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Neoadjuvant chemotherapy (NACT) is frequently used in patients with early breast cancer. Randomized controlled trials have demonstrated similar survival after NACT or adjuvant chemotherapy (ACT). However, certain subtypes may benefit more when NACT contains regimes leading to high rates of pathologic complete response (pCR) rates. In this study we analyzed data using the OncoBox research from 94,638 patients treated in 55 breast cancer centers to describe the current clinical practice of and outcomes after NACT under routine conditions. These data were compared to patients treated with ACT. 40% of all patients received chemotherapy. The use of NACT increased over time from 5% in 2007 up to 17.3% in 2016. The proportion of patients receiving NACT varied by subtype. It was low in patients with HR-positive/HER2-negative breast cancer (5.8%). However, 31.8% of patients with triple-negative, 31.9% with HR-negative/HER2-positive, and 26.5% with HR-positive/HER2-positive breast cancer received NACT. The rates of pCR were higher in patients with HR-positive/HER2-positive, HR-negative/HER2-positive and triple-negative tumors (36, 53 and 38%) compared to HR-positive/HER2-negative tumors (12%). PCR was achieved more often in HER2-positive and triple-negative tumors over time. This is the largest study on use and effects of NACT in German breast cancer centers. It demonstrates the increased use of NACT based on recommendations in current clinical guidelines. An improvement of pCR was shown in particular in HER2-positive and triple-negative breast cancer, which is consistent with data from randomized controlled trails. [ABSTRACT FROM AUTHOR]

Purpose: Cervical cancer is the fourth most common cancer in women worldwide. A successful screening concept for cervical cancer reduces the incidence and mortality of cervical cancer. Quality indicators (QIs) derived from the screening guidelines for cervical cancer and used by the certified dysplasia units and dysplasia consultancies are evaluated in this paper. The aim of this paper is to present the current data from the annual reports of these units and consultancies., Methods: The results of the basic data and indicators for the audit year 2022 in the gynaecological dysplasia consultancies and units are presented. In 2022, 84 dysplasia consultancies and 42 units were audited. 40 units and 84 consultancies are included in the annual report. QI outcomes for patients treated in certified dysplasia units and dysplasia consultancies are analysed. Median, overall proportion, and standard deviation were calculated for each QI., Results: The indicator year 2021 was analysed, which was audited in 2022 and evaluated in 2023. A total of nine QIs were analysed. Most target goals were met by the 84 certified dysplasia consultancies and by the 40 dysplasia units. The QIs evaluated are implemented to a very high degree. The targets for the three QIs were achieved by both the dysplasia consultancies and the units in at least 95% of the certified centres (QI 1: 100%, QI 2: 95%, QI 3: 100%; QI 1: 100%, QI 2: 97%, QI 3: 100%, respectively). The presentation of patients to the tumour board by the consultancies/units is working; the units are attending the tumour board more regularly than in previous years. Where the target was not met, the auditors issued deviations or reduced the duration of the certificate. The cases are discussed intensively in the sense of an individual case analysis and with the determination of measures on-site., Conclusions: The targets for the various indicators were largely met by the dysplasia consultancies and units in the 2022 audit year. The certification of gynaecological dysplasia consultancies/units which have to cooperate with certified gynaecological cancer centres, has for the first time ensured the continuity of healthcare from prevention and early diagnosis to treatment of gynaecological cancers., (© 2024. The Author(s).)

Purpose: In 2018, the first guideline-based quality indicators (QI) for vulvar cancer were implemented in the data-sheets of certified gynaecological cancer centres. The certification process includes guideline-based QIs as a fundamental component. These indicators are specifically designed to evaluate the level of care provided within the centres. This article aims to give an overview of the developing process of guideline based-QIs for women with vulvar cancer and presents the QIs results from the certified gynaecological cancer centres., Methods: The QIs were derived in a standardized multiple step process during the update of the 2015 S2k guideline "Diagnosis, Therapy, and Follow-Up Care of Vulvar Cancer and its Precursors" (registry-number: no. 015/059) and are based on strong recommendations., Results: In total, there are eight guideline-based QIs for vulvar cancer. Four QIs are part of the certification process. In the treatment year 2021, 2.466 cases of vulvar cancer were treated in 177 centres. The target values in the centres for pathology reports on tumour resection and lymphadenectomy as well as sentinel lymph nodes have increased since the beginning of the certification process and have been above 90% over the past three treatment years (2019-2021)., Discussion: QIs based on strong guideline recommendations, play a crucial role in measuring and allowing to quantify essential aspects of patient care. By utilizing QIs, centres are able to identify areas for process optimization and draw informed conclusions. Over the years the quality of treatment of vulvar cancer patients measured by the QIs was improved. The certification system is continuously reviewed to enhance patient care even further by using the outcomes from QIs revaluation., (© 2024. The Author(s).)

Background: In 2022, an update of the German lung cancer guideline, first published in 2010 and revised in 2018, was released. This article aims to show the process of updating, developing, and implementing guideline-based quality indicators (QI) into the certification system for lung cancer centers (LCC)., Methods: A multidisciplinary and interprofessional working group revised the guideline QIs from 2018 using the strong recommendations of the guideline update, a systematic review for QIs, and the results of the implemented QIs from LCC., Results: For 4 out of 8 indicators from the 2018 guideline, the LCC showed an improved implementation of the requirements in the last 3 years (2018-2020). For 3 indicators, the median of the results was constant at a very high level (≥96% or 100%). Only the "adjuvant cisplatin-based chemotherapy" indicator showed declining values between 2018 and 2020. The target values and plausibility limits were well achieved by LCC. After updating the guideline, one QI from 2018 was not included in the new QI set due to the small denominator population. Based on the new strong recommendations, 8 new QIs were defined. From the QI set of the guideline update, 13 of 15 indicators (7 since 2018 and 6 from 2022 on) were adopted into the certification program., Conclusions: The guideline recommendations are implemented by LCC at a high level. The process presented confirms the successful implementation of the so-called quality cycle in oncology. The QIs developed by the German Guideline Program in Oncology (GGPO) are adopted by the certification program. The implementation of the QI is measured in LCC, evaluated by the German Cancer Society (DKG), and reflected back to the GGPO. The "real world" data have led to the deletion of one QI and show a high implementation of most QIs in LCC., Competing Interests: Martin Utzig, Thomas Langer, Jessica Lobitz, Johannes Rückher, and Simone Wesselmann are employees of the German Cancer Society (Deutsche Krebsgesellschaft e.V.). Hans Hoffmann is the representative of the German Society for Thoracic Surgery (DGT) in the Certification Commission for Lung Cancer Centers and a member of the Guideline Commission S3 Guideline Lung Cancer. Niels Reinmuth is the representative of the German Respiratory Society (DGP) in the Certification Commission for Lung Cancer Centers and a member of the Guideline Commission S3 Guideline Lung Cancer. Wolfgang Schütte is the Guideline Commission S3 Guideline Lung Cancer coordinator and represents it in the Certification Commission for Lung Cancer Centers., (Thieme. All rights reserved.)

In the context of the COVID-19 pandemic, there has been a scarcity of resources with various effects on the care of cancer patients. This paper provides an English summary of a German guideline on prioritization and resource allocation for colorectal and pancreatic cancer in the context of the pandemic. Based on a selective literature review as well as empirical and ethical analyses, the research team of the CancerCOVID Consortium drafted recommendations for prioritizing diagnostic and treatment measures for both entities. The final version of the guideline received consent from the executive boards of nine societies of the Association of Scientific Medical Societies in Germany (AWMF), 20 further professional organizations and 22 other experts from various disciplines as well as patient representatives. The guiding principle for the prioritization of decisions is the minimization of harm. Prioritization decisions to fulfill this overall goal should be guided by (1) the urgency relevant to avoid or reduce harm, (2) the likelihood of success of the diagnostic or therapeutic measure advised, and (3) the availability of alternative treatment options. In the event of a relevant risk of harm as a result of prioritization, these decisions should be made by means of a team approach. Gender, age, disability, ethnicity, origin, and other social characteristics, such as social or insurance status, as well as the vehemence of a patient's treatment request and SARS-CoV-2 vaccination status should not be used as prioritization criteria. The guideline provides concrete recommendations for (1) diagnostic procedures, (2) surgical procedures for cancer, and (3) systemic treatment and radiotherapy in patients with colorectal or pancreatic cancer within the context of the German healthcare system., (© 2024 S. Karger AG, Basel.)

Background: In addition to erectile dysfunction, urinary incontinence is the most common functional limitation after radical prostatectomy (RPE) for prostate cancer (PCa). The German S3 guideline recommends informing patients about possible effects of the therapy options, including incontinence. However, only little data on continence from routine care in German-speaking countries after RPE are currently available, which makes it difficult to inform patients., Objective: The aim of this work is to present data on the frequency and severity of urinary incontinence after RPE from routine care., Materials and Methods: Information from the PCO (Prostate Cancer Outcomes) study is used, which was collected between 2016 and 2022 in 125 German Cancer Society (DKG)-certified prostate cancer centers in 17,149 patients using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). Changes in the "incontinence" score before (T0) and 12 months after RPE (T1) and the proportion of patients who used pads, stratified by age and risk group, are reported., Results: The average score for urinary incontinence (value range: 0-worst possible to 100-best possible) was 93 points at T0 and 73 points 12 months later. At T0, 97% of the patients did not use a pad, compared to 56% at T1. 43% of the patients who did not use a pad before surgery used at least one pad a day 12 months later, while 13% use two or more. The proportion of patients using pads differs by age and risk classification., Conclusion: The results provide a comprehensive insight into functional outcome 12 months after RPE and can be taken into account when informing patients., (© 2023. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: 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., Methods: 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., Results: 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/., Conclusion: 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., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Breidenbach, Dieng, Kowalski, Sibert, Wesselmann are employees of the two institutions in charge of the certification system (Deutsche Krebsgesellschaft e.V. and OnkoZert GmbH). Darr reports support for attending meetings by Janssen and IPSEN outside the submitted work. Stolzenburg reports outside of the submitted work: speaker honoraria from Intuitive Surgical and Janssen, as well as payments for medical advice by Avatera medical and support for attending meeting by Janssen, stock options by Avatera medical and Intuitive surgical. Conrad reports outside the submitted work honoraria from Jannsen Cilag GmbH and medac GmbH as lecturer as well as from Photocure GmbH for manuscript writing. Harke reports outside the submitted work honoraria by Intuitive Surgical and Pajunk. Lümmen reports outside the submitted work payments from Janssen. Kaftan reports outside the submitted work honoraria from uromed for participation in educationals and support for attending the annual meeting of the Deutsche Kontinenz Gesellschaft. All other authors have nothing to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Sibert et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Purpose: In 2008, the first gynecological cancer centres were certified by the German Cancer Society (DKG). Guideline-based quality Indicators (QIs) are a core element of the certification process. These QI are defined to assess the quality of care within the centres and can serve to measure the implementation of guideline recommendation. This article aims to give an overview of the developing and updating process of guideline based-QIs for women with cervical cancer and presents the QI results from the certified gynaecological cancer centres., Methods: The QIs are derived in a multiple step review process and then implemented in the certification data sheet of the certified centres. The first set of QIs created in 2014 was revised in the update process of the S3-Guideline in 2020. QIs are based on strong recommendations of the evidence-based "Guideline for patients with Cervical Carcinoma" (registry-number: 032/033OL)., Results: In total, there are nine guideline-based QIs for cervical cancer. Four QIs are part of the certification process. In the treatment year 2020, 3.522 cases of cervical cancer were treated in 169 centers. The target values for the four QIs were met in at least 95% of the certified centers. In the guideline update in 2020, a new QI was added to the set of QIs "Complete pathological report on conization findings" and the QI "Exenteration" was removed., Conclusions: QIs derived from strong recommendations of a guideline are an important tool to make essential parts of patient's care measurable and enable the centers to draw consequences in process optimization. Over the years, the number of certified centers has grown, and the quality was improved. The certification systems is under constant revision to further improve patient's care in the future, based on the results of the QI re-evaluation., (© 2023. The Author(s).)

Analyses of health and health care (hereafter referred to as "health care analyses") usually aim to make transparent the structures, processes, results and interrelationships of health care and to record the degree to which health care systems and their actors have achieved their goals. Health care-related data are an indispensable source of data for many health care analyses. A prerequisite for the examination of a degree of goal achievement is first of all an agreement on those goals that are to be achieved by the system and its substructures, as well as the identification of the determinants of the achievement of the objectives. Primarily it must be examined how safely, effectively and patient-centred systems, facilities and service providers are operating. It also addresses issues of need, accessibility, utilisation, timeliness, appropriateness, patient safety, coordination, continuity, and health economic efficiency and equity of health care. The results of health care include system services (outputs), on the one hand, and results (outcomes), on the other, whereby the results (patient-reported outcomes) and experiences (patient-reported experiences) reported are of particular importance. Health care analyses answer basic questions of health care research: who does what, when, how, why and with which resources and effects in routine health care. Health care analyses thus provide the necessary findings and key figures to further develop health care in order to improve the quality of health care. The applications range from capacity analyses to following innovations up to the concept of regional and supra-regional monitoring of the quality of care given to the population. Given the progress of digitalisation in Health Care, direct data from the care processes will be increasingly available for health care research. This can support care givers significantly if the findings of the studies are applied precisely and correctly within an adequate methodological frame. This can lead to measurable improved health care quality for patients. Data from the process of health care provision have a high potential. Their use needs the same scientific scrutiny as in all other scientific studies., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

How can we improve the interoperability of medical guidelines and the implementation and measurement of outcomes in medical health care for cancer patients as well as for care providers? This is the aim of the working group "Quality and Cross-linking". The following publication gives an overview of the targets reached in the development of guidelines together with quality indicators and documentation in cancer registries., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Purpose: Based on the example of Gynaecological Cancer Centres (GCCs) certified by the German Cancer Society, this study evaluates the results of medical-guideline-derived quality indicators (QIs) for cervical cancer (CC) and ovarian cancer (OC), examines the development of indicator implementation over time as well as the status of guideline-compliant care and identifies improvement measures., Methods: QI results for patients with CC and OC treated in GCCs between 2015 and 2019 are analysed. The median, overall proportion and standard deviation of each QI were calculated. Two-sided Cochran-Armitage tests were applied., Results: QIs are divided into two categories: process-organization (PO-QIs) and treatment-procedures (TP-QIs), to allow a differentiated analysis for identifying improvement measures. PO-QIs that reflect the implementation of processes and structures show a high degree of application. PO-QIs have a tremendous influence on the quality of care and are easy to implement through SOPs. TP-QIs report on treatments that are performed in the GCC. TP-QIs that report on systemic therapies reach a plateau where the guideline is known, but patient-related-factors meaningfully prevent further increase. TP-QIs that report on surgical interventions fluctuate. The most relevant factors are practitioners' personal skills. Besides the discussion of results amongst peers during the audit, improvement measures could include surgical courses or coaching., Conclusion: The analysis shows that a combination of different measures is necessary to anchor quality sustainably in health care and thus improve it., (© 2022. The Author(s).)

Introduction: Soft tissue sarcomas (STSs) are rare diseases. A high level of standardization and centralization was lacking in Germany until 2018., Methods: By developing an evidence-based guideline and a certification system for sarcoma centres, foundations for structured, guideline-based, and centralized sarcoma care were defined. First results of the certified sarcoma centres are presented., Results: The first 3 years of data collection show good results for case volume, presentation rates in pretherapeutic and postoperative tumour boards, psycho-oncological counselling, and study rates. However, other indicators (e.g., preoperative or postoperative radiotherapy for operated high-risk STS without GIST, counselling rates social services) still have potential for improvement. Based on these results, the set of indicators could be further improved., Conclusions: A sarcoma-specific quality assurance scheme that includes guideline-derived quality indicators was developed. In future, a broader database will allow further insights into sarcoma care in Germany., (© 2023 S. Karger AG, Basel.)

Background: In this observational study, patient-reported outcomes and short-term clinical outcome parameters in patients with colorectal cancer were studied 12 months after the start of treatment. Outcomes were also compared across German Certified Colorectal Cancer Centres., Methods: Data were collected from 4239 patients with colorectal cancer who had undergone elective tumor resection in one of 102 colorectal cancer centers and had responded to a quality-of-life questionnaire before treatment (EORTC QLQ-C30 and -CR29). 3142 (74.1%) of these patients completed a post-treatment questionnaire 12 months later. Correlation analyses were calculated and case-mix adjusted comparisons across centers were made for selected patient-reported outcomes, anastomotic insufficiency, and 30-day-mortality., Results: At 12 months, mild improvements were seen in mean quality-of-life scores (66 vs. 62 points), constipation (16 vs. 19), and abdominal pain (15 vs. 17). Worsening was seen in physical function (75 vs. 82) and pain (22 vs. 19). Better patient-reported outcomes at 12 months were associated with better scores before treatment. Better results in at least three of the five scores were associated with male sex, higher educational level, higher age, and private health insurance. Major worsening of fecal incontinence was seen among patients with rectal cancer without a stoma. The largest differences across centers were found with respect to physical function. Anastomotic insufficiency was found in 4.3% of colon cancer patients and 8.2% of rectal cancer patients. 1.9% of patients died within 30 days after their resection., Conclusion: Clinicians can use these findings to identify patients at higher risk for poorer patient-reported outcomes. The differences among cancer centers that were found imply that measures for quality improvement would be desirable.

Purpose: Provision of psychosocial care is obligatory in cancer centers certified in accordance with the criteria of the German Cancer Society, but the extent to which it is utilized differs greatly between centers. Anomalous utilization percentages are discussed during certification audits. This analysis aims to describe (1) how certified centers explain psychosocial care utilization percentages during audits and (2) the measures they then plan for improving psychosocial care utilization. The aim of the analysis is to help understand patterns of psychosocial care utilization in oncology and reduce potential disparities by describing the challenges that cancer centers face and their strategies for integrating psychosocial care into routine oncological care., Methods: The content of free-text comments regarding psychosocial utilization percentages by certified centers during certification audits in 2019 was analyzed. In total, 178 comments were analyzed from 116 prostate, colorectal, and breast cancer centers in Germany, Switzerland, Austria, Italy, and Luxembourg., Results: The explanations for utilization percentages most often mentioned involved patients' levels of interest and need, outpatient care, staff shortages, inclusion of psychosocial care in other processes in the center, documentation issues, and factors regarding different legal regulations in countries outside Germany. The measures most often planned for improving psychosocial care utilization involved adjusting work processes, increasing staff resources, optimizing documentation, and establishing quality-assurance groups/task forces., Conclusion: This exploratory analysis shows that the challenges and strategies involved in incorporating psychosocial care into routine oncological care are diverse. Further research should identify process-level strategies that can promote the integration of psychosocial care., (© 2022 John Wiley & Sons Ltd.)

Purpose: The 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 Methods: Analysis 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., Results: Adjusted 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., Conclusions: Variation 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., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Competing Interests: Die Übersicht über die Interessenkonflikte der Autorinnen und Autoren sind im Anhang veröffentlicht.

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., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Since 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 Methods: Multi-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., Results: Tumor 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, R 2 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)., Conclusion: In 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., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Aim This update of the interdisciplinary S3 guideline on the Diagnosis, Therapy and Follow-up of Cervical Cancer (AWMF Registry No. 032/033OL) was published in March 2021. This updated guideline was funded by German Cancer Aid (Deutsche Krebshilfe) as part of the German Guideline Program in Oncology. The guideline was coordinated by the German Society of Gynecology and Obstetrics ( Deutsche Gesellschaft für Gynäkologie und Geburtshilfe , DGGG) and the Working Group on Gynecological Oncology ( Arbeitsgemeinschaft Gynäkologische Onkologie , AGO) of the German Cancer Society ( Deutsche Krebsgesellschaft , DKG). Method The process of updating the S3 guideline dating from 2014 was based on an appraisal of the available evidence using the criteria of evidence-based medicine, adaptations of existing evidence-based national and international guidelines or - if evidence was lacking - on a consensus of the specialists involved in compiling the update. After an initial review of the current literature was carried out according to a prescribed algorithm, several areas were identified which, in contrast to the predecessor version from September 2014, required new recommendations or statements which took account of more recently published literature and the appraisal of the new evidence. Recommendations The short version of this guideline consists of recommendations and statements on the epidemiology, screening, diagnostic workup and therapy of patients with cervical cancer. The most important new aspects included in this updated guideline include the newly published FIGO classification of 2018, the radical open surgery approach for cervical cancers up to FIGO stage IB1, and use of the sentinel lymph node technique for tumors ≤ 2 cm. Other changes include the use of PET-CT, new options in radiotherapy (e.g., intensity-modulated radiotherapy, image-guided adaptive brachytherapy), and drug therapies to treat recurrence or metastasis., Competing Interests: Conflict of Interest/Interessenkonflikt The conflicts of interest of all the authors are listed in the long German-language version of the guideline report./Die Interessenkonflikte der Autoren sind im Leitlinienreport aufgelistet., (Thieme. All rights reserved.)

Aim This is an update of the interdisciplinary S3-guideline on the Diagnosis, Therapy and Follow-up of Cervical Cancer (AWMF Registry No. 032/033OL), published in March 2021. The work on the updated guideline was funded by German Cancer Aid (Deutsche Krebshilfe) as part of the German Guideline Program in Oncology. The guideline was coordinated by the German Society of Gynecology and Obstetrics ( Deutsche Gesellschaft für Gynäkologie und Geburtshilfe , DGGG) and the Working Group on Gynecological Oncology ( Arbeitsgemeinschaft Gynäkologische Onkologie , AGO) of the German Cancer Society ( Deutsche Krebsgesellschaft , DKG). Method The process used to update the 2014 S3-guideline was based on an appraisal of the available evidence using the criteria of evidence-based medicine, adaptations of existing evidence-based national and international guidelines or - if evidence was lacking - on the consensus of the specialists involved in compiling the update. After an initial review of the current literature was carried out according to a prescribed algorithm, several areas were identified which, in contrast to the predecessor version from September 2014, required new recommendations or statements which would take account of more recently published literature and the recent appraisal of new evidence. Recommendations The short version of this guideline consists of recommendations and statements on palliative therapy and follow-up of patients with cervical cancer. The most important aspects included in this updated guideline are the new FIGO classification published in 2018, the radical open surgery approach used to treat cervical cancer up to FIGO stage IB1, and the use of the sentinel lymph node technique for tumors ≤ 2 cm. Other changes include the use of PET-CT, new options in radiotherapy (e.g., intensity-modulated radiotherapy, image-guided adaptive brachytherapy), and drug therapies to treat recurrence or metastasis., Competing Interests: Conflict of Interest/Interessenkonflikt The conflicts of interest of all the authors are listed in the long German-language version of the guideline report./Die Interessenkonflikte der Autoren sind im Leitlinienreport aufgelistet., (Thieme. All rights reserved.)

Introduction: As part of the development of the evidence-based (S3) clinical practice guidelines for kidney and bladder cancer by the German Guideline Program in Oncology, quality indicators (QIs) were defined to measure the quality of care. Based on these guidelines and QIs, the German Cancer Society (DKG) developed two new certification systems. The aim of this article is to show the process of development and implementation of QIs in certified cancer centres., Methods: Based on strong recommendations of each guideline and an additional systematic literature review for national and international QIs, two sets of QIs were derived in a multistep standardized approach. These QIs were implemented in the centres in certification data sheets to measure their outcomes. First results of treatment years 2018 and 2019 are available., Results: The final sets include 9 QIs for kidney cancer and 12 QIs for bladder cancer. Two-thirds of the QIs were transferred to the data sheets. In 2018 and 2019, the results of all but one QI are within the plausibility limits. From 2020 on, they are replaced by stricter target values that will challenge centres to improve their outcomes., Conclusions: Guideline-derived QIs make relevant aspects of patient care measurable and consequently improvable. The first QI results are encouraging. However, the DKG certification system and the methods of measuring quality are under ongoing development. Systematic QI implementation and evaluation may help to generate broader databases and thus expand knowledge., (© 2021 S. Karger AG, Basel.)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Aim of the Study: Ethics committees (ECs) have an indispensable monitoring and regulatory function in research on human beings. In multicenter observational studies, approvals of several local ECs are often required. The aim of this analysis was to provide an overview of the resources used and the process for consulting ECs about a multicenter observational study in Germany., Methods: For this purpose, a cross-sectional analysis was carried out. Resources and activities within the consultation process were documented by the central study management for the period April 2018-April 2019. The study for which the consultation was obtained involved 106 certified colorectal cancer centers in 15 federal states in Germany., Results: We submitted applications to ECs in 14 medical associations and 7 university hospitals. In total, 6,305 euros consultation fees were charged by the ECs, with the fees varying between 50 and 1,400 euros. For the application documents, at least 2,986 sheets of DIN A4 paper were printed and sent by post to the EC. Partly, several copies of the application documents were required. The central study management spent about 210 working hours. The median of the processing time was 32 days (range: 5-177 days)., Conclusion: In order to significantly reduce the financial, material and personnel costs for scientists and ECs, a standardized and nationwide procedure for consulting ECs about multicenter studies should be pursued in the future. In the interests of economic and ecological sustainability, online procedures should be considered., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Patient-reported outcomes (PROs) are increasingly being used to compare the quality of outcomes between different healthcare providers (medical practices, hospitals, rehabilitation facilities). However, such comparisons can only be fair if differences in the case-mix between different types of provider are taken into account. This can be achieved with adequate statistical case-mix adjustment (CMA). To date, there is a lack of overview studies on current CMA methods for PROs. The aim of this study was to investigate which approaches are currently used to report and examine PROs for case-mix-adjusted comparison between providers. A systematic MEDLINE literature search was conducted (February 2021). The results were examined by two reviewers. Articles were included if they compared (a) different healthcare providers using (b) case-mix-adjusted (c) patient-reported outcomes (all AND conditions). From 640 hits obtained, 11 articles were included in the analysis. A wide variety of patient characteristics were used as adjustors, and baseline PRO scores and basic sociodemographic and clinical information were included in all models. Overall, the adjustment models used vary considerably. This evaluation is an initial attempt to systematically investigate different CMA approaches for PROs. As a standardized approach has not yet been established, we suggest creating a consensus-based methodological guideline for case-mix adjustment of PROs.

Background: In recent years, germline testing of women with a risk of developing breast and ovarian cancer has increased rapidly. This is due to lower costs for new high-throughput sequencing technologies and the manifold preventive and therapeutic options for germline mutation carriers. The growing demand for genetic counseling meets a shortfall of counselors and illustrates the need to involve the treating clinicians in the genetic testing process. This survey was undertaken to assess their state of knowledge and training needs in the field of genetic counseling and testing., Methods: A cross-sectional survey within the European Bridges Study (Breast Cancer Risk after Diagnostic Gene Sequencing) was conducted among physician members ( n = 111) of the German Cancer Society who were primarily gynecologists. It was designed to examine their experience in genetic counseling and testing., Results: Overall, the study revealed a need for training in risk communication and clinical recommendations for persons at risk. One-third of respondents communicated only relative disease risks (31.5%) instead of absolute disease risks in manageable time spans. Moreover, almost one-third of the respondents (31.2%) communicated bilateral and contralateral risk-reducing mastectomy as an option for healthy women and unilateral-diseased breast cancer patients without mutations in high-risk genes (e.g. BRCA1 or BRCA2) . Most respondents expressed training needs in the field of risk assessment models, the clinical interpretation of genetic test results, and the decision-making process., Conclusion: The survey demonstrates a gap of genetic and risk literacy in a relevant proportion of physicians and the need for appropriate training concepts., Competing Interests: The authors declare there are no conflicts of interest., (Copyright © 2020 by S. Karger AG, Basel.)

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.

Background: There has been increasing interest in integrating patient-reported outcomes (PROs) into routine oncological practice. To date, however, PROs have rarely been implemented in Germany. Currently, PROs are being used as performance measures in colorectal cancer centers in Germany. This content analysis identified factors that may inhibit or facilitate the additional use of PROMs for individual patient management., Methods: The analysis follows an exploratory approach. Out of 103 centers that participated in a multicentric PRO quality management and benchmarking program in Germany, twelve oncological health-care providers from eight certified colorectal cancer centers were interviewed using a semi-structured interview guide. The interviewees were clinicians (physicians, nurses, psycho-oncologist and physician assistant) who care for colorectal cancer patients. This analysis evaluated whether and how PROs that are primarily collected for quality management/benchmarking reasons could also be used for the management of individual patients. The data was analyzed using a content-analysis approach., Results: The interviewees were not using PRO in their routine clinical work, but they recognized its added value and pointed out potential example uses. Identified inhibiting factors for the use of PROs in clinical routine work were effortful access to PRO reports, lacking coordinating structures, time delays and time points of measurements as well as redundancy with other instruments. Facilitating factors for the use of PROs in clinical routine work that were identified included access via electronic patient records, implementation of coordinating structures for PRO processes in the center, clear PRO reports that are easy to interpret, and measurements at relevant time points., Discussion: Clinicians had quite a positive attitude toward PROs and recognized their added value. Inhibiting and facilitating factors of an organizational and technical nature were identified., Conclusions: These findings indicate how PROs used for quality management purposes may also be used for the management of individual patients. Therefore, existing structures and processes in the certified colorectal cancer centers, as well as lessons learned from the literature on the implementation of PROs monitoring individual patients need to be taken into account.

Introduction: Patient-reported outcomes (PROs) can be used in cancer care to monitor patients' disease-related symptoms and functional status. However, successful implementation of such instruments is only possible if clinical staff are convinced of the clinical benefits. It is therefore crucial to investigate the attitudes of clinical staff to PROs in routine cancer care., Methods: Semi-structured, guideline-based interviews were held with 12 clinicians working in certified colorectal cancer centers in Germany who are taking part in an observational study on PROs (five surgeons, two oncologists, one psycho-oncologist, two oncological care nurses, one stoma therapist, and one physician assistant) in order to investigate firstly, how clinicians describe PRO instruments ("wording"); and secondly, the clinicians' general attitude toward PROs. A qualitative content analysis according to Kuckartz was performed., Results: The wording used to describe PROs was not consistent. Statements on attitudes toward PROs were very heterogeneous and were therefore categorized into "(rather) positive" and "(rather) negative." The principal advantages of PROs mentioned by participants included broader, structured knowledge about patients and treatment, as well as relevance for patients. Subcategories for (rather) negative attitudes included statements expressing doubts about the questionnaires and "no need for PROs.", Discussion: The clinicians participating mainly expressed fairly positive attitudes toward PROs. However, they had little knowledge about PROs in general and the interviews therefore mainly reflect their expectations and assumptions about them. These initial impressions may be regarded as providing a basis for future implementation strategies and for training of clinicians on how to use PROs in routine cancer care.

Since 2016, certified prostate cancer centres have been able to participate in the Prostate Cancer Outcomes (PCO) study. The aim of this study is to compare outcomes across centres after local treatment for prostate cancer. The study originated from a support group initiative and is jointly carried out by the German Cancer Society (Deutsche Krebsgesellschaft), the certification institute OnkoZert, patient support groups and the participating centres. So far, centres have been more successful at recruiting patients undergoing surgery than those receiving radiotherapy as the definitive treatment. This means that conclusions for the latter group of patients are almost impossible. It is important to us that all types of treatment are equally well represented in the study; thus, we encourage radiation therapists to participate in the PCO study.