Table 3.
Summary of selected PRO instruments (N = 35), including psychometric strength, content validity and concept coverage
| Generic HRQOL | Generic concept-specific | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SF-36 | EQ-5D | BDI (BDI-II) | PHQ (PHQ-9) | HADS | TMT | HAP | RAPAa | QDIS-7a | |||||
| Time to completion | 5–10 min | 8 min | 5–10 min | 10 min | 2–5 min | 5–10 min | 5–10 min | < 2 min | < 1 min | ||||
| Items | 36 | 5 + 1 VAS (20 cm) | 21 | 9 | 14 | 2 section | 102 | 9 | 7 | ||||
| Recall | Past 4 wks/ past wk | Today | 2 wks/ including today | Past month | Past wk | Present | 7 d | NR | Past 4 wks | ||||
| Languages | 160 | 181 | 73 | 86 | 116 | 46 | NA | NR | NR | ||||
| Presence in trials | Yes | Yes | Yes | Yes | No | No | No | No | No | ||||
| Presence in labels | Yes | Yes | Yes | No | Yes | No | No | No | No | ||||
| Psychometric strength | Strong | Moderate | Weak | Weak | Moderate | Weak | Moderate | Moderate | Moderate | ||||
| Population | CKD with anaemia | Pre-dialysis CKD | CKD or dialysis | Dialysis | Dialysis | Dementia | CKD-dialysis | Healthy adults | CKD | ||||
| Content validity | Weak | Weak | Weak | Weak | Weak | Weak | Weak | Weak | Weak | ||||
| Population | Generic | Generic | Depression | Anxiety | Anxiety/ depression | Brain injury | Lung disease | Generic | Generic | ||||
| Signs/symptoms | |||||||||||||
| General | 2/30 | 1/30 | 5/30 | 3/30 | 0/30 | 0/30 | 1/30 | 1/30 | 2/30 | ||||
| Diabetes | 2/19 | 1/19 | 2/19 | 2/19 | 0/19 | 0/19 | 1/19 | 1/19 | 1/19 | ||||
| Anaemia | 2/6 | 1/6 | 1/6 | 1/6 | 0/6 | 0/6 | 1/6 | 0/6 | 1/6 | ||||
| CKD 1–3 | 2/12 | 1/12 | 2/12 | 2/12 | 0/12 | 0/12 | 0/12 | 0/12 | 2/12 | ||||
| CKD 4–5 | 2/26 | 1/26 | 4/26 | 3/26 | 0/26 | 0/26 | 1/26 | 1/26 | 2/26 | ||||
| Dialysis | 2/31 | 1/31 | 5/31 | 3/31 | 0/31 | 0/31 | 1/31 | 1/31 | 2/31 | ||||
| Life impacts | |||||||||||||
| General | 8/28 | 5/28 | 9/28 | 7/28 | 5/28 | 2/28 | 2/28 | 1/28 | 12/28 | ||||
| Diabetes | 7/20 | 4/20 | 6/20 | 6/20 | 3/20 | 1/20 | 1/20 | 1/20 | 9/20 | ||||
| Anaemia | 6/14 | 4/14 | 4/14 | 5/14 | 2/14 | 0/14 | 2/14 | 1/14 | 7/14 | ||||
| CKD 1–3 | 6/13 | 5/13 | 6/13 | 5/13 | 2/13 | 2/13 | 2/13 | 1/13 | 9/13 | ||||
| CKD 4–5 | 7/18 | 5/18 | 6/18 | 6/18 | 3/18 | 2/18 | 2/18 | 1/18 | 10/18 | ||||
| Dialysis | 8/28 | 5/28 | 9/28 | 7/28 | 5/28 | 2/28 | 2/28 | 1/28 | 12/28 | ||||
| Generic concept-specific | |||||||||||||
| BPI | FACIT-F | PSQI | SKINDEX | RLS-6 | CSI | FACT-Anb | HGS | WPAI | FAACTb | SDS (Zung)a | |||
| Time to completion | 10 min | 8–10 min | 5–10 min | NR | NR | NR | 10 min | NR | NR | 5–10 min | 10 min | ||
| Items | 56 | 40 | 24 | 10 | 6 | 33 | 47 | NR | 6 | 39 | 20 | ||
| Recall | Past wk | Past 7 d | Past month | NR | 7 d/ nights | Past 6 months | Past 7 d | NR | Current/ past 7 d | Past 7 d | In general | ||
| Languages | 52 | 58 | 77 | NR | NR | NA | 53 | NR | 70 | 31 | NR | ||
| Presence in trials | No | Yes | Yes | Yes | Yes | No | Yes | No | No | Yes | No | ||
| Presence in labels | Yes | Yes | Yes | Yes | No | No | Yes | Yes | Yes | No | No | ||
| Psychometric strength | Moderate | Moderate | Moderate | Weak | Moderate | Weak | Strong | Moderate | Weak | Weak | Weak | ||
| Population | CKD-dialysis | ESRD-dialysis | Renal transplant | Skin diseases | RLS | Dialysis | CKD with anaemia | CKD-dialysis | Anaemia | Cancer/HIV with anorexia | Depression | ||
| Content validity | Weak | Weak | Weak | Weak | Weak | Weak | Weak | Weak | Weak | Weak | Weak | ||
| Population | Pain | Chronic disease | Sleep disorder | Pruritus | RLS | Generic | Anaemia | Generic | Anaemia | Anorexia/ cachexia | Depression | ||
| Signs/symptoms | |||||||||||||
| General | 3/30 | 2/30 | 5/30 | 1/30 | 3/30 | 0/30 | 7/30 | 1/30 | 0/30 | 6/30 | 5/30 | ||
| Diabetes | 2/19 | 1/19 | 2/19 | 1/19 | 1/19 | 0/19 | 4/19 | 1/19 | 0/19 | 5/19 | 1/19 | ||
| Anaemia | 1/6 | 1/6 | 2/6 | 0/6 | 1/6 | 0/6 | 3/6 | 0/6 | 0/6 | 2/6 | 1/6 | ||
| CKD 1–3 | 2/12 | 2/12 | 2/12 | 1/12 | 2/12 | 0/12 | 3/12 | 0/12 | 0/12 | 2/12 | 2/12 | ||
| CKD 4–5 | 2/26 | 2/26 | 4/26 | 1/26 | 3/26 | 0/26 | 6/26 | 1/26 | 0/26 | 6/26 | 5/26 | ||
| Dialysis | 3/31 | 2/31 | 4/31 | 1/31 | 3/31 | 0/31 | 8/31 | 1/31 | 0/31 | 7/31 | 5/31 | ||
| Life impacts | |||||||||||||
| General | 6/28 | 3/28 | 3/28 | 7/28 | 6/28 | 2/28 | 9/28 | 0/28 | 1/28 | 10/28 | 4/28 | ||
| Diabetes | 4/20 | 2/20 | 2/20 | 4/20 | 4/20 | 2/20 | 6/20 | 0/20 | 0/20 | 7/20 | 3/20 | ||
| Anaemia | 3/14 | 2/14 | 2/14 | 2/14 | 4/14 | 1/14 | 6/14 | 0/14 | 0/14 | 6/14 | 3/14 | ||
| CKD 1–3 | 5/13 | 2/13 | 2/13 | 4/13 | 5/13 | 2/13 | 5/13 | 0/13 | 1/13 | 4/13 | 2/13 | ||
| CKD 4–5 | 3/18 | 2/18 | 2/18 | 3/18 | 5/18 | 2/18 | 7/18 | 0/18 | 0/18 | 8/18 | 3/18 | ||
| Dialysis | 6/28 | 3/28 | 3/28 | 7/28 | 6/28 | 2/28 | 9/28 | 0/28 | 1/28 | 10/28 | 4/28 | ||
| Kidney disease-specific HRQOL | |||||||||||||
| KDQOL-36 | KDQOL-SF | KDQOL | CHEQ | DSI | WHOQOL-BREF Dial. | POS-S Renal | QLI-D | CKD QOL | KDBI | CKD-SBI | |||
| Time to completion | NR | 16 min | 30 min | NR | NR | 5/15–20 min | NR | 5–10 min | NR | NR | Approx. 10 min | ||
| Items | 36 | 80 | 134 | 86 | 30 | 26 | 18 | 68 | 34 | 16 | 25 | ||
| Recall | 1 d/past 4 wks | Past 4 wks | Past 4 wks | 4 wks | Past 7 d | Past 2–4 wks | 1 wk | NR | Past 4 wks | Past month | 7 d | ||
| Languages | 37 | 25 | 41 | 2 | NR | 51 | NR | 6 | NR | NR | 1 | ||
| Presence in trials | Yes | Yes | Yes | No | Yes | No | Yes | No | No | No | No | ||
| Presence in labels | No | No | No | No | No | No | No | No | No | No | No | ||
| Psychometric strength | Moderate | Weak | Weak | Weak | Moderate | Moderate | Moderate | Moderate | Moderate | Moderate | Moderate | ||
| Population | CKD | Kidney disease-dialysis | Kidney disease-dialysis | ESRD-dialysis | CKD- dialysis | CKD- dialysis | Advanced CKD | ESRD- dialysis | CKD (3–5, dialysis & transplant) | ESRD | CKD | ||
| Content validity | Moderate | Moderate | Moderate | Strong | Strong | Strong | Moderate | Strong | Strong | Moderate | Strong | ||
| Population | Kidney disease | Kidney disease-dialysis | Kidney disease-dialysis | Kidney disease-dialysis | Dialysis | CKD (4–5) | CKD (4–5) | Kidney disease-dialysis | CKD (3–5, dialysis & transplant) | Kidney disease | CKD | ||
| Signs/symptoms | |||||||||||||
| General | 9/30 | 9/30 | 3/30 | 3/30 | 16/30 | 0/30 | 14/30 | 1/30 | 2/30 | 0/30 | 13/30 | ||
| Diabetes | 8/19 | 8/19 | 2/19 | 1/19 | 9/19 | 0/19 | 9/19 | 1/19 | 2/19 | 0/19 | 8/19 | ||
| Anaemia | 4/6 | 4/6 | 2/6 | 1/6 | 6/6 | 0/6 | 3/6 | 1/6 | 2/6 | 0/6 | 3/6 | ||
| CKD 1–3 | 6/12 | 6/12 | 2/12 | 2/12 | 6/12 | 0/12 | 6/12 | 1/12 | 2/12 | 0/12 | 4/12 | ||
| CKD 4–5 | 9/26 | 9/26 | 3/26 | 3/26 | 15/26 | 0/26 | 14/26 | 1/26 | 2/26 | 0/26 | 12/26 | ||
| Dialysis | 10/31 | 10/31 | 3/31 | 3/31 | 17/31 | 0/31 | 15/31 | 1/31 | 2/31 | 0/31 | 13/31 | ||
| Life impacts | |||||||||||||
| General | 13/28 | 13/28 | 12/28 | 14/28 | 5/28 | 5/28 | 2/28 | 4/28 | 5/28 | 4/28 | 2/28 | ||
| Diabetes | 10/20 | 10/20 | 9/20 | 12/20 | 4/20 | 4/20 | 2/20 | 3/20 | 5/20 | 2/20 | 2/20 | ||
| Anaemia | 9/14 | 9/14 | 10/14 | 11/14 | 2/14 | 5/14 | 2/14 | 4/14 | 4/14 | 1/14 | 0/14 | ||
| CKD 1–3 | 8/13 | 8/13 | 8/13 | 8/13 | 2/13 | 4/13 | 2/13 | 3/13 | 4/13 | 1/13 | 2/13 | ||
| CKD 4–5 | 10/18 | 10/18 | 10/18 | 11/18 | 5/18 | 4/18 | 2/18 | 4/18 | 5/18 | 2/18 | 2/18 | ||
| Dialysis | 13/28 | 13/28 | 12/28 | 14/28 | 5/28 | 5/28 | 2/28 | 4/28 | 5/28 | 4/28 | 2/28 | ||
| Kidney disease-specific | |||||||||||||
| ESRD-SI | HSS | FAS | FSGS | ||||||||||
| Time to completion | NR | NR | NR | NR | |||||||||
| Items | NR | 29 | 10 | 17 | |||||||||
| Recall | NR | NR | Usually | Past 7 d | |||||||||
| Languages | NR | NR | 2 | NR | |||||||||
| Presence in trials | No | No | No | No | |||||||||
| Presence in labels | No | No | No | No | |||||||||
| Psychometric strength | Moderate | Moderate | Weak | Weak | |||||||||
| Population | ESRD- dialysis | ESRD- dialysis | ESRD- dialysis | NR | |||||||||
| Content validity | Moderate | Moderate | Weak | Moderate | |||||||||
| Population | CKD-dialysis | CKD-dialysis | Fatigue | FSGS | |||||||||
| Signs/symptoms | |||||||||||||
| General | 6/30 | 7/30 | 1/30 | 7/30 | |||||||||
| Diabetes | 7/19 | 3/19 | 1/19 | 4/19 | |||||||||
| Anaemia | 5/6 | 2/6 | 1/6 | 3/6 | |||||||||
| CKD 1–3 | 5/12 | 6/12 | 1/12 | 4/12 | |||||||||
| CKD 4–5 | 6/26 | 7/26 | 1/26 | 5/26 | |||||||||
| Dialysis | 6/31 | 7/31 | 1/31 | 7/31 | |||||||||
| Life impacts | |||||||||||||
| General | 0/28 | 12/28 | 3/28 | 13/28 | |||||||||
| Diabetes | 0/20 | 7/20 | 3/20 | 12/20 | |||||||||
| Anaemia | 0/14 | 8/14 | 2/14 | 9/14 | |||||||||
| CKD 1–3 | 0/13 | 7/13 | 2/13 | 8/13 | |||||||||
| CKD 4–5 | 0/18 | 7/18 | 3/18 | 11/18 | |||||||||
| Dialysis | 0/28 | 12/28 | 3/28 | 13/28 | |||||||||
The coverage of signs/symptoms and life impacts by each PRO was categorized as good (≥6 concepts [in bold]), moderate (3–5) or poor (0–2 [in italics])
aSelected for analysis because of its potential for use in patients with CKD, although it was not among the PRO instruments identified from the data sources
bInstrument includes the FACT-G module
BPI Brief Pain Inventory, CHEQ CHOICE Health Experience Questionnaire, CKD chronic kidney disease, CKD QOL Chronic Kidney Disease Quality of Life, CKD-SBI Chronic Kidney Disease-Symptom Burden Index, CSI Coping Strategy Indicator, d days, DSI Dialysis Symptom Index, EQ-5D European quality of life – five dimension, ESRD end-stage renal disease, ESRD-SI End-Stage Renal Disease Severity Index, FAACT Functional Assessment of Anorexia/Cachexia Therapy, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue Scale, FACT-An Functional Assessment of Cancer Therapy-Anemia, FACT-G Functional Assessment of Cancer Therapy-General, FAS Hemodialysis Fatigue Scale, FSGS Focal Segmental Glomerulosclerosis Symptom Impact Questionnaire, HADS Hospital Anxiety and Depression Scale, HAP Human Activity Profile, HGS hand grip strength test, HIV human immunodeficiency virus, HRQOL health-related quality of life, HSS Hemodialysis Stressor Scale, KDBI Kidney Disease Behavior Inventory, KDQOL Kidney Disease Quality of Life, KDQOL-36 Kidney Disease Quality of Life-36, KDQOL-SF Kidney Disease Quality of Life Short Form, NA not applicable, NR not reported, PHQ Patient Health Questionnaire, POS-S Renal Palliative Care Outcome Scale-Symptoms (Renal), PRO patient-reported outcome, PSQI Pittsburgh Sleep Quality Index, QDIS-7 Quality of Life Disease Impact Scale-7, QLI-D Quality of Life Index Dialysis Version, RAPA Rapid Assessment Physical Activity, RLS restless legs syndrome, RLS-6 Restless Legs Syndrome-6 Scale, SDS (Zung) the Zung self-rating depression scale, SF-36 36-Item Short-Form Survey, SKINDEX quality-of-life measure for patients with skin disease, TMT Trail Making Test, VAS Visual Analogue Scale, WHOQOL-BREF Dial. World Health Organization Quality of Life Brief Scale in Dialysis, wk. week, WPAI Work Productivity and Activity Impairment