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Quality of Life Research
Gepubliceerd in: Quality of Life Research 10/2013

01-12-2013

Pain questionnaire performance in advanced prostate cancer: comparative results from two international clinical trials

Auteurs: Donald W. Robinson Jr., Ning Zhao, Fitzroy Dawkins, Ming Qi, Dennis Revicki

Gepubliceerd in: Quality of Life Research | Uitgave 10/2013

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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.
vorige artikel Development of a crosswalk for pain interference measured by the BPI and PROMIS pain interference short form
volgende artikel Assessing patient-reported peripheral neuropathy: the reliability and validity of the European Organization for Research and Treatment of Cancer QLQ-CIPN20 Questionnaire
Literatuur
1.
Lee, D. J., Cha, E. K., Dubin, J. M., Beltran, H., Chromecki, T. F., Fajkovic, H., et al. (2012). Novel therapeutics for the management of castration-resistant prostate cancer (CRPC). BJU International, 109(7), 968–985.PubMedCrossRef
2.
de Bono, J. S., Oudard, S., Ozguroglu, M., Hansen, S., Machiels, J.-P., Kocak, I., et al. (2010). Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: A randomised open-label trial. Lancet, 376(9747), 1147–1154.PubMedCrossRef
3.
de Bono, J. S., Logothetis, C. J., Molina, A., Fizazi, K., North, S., Chu, L., et al. (2011). Abiraterone and increased survival in metastatic prostate cancer. New England Journal of Medicine, 364(21), 1995–2005.PubMedCrossRef
4.
Parker, C., Heinrich, D., O’Sullivan, J. M., Fossá, S. D., Chodacki, A., Demkow, T., et al. (2011). Overall survival benefit of radium-223 chloride (alpharadin) in the treatment of patients with symptomatic bone metastases in castration-resistant prostate cancer (CRPC): A phase III randomized trial (ALSYMPCA). [abstract 1LBA]. European Journal of Cancer, 47(suppl 2), 3.CrossRef
5.
Mukherji, D., Pezaro, C. J., & De-Bono, J. S. (2012). MDV3100 for the treatment of prostate cancer. Expert Opinion on Investigational Drugs, 21(2), 227–233.PubMedCrossRef
6.
Fizazi, K., De Bono, J. S., Flechon, A., Heidenreich, A., Voog, E., Davis, N. B., et al. (2012). Randomised phase II study of siltuximab (CNTO 328), an anti-IL-6 monoclonal antibody, in combination with mitoxantrone/prednisone versus mitoxantrone/prednisone alone in metastatic castration-resistant prostate cancer. European Journal of Cancer, 48(1), 85–93.PubMedCrossRef
7.
Chu, F. M., Picus, J., Fracasso, P. M., Dreicer, R., Lang, Z., & Foster, B. (2011). A phase 1, multicenter, open-label study of the safety of two dose levels of a human monoclonal antibody to human αv integrins, intetumumab, in combination with docetaxel and prednisone in patients with castrate-resistant metastatic prostate cancer. Investigational New Drugs, 29(4), 674–679.PubMedCrossRef
8.
Atkinson, T. M., Mendoza, T. R., Sit, L., Passik, S., Scher, H. I., Cleeland, C., et al. (2010). The Brief Pain Inventory and its “pain at its worst in the last 24 hours” item: Clinical trial endpoint considerations. Pain Medicine, 11(3), 337–346.PubMedCrossRef
9.
Esper, P., Mo, F., Chodak, G., Sinner, M., Cella, D., & Pienta, K. J. (1997). Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology, 50(6), 920–928.PubMedCrossRef
10.
Jensen, M. P. (2003). The validity and reliability of pain measures in adults with cancer. Journal of Pain, 4(1), 2–21.PubMedCrossRef
11.
Melzack, R. (1975). The McGill Pain Questionnaire: Major properties and scoring methods. Pain, 1(3), 277–299.PubMedCrossRef
12.
Rosenfeld, B., Roth, A. J., Gandhi, S., & Penson, D. (2004). Differences in health-related quality of life of prostate cancer patients based on stage of cancer. Psycho-oncology, 13(11), 800–807.PubMedCrossRef
13.
Melzack, R., & Katz, J. (2001). The McGill Pain Questionnaire: Appraisal and current status. In D. C. Turk & R. Melzack (Eds.), Handbook of pain assessment (2nd ed., pp. 35–52). New York: Guilford Press.
14.
Cella, D., Nichol, M. B., Eton, D., Nelson, J. B., & Mulani, P. (2009). Estimating clinically meaningful changes for the Functional Assessment of Cancer Therapy–prostate: Results from a clinical trial of patients with metastatic hormone-refractory prostate cancer. Value in Health, 12(1), 124–129.PubMedCrossRef
15.
Webster, K., Cella, D., & Yost, K. (2003). The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: Properties, applications, and interpretation. Health and Quality of Life Outcomes, 1, 79.PubMedCrossRef
16.
Tannock, I. F., de Wit, R., Berry, W. R., Horti, J., Pluzanska, A., Chi, K. N., et al. (2004). Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. New England Journal of Medicine, 351(15), 1502–1512.PubMedCrossRef
17.
Halabi, S., Vogelzang, N. J., Kornblith, A. B., Ou, S.-S., Kantoff, P. W., Dawson, N. A., et al. (2008). Pain predicts overall survival in men with metastatic castration-refractory prostate cancer. Journal of Clinical Oncology, 26(15), 2544–2549.PubMedCrossRef
18.
Jensen, M. P. (2008). Pain assessment in clinical trials. In H. M. Wittink & D. B. Carr (Eds.), Pain management: Evidence, outcomes, and quality of life: A sourcebook (pp. 57–88). Philadelphia: Elsevier.
19.
Ferreira-Valente, M. A., Pais-Ribeiro, J. L., & Jensen, M. P. (2011). Validity of four pain intensity rating scales. Pain, 152(10), 2399–2404.PubMedCrossRef
20.
Cleeland, C. S., O’Mara, A., Zagari, M., & Baas, C. (2011). Integrating pain metrics into oncology clinical trials. Clinical Cancer Research, 17(21), 6646–6650.PubMedCrossRef
21.
Basch, E. M., Sit, L., Fruscione, M., Burke, L., Kane, R., George, D., et al. (2009). Pain and analgesic use in men with metastatic prostate cancer [abstract]. Journal of Clinical Oncology, 27(Suppl, 15S), e20515.
22.
Sandblom, G., Carlsson, P., Sigsjö, P., & Varenhorst, E. (2001). Pain and health-related quality of life in a geographically defined population of men with prostate cancer. British Journal of Cancer, 85(4), 497–503.PubMedCrossRef
23.
Sullivan, P. W., Mulani, P. M., Fishman, M., & Sleep, D. (2007). Quality of life findings from a multicenter, multinational, observational study of patients with metastatic hormone-refractory prostate cancer. Quality of Life Research, 16(4), 571–575.PubMedCrossRef
24.
Berthold, D. R., Pond, G. R., Roessner, M., de Wit, R., Eisenberger, M., & Tannock, A. I. (2008). Treatment of hormone-refractory prostate cancer with docetaxel or mitoxantrone: Relationships between prostate-specific antigen, pain, and quality of life response and survival in the TAX-327 study. Clinical Cancer Research, 14(9), 2763–2767.PubMedCrossRef
25.
Collette, L., van Andel, G., Bottomley, A., Oosterhof, G. O., Albrecht, W., de Reijke, T. M., et al. (2004). Is baseline quality of life useful for predicting survival with hormone-refractory prostate cancer? A pooled analysis of three studies of the European Organisation for Research and Treatment of Cancer Genitourinary Group. Journal of Clinical Oncology, 22(19), 3877–3885.PubMedCrossRef
26.
Sullivan, P. W., Nelson, J. B., Mulani, P. M., & Sleep, D. (2006). Quality of life as a potential predictor for morbidity and mortality in patients with metastatic hormone-refractory prostate cancer. Quality of Life Research, 15(8), 1297–1306.PubMedCrossRef
27.
Armstrong, A. J., Garrett-Mayer, E., Ou Yang, Y.-C., Carducci, M. A., Tannock, I., de Wit, R., et al. (2007). Prostate-specific antigen and pain surrogacy analysis in metastatic hormone-refractory prostate cancer. Journal of Clinical Oncology, 25(25), 3965–3970.PubMedCrossRef
28.
Scher, H. I., Halabi, S., Tannock, I., Morris, M., Sternberg, C. N., Carducci, M. A., et al. (2008). Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: Recommendations of the Prostate Cancer Clinical Trials Working Group. Journal of Clinical Oncology, 26(7), 1148–1159.PubMedCrossRef
29.
Armstrong, A. J., Garrett-Mayer, E. S., Yang, Y.-C., de Wit, R., Tannock, I. F., & Eisenberger, M. (2007). A contemporary prognostic nomogram for men with hormone-refractory metastatic prostate cancer: A TAX327 study analysis. Clinical Cancer Research, 13(21), 6396–6403.PubMedCrossRef
30.
Fayers, P. M., Hopwood, P., Harvey, A., Girling, D. J., Machin, D., & Stephens, R. (1997). Quality of life assessment in clinical trials–guidelines and a checklist for protocol writers: The U.K. Medical Research Council experience. MRC Cancer Trials Office. European Journal of Cancer, 33(1), 20–28.PubMedCrossRef
31.
Hahn, E. A., Webster, K. A., Cella, D., & Fairclough, D. L. (1998). Missing data in quality of life research in Eastern Cooperative Oncology Group (ECOG) clinical trials: Problems and solutions. Statistics in Medicine, 17(5–7), 547–559.PubMedCrossRef
32.
Hopwood, P., Harvey, A., Davies, J., Stephens, R. J., Girling, D. J., Gibson, D., et al. (1998). Survey of the Administration of quality of life (QL) questionnaires in three multicentre randomised trials in cancer. The Medical Research Council Lung Cancer Working Party the CHART Steering Committee. European Journal of Cancer, 34(1), 49–57.PubMedCrossRef
33.
Shrout, P. E., & Fleiss, J. L. (1979). Intraclass correlations: Uses in assessing rater reliability. Psychological Bulletin, 86(2), 420–428.PubMedCrossRef
34.
Deyo, R. A., Diehr, P., & Patrick, D. L. (1991). Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation. Controlled Clinical Trials, 12(4 Suppl), 142S–158S.PubMedCrossRef
35.
Hays, R. D., & Revicki, D. A. (2005). Reliability and validity, including responsiveness. In P. Fayers & R. Hays (Eds.), Assessing quality of life in clinical trials: Methods and practice (2nd ed., pp. 25–39). Oxford: Oxford University Press.
36.
Yuen, K. K., Shelley, M., Sze, W. M., Wilt, T. J., & Mason, M. (2006). Bisphosphonates for advanced prostate cancer. Cochrane Database of Systematic Reviews (4), CD006250.
37.
Wong, R. & Wiffen, P. J. (2002). Bisphosphonates for the relief of pain secondary to bone metastases. Cochrane Database Systematic Reviews (2), CD002068.
38.
Mercadante, S., & Fulfaro, F. (2005). World Health Organization guidelines for cancer pain: A reappraisal. Annals of Oncology, 16(Suppl 4), iv132–iv135.PubMed
39.
Bader, P., Echtle, D., Fonteyne, V., Livadas, K., De Meerleer, G., Paez Borda, A., et al. (2012). Prostate cancer pain management: EAU guidelines on pain management. World Journal of Urology, 30(5), 677–686.PubMedCrossRef
40.
Turk, D. C., Dworkin, R. H., Allen, R. R., Bellamy, N., Brandenburg, N., Carr, D. B., et al. (2003). Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain, 106(3), 337–345.PubMedCrossRef
41.
Dworkin, R. H., Turk, D. C., Wyrwich, K. W., Beaton, D., Cleeland, C. S., Farrar, J. T., et al. (2008). Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. Journal of Pain, 9(2), 105–121.PubMedCrossRef
42.
Schulz, K. F., & Grimes, D. A. (2005). Multiplicity in randomised trials I: Endpoints and treatments. Lancet, 365(9470), 1591–1595.PubMedCrossRef
43.
Turk, D. C., Dworkin, R. H., McDermott, M. P., Bellamy, N., Burke, L. B., Chandler, J. M., et al. (2008). Analyzing multiple endpoints in clinical trials of pain treatments: IMMPACT recommendations. Initiative on methods, measurement, and pain assessment in clinical trials. Pain, 139(3), 485–493.PubMedCrossRef
44.
Ahles, T. A., Herndon, J. E, 2nd, Small, E. J., Vogelzang, N. J., Kornblith, A. B., Ratain, M. J., et al. (2004). Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma: Results of Intergroup O159/Cancer and Leukemia Group B 9480. Cancer, 101(10), 2202–2208.PubMedCrossRef
45.
Berry, D. L., Moinpour, C. M., Jiang, C. S., Ankerst, D. P., Petrylak, D. P., Vinson, L. V., et al. (2006). Quality of life and pain in advanced stage prostate cancer: Results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone. Journal of Clinical Oncology, 24(18), 2828–2835.PubMedCrossRef
46.
Oh, W. K., Manola, J., Babcic, V., Harnam, N., & Kantoff, P. W. (2006). Response to second-line chemotherapy in patients with hormone refractory prostate cancer receiving two sequences of mitoxantrone and taxanes. Urology, 67(6), 1235–1240.PubMedCrossRef
47.
Wu, E. Q., Mulani, P., Farrell, M. H., & Sleep, D. (2007). Mapping FACT-P and EORTC QLQ-C30 to patient health status measured by EQ-5D in metastatic hormone-refractory prostate cancer patients. Value in Health, 10(5), 408–414.PubMedCrossRef
48.
Weinfurt, K. P., Li, Y., Castel, L. D., Saad, F., Timbie, J. W., Glendenning, G. A., et al. (2005). The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer. Annals of Oncology, 16(4), 579–584.PubMedCrossRef
49.
Gater, A., Abetz-Webb, L., Battersby, C., Parasuraman, B., McIntosh, S., Nathan, F., et al. (2011). Pain in castration-resistant prostate cancer with bone metastases: A qualitative study. Health and Quality of Life Outcomes, 9(88).
50.
Farrar, J. T. (2010). Advances in clinical research methodology for pain clinical trials. Nature Medicine, 16(11), 1284–1293.PubMed
Metagegevens
Titel
Pain questionnaire performance in advanced prostate cancer: comparative results from two international clinical trials
Auteurs
Donald W. Robinson Jr.
Ning Zhao
Fitzroy Dawkins
Ming Qi
Dennis Revicki
Publicatiedatum
01-12-2013
Uitgeverij
Springer Netherlands
Gepubliceerd in
Quality of Life Research / Uitgave 10/2013
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-013-0411-z

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