Ziel der Studie Kliniken, die auf die Behandlung von Kolon- und Rektumkarzinomen spezialisiert sind und hohen Ansprüchen an die Struktur-, Prozess- und Ergebnisqualität genügen, können sich als Darmkrebszentren zertifizieren lassen. Es soll untersucht werden, ob eine Behandlung an Darmkrebszentren verglichen mit einer Therapie an nicht zertifizierten Krankenhäusern mit einem messbaren Überlebensvorteil einhergeht. Methoden Grundlage dieser retrospektiven Kohortenstudie sind die bevölkerungsbezogenen Daten des klinischen Krebsregisters am Tumorzentrum Regensburg, das die süddeutsche Region Oberpfalz mit ca. 1,1 Mio. Einwohnern vollständig abdeckt. 4302 Patienten, bei denen man zwischen 2004 und 2013 ein Karzinom des Dick- oder Enddarms in radikaler Intention entfernte, wurden in 4 Vergleichsgruppen eingeteilt, um Zentren mit Nicht-Zentren zu vergleichen und die Versorgungssituation vor und nach Einführung der Zertifizierung abzubilden. Zur Untersuchung des 3-Jahres-Gesamtüberlebens kommen neben dem üblichen Kaplan-Meier-Verfahren auch multivariable Cox-Regression und Modelle zur Berechnung des relativen Überlebens zum Einsatz. Eine Sensitivitätsanalyse für fehlende Daten wird ebenfalls durchgeführt. Ergebnisse Die geschätzte 3-Jahres-Überlebensrate von Zentrumspatienten und -patientinnen beträgt 71,6% verglichen mit 63,6% an nicht zertifizierten Krankenhäusern. Auch nach Adjustierung für wichtige Einflussvariablen ist die Behandlung an zertifizierten Darmkrebszentren mit einem signifikanten Überlebensvorteil verbunden (HR=0,808, KI: 0,665–0,982). Vergleicht man im zeitlichen Längsschnitt die Fälle heutiger Darmkrebszentren vor und nach Zertifizierung ergeben sich fast identische 3-Jahres Überlebensraten und auch in der Cox-Regression sind keine signifikanten Unterschiede festzustellen (HR=0,964, KI: 0,848–1,096). Schlussfolgerung Die Behandlung an zertifizierten Darmkrebszentren ist im Vergleich zur Therapie an anderen Krankenhäusern mit besseren Überlebensraten assoziiert. Dass es im Längsschnitt betrachtet keinen messbaren Überlebens-Unterschied zwischen Fällen einer Klinik vor und nach ihrer Zertifizierung gibt, könnte auf eine frühzeitige und erfolgreiche Implementierung der geforderten Qualitätsstandards hinweisen. Aim of the study Hospitals specializing in the treatment of colorectal carcinoma with high quality standards can apply for certification as colorectal cancer centers. The aim of this study was to clarify if there is a substantial difference between certified and non-certified hospitals in terms of long-term survival of patients. Methods This is a population-based retrospective cohort study using the data of a clinical cancer registry (Tumorzentrum Regensburg) which covers a southern German region of approximately 1.1 million inhabitants. 4302 patients with colorectal carcinoma who underwent radically surgery between 2004 and 2013 were divided into 4 groups for comparing certified and non-certified centers as well as the situation before and after certification. 3-year overall survival is displayed using Kaplan-Meier analysis, multivariate cox regression and relative survival models. Sensitivity analysis for missing data was conducted. Results The estimated 3-year survival rates of patients treated at certified compared to non-certified centers were 71.6% and 63.6%, respectively. Even after adjusting for possible confounders, treatment at certified centers was associated with significant survival benefits for patients (HR=0.808, CI: 0.665–0.982). Comparison of colorectal cancer centers before and after certification showed almost identical 3-year survival rates. Cox regression analysis also showed no substantial difference between the two (HR=0.964, CI: 0.848–1.096). Conclusion Patients with colorectal cancer treated in certified compared to non-certified centers show long-term survival benefits. Patients of certified colorectal cancer centers show long-term survival benefits compared to those treated at non-certified centers. Early and successful implementation of high quality standards could explain why survival rates before and after certification do not differ. ^* geteilte Erstautorenschaft

Background: Rectal cancer is frequent in Germany and worldwide. Several studies have assessed laparoscopic surgery as a treatment option and most have shown favorable results. However, long-term oncologic safety remains a controversial issue. Methods: The current dataset derives from 30 clinical cancer registries in Germany and includes 16,378 patients diagnosed with rectal cancer between 2007 and 2016. Outcomes were 90-day mortality, overall survival (OS), local recurrence-free survival (RFS) and relative survival of patients treated with either open or laparoscopic surgery. Multivariable logistic regression was used to evaluate factors that affected the probability of a patient undergoing laparoscopic surgery as well as to evaluate short-term mortality. OS and RFS were analyzed by Kaplan–Meier plots and multivariable Cox regression conducted separately for UICC stages I–III, tumor location, and sex as well as by propensity score matching followed by univariable and multivariable survival analysis. Results: Of 16,378 patients, 4540 (27.7%) underwent laparoscopic surgery, a trend which increased during the observation period. Patients undergoing laparoscopy attained better results for 90-day mortality (odds ratio, OR 0.658, 95% confidence interval, CI 0.526–0.822). The 5-year OS rate in the laparoscopic group was 82.6%, vs. 76.6% in the open surgery group, with a hazard ratio (HR) of 0.819 in multivariable Cox regression (95% CI 0.747–0.899, p < 0.001). The laparoscopic group showed a better 5-year RFS, with 81.8 vs. 74.3% and HR 0.770 (95% CI 0.705–0.842, p < 0.001). The 5-year relative survival rates were also in favor of laparoscopy, with 93.1 vs. 88.4% (p = 0.012). Conclusion: Laparoscopic surgery for rectal cancer can be performed safely and, according to this study, is associated with an oncological outcome superior to that of the open procedure. Therefore, in the absence of individual contraindications, it should be considered as a standard approach.

Zusammenfassung: Für die Nutzung vorhandener Versorgungsdaten gibt es immer mehr gute Gründe, wobei v. a. die Nutzung von Registerdaten im Fokus steht. Das zugehörige, klar strukturierte methodische Vorgehen ist bisher noch unzureichend zusammengeführt, aufbereitet und transparent dargestellt. Das Deutsche Netzwerk Versorgungsforschung (DNVF) hat deswegen eine Ad hoc Kommission zur Nutzung versorgungsnaher Daten (RWE/RWD) ins Leben gerufen. Der vom IQWiG erstellte Rapid Report über die wissenschaftliche Ausarbeitung von Konzepten zur „Generierung versorgungsnaher Daten und deren Auswertung zum Zwecke der Nutzenbewertung von Arzneimitteln nach § 35a SGB V“ ist ein wesentlicher Schritt für die Nutzung von Registerdaten zur Evidenzgenerierung. Das vom DNVF 2020 veröffentlichte „Memorandum Register – Update 2019“ beschreibt Anforderungen und methodische Grundlagen von Registern. Best Practice Beispiele aus der Onkologie, die auf dem einheitlichen onkologischen Basisdatensatz für die Klinische Krebsregistrierung (§ 65c SGB V) beruhen, zeigen z. B., dass im Sinne einer wissensgenerierenden Versorgungsforschung mithilfe von Registerdaten Leitlinien überprüft sowie Empfehlungen für Leitlinien und notwendige Interventionen abgeleitet werden können. Gleichzeitig fehlen jedoch klare Qualitätsanforderungen und strukturierte formale und inhaltliche Vorgehensweisen in den Bereichen Datenzusammenführung, Datenprüfung und Nutzung spezifischer Methoden je nach vorhandener Fragestellung. Die bisher uneinheitlichen Vorgaben sollen aufgearbeitet und ein Methoden-Leitfaden zur Nutzung versorgungsnaher Daten entwickelt und veröffentlicht werden. Das erste Kapitel des Manuals zu Methoden versorgungsnaher Daten erläutert Zielstellung und Struktur des Manuals. Es wird dargelegt, warum die Verwendung des Begriffes „Versorgungsnahe Daten (VeDa)“ zielführender ist als die Nutzung der Begriffe Real Word Data (RWD) und Real World Evidence (RWE). Mit der Vermeidung des Begriffes „Real World“ soll insbesondere unterstrichen werden, dass auch qualitativ hochwertige Forschung auf Versorgungsdaten aufsetzen kann (z. B. registerbasierte vergleichende Studien).

The implementation of quality of life (QoL) concepts in routine care, is still an open matter. We followed the Medical Research Council framework for complex interventions to implement a model of QoL diagnosis and therapeutic options, and investigated its effectiveness in patients with colorectal cancer. This randomised, single-blind, multicentre, clinical trial enrolled patients diagnosed with primary colorectal cancer aged 18 years or older who were surgically treated in one of four recruiting hospitals in Germany. All patients received aftercare from one of 178 coordinating practitioners (CPs) who had access to 75 healthcare professionals providing tailored therapies. QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery (baseline) and during aftercare (3, 6, 12, 18 months). Patients were randomised (1:1) into two groups: a care pathway, including QoL-profiles consisting of 13 QoL scales plus specific therapeutic recommendations forwarded to the patient's CP or standard postoperative care adhering to the German national guideline for colorectal cancer (control). The primary endpoint was the proportion of patients in each group with a need for QoL therapy 12 months after surgery. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02321813 and closed to accrual. Between Jan 13, 2014, and Oct 28, 2015, 220 patients were enrolled and randomly assigned (n = 110 per group). At baseline (in hospital after surgery), a need for QoL therapy was diagnosed in 92/103 (89%) of intervention and 86/104 (83%) of control group patients. At 12 months (primary endpoint) the proportion of patients with a need for QoL therapy was 35/83 (42%; 95% CI 31-54%) in the intervention group versus 50/87 (57%; 95% CI: 46-68%) in the control group (p = 0·046, number needed to treat = 7; 95% CI 3-225). Patients profited from the diagnosis of QoL deficits and tailored therapeutic options in their treatment of colorectal cancer. This trial confirmed the results of a previous RCT in breast cancer patients. The implementation of QoL concepts should become standard in treatment guidelines on cancer care. Federal Ministry of Education and Research (BMBF; grant no. 01GY1339). NCT02321813.

The recollections of survivors of breast cancer are an important source of information about the disease for their family, friends, and newly diagnosed patients. So far, little is known about these memories. This study investigated how accurately survivors of breast cancer remember their past quality of life (QoL) during the disease and if this memory is modified by women`s present QoL and negative affect. The longitudinal population-based study included 133 survivors of breast cancer (response rate 80%). Participants were asked for their present QoL and to recall their baseline QoL (EORTC QLQ-C30, QLQ-BR23) that had been assessed about seven years ago before discharge from hospital. The dependent variable was recall bias in ten QoL dimensions. Present QoL and negative affect (PANAS) were investigated as predictor variables. Overall, baseline QoL was retrospectively underrated on seven out of ten scales whereas no significant overestimation was found. In multiple linear regression analyses, controlling for confounders, a stronger underrating of QoL was significantly predicted by a lower present QoL on nine out of ten scales and by higher negative affect on six scales. Survivors of breast cancer tend to underestimate their past QoL during the disease when asked about seven years later. Lower present QoL and higher negative affect contribute to this recall bias. This needs to be considered when interpreting retrospectively reported QoL data. Results are discussed in relation to theory of change or stability and mood congruency theory.

Purpose: The German guideline for breast cancer recommends using chemotherapy (CHT) in patients with hormone receptor-positive and node-positive, invasive breast cancer. The aim of this study was to analyse the effects of CHT in this patient group on overall survival (OS) and distant metastases-free survival (DMFS), especially considering the 70-year threshold. Methods: 1772 patients from the clinical cancer registry Regensburg (Germany) with hormone receptor-positive and node-positive, invasive breast cancer diagnosed between 2003 and 2013 were analysed in a retrospective cohort study. OS and DMFS were evaluated by means of Kaplan–Meier and multivariable Cox-regression method. Results were further examined according to age at diagnosis. Results: The comparison of 1544 patients with CHT to 228 patients without CHT showed a significant benefit for CHT regarding 5-year OS (91.3% vs. 76.8%) and 5-year DMFS (86.7% vs. 74.4%, both p < 0.001). Likewise, better OS and DMFS were seen in patients aged < 70 years using CHT compared to patients without CHT of the same age. Patients aged ≥ 70 years with CHT had a minimal benefit regarding 5-year OS compared to patients without CHT, but no advantage considering DMFS. All results were confirmed in multivariable analyses except for patients being ≥ 70 years of age. Conclusion: Patients with hormone receptor-positive and node-positive, invasive breast cancer benefit from chemotherapy with regard to a significantly better overall and distant metastases-free survival, although chemotherapy use in patients aged ≥ 70 years results in a smaller benefit considering OS and no benefit considering DMFS.