Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MGDevelopment and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology 56(6): 899-905

Department of Surgery, University of Michigan, Ann Arbor, Michigan, United States
Urology (Impact Factor: 2.19). 12/2000; 56(6):899-905. DOI: 10.1016/S0090-4295(00)00858-X
Source: PubMed


Objectives. 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.Methods. 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.Results. 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.Conclusions. 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.

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    • "Patient representatives strongly stated that monitoring of these outcomes is important, even among men with advanced disease. We included the Expanded Prostate Cancer Index Composite (EPIC) to assess these complications among men previously treated with local therapy or hormonal therapy because it is a single instrument that assesses the domains of sexual, urinary, hormonal, and bowel function [17]. In addition, it was recommended in the ICHOM localized prostate cancer standard set, allowing a natural continuation of outcome measurement and instrument familiarity for patients who experience recurrence after localized disease [7]. "
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    ABSTRACT: There are no universally monitored outcomes relevant to men with advanced prostate cancer, making it challenging to compare health outcomes between populations. We sought to develop a standard set of outcomes relevant to men with advanced prostate cancer to follow during routine clinical care. The International Consortium for Health Outcomes Measurement assembled a multidisciplinary working group to develop the set. We used a modified Delphi method to achieve consensus regarding the outcomes, measures, and case mix factors included. The 25 members of the multidisciplinary international working group represented academic and nonacademic centers, registries, and patients. Recognizing the heterogeneity of men with advanced prostate cancer, the group defined the scope as men with all stages of incurable prostate cancer (metastatic and biochemical recurrence ineligible for further curative therapy). We defined outcomes important to all men, such as overall survival, and measures specific to subgroups, such as time to metastasis. Measures gathered from clinical data include measures of disease control. We also identified patient-reported outcome measures (PROMs), such as degree of urinary, bowel, and erectile dysfunction, mood symptoms, and pain control. The international multidisciplinary group identified clinical data and PROMs that serve as a basis for international health outcome comparisons and quality-of-care assessments. The set will be revised annually. Our international group has recommended a standardized set of patient-centered outcomes to be followed during routine care for all men with advanced prostate cancer. Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.
    European Urology 06/2015; 68(5). DOI:10.1016/j.eururo.2015.06.007 · 13.94 Impact Factor
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    • "The primary outcome was the composite rate of genitourinary side effects measured using validated patient questionnaires [15] [16] [17]. "
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    ABSTRACT: Although localised prostate cancer is multifocal in most instances, the index lesion might be responsible for disease progression. To determine the early genitourinary functional and cancer control outcomes of index lesion ablation. This was a single-centre prospective development study in which 56 men were treated (July 2009-January 2011). The mean age was 63.9 yr (standard deviation 5.8) and median prostate-specific antigen (PSA) was 7.4 ng/ml (interquartile range [IQR] 5.6-9.5). There were seven (12.5%) low-risk, 47 (83.9%) intermediate-risk, and two (3.6%) high-risk cancers. Multiparametric magnetic resonance imaging (mpMRI) and prostate biopsies to localise disease, followed by index lesion ablation using high-intensity focused ultrasound. Primary outcomes were genitourinary side effects measured using validated questionnaires. Secondary outcomes included absence of clinically significant disease at 12 mo. The composite of leak-free, pad-free continence, and erections sufficient for penetration decreased from a baseline frequency of 40/56 (71.4%) to 33/56 (58.9%) at 12 mo. Pad-free and leak-free, pad-free continence was preserved in 48/52 (92.3%) and 46/50 (92.0%) patients, respectively. Erections sufficient for intercourse were preserved in 30/39 (76.9%) patients. The median PSA nadir decreased to 2.4 ng/ml (IQR 1.6-4.1). At 12 mo, 42/52 (80.8%) patients had histological absence of clinically significant cancer and 85.7% (48/56) had no measurable prostate cancer (biopsy and/or mpMRI). Two (3.6%) patients had clinically significant disease in untreated areas not detected at baseline. The main study limitation is the short follow-up duration. Index lesion ablation had low rates of genitourinary side effects and acceptable short-term absence of clinically significant cancer. Comparative effectiveness trials are required to assess cancer control outcomes against radical therapy. In this study we looked at whether it is possible to treat the largest and highest-grade tumour in men who have more than one known prostate tumour. We show that the side effects of targeted ablation were low, with acceptable rates of early cancer control. Larger studies with longer follow-up are needed. NCT00988130. Copyright © 2015. Published by Elsevier B.V.
    European Urology 02/2015; DOI:10.1016/j.eururo.2015.01.030 · 13.94 Impact Factor
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    • "Trial flow. QoL), 15-Item International Index of Erectile Function (IIEF- 15), UCLA Expanded Prostate Cancer Index Composite (EPIC) urinary and bowel domains, EQ-5D Health related Quality-oflife , Functional Assessment of Cancer Therapy for Prostate (FACT-P) and Memorial Anxiety Scale for Prostate Cancer (MAX-PC) [28] [29] [30] "
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    ABSTRACT: Introduction Focal therapy may reduce the toxicity of current radical treatments while maintaining the oncological benefit. Irreversible Electroporation (IRE) has been proposed to be tissue selective and so might have favourable characteristics compared to currently used prostate ablative technologies. The aim of this trial is to determine the adverse events, genito-urinary side effects and early histological outcomes of focal IRE in men with localised prostate cancer. Methods Single centre prospective development (stage 2a) study following the IDEAL recommendations for evaluating new surgical procedures. Twenty men who have MRI-visible disease localised in the anterior part of the prostate will be recruited. The sample size permits a precision estimate around key functional outcomes. Inclusion criteria include PSA </= 15ng/ml, Gleason score </= 4+3, stage T2N0M0 and absence of clinically significant disease outside the treatment area. Treatment delivery will be changed in an adaptive iterative manner so as to allow optimisation of the IRE protocol. After focal IRE, men will be followed during 12 months using validated patient reported outcome measures (IPSS, IIEF-15, UCLA-EPIC, EQ-5D, FACT-P, MAX-PC). Early disease control will be evaluated by mpMRI and targeted transperineal biopsy of the treated area at 6 months. Discussion The NEAT trial will assess the early functional and disease control outcome of focal IRE using an adaptive design. Our protocol can provide guidance for designing an adaptive trial to assess new surgical technologies in the challenging landscape of health technology assessment in prostate cancer treatment.
    Contemporary Clinical Trials 09/2014; 39(1). DOI:10.1016/j.cct.2014.07.006 · 1.94 Impact Factor
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