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Health and Quality of Life Outcomes

, 9:88

First Online: 12 October 2011Received: 16 March 2011Accepted: 12 October 2011

Abstract

BackgroundBone metastases are a common painful and debilitating consequence of castration-resistant prostate cancer CPRC. Bone pain may predict patients- prognosis and there is a need to further explore CRPC patients- experiences of bone pain in the overall context of disease pathology. Due to the subjective nature of pain, assessments of pain severity, onset and progression are reliant on patient assessment. Patient reported outcome PRO measures, therefore, are commonly used as key endpoints for evaluating the efficacy of CRPC treatments. Evidence of the content validity of leading PRO measures of pain severity used in CRPC clinical trials is, however, limited.

MethodsTo document patients- experience of CRPC symptoms including pain, and their impact on health-related quality of life HRQL, semi-structured in-depth qualitative interviews were conducted with 17 patients with CRPC and bone metastases. The content validity of the Present Pain Intensity PPI scale from the McGill Pain Questionnaire MPQ, and the -Average Pain- and -Worst Pain- items of the Brief Pain Inventory Short-Form BPI-SF was also assessed.

ResultsPatients with CRPC and bone metastases present with a constellation of symptoms that can have a profound effect on HRQL. For patients in this study, bone pain was the most prominent and debilitating symptom associated with their condition. Bone pain was chronic and, despite being generally well-managed by analgesic medication, instances of breakthrough cancer pain BTcP were common. Cognitive debriefing of the selected PRO measures of pain severity highlighted difficulties among patients in understanding the verbal response scale VRS of the MPQ PPI scale. There were also some inconsistencies in the way in which the BPI-SF -Average Pain- item was interpreted by patients. In contrast, the BPI-SF -Worst Pain- item was well understood and interpreted consistently among patients.

ConclusionsStudy findings support the importance of PRO measures of pain severity as key endpoints for evaluating the efficacy of treatments for CRPC, particularly for patients with bone metastases where episodes of BTcP are common. Qualitative evidence from CRPC patients supports the content validity of the BPI-SF -Worst Pain- item and promotes use of this item for measuring pain severity in this population.

AbbreviationsASRAge-standardised incidence rate

BPI-SFBrief Pain Inventory Short-Form

BTcPBreakthrough cancer pain

CIPNChemotherapy-induced peripheral neuropathy

CRPCCastration-resistant prostate cancer

FDAFood and Drug Administration

HRQLHealth-related quality of life

IMMPACTInitiative on Methods, Measurement, and Pain Assessment in Clinical Trial

MPQ-SFMcGill Pain Questionnaire Short-Form

NRSNumerical rating scale

PPIPresent pain intensity

PROPatient reported outcome

VRSVerbal rating scale.

Electronic supplementary materialThe online version of this article doi:10.1186-1477-7525-9-88 contains supplementary material, which is available to authorized users.

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Autor: Adam Gater - Linda Abetz-Webb - Clare Battersby - Bhash Parasuraman - Stuart McIntosh - Faith Nathan - Elisabeth C Piault

Fuente: https://link.springer.com/







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