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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.

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Abbreviations

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

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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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Authors and Affiliations

  1. Janssen Global Services, LLC, 200 Great Valley Parkway, Malvern, PA, 19355, USA

    Donald W. Robinson Jr. & Ning Zhao

  2. Janssen Research & Development, LLC, Spring House, PA, USA

    Fitzroy Dawkins & Ming Qi

  3. United BioSource Corporation, Bethesda, MD, USA

    Dennis Revicki

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  1. Donald W. Robinson Jr.
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  2. Ning Zhao
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Correspondence to Donald W. Robinson Jr..

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Robinson, D.W., Zhao, N., Dawkins, F. et al. Pain questionnaire performance in advanced prostate cancer: comparative results from two international clinical trials. Qual Life Res 22, 2777–2786 (2013). https://doi.org/10.1007/s11136-013-0411-z

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