Coverage of life impacts high

• Presence in trials and labels

• Content and psychometric validity
FACT-An [3840] 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 [4345] Generic concept-specific

• Coverage of relevant specific concepts; depression

• Presence in trials and labels

• Content and psychometric validity
KDQOL-36 [4648] 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 [5052] 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