Prioritization and resource allocation in the context of the COVID-19 pandemic. Recommendations for colorectal and pancreatic cancer in Germany.

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.

Technical assessment in minimally invasive complete mesocolic excision: Is the complete mesocolic excision competency assessment tool valid and reliable?

AIM: The complete mesocolic excision competency assessment tool (CMECAT) is a novel tool designed to assess technical skills in minimally invasive complete mesocolic excision (CME) surgery. The aim of this study was to assess construct validity and reliability of CMECAT in a clinical context. METHOD: Colorectal surgeons were asked to submit video recorded laparoscopic CME resections for independent assessment of their technical abilities. The videos were grouped by surgeons' training level, and four established CME experts were recruited as CMECAT assessors. Extended reliability analysis (G-theory) was applied to describe assessor agreement. RESULTS: A total of 19 videos and 72 assessments were included in the analysis. Overall, technical skills assessed by CMECAT improved with increased training level: the experts scored significantly better than the untrained surgeons (3.3 vs. 2.5 points; p < 0.01). On right-sided resections, significantly higher scores were reported with increased training level for all categories and sections, while for left-sided resections, the variance across groups was smaller and significantly higher scores were only reported for oncological safety describing items. Overall, assessor agreement was high (G-coefficient: 0.81). CONCLUSION: This study confirms that CMECAT can be applied to video recorded CME cases for technical skill assessment. Further, it can reliably assess technical performance in right sided CME surgery, where construct validity has now been established. More videos are required to evaluate its validity on left colonic CME. In the future, we hope CMECAT can improve feedback during CME training, serve as a tool in certification processes and contribute to distinguishing CME from conventional surgery in future research.

Treatment of Colorectal Cancer in Certified Centers: Results of a Large German Registry Study Focusing on Long-Term Survival.

(1) Background: The WiZen study is the largest study so far to analyze the effect of the certification of designated cancer centers on survival in Germany. This certification program is provided by the German Cancer Society (GCS) and represents one of the largest oncologic certification programs worldwide. Currently, about 50% of colorectal cancer patients in Germany are treated in certified centers. (2) Methods: All analyses are based on population-based clinical cancer registry data of 47.440 colorectal cancer (ICD-10-GM C18/C20) patients treated between 2009 and 2017. The primary outcome was 5-year overall survival (OAS) after treatment at certified cancer centers compared to treatment at other hospitals; the secondary endpoint was recurrence-free survival. Statistical methods included Kaplan-Meier analysis and multivariable Cox regression. (3) Results: Treatment at certified hospitals was associated with significant advantages concerning 5-year overall survival (HR 0.92, 95% CI 0.89, 0.96, adjusted for a broad range of confounders) for colon cancer patients. Concentrating on UICC stage I-III patients, for whom curative treatment is possible, the survival benefit was even larger (colon cancer: HR 0.89, 95% CI 0.84, 0.94; rectum cancer: HR 0.91, 95% CI 0.84, 0.97). (4) Conclusions: These results encourage future efforts for further implementation of the certification program. Patients with colorectal cancer should preferably be directed to certified centers.

A contemporary assessment of total neoadjuvant therapy (TNT) protocols for locally advanced rectal cancer: adoption and expert perspectives at German Cancer Society (DKG)-certified colorectal cancer centers.

PURPOSE: The treatment paradigm for locally advanced rectal cancer (LARC) is shifting toward the total neoadjuvant therapy (TNT) concept, which administered systemic chemotherapy in the neoadjuvant setting, either before or after chemoradiotherapy (CRT) or short-course radiotherapy (SCRT). First results have shown higher pathologic complete response (pCR) rates and a favorable impact on disease-free survival (DFS). Our study aimed to evaluate the current clinical practice and expert opinion regarding TNT for locally advanced rectal cancer across DKG (German Cancer Society)-certified colorectal cancer centers. METHODS: A comprehensive online questionnaire, constituted of 14 TNT-focused queries targeting patients with locally advanced rectal cancer, was conducted among DKG-certified colorectal cancer centers registered within the database of the Addz (Arbeitsgemeinschaft Deutscher Darmzentren) between December 2022 and January 2023. RESULTS: A significant majority (68%) indicated that they treated between 0 and 10 patients using a TNT protocol. Only a third (36%) of these centers participated in patient enrollment for a TNT study. Despite this, 84% of centers reported treating patients in a manner analogous to a TNT study, with the RAPIDO regimen being the most prevalent approach, employed by 60% of the respondents. The decision to adopt a TNT approach was primarily influenced by factors, such as the lower third of the rectum (93% of centers), cT4 stage (86% of centers), and a positive circumferential resection margin (80% of centers). Regarding concerns, 65% of the survey respondents expressed no reservations about the TNT concept, while 35% had concerns. In particular, there appears to be disagreement and uncertainty in regard to a clinical complete response and the "Watch and Wait" approach. While some centers adopt the watch-and-wait approach (42%), others only utilize it when extirpation is otherwise necessary (39%), and a portion still proceeds with surgery as initially planned (19%). The survey also addressed unmet needs, which were elaborated in the free-text responses. Overall, there was high interest in participating in planned observational studies. CONCLUSIONS: This study presents an overview of current clinical practice and unmet needs within DKG-certified German colorectal cancer centers. It is noteworthy that total neoadjuvant therapy (TNT) is predominantly performed outside of clinical trials. Moreover, across the centers, there is significant heterogeneity in handling clinical complete response and adopting the "watch and wait" approach. Further research is needed to establish standardization in the care of locally advanced rectal cancer.

Development of a procedure-specific tool for skill assessment in left- and right-sided laparoscopic complete mesocolic excision.

AIM: To (1) develop an assessment tool for laparoscopic complete mesocolic excision (LCME) and (2) report evidence of its content validity. METHOD: Assessment statements were revealed through (1) semi-structured expert interviews and (2) consensus by the Delphi method, both involving an expert panel of five LCME surgeons. All experts were interviewed and then asked to rate LCME describing statements from 1 (strongly disagree) to 5 (strongly agree). Responses were returned anonymously to the panel until consensus was reached. Statements were directly included as content in the assessment tool if ≥60% of the experts responded "agree" or "strongly agree" (ratings 4 and 5), with the remaining responses being "neither agree nor disagree" (rating 3). Interclass correlation coefficient (ICC) was calculated for expert agreement evaluation. All included statements were subsequently reformulated as tool items and approved by the experts. RESULTS: Four Delphi rounds were performed to reach consensus. Disagreement was reported for statements describing instrument handling around pancreas; visualisation of landmarks before inferior mesenteric artery ligation; lymphadenectomy around the inferior mesenteric artery, and division of the terminal ileum and transverse colon. ICC in the last Delphi-round was 0.84. The final tool content included 73 statements, converted to 48 right- and 40 left-sided items for LCME assessment. CONCLUSION: A procedure-specific, video-based tool, named complete mesocolic excision competency assessment tool (CMECAT), has been developed for LCME skill assessment. In the future, we hope it can facilitate assessment of LCME surgeons, resulting in improved patient outcome after colon cancer surgery.

The retrocolic fascial system revisited for right hemicolectomy with complete mesocolic excision based on anatomical terminology: do we need the eponyms Toldt, Gerota, Fredet and Treitz?

AIM: Right hemicolectomy with complete mesocolic excision (CME) requires the removal of an intact mesocolic envelope. The study aimed to determine, on the basis of macroscopic and microscopic anatomical studies, the optimal surgical dissection planes for CME to preserve fascial integrity. Unequivocal anatomical nomenclature was applied to describe the retrocolic fascial system and compared to frequently used eponyms (Toldt, Gerota, Fredet, Treitz). METHOD: Stepwise macroscopic dissections, cross-section studies and histological analysis were performed on body donors to identify the components of the retrocolic fascial system. Based on these anatomical findings, the optimal surgical dissection planes for CME were validated in laparoscopic training courses on body donors and in robot-assisted surgical procedures in patients. RESULTS: The mesocolic tissue and lymphovascular pedicles were enveloped by the ventral and dorsal mesocolic leaf (mesocolic fascia). The mesocolic fascia was attached to the parietal peritoneal fascia ('fascia of Toldt') along the parieto-mesocolic interface, and further cranially to the pre-duodenopancreatic fascia along the mesocolic-duodenopancreatic interface ('space of Fredet'). Dorsally, the parietal peritoneal fascia was separated from the anterior renal fascia ('fascia of Gerota') by the parieto-renal interface. Dissection along this interface in front of the anterior renal fascia followed by incision of the parietal peritoneal fascia at the duodenal border and opening the mesocolic-duodenopancreatic interface yielded the best macroscopic appearance of specimens and was considered optimal for CME. CONCLUSION: The retrocolic fascial system as well as the surgical dissection planes for CME can be described by clearly defined anatomical terms rather than potentially confusing eponyms.

[Routine Practice Data for Health Care Analyses: Part 3 of the Manual]. / Versorgungsnahe Daten für Versorgungsanalysen ­ Teil 3 des Manuals.

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.

Outcome Quality After Colorectal Cancer Resection in Certified Colorectal Cancer Centers­Patient-Reported and Short-Term Clinical Outcomes.

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.

Complete mesocolic excision for right colonic cancer: prospective multicentre study.

BACKGROUND: Complete mesocolic excision (CME) for right colonic cancer is a more complex operation than standard right hemicolectomy but evidence to support its routine use is still limited. This prospective multicentre study evaluated the effect of CME on long-term survival in colorectal cancer centres in Germany (RESECTAT trial). The primary hypothesis was that 5-year disease-free survival would be higher after CME than non-CME surgery. A secondary hypothesis was that there would be improved survival of patients with a mesenteric area greater than 15 000 mm2. METHODS: Centres were asked to continue their current surgical practices. The surgery was classified as CME if the superior mesenteric vein was dissected; otherwise it was assumed that no CME had been performed. All specimens were shipped to one institution for pathological analysis and documentation. Clinical data were recorded in an established registry for quality assurance. The primary endpoint was 5-year overall survival for stages I-III. Multivariable adjustment for group allocation was planned. Using a primary hypothesis of an increase in disease-free survival from 60 to 70 per cent, a sample size of 662 patients was calculated with a 50 per cent anticipated drop-out rate. RESULTS: A total of 1004 patients from 53 centres were recruited for the final analysis (496 CME, 508 no CME). Most operations (88.4 per cent) were done by an open approach. Anastomotic leak occurred in 3.4 per cent in the CME and 1.8 per cent in the non-CME group. There were slightly more lymph nodes found in CME than non-CME specimens (mean 55.6 and 50.4 respectively). Positive central mesenteric nodes were detected more in non-CME than CME specimens (5.9 versus 4.0 per cent). One-fifth of patients had died at the time of study with recorded recurrences (63, 6.3 per cent), too few to calculate disease-free survival (the original primary outcome), so overall survival (not disease-specific) results are presented. Short-term and overall survival were similar in the CME and non-CME groups. Adjusted Cox regression indicated a possible benefit for overall survival with CME in stage III disease (HR 0.52, 95 per cent c.i. 0.31 to 0.85; P = 0.010) but less so for disease-free survival (HR 0.66; P = 0.068). The secondary outcome (15 000 mm2 mesenteric size) did not influence survival at any stage (removal of more mesentery did not alter survival). CONCLUSION: No general benefit of CME could be established. The observation of better overall survival in stage III on unplanned exploratory analysis is of uncertain significance.

[Minimum case volumes from the perspective of specialists in smaller facilities]. / Mindestmengen aus der Sicht des Spezialisten am kleineren Haus.

BACKGROUND: The introduction of compulsory minimum hospital volumes for the majority of operations in visceral surgery according to the current state of discussions will lead to a profound change in the provision of surgical treatment in Germany. METHODS: This article gives a narrative review of the literature and evidence as well as current regulations. RESULTS: In Germany gastric interventions for cancer are associated with the highest perioperative risk in visceral surgery with a mortality of 11.7%. The highest number of annual fatalities by far are reported after colorectal resections (n = 6186). The already decided and planned minimum volumes (esophagus and pancreas) not only do not address these urgent quality issues but even lead to a paradoxical decentralization effect for colorectal and gastric interventions, by weakening medium size and also large hospitals. The minimum volumes that are planned to be subsequently introduced for liver resection, gastric cancer surgery, colorectal cancer surgery, resection for diverticulitis and thyroid resection will not enable a persistence of visceral surgery as a coherent specialty in the remaining clinical landscape. As an alternative, a three-stage model is suggested that defines groups of operations with similar complexity with a common compulsory minimum volume. These groups together with the respective requirements in infrastructure, make up a certain level of care. CONCLUSION: The model suggested will induce a meaningful differentiation of surgical treatment providers that will adequately address surgical quality as well as the preservation of visceral surgery as a coherent specialty.

[Routine Practice Data for Evaluating Intervention Effects: Part 2 of the Manual]. / Versorgungsnahe Daten zur Evaluation von Interventionseffekten: Teil 2 des Manuals.

The evaluation of intervention effects is an important domain of health services research. The ad hoc commission for the use of routine practice data of the German Network for Health Services Research (DNVF) therefore provides this second part of its manual focusing on the use of routine practice data for the evaluation of intervention effects. First, we discuss definition issues and the importance of contextual factors. Subsequently, general requirements for planning, data collection and analysis as well as concrete examples for the evaluation of intervention effects for the 3 fields of application regarding pharmacotherapy, nonpharmaceutical interventions as well as complex interventions are elaborated. We consider scenarios in which no information from randomized controlled trials (RCTs) comparing the two groups directly is yet available or in which RCTs are already available but an extension of the research question is required. In all examples either with or without randomization, the first and foremost question is always whether the data source is suitable for the specific research question. Most of the examples chosen are from oncology trials, because the necessary data are already available for Germany, at least in some form. Finally, the manual discusses possible challenges for future use of these data.

[Manual for Methods and Use of Routine Practice Data for Knowledge Generation]. / Manual für Methoden und Nutzung versorgungsnaher Daten zur Wissensgenerierung.

" There are more and more good reasons for using existing care data, with the focus in particular on the use of register data. The associated, clearly structured methodological procedure has so far been insufficiently combined, prepared and presented transparently. The German Network for Health Services Research (DNVF) has therefore set up an ad hoc commission for the use of routine practice data (RWE/RWD). The rapid report prepared by IQWiG on the scientific development of concepts for "generation of care-related data and their evaluation for the purpose of benefit assessment of medicinal products according to § 35a SGB V" is an essential step for the use of register data for the generation of evidence. The "Memorandum Register - Update 2019" published by DNVF 2020 also describes the requirements and methodological foundations of registers. Best practice examples from oncology, which are based on the uniform oncological basic data set for clinical cancer registration (§ 65c SGB V), show, for example, that guidelines can be checked and recommendations for guidelines and necessary interventions can be derived in the sense of knowledge-generating health services research using register data. At the same time, however, there are no clear quality requirements and structured formal and content-related procedures in the areas of data consolidation, data verification and the use of specific methods depending on the question at hand. The previously inconsistent requirements are to be revised and a method guide for the use of suited data is to be developed and published. The first chapter of the manual on methods of care-related data explains the objective and structure of the manual. It explains why the use of the term "routine practice data" is more effective than the use of the terms Real Word Data (RWD) and Real World Evidence (RWE). By avoiding the term "real world" it should be emphasized in particular that high-quality research can also be based on routine practice data (e. g. register-based comparative studies).

Oncological colorectal surgery during the COVID-19pandemic-a national survey.

PURPOSE: The aim of this study was to clarify the surgical supply situation of oncological colorectal patients in Germany during limitations of the OR caseload due to the COVID-19 pandemic. METHODS: Between 11th and 19th April 2020, all members of a consortium of German colorectal cancer centers were invited to participate in a web-based survey on the current status of surgical care situation of colorectal cancer patients in Germany. RESULTS: A total of 112 colorectal surgeons of 101 German hospitals participated in the survey. Eighty-seven percent of the participating hospitals had to reduce their total surgical caseload and 34% their surgical volume for oncological colorectal patients during COVID-19 pandemic. Restrictions of the surgical caseload were independent of the size of the hospital and the number of cases of COVID-19 in the federal state of the hospital. Sixteen percent of colorectal surgeons consider surgical limitations to be not justified and 78% to be justified only if the care of oncological patients is ensured. Ninety-five percent of the colorectal surgeons interviewed stated that all oncological colorectal patients with an indication for surgery should be operated in time, despite the current reservations for COVID-19 patients. For the majority of the respondents (63% and 51%, respectively), an extended waiting time for surgery of up to 2 weeks was acceptable for non-metastatic and metastatic patients, respectively. CONCLUSION: In Germany, there is a temporarily relevant reduction of surgical volume in oncological colorectal patients. Most colorectal surgeons stated that oncological colorectal surgery should not be compromised despite the measures taken during the COVID-19 pandemic.

Gender comparison of clinical, histopathological, therapeutic and outcome factors in 185,967 colon cancer patients.

INTRODUCTION: Colorectal carcinomas represent the third most common cause of cancer-related deaths in Germany. Although the incidence is significantly higher in men compared with women and gender is a well-established crucial factor for outcome in other diseases, detailed gender comparisons for colon cancer are lacking. METHODS: This retrospective population-based cohort study included all patients diagnosed with colon cancer in Germany between 2000 and 2016 who were included in the common dataset of colorectal cancer patients from the quality conference of the German Cancer Society. We compared clinical, histopathological, and therapeutic characteristics as well as overall and recurrence-free survival. RESULTS: A total of 185,967 patients were included in the study, of which 85,685 were female (46.1%) and 100,282 were male (53.9%). The proportion of women diagnosed with colon cancer decreased from 2000 to 2016 (f: 26.6 to 40.1%; m: 24.9 to 41.9%; p < 0.001), and the proportion of very old patients was especially high in women (f: 27.3%; m: 15.6%; p < 0.001). The localization in women was more right-sided (f: 45.0%, m: 36.7%; p < 0.001), and women had a higher tumor grading and a higher UICC stage (especially stage III nodal-positive) at diagnosis of primary colon cancer (UICC III: f: 22.7%, m: 21.0%; p < 0.001). We could detect a significantly better overall (hazard ratio: 0.853, lower 95%: 0.841, upper 95%: 0.864; p < 0.001) and recurrence-free survival (hazard ratio: 0.857, lower 95%: 0.845, upper 95%: 0.868; p < 0.001) in women compared with men, even though women received chemotherapy less frequently compared with men (f: 26.1%, m: 28.1%; p < 0.001). CONCLUSION: We could detect several variables that differed significantly between men and women regarding clinical, histopathological, therapeutic, and outcome factors. We believe that it is crucial to consider gender as a key factor in the diagnosis and treatment of colon cancer. Sex-specific diagnostic tools could lead to an earlier diagnosis of colon cancer in women, and ways to increase the rate of chemotherapy in women should be evaluated. Furthermore, we recommend stratifying randomized trials by gender.