Arch Gynecol Obstet (2014) 289:7–12 DOI 10.1007/s00404-013-3084-5

REVIEW

The concept of the certification system of the German Cancer Society and its impact on gynecological cancer care Simone Wesselmann • M. W. Beckmann A. Winter

•

Received: 10 September 2013 / Accepted: 29 October 2013 / Published online: 13 November 2013 Ó Springer-Verlag Berlin Heidelberg 2013

Abstract Purpose This article describes the status of gynecological cancer care in Germany and gives an overview of the certification of gynecological cancer care by the German Cancer Society (Deutsche Krebsgesellschaft DKG). The DKG certifies cancer centers to promote a high-quality level in the treatment of oncological patients. Methods Searches were conducted in PubMed and ScienceDirect to identify the relevant literature. Catalog of requirements for centers certification as well as benchmark reports were used to characterize cancer care in centers certified by DKG. Results and conclusions The certification system of the DKG has been developed to ensure comprehensive care for cancer patients in Germany. The criteria for certification are based on interdisciplinary and inter-professional care conforming to guidelines and specialist expertise. These requirements have been shown to improve structural and process quality, and thus satisfaction and health outcomes in patients. Keywords German Cancer Society
Certification
Gynecological Cancers Centers
National Cancer Plan
Quality management
Oncological care

S. Wesselmann (&)
A. Winter Deutsche Krebsgesellschaft e. V., Kuno-Fischer-Straße 8, 14057 Berlin, Germany e-mail: [email protected] M. W. Beckmann Universita¨tsklinikum Erlangen, Maximiliansplatz 2, 91054 Erlangen, Germany

Introduction Every year, more than 4,50,000 persons in Germany are diagnosed with cancer, with 2,16,000 dying from the disease, which makes it the second most common cause of death after heart disease [1]. Cancer most commonly affects older people. Due to the increasing proportion of the elderly population, the number of new cases is expected to reach 45 % by 2050 [2]. At the same time, diagnostic methods and therapies for oncological tumors are improving––a development that can be seen in the majority of malignant tumor diseases. New screening strategies, such as modern imaging methods, have the potential to lower stage at diagnosis [3] [4]. In addition, better and more accurate tumor staging will enhance the selection of cases for surgery, intensive multimodality therapy and post-operative adjuvant treatment. Despite the improvements in oncological care, the survival times of patients still vary [5, 6]. Ovarian carcinoma, which takes second place after endometrial carcinoma in respect of gynecological malignomas, shows a low overall 5-year survival rate of less than 40 % at FIGO stages IIB to IV and is responsible for the highest mortality rate in malignant gynecological tumor diseases [7]. The greatest challenge for clinicians arises from the fact that the interval before symptoms occur is usually long. It is for this reason that about 70 % of these tumors are diagnosed only in advanced stages when metastases have developed outside the minor pelvis (FIGO III). Radical tumor-reductive surgery (‘‘debulking’’) together with novel and highly effective combined chemotherapy can significantly extend survival times even in advanced ovarian carcinoma as compared with the treatments formerly employed. It does, however, require high-quality surgical training and highly

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efficient interdisciplinary structure, organization and collaboration within the clinical facility. The importance of quality control in ovarian cancer surgery is emphasized through several studies [8, 9]. Bristow et al. [10] evaluated the impact of surgeon and hospital case volume on short-term outcomes after surgery for ovarian cancer and found that surgery performed by a highvolume surgeon was associated with a 69 % reduction in the risk of in-hospital death. Similar conclusions were drawn for cervical cancer by Wright et al. [11]. In addition, ovarian cancer surgery by specialized gynecologists has been found to be linked to longer survival [12, 13]. Munstedt et al. [14] advocated in 2003 that gynecological cancer surgery should be strictly reserved for specialized institutions and gynecologists. This statement is supported by Du Bois et al. [15]. They have concluded that better utilization of existing knowledge and institutional potential as well as board-certificated gynecologic oncologists may improve outcomes in ovarian carcinoma [15]. Moreover, there is an evidence that the treatment of patients with gynecological cancer often deviates significantly from the relevant national and international guidelines [16]. A fact that is reflected in variations of patient survival rates. The establishment of high-quality oncologic care and control of oncological care is even more important with regard to the expected increase in cancer incidence in the coming decades as a consequence of demographic changes. Furthermore, medical progress leads to increasing complexity of diagnosis, therapy, and after care, which strengthen the need for responsible care of the attending physicians and concomitant assessment of scientific evidence. To achieve best possible treatment, synergistic collaboration of all disciplines and professional groups involved in oncological care as well as pursuing specialization of the physicians are important elements. Experts from various disciplines need to work hand in hand to enable quality improvement in oncological care. Stronger interdisciplinary collaboration and evidence-based treatment are essential prerequisites for comprehensive care.

The certification system of the German Cancer Society On the basis of these considerations, the German Cancer Society (DKG) and the oncological associations have collaborated to create a concept for new care structures in Germany which, by now, has become a quality standard for oncological care. Only the medical units that have undergone certification procedures and have proven to meet the high requirements of oncological care will be certified. The certification system aims at giving cancer patients in every stage and for

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every aspect of their disease a comprehensive treatment. Such treatment is possible through interdisciplinary, transsectoral and multi-professional collaboration of all professional disciplines involved and comprises all steps from diagnosis, therapy and aftercare to palliative and hospice care. Related to gynecological cancer, the interdisciplinary treatment team includes, for example, gynecologic and medical oncologists as well as radiotherapists, pathologists and palliative specialists or specialized oncologic nurses. In addition to the different medical disciplines, a center also integrates other professional disciplines important for the care of oncological patients, such as psychosocial and psycho-oncological care as well as self-help organizations within the certified network. Interdisciplinary collaboration is for instance effected through tumor conferences and round tables where all partners contribute their expertise and discuss the best diagnostic and therapeutic approaches for their patients.

Implementation of the certification system in Germany The certification system of the DKG which includes certified centers for different tumor entities does exist since 10 years. The certification of the gynecological cancer centers started in 2008 [17]. In the course of the past 5 years, the number of gynecological cancer centers has grown steadily (Fig. 1) and in 2013, 91 gynecological cancer centers have been certified by the DKG. In addition, certified cancer centers for other tumor entities have been developed nationwide to ensure that all tumor patients have access to state-of-the-art diagnostics and therapy. As of June 2013, there are 840 centers for oncological care that have been awarded the quality signature of the German Cancer Society (Table 1). In parallel with the progression of the certification system since 2003, the overall concept of oncological care in Germany continued to develop, and within this process, the three-stage model of oncological care [18] was created in 2007 which subsequently became an integral part of the National Cancer Plan. The National Cancer Plan was initiated by the Federal Ministry of Health, the Work Group of German Cancer Registries, the German Cancer Society, and the German Cancer Aid in 2008 [19] and emphasis on quality assurance concepts in oncologic care such as the model of certified cancer centers. The base of the integrated three-stage model is formed by the so-called organ cancer centers, which are specialized in the treatment of one tumor entity. They deal with the most frequent tumor diseases such as carcinoma of the gynecological organs, breast, prostate, colorectal, skin or lungs. The second level includes oncological centers. In these centers which are often composed by several organ cancer centers and

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Fig. 1 Number of gynecological cancer centers from 2009 to 2013

Table 1 Certified centers related to the three-stage model of oncological care (30 June 2013) Certified centers

Organ cancer centers (C)

Oncology centers (CC)

Comprehensive cancer centers (CCC)

Breast

Colorectal

Gyn.

Skin

Lung

Prostate

Start of procedure

2003

2006

2008

2009

2009

2008

2009

2006

Certified center

216

256

91

39

35

95

46

12

Primary cases overall 2011

50,927

22,224

8,244

9,518

13,449

21,751

–

–

Cancer incidencea

69,270

62,956

23,748

189,171b

48,986

64,467

–

–

Overall percentagea

71.7 %

35.0 %

33.6 %

47.9 %

27.0 %

33.4 %

–

–

a

GEKID data 2010

b

Only malignant melanoma

modules for less frequent malignancies, patients are treated by interdisciplinary expert teams. The uppermost tier of the system is formed by comprehensive cancer centers that engage not only in clinical care, but also in holistic research and teaching. The three-stage model of certified centers reflects the different tasks in oncological care and ensures that all oncological patients in Germany will receive high-quality care that meets international standards.

DKG-certified gynecological cancer centers The gynecological cancer centers treat approximately 27.5 % (N = 7,275) of patients with first diagnosis of malignant gynecological tumors per year. At the beginning of certification, the majority of gynecological cancer centers was associated with already existing breast cancer centers, and thus benefited from the structures currently in place. This is due to the fact that in Germany breast cancer is predominantly treated by gynecologist or

specialized gynecological oncologists. But gynecological centers are becoming more and more independent. While in 2011, only ten gynecological hospitals received their first certification independently, their number has risen to 17 by 2013. The certification is based on the catalog of requirements in which the way of collaboration and the demands on the qualitative and quantitative expertise of all partners within the network is clearly defined [20]. In addition to the medical disciplines directly dealing with gynecological cancer care, psycho-oncological and social services as well as self-help groups and cancer registries have to be integrated in the network. The center should have at least two gynecologists with board certification in gynecological oncology. Collaboration with urologists and visceral surgeons is obligatory to be able to perform multi-organ surgery. For a comprehensive treatment of the patients, the cooperation of hospital physicians and physicians in private practice is a major task within the certified center. At least 75 patients with the diagnosis of a malignant gynecological tumor have to be treated in the center per year.

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Table 2 Quality indicators of the evidence-based guideline ‘‘diagnosis, treatment and follow-up care of malignant ovarian tumors’’ Quality indicator Quality indicator 1: operative staging early ovarian carcinoma Counter C: number pat. with operative staging: Laparotomy Peritoneal cytology Peritoneal biopsies Adnex exstirpation bilateral Hysterectomy, if necessary extra peritoneal procedure Omentectomy min. infracolic Bilateral pelvine a. paraaortale lymphonodectomy Denominator D: all pat. with initial diagnosis OC FIGO I–IIIA Quality indicator 2: intraoperative tumor rupture C: Number pat. with intraoperative tumor rupture D: All pat. with initial diagnosis of OC FIGO IA o. IB Quality indicator 3: macroscopic complete resection advanced ovarian carcinoma C: Number pat. with macroscopic complete resection D: All pat. with initial diagnosis Ov––Ca C FIGO IIB and operative tumor removal Quality indicator 4: operation advanced ovarian carcinoma C: Number pat. whose definitive operative therapy was carried out by a gynecological oncologist D: All pat. with initial diagnosis OC FIGO C IIB after completion of operative therapy Note: gynecological oncologist = medical specialist of gynecology and obstetrics with special training in gynecological oncology Quality indicator 5: post-operative chemotherapy advanced ovarian carcinoma C: Number pat. with post-operative chemotherapy D: All pat. with initial diagnosis OC C FIGO IIB and chemotherapy Quality indicator 6: no adjuvant chemotherapy early ovarian carcinoma C: Number pat. with adjuvant chemotherapy D: All pat. with initial diagnosis OC FIGO IA, G 1 and complete operative staging Note: Update of FIGO-classification should be respected! (status: 12.2012) Quality indicator 7: platinum-based chemotherapy early ovarian carcinoma C: Number pat. with platinum-based chemotherapy D: All pat. with initial diagnosis OC FIGO IC o. IA/B with Grad 3 Quality indicator 8: first-line chemotherapy advanced ovarian carcinoma C: Number pat. with 6 cycles first-line chemotherapy Carboplatin AUC 5 a. Paclitaxel 175 mg/m2 D: All pat. with initial diagnosis OC C FIGO IIB Quality indicator 9: chemotherapy for platinum-resistant a/o––refractory first relapse C: Number pat. with nonplatinum-based monotherapy with pegylated liposomal Doxorubicin, Topotecan, Gemcitabine o. Paclitaxel weekly D: All pat. with platinum-resistant a/o––refractory first relapse of OCa and first relapse chemotherapy outside clinical trials Note: platinum-resistant relapse: relapse within 6 months after completion of primal therapy Quality indicator 10: combination therapy of platinum-sensitive relapse C: Number pat. with platinum-based combination therapy D: All pat. with platinum-sensitive relapse of OC and relapse chemotherapy, outside clinical trials Quality indicator 11: counseling social service C: Number pat. with counseling by social service D: All pat. with initial diagnosis OC and treatment at the facility Quality indicator 12: no adjuvant therapy BOT C: Number pat. with adjuvant therapy D: All pat. with initial diagnosis of BOT

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Quality assurance

Summary and future developments

The audit of the certified centers takes place once a year, and within this procedure the centers are required to demonstrate that they meet the professional requirements which are summarized in the catalog of requirements. Important component of the catalog is quality indicators that reflect the cooperation and quality of care of the partners in the network. Since this year the set of quality indicators is extended by indicators, which have been derived from gynecological guidelines. In June 2013, the evidence-based guideline for the diagnosis, treatment and follow-up of malignant ovarian tumors was published [21]. Further evidence-based guidelines for endometrial and cervical carcinoma will follow in a timely manner. Within the development process of the guidelines, an obligatory step is the deduction of quality indicators from the strong recommendations of the guideline. These quality indicators are included in the catalog of requirements (Table 2). For successful certification, the centers must prove that they fulfill the references of the quality indicators and, therefore, treat their patients following the evidence-based guidelines. By this way, the guidelines, in the form of quality indicators, are introduced and established in-hospital routine. The results for all quality indicators are documented by the center and plausibility checked by the auditor before and during the audit. The results serve the centers to discuss the ongoing development of the certified network with the auditor at the on-site inspection and among the partners and to suggest improvements where necessary. The certification, thus, is an important tool in quality management that functions as a classical plan-do-check-act cycle with the aim of continuous quality improvement.

Certification of oncological structures results in optimizing work processes and performance, and thus, in enhanced quality of care. Several retrospective studies showed an improving course of disease of patients treated at DKGcertified centers [23, 24]. An analysis of Heil et al. [24] carried out from 2003 to 2010 demonstrated better outcomes for breast cancer patients when treated in certified centers [25]. In addition, the high level of quality is expressed both in patient satisfaction and in the motivation of the centers’ staff. According to a survey of breast cancer patients treated in certified cancer centers, the patients felt very well treated by the medical and care personnel of the center [24]. In addition, interviews of key persons in certificated breast cancer and colorectal cancer centers have shown that the concept of certification is considered as highly efficient, and contributing to improved health care [26, 27]. These positive results demonstrate the particular significance of the certification system from the perspectives of both patients and personnel. The published benchmarking report presents the results of certified gynecological cancer centers. Decisive aspects for improving the quality of care include a structured dialog conducted inside the certified center and with the auditor. In the future, the presentation of the cohort development of the quality indicators will provide further support for nuanced analysis. Adopting quality indicators from the evidence-based guideline on ovarian cancer established an important prerequisite for applying the content of the guidelines safely in everyday clinical work. During update processes of the guideline, the benchmarking report will provide the guideline group with central information on the extent to which the guideline recommendations are being implemented, and in the long term––together with analyses of the clinical cancer registries––this will also allow the guidelines to be evaluated. With the described structures of oncological care an effective system was implemented in clinical practice, which makes the quality of oncological care transparent, reflects and continuously improves it, in the interests of care providers and patients.

Benchmarking reports The results for the quality indicators are presented and evaluated in annual benchmarking reports. Regarding to gynecological cancer centers, the benchmarking report is published for the first time in 2013 and allows an effective overview about important quality of care aspects in the year 2012 [22]. A substantial part of the report reflects the interdisciplinary collaboration of the partners, such as case presentation at tumor boards. The centers use these nationwide evaluations to compare their results with the results of other certified centers. Moreover, they discuss patient outcomes in their steering committees to evaluate the quality of care in the center and to find out their strong and weak points. In this way, the benchmark reports help to ensure quality of care and ongoing improvement of the network.

Acknowledgments The authors would like to thank the members of the certification commission of the gynecological cancer centers for their valuable contribution to the certification system: Bernd AltEpping, Mainrad Beer, Manfred Dietel, Andreas du Bois, Gu¨nter Emons, Marion Gebhardt, Ullrich Graeven, Bernd Hamm, Peer Hantschmann, Annette Hasenburg, Susanna Hegewisch-Becker, Volker Heinemann, Peter Hillemanns, Dieter Ho¨lzel, Lars-Christian Horn, Rainer Kimmig, Oliver Ko¨lbl, Jo¨rg Kotzerke, Susanne Krege, Hans Kreipe, Volkmar Ku¨ppers, Peter Mallmann, Simone MarnitzSchulze, Lars Meyer, Stefan Mu¨ller, Carsten Mu¨nstedt, Olaf

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Ortmann, Pompiliu Piso, Jens Quaas, Katrin Reuter, Ingo Runnebaum, Dieter Schmidt, H.G. Schnu¨rch, Uwe Ulrich, Birgitt van Oorschot, Dirk Vordermark, Uwe Wagner, Diethelm Wallwiener, Ilse Weis, Joachim Weis, Isolde Weisse, Sophie Wetzel, Wolfgang Zieger and Marek Zygmunt. Conflict of interest of interest.

The authors declare that they have no conflict

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