24. Structures for the provision of medical care – Cervical Carcinoma

Caring for patients with suspected or diagnosed cervical carcinoma is an interdisciplinary and cross-sectoral task. To ensure that optimal treatment results are achieved for the patient, it is necessary for the various structures and individuals working in the chain of care to collaborate in a coordinated, interdisciplinary, and cooperative fashion [841], [842]. The basis for this type of care is the definition of centers stated in the framework of the National Cancer Plan: “A center consists of a network of qualified and jointly certified, interdisciplinary and trans-sectoral, possibly multiple-site, institutions (hospitals, medical practices, rehabilitation institutions), which so far as is technically appropriate reflect if possible the entire chain of care for those affected” [841]. The results of surveys in certified centers for breast cancer and bowel cancer have shown that implementing this concept of a center has positive effects from the point of view of health-care providers on the quality of care for the patients who are treated in the certified networks [843], [844], and also that the level of patient satisfaction is very high [845]. In addition, analyses of the guideline-based quality indicators in certified centers show that the content of the guidelines is being well implemented and that patients are receiving treatment in accordance with the guidelines [846].

Within this system, the aim is to achieve high-quality prevention, diagnosis, and treatment, including rehabilitation and palliation, for the patients. For this purpose, the procedures and structures within the network need to be optimized in an interdisciplinary and cross-sectoral fashion. The three-level model for centers in the National Cancer Plan — with the establishment of organ cancer centers, oncological centers, and comprehensive cancer centers with collaborating partners (such as private practices) at all levels of care — represents the foundation for this high-quality structure for the provision of care [841], [847].

Gynecological cancer centers have been certified by German the Cancer Association (DKG), the German Society for Gynecology and Obstetrics (DGGG), and the Working Group on Gynecological Oncology (AGO) since 2008.

The 2020 analysis of key figures in the annual report of the Certified Gynecological Cancer Centers for audit year 2019 – key figure year 2018 lists 155 certified centers as of December 31, 2019. At the time when the previous version of this guideline was compiled, there were 100 certified centers (in March 2014). This shows the continuous increase in certified centers that has taken place since the start of certification in 2008. Overall, 43–50% of all gynecological carcinomas are treated in certified centers [848]. In the meantime, thanks to the large numbers of treatments, the corresponding amounts of data on the implementation of the quality indicators of the individual guidelines are also available, so that the guideline committees are able to reflect on the individual data. The gynecological tumors ovarian carcinoma, cervical carcinoma, and endometrial carcinoma are all covered by Level 3 guidelines in the oncological guideline program. Consensus-based (Level 2) guidelines are available for vulvar carcinoma, vaginal carcinoma, and other tumors (trophoblastic tumors and sarcomas). The diagnosis, treatment, and follow-up of gynecological carcinomas are thus very well covered by guidelines.

The interdisciplinary tumor conference is the central element for the required coordination of the various levels of care and patient-related decision-making on diagnosis and treatment in which the various partners involved in treatment take part. It is at the tumor conference that decisions are made regarding diagnostic and therapeutic procedures for patients. In order to achieve the optimal patient-related oncological treatment results while at the same time maintaining the lowest possible morbidity, a central prerequisite is to establish — in the framework of the interdisciplinary tumor conference — an agreed interdisciplinary treatment approach for patients with a first diagnosis of, or with recurrent/metastatic, cervical carcinoma. The interdisciplinary tumor conference is therefore a central point in the certification process. The interdisciplinary tumor conference on the treatment of patients with cervical carcinoma requires at least the presence of a gynecological oncologist, a pathologist, a radiologist, and a radio-oncologist; additional disciplines such as a nuclear medicine specialist may be added when needed.

These center structures have to be financed in the health-care system. Care for patients should focus on units that offer the entire range of standard therapies in order to allow comprehensive, quality-assured care for patients while at the same time maintaining optimal usage of limited resources. Resources should be used in a targeted fashion, diagnosis and treatment should be in accordance with guidelines, and quality should be verifiable through the relevant documentation [847], [854].

The first element in the chain of care is the private-practice gynecologist, who identifies a patient with cervical carcinoma either through her participation in statutory early cancer detection examinations or as a result of abnormal symptoms.

On April 3, 2013, the Cancer Early Detection and Registry Law (Krebsfrüherkennungs- und -registergesetz, KFRG) was passed in Germany. The framework of the law established two screening program: for cervical carcinoma and colon/rectal carcinoma, , among other things. This entitles people with statutory health insurance to free participation in organized screening, clarification of unusual findings in certified dysplasia consultations or units, and care in certified gynecological cancer centers. Due to the statutory status assigned to cancer registration, requiring the corresponding documentation, screening was implemented on January 1, 2020 after the establishment of the cancer registries.

Following the gynecological examination, and in the presence of an abnormal cytological smear and/or HPV test result, a patient with the relevant expert opinion receives further histological clarification either locally or in a gynecological dysplasia consultation or unit (see Fig. 8).

The decisive element in the entire chain of care is that information from the individual areas of care is collected and systematically documented in order to allow statements to be made that are relevant to the patient’s care in relation to the quality of the process, of its structure, and of its results.

This approach is adopted in the new Cancer Early Detection and Registry Law (KFRG), as it specifies that data should be compiled centrally and thus collected on both a cross-sectoral and also multiple-site basis, so that they can be used to present the quality of the results.

For this purpose, the Working Group on Data-Minimizing Standard Tumor Documentation (Datensparsame Einheitliche Tumordokumentation, DET), initiated by the Federal Ministry of Health (BMG), has defined a basic dataset with which the data are to be documented on a cross-sectoral basis. This basic dataset also includes the data fields required to reflect the quality indicators that are acquired in the framework of the Level 3 guideline “Diagnosis, Treatment, and Follow-Up in Patients with Cervical Carcinoma” (AWMF register no. 032/033OL) and Level 3 guideline “Prevention of Cervical Carcinoma” (AWMF register no. 015/027OL), as well as quality assurance measures from the Federal Joint Committee (G-BA) and the various areas of care provision in the health-care system.

Following decentralized input from all care providers, central data documentation and analysis is intended to make the necessary information available again to the physicians and the patients they are treating.

In connection with the Eighth National Oncological Quality Conference held in 2020 at the German Cancer Congress, the existing data from the various tumor centers from the years 2000 to 2018 were summarized. Twenty-one clinical registries from 11 federal states participated. The data showed a median age at presentation of in situ carcinoma of 34 years, and for invasive cervical carcinoma of 50 years. The median age at diagnosis for invasive carcinoma is rising, while for in situ carcinoma it is falling. In addition, the ratio of in situ to invasive carcinomas is changing. It clearly shows an increase in preinvasive lesions with a simultaneous decrease in invasive carcinomas. This can be regarded as a success for cervical carcinoma prevention [856].

In terms of grading, morphology, T, N, M and UICC stages, there are no significant changes, although there has been a significant increase in the number of lymph nodes examined.

With regard to treatment approaches, a decrease in the combination of surgery and radiochemotherapy has been seen since the introduction of the guideline, as is also the case for surgery and radiotherapy alone. There has been an increase in the specification of a single treatment option — primary surgery or primary radio-chemotherapy. This shows that the guideline recommendations have been comprehensively implemented nationally [856].

The quality cycle in oncology is a central consequence of the National Cancer Plan and combines the goals of guidelines, centers, and documentation that it sets out. The starting point for the cycle is the evidence-based guidelines with their obligatory procedure for obtaining quality indicators (QIs; for methodology, see Chapter 25 and the guideline report). These QIs are incorporated into the requirement catalogues of the certified centers — in this case, the gynecological cancer centers. The results of the QIs are published annually in the form of annual reports [857]. The 2020 annual report includes the results for 2234 patients who received an initial diagnosis of cervical cancer in 2018, representing 51% of the incident cases [858]. The results of the QIs are discussed in the interdisciplinary and multi-profession certification committees in order to check the degree of implementation of guideline contents and to compare the real care situation with the guideline recommendations. However, the results of the QIs are also fed back to the guideline group and provide it with an overview of the degree of implementation of its work. Since QIs are primarily aimed at areas with a potential for improvement, QIs can be deleted from the set if the underlying recommendations have been comprehensively implemented and no further potential for improvement is apparent. However, new QIs are also defined, which anchor the new recommendations from the guideline update in the clinical routine in the certified centers and promote and require adaptation to the current state of the evidence or consensus.

Various publications have shown that the quality cycle — consisting of guidelines, centers, and documentation — leads, in the patients’ interest, to improvements in oncological care for all cancer patients, including patient-relevant end points. Analyses of clinical cancer registries, statutory health-insurance companies’ data, and rehabilitation facilities show, depending on the focus of the evaluation, an improvement in overall survival, a reduction in postoperative mortality, and an improvement in the functional outcome after surgery when the patients are treated in certified centers [859], [860], [861], [862], [863], [864], [865], [866].

The guideline group is not aware of any meta-analyses, randomized studies, or observational studies on the training situation relative to cervical carcinoma in Germany. This section is therefore at the level of an expert consensus.

As larger numbers of patients with cervical carcinoma are nowadays often only treated in certified networks, training for physicians who treat cervical carcinoma patients is also becoming concentrated in the certified networks [841], [853], [854]. The guidelines in the 2004 further training regulations for the performance figures that have to be achieved during medical specialist training, advanced specialist training, and/or optional further training are difficult to achieve outside of these care structures, with regard to both time periods and also target numbers. Administration of brachytherapy in cervical carcinoma, major surgical procedures in the context of advanced training in gynecological oncology, and disease-specific chemotherapy procedures in the context of additional training in drug therapy for tumors can only be provided in locations where patients with these clinical pictures are being treated by physicians with the relevant further training and qualification requirements, and where there is established oncological experience in interdisciplinary care for patients with cervical carcinoma. Currently, the large number of specialists and advanced specialists in the various areas of care allows comprehensive care provision, but the numbers of authorizations for further training are stagnating or have been declining slightly in recent years. It is becoming clear that in the future, the numbers of individuals in specialized further training will be lower, so that care for patients with cervical carcinoma is likely to become more difficult [853], [854].