Introduction
Methods
Systematic review
Evaluating Measures of Patient-Reported Outcomes (EMPRO)
Standardized EMPRO evaluation
Statistical analysis
Results
Characteristics of instruments
Instrument | Author | No. of manuscriptsa
| Purpose of development | Disease stage | Response option; score range | Time framework | No. of items (time to complete) | No. of domains | Domains measured (no. of items) | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Bowel | Sexual | Urinary | Other | |||||||||
1. ESCAP-CDV | Morales et al. [31] | 2 | To design a prostate cancer-specific QoL instrument valid in Spanish population, based on the EORTC QLQ-C3 | All stages | Four-point Likert’s (lower scores mean better QoL) | Last 4 weeks | 34 (10′) | 9 | – | – | – | Eight general health domains (30) One prostate cancer-specific domain (6) |
2. EORTC QLQ-PR25 | Van Andel et al. [32] | 5 (3) | To assess treatment-related complications of prostate cancer therapy | All stages | Four-point Likert’s; 0–100b
| Last 1–4 weeks | 25 (15′) | 6 | B. symptom (4) | S. active (2) S. functioning (1c) | U. symptom (8) Incontinence aid (1c) | Hormonal symptom (6) |
3. EPIC | Wei et al. [35] | 13 (4) | To facilitate a more comprehensive QoL assessment by capturing impact of new treatments | Early stage | Five-point Likert’s; 0–100 (worst to best) | Last 4 weeks | 50 (20′ with SF-12) | 4 (8 subscales) | B. summary (14) B. function (7) B. bother (7) | S. summary (13) S. function (9) S. bother (4) | U. summary (12) U. incontinence (4) U. irritative-obstructive (7) | Hormonal summary (11) Hormonal function (5) Hormonal bother (6) |
4. FACT-P | Esper et al. [33] | 12 (3) | To assess treatment-related complications of prostate cancer therapy | All stages | Five-point Likert’s; 0–48 (worst to best) | Last week | 12 (8–10′) | 1 | – | – | – | – |
5. PC-QoL | Giesler et al. [36] | 3 | To develop a comprehensive instrument for use in clinic and research settings | Early stage | 4–6-point Likert’s; 0–100 (worst to best) | Last 4 weeks | 52 (15′) | 10 | B. function (7) B. role activity limitation (5) B. bother (4) | S. function (7) S. role activity limitation (5) S. bother (6) | U. function (5) U. role activity limitation (5) U. bother (4) | Cancer worry (4) |
6. PCSI | Clark et al. [37] | 5 | To assess treatment-related complications of early prostate cancer therapy | Early Stage | 4–5-point Likert’s; 0–100 (best to worst) | Last 1–4 weeks | 29 (n.i.) | 8 | B. dysfunction (6) B. symptom distress (4) | S. dysfunction (5) S. symptom distress (2) | Incontinence dysfunction (3) O–I dysfunction (5) Incontinence distress (1) O–I distress (5) | – |
7. PORPUS | Krahn et al. [34] | 5 | To develop a health-state classification system for multiple purposes (econometric and psychometric methods) | All stages | 4–6-point Likert’s; 0–1 (death to best health) | Last 2 weeks | 10 (n.i.) | 1 | – | – | – | – |
8. UCLA-PCI | Litwin et al. [38] | 16 (5) | To assess health concerns central to patients that undergo surgery or radiotherapy | Early stage | 3–5-point Likert’s; 0–100 (worst to best) | Last 4 weeks | 20 (20′ with SF-36) | 6 | B. function (4) B. bother (1) | S. function (8) S. bother (1) | U. function (5) U. bother (1) | – |
Retrieved information
Instrument: abbreviation and full name | Total manuscripts identified | Manuscripts excluded | Manuscripts with metric information (country-specific) | |||
---|---|---|---|---|---|---|
Without instrument information | Without metric information | Other language | Total excluded | |||
ESCAP-CDV | 2 | – | – | – | 0 | 2 |
EORTC QLQ-PR25 | 236 | 181 | 51 | – | 232 | 5 (3) |
EPIC | 236 | 70 | 151 | 2 | 223 | 13 (4) |
FACT-P | 182 | 109 | 59 | 2 | 170 | 12 (3) |
PC-QoL | 145 | 132 | 10 | – | 142 | 3 |
PCSI | 27 | 15 | 7 | – | 22 | 5 |
PORPUS | 12 | 2 | 6 | – | 8 | 5 |
UCLA-PCI | 323 | 91 | 216 | 1 | 307 | 16 (5) |
Results of the EMPRO ratings
Attributes | ESCAP-CDV | EORTC PR25 | EPIC | FACT-P | PC-QoL | PCSI | PORPUS | UCLA-PCI |
---|---|---|---|---|---|---|---|---|
Concept and measurement model | 42.9 | 52.4 | 90.5 | 42.9 | 57.1 | 66.7 | 52.4 | 90.5 |
1. Concept of measurement stated | ++++ | ++++ | ++++ | ++++ | ++++ | ++++ | ++++ | ++++ |
2. Obtaining and combining items described | ++ | ++ | ++++ | ++ | +++ | ++++ | ++++ | ++++ |
3. Rationality for dimensionality and scales | ++ | ++ | ++++ | + | +++ | ++++ | ++ | ++++ |
4. Involvement of target population | ++ | +++ | ++++ | +++ | ++++ | +++ | ++++ | ++++ |
5. Scale variability described and adequate | ++ | ++++ | +++ | ++ | +++ | ++ | ++ | ++++ |
6. Level of measurement described | ++ | + | +++ | + | – | ++ | + | ++ |
7. Procedures for deriving scores | ++ | ++ | ++++ | +++ | + | ++ | + | ++++ |
Reliability—total score | 37.5 | 62.5 | 66.7 | 25.0 | 75 | 37.5 | 33.3 | 37.5 |
Reliability: internal consistency | 37.5 | 62.5 | 62.5 | 25.0 | 75 | 37.5 | 37.5 | |
8. Data collection methods described | +++ | ++++ | ++++ | ++ | ++++ | +++ | – | ++ |
9. Cronbach’s alpha adequate | ++ | +++ | +++ | ++ | ++++ | ++ | – | +++ |
10. IRT estimates provided | – | – | – | – | – | – | – | – |
11. Testing in different populations | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. |
Reliability: reproducibility | 33.3 | 66.7 | 0 | 50 | 16.7 | 33.3 | 33.3 | |
12. Data collection methods described | ++ | – | +++ | + | ++++ | ++ | +++ | +++ |
13. Test–retest and time interval adequate | ++ | – | ++++ | + | +++ | ++ | ++ | ++ |
14. Reproducibility coefficients adequate | +++ | – | ++++ | + | ++ | – | ++ | ++ |
15. IRT estimates provided | – | +++ | – | – | – | – | – | – |
Validity | 25.0 | 50 | 91.7 | 58.3 | 91.7 | 50 | 100 | 91.7 |
16. Content validity adequate | ++ | + | +++ | +++ | +++ | ++ | ++++ | ++++ |
17. Construct/criterion validity adequate | ++ | ++++ | ++++ | +++ | ++++ | ++ | ++++ | +++ |
18. Sample composition described | + | +++ | ++++ | ++ | ++++ | +++ | ++++ | ++++ |
19. Prior hypothesis stated | ++ | ++ | ++++ | +++ | ++++ | +++ | ++++ | ++++ |
20. Rational for criterion validity | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. |
21. Tested in different populations | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. |
Responsiveness | 33.3 | 88.9 | 55.6 | 100 | 55.6 | 88.9 | 88.9 | |
22. Adequacy of methods | – | +++ | ++++ | +++ | ++++ | +++ | +++ | +++ |
23. Description of estimated magnitude of change | – | ++ | ++++ | +++ | ++++ | +++ | ++++ | ++++ |
24. Comparison of stable and unstable groups | – | – | +++ | ++ | ++++ | ++ | ++++ | ++++ |
Interpretability | 77.8 | 88.9 | 55.6 | 77.8 | 77.8 | |||
25. Rational of external criteria | – | – | +++ | +++ | – | +++ | ++++ | +++ |
26. Description of interpretation strategies | – | – | +++ | ++++ | – | +++ | ++ | +++ |
27. How data should be reported stated | – | – | ++++ | ++++ | – | ++ | ++++ | ++++ |
OVERALL SCORE
|
21.1
|
39.7
|
83.1
|
54.1
|
64.8
|
53.1
|
70.5
|
77.3
|
Burden | ||||||||
Burden: respondent | 22.2 | 33.3 | 44.4 | 22.2 | 55.6 | 0 | 66.7 | |
28. Skills and time needed | ++ | ++ | ++ | ++ | ++++ | – | + | ++++ |
29. Impact on respondents | ++ | +++ | ++++ | ++ | +++ | – | + | ++++ |
30. Not suitable circumstances | – | – | – | – | – | – | – | – |
Burden: administrative | 91.7 | 75 | 8.3 | 91.7 | ||||
31. Resources required | – | – | ++++ | – | ++++ | – | + | ++++ |
32. Time required | – | – | ++++ | – | ++++ | – | ++ | ++++ |
33. Training and expertise needed | – | – | +++ | – | ++++ | – | – | ++++ |
34. Burden of score calculation | ++ | + | ++++ | + | – | – | – | +++ |
Attribute | Administration forms | Short forms | |||
---|---|---|---|---|---|
EPIC—interactive voice response | UCLA-PCI-web-based mode | EPIC-26 | EPIC-clinical practice | UCLA-PCI short form | |
Alternative forms | 50 | 50 | 66.7 | 66.7 | 16.7 |
35. Metric characteristics of alternative forms | ++ | – | +++ | +++ | ++ |
36. Comparability of alternative forms | +++ | ++++ | +++ | +++ | – |