Pain questionnaire performance in advanced prostate cancer: comparative results from two international clinical trials
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Abstract
Purpose
To compare pain assessment questionnaires commonly used in advanced prostate cancer trials and to determine the psychometric characteristics and longitudinal relationships by contrasting questionnaire data from two international phase 2 trials.
Methods
Scores from the Present Pain Intensity (PPI) question of the McGill Pain Questionnaire, the pain intensity scale of the Brief Pain Inventory (BPI), and the Functional Assessment of Cancer Therapy-Prostate (FACT-P) were analyzed using Pearson correlation, intraclass correlation coefficient, and Cronbach’s α, respectively. Concordance was evaluated with Cohen’s kappa coefficient and McNemar test at baseline (n = 224) and two subsequent observations.
Results
PPI and FACT-P scores were associated with the BPI score at baseline for Trials 1 and 2: PPI r = 0.66 and 0.80, respectively (P < 0.001); FACT-P (pain scale) r = −0.76 and −0.82, respectively (P < 0.001). However, concordance analysis revealed that the BPI identified pain (score > 0) at higher rates than the PPI: at baseline, BPI: 89 % (64/72) and 77 % (95/124), PPI: 68 % (49/72) and 64 % (79/124) [Trials 1 and 2, respectively; McNemar test (P < 0.001) for both studies]. The FACT-P pain scale identified pain similarly to the BPI pain intensity scale; longitudinal analysis produced comparable findings. All pain scales met standard psychometric acceptability criteria, but the BPI and FACT-P performed better than the PPI.
Conclusions
Data suggest the BPI pain intensity and FACT-P pain scales are better than the PPI question at capturing the pain experience among patients with advanced prostate cancer. Additional comparative research is needed in larger population samples.
Keywords
Prostate cancer Pain Symptoms Psychometrics Epidemiology Quality of lifeAbbreviations
- ALP
Alkaline phosphatase
- BMI
Body mass index
- BPI
Brief Pain Inventory
- CRP
C-reactive protein
- CRPC
Castrate-resistant prostate cancer
- ECOG
Eastern Cooperative Oncology Group
- ECOG PS
Eastern Cooperative Oncology Group performance status
- ESA
Erythropoietin-stimulating agents
- FACT
Functional Assessment of Cancer Therapy
- FACT-P
Functional Assessment of Cancer Therapy-Prostate
- FACT-PCS
Functional Assessment of Cancer Therapy-Prostate prostate cancer scale
- Hgb
Hemoglobin
- HRQoL
Health-related quality of life
- ICC
Intraclass correlation coefficient
- LDH
Lactate dehydrogenase
- NA
Data not available
- PPI
Present Pain Intensity
- PSA
Prostate-specific antigen
- SD
Standard deviation
- T1
Trial 1
- T2
Trial 2
Notes
Acknowledgments
The authors thank Lyn Lai, Mary Sorrentino, and Rob Achenbach of the Medical Affairs Publications Group of Janssen Services, LLC, for their editorial and submission support. Brenda Foster, MD, PhD, provided clinical insight into an early draft of this manuscript. We greatly appreciate the patients who participated in this study and shared their perceptions of health with us.
Conflict of interest
Janssen Biotech, Inc., sponsored the study. Fitzroy Dawkins, Ming Qi, Donald Robinson Jr., and Ning Zhao are Janssen Research & Development, LLC, employees. Dennis Revicki was a Janssen Global Services, LLC, consultant, but received no compensation for this work.
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