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Table 6 Psychometric properties

From: Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union

Psychometric properties reported in published literature for patients with mCRPCa

BPI-SF worst pain item

BPI-SF average pain item

PPI item from MPQ

FACT-P

Reliability

    

 Test-retest

–/b

–/c

 Internal consistency

NA

NA

NA

Construct validity

    

 Convergent

d

 Divergent

d

Known-groups/discriminant validity

Responsivenesse

–/f

Interpretation/clinically meaningful change established

g

g

References

[[16],[23],[31],[34],[26],[27]]

[[16],[23],[34]]

[[17],[21],[23],[30]]

[[18],[23],[28],[32],[34],[26],[29]]

  1. BPI-SF = Brief Pain Inventory–Short Form; FACT-P = Functional Assessment of Cancer Therapy–Prostate Module; ICC = intraclass correlation coefficient; mCRPC = metastatic castration-resistant prostate cancer; MPQ = McGill Pain Questionnaire; NA = not applicable; PPI (from MPQ) = Present Pain Intensity component of the McGill Pain Questionnaire.
  2. a= Yes, measurement property identified as evaluated based on patients with mCRPC; − = No, measurement property not identified as evaluated based on patients with mCRPC.
  3. bRobinson and colleagues reported acceptable (i.e., ICC > 0.70) test-retest reliability for the BPI-SF pain intensity scale and worst pain item alone but not for the individual average pain item [[23]].
  4. cRobinson and colleagues reported nonacceptable (i.e., ICC < 0.70) test-retest reliability of ICC = 0.56 for the PPI in one trial of 69 patients with mCRPC but acceptable test-retest reliability (ICC = 0.85) in another trial of 93 patients with mCRPC [[23]].
  5. dConvergent and divergent validity established for the four-item FACT-P pain scale, prostate cancer subscale, and total scale scores in patients with mCRPC [[23]].
  6. eEvidence of responsiveness of the PRO measure in one or more phase 2 or 3 randomized controlled trials evaluating one of the mCRPC drugs of interest.
  7. fPain progression and pain response endpoints did not differentiate between treatment arms in the phase 3 registration study for cabazitaxel in patients with mCRPC [[30]].
  8. gPatient scores ≥ 5 on the BPI-SF worst pain item are associated with significant and meaningful impairments in patients with mCRPC, thus supporting the adequacy of this cut point as an appropriate definition of pain progression in this population [[31]]; a clinically meaningful change of 6 to 10 was estimated for the FACT–P total score (score range: 0–156) [[32]].