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Incontinence and sexual dysfunction are long-lasting side effects after surgical treatment (radical prostatectomy, RP) of prostate cancer (PC). For an informed treatment decision, physicians and patients should discuss expected impairments. Therefore, this paper firstly aims to develop and validate prognostic models that predict incontinence and sexual function of PC patients one year after RP and secondly to provide an online decision making tool. Observational cohorts of PC patients treated between July 2016 and March 2021 in Germany were used. Models to predict functional outcomes one year after RP measured by the EPIC-26 questionnaire were developed using lasso regression, 80-20 splitting of the data set and 10-fold cross validation. To assess performance, R2, RMSE, analysis of residuals and calibration-in-the-large were applied. Final models were externally temporally validated. Additionally, percentages of functional impairment (pad use for incontinence and firmness of erection for sexual score) per score decile were calculated to be used together with the prediction models. For model development and internal as well as external validation, samples of 11 355 and 8 809 patients were analysed. Results from the internal validation (incontinence: R2 = 0.12, RMSE = 25.40, sexual function: R2 = 0.23, RMSE = 21.44) were comparable with those of the external validation. Residual analysis and calibration-in-the-large showed good results. The prediction tool is freely accessible: https://nora-tabea.shinyapps.io/EPIC-26-Prediction/. The final models showed appropriate predictive properties and can be used together with the calculated risks for specific functional impairments. Main strengths are the large study sample (> 20 000) and the inclusion of an external validation. The models incorporate meaningful and clinically available predictors ensuring an easy implementation. All predictions are displayed together with risks of frequent impairments such as pad use or erectile dysfunction such that the developed online tool provides a detailed and informative overview for clinicians as well as patients.

Background Integrated social care may help to mitigate social risk factors in order to achieve more equitable health outcomes. In cancer centers certified according to the criteria set out by the German Cancer Society, every patient must be given low-threshold access to qualified social workers at the center for in-house social service counseling (SSC). Previous analyses have demonstrated large variation in the utilization of these services across individual centers. Therefore, this research aims at investigating whether SSC utilization varies regarding breast cancer patient characteristics and center characteristics presenting a unique approach of using routine data. Methods Multilevel modeling was performed using quality assurance data based on 6339 patients treated in 13 certified breast cancer centers in Germany in order to investigate whether SSC utilization varies with patient sex, age, and disease characteristics as well as over time and across centers. Results In the sample, 80.3% of the patients used SSC. SSC use varies substantially between centers for the unadjusted model (ICC = 0.24). Use was statistically significantly ( P  < .001) more likely in women, patients with invasive (in comparison to tumor in situ/ductal carcinoma in situ) diseases ( P  < .001), patients with both breasts affected ( P = . 03), patients who received a surgery ( P  < .001), patients who were diagnosed in 2015 or 2017 compared to 2016 ( P  < .001) and patients older than 84 years as compared to patients between 55 and 64 years old ( P  = .002). Conclusion The analysis approach allows a unique insight into the reality of cancer care. Sociodemographic and disease-related patient characteristics were identified to explain SSC use to some extent.

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.

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. The paper identifies patient and center characteristics that account for the use of psycho‐oncological services by prostate cancer patients in certified prostate cancer centers in Germany. Multilevel analysis was conducted. The results indicate that the varying utilization of psycho‐oncological services in certified prostate cancer centers may be better explained by characteristics of the centers and the patients’ clinical characteristics, rather than by the patients’ sociodemographic features.

PurposeFor 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).MethodsA 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.ResultsThe 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).ConclusionsPsychometric 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.

Background With over 65,000 new cases per year in Germany, prostate cancer (PC) is the most common cancer in men in Germany. Localized PC is often treated by radical prostatectomy and has a very good prognosis. Postoperative quality of life (QoL) is significantly influenced by the side effects of surgery. One possible approach to improve QoL is postoperative symptom monitoring using ePROMs (electronic patient-reported outcome measures) to accurately identify any need for support. Methods The PRO-P (“Influence of ePROMS in surgical therapy of PC on the postoperative course”) study is a randomized controlled trial employing 1:1 randomization at 6 weeks postoperatively, involving 260 patients with incontinence (≥ 1 pad/day) at six participating centers. Recruitment is planned for 1 year with subsequent 1-year follow-up. PRO-monitoring using domains of EPIC-26, psychological burden, and QoL are assessed 6, 12, 18, 24, 36, and 52 weeks postoperatively. Exceeding predefined PRO-score cutoffs triggers an alert at the center, prompting patient contact, medical consultation, and potential interventions. The primary endpoint is urinary continence. Secondary endpoints refer to EPIC-26 domains, psychological distress, and QoL. Aspects of feasibility, effect, and implementation of the intervention will be investigated within the framework of a qualitative process evaluation. Discussion PRO-P investigates the effect on postoperative symptom monitoring of a structured follow-up using ePROMs in the first year after prostatectomy. It is one of the first studies in cancer surgery investigating PRO-monitoring and its putative applicability to routine care. Patient experiences with intensified monitoring of postoperative symptoms and reflective counseling will be examined in order to improve primarily urinary continence, and secondly other burdens of physical and psychological symptoms, quality-of-life, and patient competence. The potential applicability of the intervention in clinical practice is facilitated by IT adaption to the certification standards of the German Cancer Society and the integration of the ePROMs survey via a joint patient portal. Positive outcomes could readily translate this complex intervention into routine clinical care. PRO-P might improve urinary incontinence and QoL in patients with radical prostatectomy through the structured use of ePROMs. Trial registration ClinicalTrials.gov NCT05644821. Registered on 09 December 2022.

PurposeThe extent of variation in urinary and sexual functional outcomes after radical prostatectomy (RPE) between prostate cancer (PC) operating sites remains unknown. Therefore, this analysis aims to compare casemix-adjusted functional outcomes (EPIC-26 scores incontinence, irritative/obstructive function and sexual function) between operating sites 12 months after RPE.Materials and methodsAnalysis of a cohort of 7065 men treated with RPE at 88 operating sites (prostate cancer centers, “PCCs”) between 2016 and 2019. Patients completed EPIC-26 and sociodemographic information surveys at baseline and 12 months after RPE. Survey data were linked to clinical data. EPIC-26 domain scores at 12 months after RPE were adjusted for relevant confounders (including baseline domain score, clinical and sociodemographic information) using regression analysis. Differences between sites were described using minimal important differences (MIDs) and interquartile ranges (IQR). The effects of casemix adjustment on the score results were described using Cohen’s d and MIDs.ResultsAdjusted domain scores at 12 months varied between sites, with IQRs of 66–78 (incontinence), 89–92 (irritative/obstructive function), and 20–29 (sexual function). Changes in domain scores after casemix adjustment for sites ≥ 1 MID were noted for the incontinence domain (six sites). Cohen’s d ranged between − 0.07 (incontinence) and − 0.2 (sexual function), indicating a small to medium effect of casemix adjustment.ConclusionsVariation between sites was greatest in the incontinence and sexual function domains for RPE patients. Future research will need to identify the factors contributing to this variation.Trial Registry.The study is registered at the German Clinical Trial Registry (https://www.drks.de/drks_web/) with the following ID: DRKS00010774.

PurposeSince 2008, guidelines recommend that patients with HER2-positive early breast cancer (BC) should receive adjuvant chemotherapy in combination with trastuzumab in Germany. However, recent studies highlight that a substantial share of patients do not receive trastuzumab. We investigate which patient characteristics are associated with a tumor board recommendation for trastuzumab in Breast Cancer Centers (BCC) certified by the German Cancer Society (DKG) and the German Society for Senology, and if the recommendation differs between BCCs.Materials and methodsMulti-level modeling was performed using quality assurance data based on 3052 HER2-positive, operated patients with a first diagnosis of early BC treated between 2006 and 2019 in 17 BCCs in Germany to investigate whether trastuzumab recommendation varies with patient sex, age, and disease characteristics, as well as over time and across BCCs.ResultsTumor board recommendations for trastuzumab differ substantially between BCCs (intraclass correlation coefficient [ICC] null model: 0.11). Our final model (ICC 0.17, Akaike Information Criterion [AIC], 1328.0, R2 0.69) shows that physicians in BCCs more often recommend trastuzumab to patients who are younger than 60 years and those with a recommendation for any additional therapy (chemotherapy, radiation or endocrine therapy) (all p < 0.05). Furthermore, there is a significant time-dependent increase of trastuzumab recommendations (odds ratio [OR] = 1.38, 95% confidence interval [CI] = 1.31–1.46, p < 0.05).ConclusionIn certified BCCs in Germany, guideline concordant trastuzumab recommendation is increasing since 2006 (positive cohort effect). Recommendation of trastuzumab for HER2-positive BC patients in BCCs is significantly associated with patients’ age and the recommendations for other additional therapy strategies, apart from surgery. The quality assurance data analyzed do not include potentially relevant confounders, such as socioeconomic status or comorbidities.

Background For the treatment of colorectal cancer, the S3-Guideline of the German Guideline Program in Oncology supports clinical decision-making. Centers certified by the German Cancer Society are required to implement the guideline recommendations as comprehensively as possible. When guidelines provide insufficient or ambiguous evidence, heterogeneity of treatment preferences is likely to emerge across individual centers. The aim of this study is to describe the preferences of the centers’ tumor boards for treatment decisions when clear, evidence-based guideline recommendations are lacking. Methods To investigate the tumor boards’ preferences for different treatment options, an anonymous online survey was conducted among 314 certified colorectal cancer centers. The survey included seven visceral oncological and nine visceral surgical case vignettes. Centers were asked to discuss the vignettes in the tumor board or, alternatively, delegate them to an appropriate physician representatively speaking for the tumor board. The responses were analyzed descriptively and normalized entropy estimates (NE) were calculated for each vignette. Results A total of 123 centers (39%) responded to the survey. For oncological cases without clear guideline recommendations, substantial heterogeneity (NE: 0.39–0.71) in treatment preferences was observed. For instance, opinions varied widely for UICC II pT4a colon cancer. In this situation, 28% of centers would prefer fluoropyrimidine monotherapy, 39% oxaliplatin-based combination therapy and 33% no adjuvant chemotherapy at all. Surgical vignettes showed a preference for laparoscopic and robotic approaches, with variations based on tumor location (NE: 0.46–0.67). Importantly, in case of a clear evidence-based guideline recommendation, treatment preferences did not differ considerably between hospital sites. Conclusions In prototypical case vignettes without evidence-based guideline recommendations, pronounced heterogeneity of treatment preferences between centers was found. Reconstructing these treatment preferences can contribute to enhancing the quality of evidence derived from observational studies. This seems especially important in the context of clinical questions that cannot be assessed in randomized trials; clinical routine data represent an adequate resource for evidence generation in these scenarios. Trial registration After conducting this study, the main study was registered in the German Clinical Trials Register (DRKS) on October 4, 2024 under study No. DRKS00034650.

Purpose Social service counseling (SSC) is an important instrument to support cancer patients, for example, regarding legal support, or rehabilitation. Several countries have established on-site SSC in routine care. Previous analyses have shown that SSC utilization varies across cancer centers. This analysis investigates patient and center-level predictors that explain variations in SSC utilization between centers. Methods Logistic multilevel analysis was performed with data from 19,865 prostate cancer patients from 102 prostate cancer centers in Germany and Switzerland. Data was collected within an observational study between July 2016 and June 2020 using survey (online and paper) and tumor documentation. Results The intraclass correlation coefficient for the null model implies that 51% of variance in SSC utilization is attributable to the center a patient is treated in. Patients aged 80 years and older, with higher education, private insurance, without comorbidities, localized intermediate risk, and undergoing androgen deprivation therapy before study inclusion were less likely to utilize SSC. Undergoing primary radiotherapy, active surveillance, or watchful waiting as compared to prostatectomy was associated with a lower likelihood of SSC utilization. Significant negative predictors at the center level were university hospital, center’s location in Switzerland, and a short period of certification. Conclusion The results show that patient and center characteristics contribute to explaining the variance in SSC utilization in prostate cancer centers to a large extent. The findings may indicate different organizational processes in the countries included and barriers in the sectoral structure of the healthcare system. In-depth analyses of processes within cancer centers may provide further insights into the reasons for variance in SSC utilization.