Expanded Prostate Cancer Index Composite for Clinical Practice: Development and Validation of a Practical Health Related Quality of Life Instrument for Use in the Routine Clinical Care of Patients With Prostate Cancer (original) (raw)
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Urology, 2001
Objectives. To present our experience with the clinical use of a modified American Urological Association Symptom Score (AUASS) and a quality-of-life (QOL) questionnaire in obtaining clinically available information and to investigate whether a relatively short questionnaire, administered in the clinic, can help in identifying symptoms and QOL issues associated with various types of definitive treatments (DTs) for prostate cancer (PCa) and its impact on patients' QOL. Methods. The AUASS was modified to contain questions on continence and was combined with a short QOL questionnaire. It was administered to control groups and all patients with PCa during their clinic visit. The responses were analyzed and correlated with the DT of PCa. Results. The questionnaire was administered 846 times to 375 patients with PCa and to 170 controls during clinic visits. We found that patients on watchful waiting had symptom scores and QOL responses similar to controls and that DT was associated with worse scores and a reduced QOL. DT with continence was associated with a better QOL than DT with incontinence. Incontinence of either urine or stool, among DT patients, had similar adverse impact on QOL, compared with continent DT patients. Conclusions. The questionnaire, administered in a clinical setting, provides insight into the QOL and symptoms associated with interventions aimed at curing PCa. The use of such a questionnaire enhances the objective documentation of treatment outcomes of PCa and benefits the patients by increasing their opportunities to express their problems.
Urology, 2000
Health-related quality of life (HRQOL) is an increasingly important endpoint in prostate cancer care. However, pivotal issues that are not fully assessed in existing HRQOL instruments include irritative urinary symptoms, hormonal symptoms, and multi-item scores quantifying bother between urinary, sexual, bowel, and hormonal domains. We sought to develop a novel instrument to facilitate more comprehensive assessment of prostate cancer-related HRQOL. Instrument development was based on advice from an expert panel and prostate cancer patients, which led to expanding the 20-item University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) to the 50-item Expanded Prostate Index Composite (EPIC). Summary and subscale scores were derived by content and factor analyses. Reliability and validity were assessed by test-retest correlation, Cronbach's alpha coefficient, interscale correlation, and EPIC correlation with other validated instruments. Test-retest reliability and internal consistency were high for EPIC urinary, bowel, sexual, and hormonal domain summary scores (each r >/=0.80 and Cronbach's alpha >/=0.82) and for most domain-specific subscales. Correlations between function and bother subscales within domains were high (r >0.60). Correlations between different primary domains were consistently lower, indicating that these domains assess distinct HRQOL components. EPIC domains had weak to modest correlations with the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12), indicating rationale for their concurrent use. Moderate agreement was observed between EPIC domains relevant to the Functional Assessment of Cancer Therapy Prostate module (FACT-P) and the American Urological Association Symptom Index (AUA-SI), providing criterion validity without excessive overlap. EPIC is a robust prostate cancer HRQOL instrument that complements prior instruments by measuring a broad spectrum of urinary, bowel, sexual, and hormonal symptoms, thereby providing a unique tool for comprehensive assessment of HRQOL issues important in contemporary prostate cancer management.
The Journal of Urology, 2006
Purpose: Although measuring quality of life of patients with prostate cancer serves important research goals, its primary clinical purpose is informing patients. Sophisticated quality of life measures produce purely numerical results that patients have difficulty understanding. We present an approach that preserves the methodological strengths of validated multi-item measures but provides more accessible information for clinical use. Materials and Methods: Using validated indexes measuring urinary, bowel and sexual function we surveyed patients with clinically localized prostate cancer before treatment and at intervals thereafter. Based on patient responses to parallel distress measures we defined 3 levels of function, including normal-no abnormal symptom, intermediate-any abnormal symptom but none severely abnormal and poor-any severely abnormal symptom. We then translated patient survey results into these levels. To assess measurement properties we compared average symptom distress scores in patients at each symptom level. Results: Levels of function and patient distress scores correlated strongly. Large and approximately equal differences in distress scores separated patients at successive levels in all symptom indexes (effect size greater than 1.2, p Ͻ0.0001). Using these categories we created tables showing 24-month outcomes in 417 previously reported patients by pretreatment symptom level and treatment, providing a tool for patients to determine posttreatment outcomes in similar patients. Conclusions: Using symptom indexes to define levels of function produces a quality of life metric that is valid, defines quantitative intervals, is transparent and may be more useful to patients. This approach provides methodologically sound outcome information to patients attempting to choose a prostate cancer treatment.
Clinical Prostate Cancer, 2005
Background: We revised our prostate cancer-specific measure to better address the physiologic complications of the 3 major therapies for clinically localized prostate cancer and to assess the impact of symptoms on broader aspects of patient functioning. The study used a crosssectional design, and participants completed the measure in a clinical setting. Patients and Methods: Participants underwent radical prostatectomy (n = 130), external beam radiation therapy (n = 120), or brachytherapy (n = 129). Their mean age was 66 years (standard deviation [SD], 8.2 years), and the median time since treatment was 12.36 months (mean, 21.7; SD, 25.4). Items were derived from previously validated instruments or developed based on the clinical experience of a multidisciplinary group of health professionals. Results: The revised instrument included 46 items that formed 8 physiologic scales (2 urinary, 3 sexual, and 3 bowel function); 3 associated bother scales; and cancer worry, treatment regret, and treatment satisfaction scales. Correlations among scales provided evidence of convergent/divergent validity. Significant group differences were found using analysis of covariance (with time since treatment and age as covariates) on 6 of the 8 physiologic scales and on bowel bother and treatment satisfaction. Conclusion: The instrument provides a sensitive measure of physiologic differences across the 3 primary treatment groups and indicates that there are few differences across treatment groups on broader aspects of health-related quality of life. Further development of the measure is recommended.
Urology, 2010
Widespread implementation of health-related quality-of-life (HRQOL) measurement in prostate cancer practice and research requires concise instruments. With 50 questions, the full-length Expanded Prostate Cancer Index Composite (EPIC) is cumbersome to administer outside of studies focusing exclusively on HRQOL. To facilitate HRQOL measurement in a broad range of prostate cancer research and practice settings, we developed and validated an abbreviated version of the EPIC. The 50 questions that constitute the full-length EPIC-50 were evaluated to identify the items suitable for elimination while retaining the ability to measure the 5 prostate cancer-specific HRQOL domains of the EPIC-50. The resulting abbreviated version (EPIC-26) was validated using question responses from 252 subjects who had undergone brachytherapy, external beam radiotherapy, or prostatectomy for prostate cancer. The EPIC-26 internal consistency was measured by Cronbach's α coefficient and reliability using tes...
Quality of Life Research, 2014
Purpose The objective was to obtain a standardized evaluation of available prostate cancer-specific quality of life instruments used in patients with early-stage disease. Methods We carried out systematic literature reviews in the PubMed database to identify manuscripts which contained information regarding either the development process or metric properties of prostate cancer-specific quality of life instruments. Each instrument was evaluated by two experts, independently, using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. An overall and seven attribute-specific EMPRO scores were calculated (range 0-100, worst to best): measurement model, reliability, validity, responsiveness, interpretability, burden and alternative forms. Results Eight instruments and 57 manuscripts (2-15 per instrument) were identified. The Expanded Prostate Cancer Index Composite (EPIC) was the best rated (overall EM-PRO score 83.1 points). Good results were also obtained by University of California Los Angeles-Prostate Cancer Index (UCLA-PCI), Patient-Oriented Prostate Utility Scale (PORPUS) and Prostate Cancer Quality of Life Instrument (PC-QoL) with 77.3, 70.5 and 64.8 points, respectively. These four instruments passed with distinction the validity and responsiveness evaluation. Insufficient reliability results were observed for UCLA-PCI and PORPUS. Conclusions Current evidence supports the choice of EPIC, PORPUS or PC-QoL. Attribute-specific EMPRO results facilitate selecting the adequate instrument for every purpose. For longitudinal studies or clinical trials, where responsiveness is the priority, EPIC or PC-QoL should be considered. We recommend the PORPUS for economic evaluations because it allows cost-utility analysis, and EPIC short versions to minimize administration burden.