Determinants of self-reported functional status (EPIC-26) in prostate cancer patients prior to treatment.

PURPOSE: The self-reported functional status (sr-FS) of prostate cancer (PCa) patients varies substantially between patients and health-care providers before treatment. Information about this issue is important for evaluating comparisons between health-care providers and to assist in treatment decision-making. There have been few reports on correlates of pretherapeutic sr-FS. The objective of the article, therefore, is to describe clinical and sociodemographic correlates of pretherapeutic sr-FS, based on a subset of the TrueNTH Global Registry, a prospective cohort study. METHODS: A total of 3094 PCa patients receiving local treatment in 44 PCa centers in Germany were recruited between July 2016 and April 2018. Multilevel regression models were applied to predict five pretherapeutic sr-FS (EPIC-26) scores based on clinical characteristics (standard set suggested by the International Consortium for Health Outcomes Measurement), sociodemographic characteristics, and center characteristics. RESULTS: Impaired pretherapeutic sr-FS tended to be associated with lower educational level and poorer disease characteristics-except for "urinary incontinence" which was only associated with age. Notably, age was a risk factor ("urinary incontinence," "urinary irritative/obstructive," "sexual") as well as a protective factor ("hormonal") for pretherapeutic sr-FS. Pretherapeutic sr-FS varies little across centers. CONCLUSIONS: Pretherapeutic sr-FS varies by clinical patient characteristics and age as well as by socioeconomic status. The findings point out the benefit of collecting and considering socioeconomic information in addition to clinical and demographic patient characteristics for treatment decision-making and fair comparisons between health-care providers.

Psychometric validation of the German version of the EPIC-26 questionnaire for patients with localized and locally advanced prostate cancer.

PURPOSE: For patients with prostate cancer, validated and reliable instruments are essential for measuring patient-reported outcomes. The aim of this study was to validate the German version of the widely established Expanded Prostate Cancer Index Composite with 26 items (EPIC-26). METHODS: A German translation of the original questionnaire was tested in 3094 patients with localized or locally advanced (any T, any N and M0) prostate cancer with treatment intent (including radical prostatectomy, brachytherapy, active surveillance, watchful waiting). They completed the EPIC-26 questionnaire before treatment. A total of 521 of them also completed a questionnaire 12 months afterward. Internal consistency, sensitivity to change, and construct validity were assessed. RESULTS: The internal consistency of all domains was sufficient (Cronbach's alpha between 0.64 and 0.93). Item-to-scale correlation coefficients showed acceptable associations between items and their domain score (all > 0.30), with the lowest scores for "bloody stools" (r = 0.37) and "breast problems" (r = 0.32). Confirmatory and exploratory factor analysis confirmed the five-dimension structure of the EPIC-26 (comparative fit index 0.95). CONCLUSIONS: Psychometric evaluation suggests that the German version of the EPIC-26 is a well-constructed instrument for measuring patient-reported health-related symptoms in patients with prostate cancer.

A multicenter paper-based and web-based system for collecting patient-reported outcome measures in patients undergoing local treatment for prostate cancer: first experiences.

PURPOSE: To give an overview of the multicenter Prostate Cancer Outcomes (PCO) study, involving paper-based and web-based collection of patient-reported outcome measures (PROM) in patients undergoing local treatment for prostate cancer in certified centers in Germany. The PCO study is part of the larger Movember-funded TrueNTH Global Registry. The article reports on the study's design and provides a brief progress report after the first 2 years of data collection. METHODS: Prostate cancer centers (PCCs) certified according to German Cancer Society requirements were invited to participate in collecting patient-reported information on symptoms and function before and at least once (at 12 months) after treatment. The data were matched with disease and treatment information. This report describes progress in patient inclusion, response rate, and variations between centers relative to online/paper use, and also data quality, including recruitment variations relative to treatment in the first participating PCCs. RESULTS: PCC participation increased over time; 44 centers had transferred data for 3094 patients at the time of this report. Patient recruitment varied widely across centers. Recruitment was highest among patients undergoing radical prostatectomy. The completeness of the data was good, except for comorbidity information. CONCLUSIONS: The PCO study benefits from a quality improvement system first established over 10 years ago, requiring collection and harmonization of a predefined clinical dataset across centers. Nevertheless, establishing a PROM routine requires substantial effort on the part of providers and constant monitoring in order to achieve high-quality data. The findings reported here may be useful for guiding implementation in similar initiatives.

Use of psycho-oncological services by prostate cancer patients: A multilevel analysis.

BACKGROUND: Cancer patients often suffer from psychological distress. Psycho-oncological services (POS) have been established in some health care systems in order to address such issues. This study aims to identify patient and center characteristics that elucidate the use of POS by patients in prostate cancer centers (PCCs). METHODS: Center-reported certification and patient survey data from 3094 patients in 44 certified PCCs in Germany were gathered in the observational study (Prostate Cancer Outcomes). A multilevel analysis was conducted. RESULTS: Model 1 showed that utilization of POS in PCCs is associated with patients' age (OR = 0.98; 95%-CI = 0.96-0.99; P < .001), number of comorbidities (1-2 vs 0, OR = 1.27; 95%-CI = 1.00-1.60; P=.048), disease staging (localized high-risk vs localized intermediate risk, OR = 1.41; 95%-CI = 1.14-1.74; P < .001), receiving androgen deprivation therapy before study inclusion (OR = 0.19; 95%-CI = 0.10-0.34; P < .001), and hospital teaching status (university vs academic, OR = 0.09; 95%-CI = 0.02-0.55; P = .009). Model 2 additionally includes information on treatment after study inclusion and shows that after inclusion, patients who receive primary radiotherapy (OR = 0.05; 95%-CI = 0.03-0.10; P < .001) or undergo active surveillance/watchful waiting (OR = 0.06; 95%-CI = 0.02-0.15; P < .001) are less likely to utilize POS than patients who undergo radical prostatectomy. Disease staging (localized high-risk vs localized intermediate risk, OR = 1.31; 95%-CI = 1.05-1.62; P = .02) and teaching status (university vs academic, OR = 0.08; 95%-CI = 0.01-0.65; P = .02) are also significant predictors for POS use. The second model did not identify any other significant patient characteristics. CONCLUSIONS: Future research should explore the role of institutional teaching status and whether associations with therapy after study inclusion are due to treatment effects - for example, less need following radiotherapy - or because access to POS is more difficult for those receiving radiotherapy.