The Breast 24 (2015) 118e123
Contents lists available at ScienceDirect
The Breast journal homepage: www.elsevier.com/brst
Original article
Quality of care in breast cancer centers: Results of benchmarking by the German Cancer Society and German Society for Breast Diseases Christoph Kowalski a, *, Julia Ferencz b, 1, Sara Y. Brucker c, 2, Rolf Kreienberg d, Simone Wesselmann a, 3 a
German Cancer Society, Kuno-Fischer-Strasse 8, 14057 Berlin, Germany OnkoZert, Certification Institute of the German Cancer Society, Gartenstrasse 24, 89231 Neu-Ulm, Germany University Hospital Tübingen, Calwerstrasse 7, 72076 Tübingen, Germany d University Hospital Ulm, Prittwitzstrasse 43, 89075 Ulm, Germany b c
a r t i c l e i n f o
a b s t r a c t
Article history: Received 22 July 2014 Received in revised form 27 October 2014 Accepted 22 November 2014 Available online 13 December 2014
A total of 218 breast cancer centers, with 274 operating sites, have been certified since 2003 in accordance with the criteria set out by the German Cancer Society (Deutsche Krebsgesellschaft) and the German Society for Breast Diseases (Deutsche Gesellschaft für Senologie). Most of these centers are located in Germany, but centers in Austria, Switzerland, and Italy have also been certified. This paper presents the results for quality indicators (QIs) from 2009 to 2012, based on data from 195,342 primary breast cancer patients, in order to illustrate the development and progress of these centers. Descriptive results on interdisciplinary collaboration (6 QIs), guideline adherence (15 QIs), and specialist expertise (7 QIs) are reported over time. Fulfillment of the certification requirements was high and remained relatively stable over time, with the extent of variation between sites declining. Sites that do not reach the target values are asked to comment on the discrepancies, and their comments, as well as the QI results, are used by centers and auditors during an on-site auditing process and to constantly revise the QIs set out by the guideline and the certification commission. © 2014 Elsevier Ltd. All rights reserved.
Keywords: Breast cancer center Certification Benchmarking German Cancer Society Care quality
Introduction To ensure high standards of breast cancer care in Germany, the German Cancer Society (Deutsche Krebsgesellschaft) and the German Society for Breast Diseases (Deutsche Gesellschaft für Senologie) introduced a certification system in 2003 that included many of the requirements discussed in the EUSOMA position paper [8]. Partly as a response to the poor results in the care of patients with breast cancer in Germany identified in the EUROCARE study [23] and by the German Advisory Council for Concerted Action in Health Care [22], and with strong support both from self-help
* Corresponding author. Tel.: þ49 (0)30 322 932 947; fax: þ49 (0)30 322 932 966. E-mail addresses: [email protected] (C. Kowalski), j.ferencz@ onkozert.de (J. Ferencz), [email protected] (S.Y. Brucker), r. [email protected] (R. Kreienberg), [email protected] (S. Wesselmann). 1 Tel.: þ49 (0)731 705 116 0; fax: þ49 (0)731 705 116 16. 2 Tel.: þ49 (0)7071 29 80791 82211; fax: þ49 (0)7071 29 4805. 3 Tel.: þ49 (0)30 322 932 990; fax: þ49 (0)30 322 932 966. http://dx.doi.org/10.1016/j.breast.2014.11.014 0960-9776/© 2014 Elsevier Ltd. All rights reserved.
organizations and from an appeal by the European Union [7], the certification system was developed with criteria intended to improve multidisciplinary, trans-sectoral, and multiprofessional cooperation, and to implement the contents of evidence-based guidelines in practice [6]. Breast cancer centers were the first specialized cancer centers that were established by the German Cancer Society, followed by centers for colorectal (2006), lung, prostate, skin, and gynecological tumors (all in 2008). Although the vast majority of the certified centers are located in Germany, centers in other countries have also been certified in accordance with the German Cancer Society criteria, including breast cancer centers in Italy, Austria, and Switzerland. The certification system is part of the German Cancer Plan, according to which a certified center is “a network of qualified and jointly certified interdisciplinary and trans-sectoral … institutions that … if possible represent the entire chain of health care for those affected” [10]. According to the requirements of the German Cancer Society and the German Society for Breast Diseases, breast cancer center sites have to provide the disciplines, structures, and processes necessary for diagnosing and treating breast cancerdincluding, but not limited to, genetic testing, treatment of primary as well as
C. Kowalski et al. / The Breast 24 (2015) 118e123
advanced tumors, follow-up and palliative care. Care is to be provided by multidisciplinary teams including all of the relevant medical specialists, as well as social workers and psychologists. The centers need to treat a minimum number of patients per annum and must provide personnel, expertise and equipment. In addition, the certification system requires patient surveys and documentation for quality assurance based on the evidence-based guideline for diagnosis, therapy, and follow-up of breast cancer [17]. The certification process thus ensures that the contents of evidence-based guidelines are implemented in a sustainable way and on a population-wide scale in everyday clinical care. Breast cancer centers are part of the “three-step model” [1] for oncologic care described in the National Cancer Plan, consisting of specialized organ cancer centers (implemented all over the country to provide population-wide quality care for the common tumor entities, such as breast cancer centers and colorectal cancer centers); oncology centers (which pool expertise on several tumor entities, especially rare ones); and comprehensive cancer centers (a few throughout the country, certified by German Cancer Aid, focusing on developing innovative treatment strategies and establishing new standards). This paper describes the development and updating of the requirements for certification and the quality indicators (QIs) specified, and presents the results for the QIs collected during the certification process [5]. The results presented cover patients from a period of four years (2009e2012). Following a description of patient volumes and the development of operating sites, an analysis is given of QIs for interdisciplinary cooperation, guideline adherence, and specialist expertise. The paper then considers whether 1) fulfillment of the requirements has been increasing; and 2) whether differences between sites are becoming smaller over time. Methods Quality indicators and the certification process The German Cancer Society's certification system is divided into three parts: legislative, judicial, and executive. The certification commission, with around 35 experts mandated by the medical and professional associations in the field of breast cancer (among them gynecologists, surgeons, radiotherapists, radiologists, and pathologists), along with self-help organizations, develop a catalog of requirements that contains the quality indicators (QIs) (“legislative”). The certification commission meets every 2 years to update these requirements, taking into account new evidence from clinical guideline updates and from experience gained during certification. Proposals by the committee members, centers, and auditors are collected, formatted and sent out to members by the German Cancer Society office before the committee meeting. During the committee meeting, which takes one full day, all of the proposals are discussed and consented or voted on. The updated requirements become effective the following yeardi.e., updates agreed on in the summer of 2014 were sent out to the centers soon after the meeting to give them time for preparation and will become effective on 1 January 2015. The implementation of these requirements is audited by medical experts working in the field of oncology, on the basis of the data collected (“executive”). These oncologic medical experts are not permitted also to be members of the certification commission. On the basis of the expert and site documentation, the board issuing the certificate decides whether the breast cancer network will be awarded the certificate (“judicial”). Each of the QIs, a substantial part of the certification process, has a distinct definition, and most have margins or targets that need to be reached. This allows for inter-site comparisons, as well as comparison of sites over time. The reported results are discussed not only in the on-site auditing process involving the centers and
119
auditors, but also at meetings of the centers' directors, annually or more frequently in nearly all centers [15]. Anonymized results are additionally reported annually to the public for all breast cancer centers through benchmarking reports [5]. This is done to make the certification system and the results of all the hospitals within the system transparent, but without revealing the centers' names to the public, in order to avoid misguided incentives. Instead, the purpose of the benchmarking reports is to allow the centers to compare their results with those of all the other centers and to develop strategies for improving them. The first breast cancer center sites were certified in 2003, and the number of certified sites was constantly increasing up to the end of 2013 (n ¼ 274 sites). Data collection and analysis The results for the 28 QIs are collected annually using an electronic questionnaire that is submitted to OnkoZert, an independent certification institute that organizes the auditing procedure on behalf of the German Cancer Society. OnkoZert is also responsible for collecting the data, testing their plausibility, and editing them. Quality assurance during the process of data collection and analysis is achieved using various measures. 1) Data received by OnkoZert are checked for completeness, as well as for consistency with the center's other documented results. 2) Most QIs are assigned a plausibility threshold or a target value. If a plausibility threshold or target value is not reached, the center is required to comment on the discrepancy. 3) Following the year of reporting, sites are audited by the trained oncologic medical experts. Prior to the audit, results are sent to the auditor, who carries out initial checking of the results provided. 4) During the audit, further reflection about the results and comments is carried out, along with checks on randomly chosen patient files. The results are published during the subsequent year. Thus, 2012 QI data are audited during 2013, and published in 2014; i.e., the most recent data presented here are based on patients treated in 2012. All of the QIs reported (except for patient volume, breast reconstruction, and case presentation in cases of metastases/local recurrence) consist of fractions in which the denominator represents the total number of patients eligible for a specific procedure and the numerator represents the actual number of patients who were recommended to receive or did receive the procedure concerned. The QIs are in line with established definitions [20], as they measure particular health-care processes and outcomes and are used to monitor and evaluate them. The data presented here are limited to those from the 2009 patient cohort and onwards, at a time when the data collection method and quality assurance procedures were fully established. This paper presents the results for all QIs, in order to provide an overview of the three different groups of QIsdthose relevant to interdisciplinary collaboration, adherence to guideline recommendations, and on specialist expertise. Following a description of the sites included in the analyses, medians are presented for all of the selected QIs and years, along with the proportion of sites that fulfilled the target values in 2012. The analyses were carried out using the Data-WhiteBox, the benchmarking tool developed by OnkoZert, which allows standardized analyses of the data and is at the same time the database for the QI data. Results Site development The annual data presented here are based on the sites that were already certified in the previous year; 274 sites were certified in 2013. Five of these were excluded from the analysis because they had been certified for the first time in 2013 and data recording was
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therefore not obligatory for the whole calendar year. One site was not included due to software changes, leaving 268 sites for analysis. The number of sites certified increased steadily from 2009 to 2012, as did the number of sites considered for benchmarking purposes (Table 1; cf. also www.oncomap.de for a visualization of the geographic distribution of the centers). Table 1 presents an overview of the centers that were certified at the end of the years 2009e2012, centers applying for certification, the number of certified sites, the number of sites the centers consist of, and the number of patients treated in these centers. In 2012, for example, 44 centers consisted of two sites, whereas 169 consisted of only one. Newly applying centers are no longer allowed to consist of more than two sites with every site fulfilling the quantitative requirements. However, centers consisting of three or four sites that were certified before 2012 are allowed to continue. Both the number of sites and the number of centers increased. The number of newly diagnosed patients treated in certified breast cancer centers declined between 2009 and 2010, and subsequently increased again. Of the 274 sites certified in 2013, eight were located outside Germany (four in Switzerland, two in Italy, and two in Austria). Quality indicator results Table 2 presents the data for the 28 QIs. For most of the QIs with target values, the great majority of the sites (75%) reached the targets in 2012. This was the case, for example, for postoperative case presentation; recommendation of radiotherapy (RT) after breast-conserving therapy (BCT) in patients with invasive breast carcinoma; pretreatment histological examination; sentinel lymph-node excision (SLNE) alone in patients staged pN0 without preoperative treatment; details of resection and safety margin; intraoperative sample radiography/ultrasonography after preoperative marking; the number of primary cases; and postoperative wound infection. The medians show a high level of implementation of the requirements over time, which is either increasing or generally stable for all QIs, with the exception of the percentage of study patients and the number of patients receiving breast reconstruction. Additional analyses were conducted (data not presented here) of QIs with target values that were met by less than 75% of the sites and for which data were available for more than 1 year: RT recommended after BCT in patients with ductal carcinoma in situ (DCIS); RT recommended after mastectomy in invasive breast carcinoma; trastuzumab therapy recommended over 1 year in patients with HER-2epositive results; and percentage of study patients. A clear increase in the number of sites that were reaching the target value and a decrease in the degree of variation between sites was observed for RT recommended after BCT in DCIS and for
recommended trastuzumab therapy, but only small changes in the proportion and variation were seen for RT recommended after mastectomy. The percentage of patients included in studies decreased during the period, however, while variation between hospitals increased. Sites are obliged to state the reasons why target values are not met, and some of these reasons are presented in the Discussion section below. For QIs without target values, betweensite variation is generally greater than for QIs with target values (data not presented). Discussion This report presents the results for the quality indicators collected during the process of certifying breast cancer centers in four European countries in accordance with the criteria set out by the German Cancer Society and the German Society for Breast Diseases. Overall, the certified breast cancer centers show a very high level of fulfillment of the QIs. Fulfillment also improved slightly over time, with variation between sites declining slightly, possibly due to a learning effect as a result of the certification process; this has also been observed in other quality improvement programs [26]. There was greater variation between sites for QIs without target values. QIs derived from the national evidencebased guideline show a high level of implementation. Most QIs that refer to specialist expertise show constantly good results over time, with median BCT rates in pT1 of around 85% and hardly any revision operations or postoperative wound surgeries. The percentage of study patients had peaks in 2009 and 2010, when major studies included large numbers of patients. The breast cancer center certification system was introduced partly due to the unsatisfactory results for breast cancer care that were identified in the EUROCARE study [23]. Since then, the available data having been showing a substantial increase in the 5year, age-standardized relative survival rates among breast cancer patients [4,13]. This coincided with improvements in various quality indicators between 2003 and 2010 [19]. In addition to the certification program, a few other factors are also likely to have contributed to these results. First and foremost is progress in diagnosis and therapy, as well as the introduction of evidencebased guidelines and a national breast cancer screening program in Germany. It is difficult to draw any conclusions on whether or to what extent these major efforts contributed causally to the improved patient outcomes. However, available research results based on patient and hospital management perspectives show a high degree of satisfaction with these measures and wide acceptance of them [3,14e16], along with the expected positive effects of compliance with guidelines [29]. The German Cancer Society requirements cover a wider range than those presented by EUSOMA [28], but share a common basis,
Table 1 Development of site structure 2009 to 2012 and patients treated.
Centers newly applying Certified centers Certified sites Centers consisting of 1 site Centers consisting of 2 sites Centers consisting of 3 sites Centers consisting of 4 sites Newly diagnosed patients with breast cancer treated in cert. centers Certified centers with data available Patients from centers with data available
As of December 31, 2013 (primary cases 2012)
As of December 31, 2012 (primary cases 2011)
As of December 31, 2011 (primary cases 2010)
As of December 31, 2010 (primary cases 2009)
2 218 274 169 44 3 2 51,826
6 212 267 163 45 2 2 50,329
4 204 261 153 47 2 2 49,332
8 200 258 149 46 3 2 52,345
268 50,195
256 48,608
252 47,725
246 48,814
C. Kowalski et al. / The Breast 24 (2015) 118e123
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Table 2 Quality indicators, 2009e2012. Quality indicators Postoperative case presentation (1)a Pretreatment case presentation (2) Case discussion of local recurrence/metastases (3) Psycho-oncologic care (>30 min) (12) Social-service counseling (13) Participation in research study (14) Guideline Recommended RT after BCT in cases of inv. BreCa recommendations (4.1) GL QI 6b Recommended RT after BCT in cases of DCIS (5.1) Recommended RT after a mastectomy in cases of inv. BreCa (6.1) GL QI 10 Recommended chemotherapy in cases of steroid receptor negative diagnostic finding (7.1) GL QI 9 Recommended chemotherapy in cases of receptor positive and nodal positive diagnostic finding (8.1) Recommended endocrine therapy in cases of steroid receptor positive diagnostic finding (9.1) GL QI 7 Recommended Trastuzumab therapy over one year in cases of HER-2 positive diagnostic finding (10.1) GL QI 8 Endocrine therapy in cases of metastases (11) GL QI 11 Pre-therapeutic histological confirmation (15) GL QI 1 LN dissection in cases of DCIS (20) GL QI 3 Determination of the nodal status in cases of inv. Br eCa (21) SLNE only in cases of pN0 GL QI 4 (22) Intraoperative specimen radio-/sonography (23) GL QI 2 Specification of the resection margin and safety margin (27) GL QI 5 Report to the cancer registry (28) GL QI 12 Specialist expertise Primary cases BreCa (16) BCT in cases of pT1 primary cases (17) Mastectomies primary cases (18) DCIS in initial procedure primary cases (pTIS) (19) Revision operations primary cases (24) Postoperative wound infection primary cases (25) Breast reconstruction (26) Interdisciplinary collaboration
Median 2012 Median 2011 Median 2010 Median 2009 Target value Sites with target fulfilled 2012 100% 58.3% 18.0 69.0% 87.9% 11.3% 97.8%
100% 46.7% 20.5 66.0% 92.2% 14.1% 98.1%
100% 37.7% 20.0 65.6% 91.6% 22.3% 98.0%
99.3% / / 66.7% 89.5% 21.5% /
95% None None None None 10% 95%
99.3% / / / / 58.6% 90.7%
100% 95.2%
100% 95.6%
100% 95.6%
/ /
95% 95%
72,9% 52.2%
89.5%
90.0%
86.2%
/
80%
89.9%
75.0%
76.1%
77.3%
/
60%
92.2%
96.3%
96.8%
96.7%
/
80%
100%
93.8%
85.7%
83.3%
/
95%
45.5%
82.1%
/
/
/
95%
36.0%
97.5%
97.5%
97.4%
97.6%
90%
97.4%
0.0% 97.7%
/ 97.8%
/ 97.8%
/ 96.9%
5% None
59.9% /
95.2% 100%
95.5% 100%
93.3% 100%
90.7% 100%
80% 95%
97.8% 88.8%
99.9%
99.7%
100%
100%
95%
98.1%
100% 170.5 85.3% 28.6% 10.1% 3.1% 1.4% 15
/ 166.0 84.5% 28.8% 10.1% 2.8% 1.3% 31
/ 166.5 84.3% 28.5% 10.4% 2.6% 1.4% 30
/ 176.5 87.1% 21.6% 10.5% 2.2% 1.3% 27
95% 100 70% None None 5% 5% None
81.4% 88.4% 77.6% / / 86.5% 95.9% /
Proportion of patients eligible for a specific treatment who receive the treatment or the respective recommendation, except “primary cases BreCa,” “Case discussion of local recurrence/metastases,” and “breast reconstruction”: number of cases. a No. in brackets refers to the number of the QI in the benchmark report. b QI derived from evidence based national guideline. GL QI refers to the respective QI in the guideline [17].
in that the ultimate aim is to provide the best available care to the population through multidisciplinary teams in specialized units. The implementation of the requirements reduces the individual risk of not receiving state-of-the-art care, and the declining variation in the extent of implementation over time reduces the risk for patients of being treated at a substandard site. Certification means that a typical planedoecheckeact (PDCA) cycle is effectively incorporated into the daily routine at the breast cancer centers. At the same time, the public receives information about the overall results and the certification process, without being able to identify the respective hospitals. The aim of the reporting system is not to report results openly to the public for each center, but instead allow the centers to work on improving their performance in a process of structured dialog with the auditors. Not openly reporting the results to the public has proved to be useful, since otherwise false reporting or rejection by centers of patients with unfavorable risk profiles may be incentivized. Furthermore, quality indicators designed for public reporting would need a much easier set-up. As yet, there is no system in Germany that provides a care quality benchmark that is openly reported and understood by a substantive part of the population. Centers document treatments and results
and present them in a transparent manner, which allows comparison of their own results from previous years with those of other centers, as well as the subsequent introduction of measures for quality improvement. These measures are developed in collaboration with the auditors, and the effects of the measures taken are reviewed in the following year. In this process, certified breast cancer centers are subject to rigorous quality analysis and improvement. The reporting system that has been established may be able to serve as a model for the many countries that do not yet have programs for reporting quality indicators [9]. It is notable that the efforts that have been undertaken by the centers to implement the quality assurance system have been made without any direct financial compensation. Varying proportions of sites fulfilled the target values. However, not fulfilling the target value does not automatically result in refusal of certification. On the contrary, there may be good reasons why specific criteria have not been fulfilled. Sites are therefore obliged to comment on divergences from target values. One example of an explanation for why a relatively large proportion of sites did not reach the target values for an indicator was that the patients concerned were of advanced age and had comorbidities
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(recommended RT after BCT in invasive breast carcinoma). Discrepancies were investigated by the auditors at the level of patient files, and the explanations were considered adequate at all of the sites concerned. A review of the group of patients with an RT recommendation 1 year later showed that nearly all of the patients did indeed receive RT, except for patients who declined it. The centers' explanations for missed targets are discussed in the certification and guideline commissions, and this may lead to a revision of the QIs involved. This was the case, for example, with the QI for stating resection and safety margins. Other guideline-derived QIs show similarly good implementation of the content of the 2008 guideline [18] in clinical routine over the yearsdsuch as SLNE alone in patients with pN0 and without preoperative treatment. A total of 97.8% of the centers fulfilled this requirement. The six centers that did not meet the target value stated that in addition to the marked sentinel node they had also removed lymph nodes with suspicious palpatory findings intraoperatively during lymph-node sampling, but without performing an axillary dissection. Another example of the implementation of a new, guideline-recommended form of treatment is the recommendation for 1 year of trastuzumab therapy in patients with HER2epositive results after a primary diagnosis of breast cancer. In 2012, this treatment had become an established standard, and only older patients or patients with comorbidities and contraindications did not receive a recommendation for it. In addition to guideline-derived QIs, it can be seen that different national requirements lead to relatively large variation in the QIs for some indicators. For example, six of the 11 sites in which
Contents lists available at ScienceDirect
The Breast journal homepage: www.elsevier.com/brst
Original article
Quality of care in breast cancer centers: Results of benchmarking by the German Cancer Society and German Society for Breast Diseases Christoph Kowalski a, *, Julia Ferencz b, 1, Sara Y. Brucker c, 2, Rolf Kreienberg d, Simone Wesselmann a, 3 a
German Cancer Society, Kuno-Fischer-Strasse 8, 14057 Berlin, Germany OnkoZert, Certification Institute of the German Cancer Society, Gartenstrasse 24, 89231 Neu-Ulm, Germany University Hospital Tübingen, Calwerstrasse 7, 72076 Tübingen, Germany d University Hospital Ulm, Prittwitzstrasse 43, 89075 Ulm, Germany b c
a r t i c l e i n f o
a b s t r a c t
Article history: Received 22 July 2014 Received in revised form 27 October 2014 Accepted 22 November 2014 Available online 13 December 2014
A total of 218 breast cancer centers, with 274 operating sites, have been certified since 2003 in accordance with the criteria set out by the German Cancer Society (Deutsche Krebsgesellschaft) and the German Society for Breast Diseases (Deutsche Gesellschaft für Senologie). Most of these centers are located in Germany, but centers in Austria, Switzerland, and Italy have also been certified. This paper presents the results for quality indicators (QIs) from 2009 to 2012, based on data from 195,342 primary breast cancer patients, in order to illustrate the development and progress of these centers. Descriptive results on interdisciplinary collaboration (6 QIs), guideline adherence (15 QIs), and specialist expertise (7 QIs) are reported over time. Fulfillment of the certification requirements was high and remained relatively stable over time, with the extent of variation between sites declining. Sites that do not reach the target values are asked to comment on the discrepancies, and their comments, as well as the QI results, are used by centers and auditors during an on-site auditing process and to constantly revise the QIs set out by the guideline and the certification commission. © 2014 Elsevier Ltd. All rights reserved.
Keywords: Breast cancer center Certification Benchmarking German Cancer Society Care quality
Introduction To ensure high standards of breast cancer care in Germany, the German Cancer Society (Deutsche Krebsgesellschaft) and the German Society for Breast Diseases (Deutsche Gesellschaft für Senologie) introduced a certification system in 2003 that included many of the requirements discussed in the EUSOMA position paper [8]. Partly as a response to the poor results in the care of patients with breast cancer in Germany identified in the EUROCARE study [23] and by the German Advisory Council for Concerted Action in Health Care [22], and with strong support both from self-help
* Corresponding author. Tel.: þ49 (0)30 322 932 947; fax: þ49 (0)30 322 932 966. E-mail addresses: [email protected] (C. Kowalski), j.ferencz@ onkozert.de (J. Ferencz), [email protected] (S.Y. Brucker), r. [email protected] (R. Kreienberg), [email protected] (S. Wesselmann). 1 Tel.: þ49 (0)731 705 116 0; fax: þ49 (0)731 705 116 16. 2 Tel.: þ49 (0)7071 29 80791 82211; fax: þ49 (0)7071 29 4805. 3 Tel.: þ49 (0)30 322 932 990; fax: þ49 (0)30 322 932 966. http://dx.doi.org/10.1016/j.breast.2014.11.014 0960-9776/© 2014 Elsevier Ltd. All rights reserved.
organizations and from an appeal by the European Union [7], the certification system was developed with criteria intended to improve multidisciplinary, trans-sectoral, and multiprofessional cooperation, and to implement the contents of evidence-based guidelines in practice [6]. Breast cancer centers were the first specialized cancer centers that were established by the German Cancer Society, followed by centers for colorectal (2006), lung, prostate, skin, and gynecological tumors (all in 2008). Although the vast majority of the certified centers are located in Germany, centers in other countries have also been certified in accordance with the German Cancer Society criteria, including breast cancer centers in Italy, Austria, and Switzerland. The certification system is part of the German Cancer Plan, according to which a certified center is “a network of qualified and jointly certified interdisciplinary and trans-sectoral … institutions that … if possible represent the entire chain of health care for those affected” [10]. According to the requirements of the German Cancer Society and the German Society for Breast Diseases, breast cancer center sites have to provide the disciplines, structures, and processes necessary for diagnosing and treating breast cancerdincluding, but not limited to, genetic testing, treatment of primary as well as
C. Kowalski et al. / The Breast 24 (2015) 118e123
advanced tumors, follow-up and palliative care. Care is to be provided by multidisciplinary teams including all of the relevant medical specialists, as well as social workers and psychologists. The centers need to treat a minimum number of patients per annum and must provide personnel, expertise and equipment. In addition, the certification system requires patient surveys and documentation for quality assurance based on the evidence-based guideline for diagnosis, therapy, and follow-up of breast cancer [17]. The certification process thus ensures that the contents of evidence-based guidelines are implemented in a sustainable way and on a population-wide scale in everyday clinical care. Breast cancer centers are part of the “three-step model” [1] for oncologic care described in the National Cancer Plan, consisting of specialized organ cancer centers (implemented all over the country to provide population-wide quality care for the common tumor entities, such as breast cancer centers and colorectal cancer centers); oncology centers (which pool expertise on several tumor entities, especially rare ones); and comprehensive cancer centers (a few throughout the country, certified by German Cancer Aid, focusing on developing innovative treatment strategies and establishing new standards). This paper describes the development and updating of the requirements for certification and the quality indicators (QIs) specified, and presents the results for the QIs collected during the certification process [5]. The results presented cover patients from a period of four years (2009e2012). Following a description of patient volumes and the development of operating sites, an analysis is given of QIs for interdisciplinary cooperation, guideline adherence, and specialist expertise. The paper then considers whether 1) fulfillment of the requirements has been increasing; and 2) whether differences between sites are becoming smaller over time. Methods Quality indicators and the certification process The German Cancer Society's certification system is divided into three parts: legislative, judicial, and executive. The certification commission, with around 35 experts mandated by the medical and professional associations in the field of breast cancer (among them gynecologists, surgeons, radiotherapists, radiologists, and pathologists), along with self-help organizations, develop a catalog of requirements that contains the quality indicators (QIs) (“legislative”). The certification commission meets every 2 years to update these requirements, taking into account new evidence from clinical guideline updates and from experience gained during certification. Proposals by the committee members, centers, and auditors are collected, formatted and sent out to members by the German Cancer Society office before the committee meeting. During the committee meeting, which takes one full day, all of the proposals are discussed and consented or voted on. The updated requirements become effective the following yeardi.e., updates agreed on in the summer of 2014 were sent out to the centers soon after the meeting to give them time for preparation and will become effective on 1 January 2015. The implementation of these requirements is audited by medical experts working in the field of oncology, on the basis of the data collected (“executive”). These oncologic medical experts are not permitted also to be members of the certification commission. On the basis of the expert and site documentation, the board issuing the certificate decides whether the breast cancer network will be awarded the certificate (“judicial”). Each of the QIs, a substantial part of the certification process, has a distinct definition, and most have margins or targets that need to be reached. This allows for inter-site comparisons, as well as comparison of sites over time. The reported results are discussed not only in the on-site auditing process involving the centers and
119
auditors, but also at meetings of the centers' directors, annually or more frequently in nearly all centers [15]. Anonymized results are additionally reported annually to the public for all breast cancer centers through benchmarking reports [5]. This is done to make the certification system and the results of all the hospitals within the system transparent, but without revealing the centers' names to the public, in order to avoid misguided incentives. Instead, the purpose of the benchmarking reports is to allow the centers to compare their results with those of all the other centers and to develop strategies for improving them. The first breast cancer center sites were certified in 2003, and the number of certified sites was constantly increasing up to the end of 2013 (n ¼ 274 sites). Data collection and analysis The results for the 28 QIs are collected annually using an electronic questionnaire that is submitted to OnkoZert, an independent certification institute that organizes the auditing procedure on behalf of the German Cancer Society. OnkoZert is also responsible for collecting the data, testing their plausibility, and editing them. Quality assurance during the process of data collection and analysis is achieved using various measures. 1) Data received by OnkoZert are checked for completeness, as well as for consistency with the center's other documented results. 2) Most QIs are assigned a plausibility threshold or a target value. If a plausibility threshold or target value is not reached, the center is required to comment on the discrepancy. 3) Following the year of reporting, sites are audited by the trained oncologic medical experts. Prior to the audit, results are sent to the auditor, who carries out initial checking of the results provided. 4) During the audit, further reflection about the results and comments is carried out, along with checks on randomly chosen patient files. The results are published during the subsequent year. Thus, 2012 QI data are audited during 2013, and published in 2014; i.e., the most recent data presented here are based on patients treated in 2012. All of the QIs reported (except for patient volume, breast reconstruction, and case presentation in cases of metastases/local recurrence) consist of fractions in which the denominator represents the total number of patients eligible for a specific procedure and the numerator represents the actual number of patients who were recommended to receive or did receive the procedure concerned. The QIs are in line with established definitions [20], as they measure particular health-care processes and outcomes and are used to monitor and evaluate them. The data presented here are limited to those from the 2009 patient cohort and onwards, at a time when the data collection method and quality assurance procedures were fully established. This paper presents the results for all QIs, in order to provide an overview of the three different groups of QIsdthose relevant to interdisciplinary collaboration, adherence to guideline recommendations, and on specialist expertise. Following a description of the sites included in the analyses, medians are presented for all of the selected QIs and years, along with the proportion of sites that fulfilled the target values in 2012. The analyses were carried out using the Data-WhiteBox, the benchmarking tool developed by OnkoZert, which allows standardized analyses of the data and is at the same time the database for the QI data. Results Site development The annual data presented here are based on the sites that were already certified in the previous year; 274 sites were certified in 2013. Five of these were excluded from the analysis because they had been certified for the first time in 2013 and data recording was
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therefore not obligatory for the whole calendar year. One site was not included due to software changes, leaving 268 sites for analysis. The number of sites certified increased steadily from 2009 to 2012, as did the number of sites considered for benchmarking purposes (Table 1; cf. also www.oncomap.de for a visualization of the geographic distribution of the centers). Table 1 presents an overview of the centers that were certified at the end of the years 2009e2012, centers applying for certification, the number of certified sites, the number of sites the centers consist of, and the number of patients treated in these centers. In 2012, for example, 44 centers consisted of two sites, whereas 169 consisted of only one. Newly applying centers are no longer allowed to consist of more than two sites with every site fulfilling the quantitative requirements. However, centers consisting of three or four sites that were certified before 2012 are allowed to continue. Both the number of sites and the number of centers increased. The number of newly diagnosed patients treated in certified breast cancer centers declined between 2009 and 2010, and subsequently increased again. Of the 274 sites certified in 2013, eight were located outside Germany (four in Switzerland, two in Italy, and two in Austria). Quality indicator results Table 2 presents the data for the 28 QIs. For most of the QIs with target values, the great majority of the sites (75%) reached the targets in 2012. This was the case, for example, for postoperative case presentation; recommendation of radiotherapy (RT) after breast-conserving therapy (BCT) in patients with invasive breast carcinoma; pretreatment histological examination; sentinel lymph-node excision (SLNE) alone in patients staged pN0 without preoperative treatment; details of resection and safety margin; intraoperative sample radiography/ultrasonography after preoperative marking; the number of primary cases; and postoperative wound infection. The medians show a high level of implementation of the requirements over time, which is either increasing or generally stable for all QIs, with the exception of the percentage of study patients and the number of patients receiving breast reconstruction. Additional analyses were conducted (data not presented here) of QIs with target values that were met by less than 75% of the sites and for which data were available for more than 1 year: RT recommended after BCT in patients with ductal carcinoma in situ (DCIS); RT recommended after mastectomy in invasive breast carcinoma; trastuzumab therapy recommended over 1 year in patients with HER-2epositive results; and percentage of study patients. A clear increase in the number of sites that were reaching the target value and a decrease in the degree of variation between sites was observed for RT recommended after BCT in DCIS and for
recommended trastuzumab therapy, but only small changes in the proportion and variation were seen for RT recommended after mastectomy. The percentage of patients included in studies decreased during the period, however, while variation between hospitals increased. Sites are obliged to state the reasons why target values are not met, and some of these reasons are presented in the Discussion section below. For QIs without target values, betweensite variation is generally greater than for QIs with target values (data not presented). Discussion This report presents the results for the quality indicators collected during the process of certifying breast cancer centers in four European countries in accordance with the criteria set out by the German Cancer Society and the German Society for Breast Diseases. Overall, the certified breast cancer centers show a very high level of fulfillment of the QIs. Fulfillment also improved slightly over time, with variation between sites declining slightly, possibly due to a learning effect as a result of the certification process; this has also been observed in other quality improvement programs [26]. There was greater variation between sites for QIs without target values. QIs derived from the national evidencebased guideline show a high level of implementation. Most QIs that refer to specialist expertise show constantly good results over time, with median BCT rates in pT1 of around 85% and hardly any revision operations or postoperative wound surgeries. The percentage of study patients had peaks in 2009 and 2010, when major studies included large numbers of patients. The breast cancer center certification system was introduced partly due to the unsatisfactory results for breast cancer care that were identified in the EUROCARE study [23]. Since then, the available data having been showing a substantial increase in the 5year, age-standardized relative survival rates among breast cancer patients [4,13]. This coincided with improvements in various quality indicators between 2003 and 2010 [19]. In addition to the certification program, a few other factors are also likely to have contributed to these results. First and foremost is progress in diagnosis and therapy, as well as the introduction of evidencebased guidelines and a national breast cancer screening program in Germany. It is difficult to draw any conclusions on whether or to what extent these major efforts contributed causally to the improved patient outcomes. However, available research results based on patient and hospital management perspectives show a high degree of satisfaction with these measures and wide acceptance of them [3,14e16], along with the expected positive effects of compliance with guidelines [29]. The German Cancer Society requirements cover a wider range than those presented by EUSOMA [28], but share a common basis,
Table 1 Development of site structure 2009 to 2012 and patients treated.
Centers newly applying Certified centers Certified sites Centers consisting of 1 site Centers consisting of 2 sites Centers consisting of 3 sites Centers consisting of 4 sites Newly diagnosed patients with breast cancer treated in cert. centers Certified centers with data available Patients from centers with data available
As of December 31, 2013 (primary cases 2012)
As of December 31, 2012 (primary cases 2011)
As of December 31, 2011 (primary cases 2010)
As of December 31, 2010 (primary cases 2009)
2 218 274 169 44 3 2 51,826
6 212 267 163 45 2 2 50,329
4 204 261 153 47 2 2 49,332
8 200 258 149 46 3 2 52,345
268 50,195
256 48,608
252 47,725
246 48,814
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Table 2 Quality indicators, 2009e2012. Quality indicators Postoperative case presentation (1)a Pretreatment case presentation (2) Case discussion of local recurrence/metastases (3) Psycho-oncologic care (>30 min) (12) Social-service counseling (13) Participation in research study (14) Guideline Recommended RT after BCT in cases of inv. BreCa recommendations (4.1) GL QI 6b Recommended RT after BCT in cases of DCIS (5.1) Recommended RT after a mastectomy in cases of inv. BreCa (6.1) GL QI 10 Recommended chemotherapy in cases of steroid receptor negative diagnostic finding (7.1) GL QI 9 Recommended chemotherapy in cases of receptor positive and nodal positive diagnostic finding (8.1) Recommended endocrine therapy in cases of steroid receptor positive diagnostic finding (9.1) GL QI 7 Recommended Trastuzumab therapy over one year in cases of HER-2 positive diagnostic finding (10.1) GL QI 8 Endocrine therapy in cases of metastases (11) GL QI 11 Pre-therapeutic histological confirmation (15) GL QI 1 LN dissection in cases of DCIS (20) GL QI 3 Determination of the nodal status in cases of inv. Br eCa (21) SLNE only in cases of pN0 GL QI 4 (22) Intraoperative specimen radio-/sonography (23) GL QI 2 Specification of the resection margin and safety margin (27) GL QI 5 Report to the cancer registry (28) GL QI 12 Specialist expertise Primary cases BreCa (16) BCT in cases of pT1 primary cases (17) Mastectomies primary cases (18) DCIS in initial procedure primary cases (pTIS) (19) Revision operations primary cases (24) Postoperative wound infection primary cases (25) Breast reconstruction (26) Interdisciplinary collaboration
Median 2012 Median 2011 Median 2010 Median 2009 Target value Sites with target fulfilled 2012 100% 58.3% 18.0 69.0% 87.9% 11.3% 97.8%
100% 46.7% 20.5 66.0% 92.2% 14.1% 98.1%
100% 37.7% 20.0 65.6% 91.6% 22.3% 98.0%
99.3% / / 66.7% 89.5% 21.5% /
95% None None None None 10% 95%
99.3% / / / / 58.6% 90.7%
100% 95.2%
100% 95.6%
100% 95.6%
/ /
95% 95%
72,9% 52.2%
89.5%
90.0%
86.2%
/
80%
89.9%
75.0%
76.1%
77.3%
/
60%
92.2%
96.3%
96.8%
96.7%
/
80%
100%
93.8%
85.7%
83.3%
/
95%
45.5%
82.1%
/
/
/
95%
36.0%
97.5%
97.5%
97.4%
97.6%
90%
97.4%
0.0% 97.7%
/ 97.8%
/ 97.8%
/ 96.9%
5% None
59.9% /
95.2% 100%
95.5% 100%
93.3% 100%
90.7% 100%
80% 95%
97.8% 88.8%
99.9%
99.7%
100%
100%
95%
98.1%
100% 170.5 85.3% 28.6% 10.1% 3.1% 1.4% 15
/ 166.0 84.5% 28.8% 10.1% 2.8% 1.3% 31
/ 166.5 84.3% 28.5% 10.4% 2.6% 1.4% 30
/ 176.5 87.1% 21.6% 10.5% 2.2% 1.3% 27
95% 100 70% None None 5% 5% None
81.4% 88.4% 77.6% / / 86.5% 95.9% /
Proportion of patients eligible for a specific treatment who receive the treatment or the respective recommendation, except “primary cases BreCa,” “Case discussion of local recurrence/metastases,” and “breast reconstruction”: number of cases. a No. in brackets refers to the number of the QI in the benchmark report. b QI derived from evidence based national guideline. GL QI refers to the respective QI in the guideline [17].
in that the ultimate aim is to provide the best available care to the population through multidisciplinary teams in specialized units. The implementation of the requirements reduces the individual risk of not receiving state-of-the-art care, and the declining variation in the extent of implementation over time reduces the risk for patients of being treated at a substandard site. Certification means that a typical planedoecheckeact (PDCA) cycle is effectively incorporated into the daily routine at the breast cancer centers. At the same time, the public receives information about the overall results and the certification process, without being able to identify the respective hospitals. The aim of the reporting system is not to report results openly to the public for each center, but instead allow the centers to work on improving their performance in a process of structured dialog with the auditors. Not openly reporting the results to the public has proved to be useful, since otherwise false reporting or rejection by centers of patients with unfavorable risk profiles may be incentivized. Furthermore, quality indicators designed for public reporting would need a much easier set-up. As yet, there is no system in Germany that provides a care quality benchmark that is openly reported and understood by a substantive part of the population. Centers document treatments and results
and present them in a transparent manner, which allows comparison of their own results from previous years with those of other centers, as well as the subsequent introduction of measures for quality improvement. These measures are developed in collaboration with the auditors, and the effects of the measures taken are reviewed in the following year. In this process, certified breast cancer centers are subject to rigorous quality analysis and improvement. The reporting system that has been established may be able to serve as a model for the many countries that do not yet have programs for reporting quality indicators [9]. It is notable that the efforts that have been undertaken by the centers to implement the quality assurance system have been made without any direct financial compensation. Varying proportions of sites fulfilled the target values. However, not fulfilling the target value does not automatically result in refusal of certification. On the contrary, there may be good reasons why specific criteria have not been fulfilled. Sites are therefore obliged to comment on divergences from target values. One example of an explanation for why a relatively large proportion of sites did not reach the target values for an indicator was that the patients concerned were of advanced age and had comorbidities
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(recommended RT after BCT in invasive breast carcinoma). Discrepancies were investigated by the auditors at the level of patient files, and the explanations were considered adequate at all of the sites concerned. A review of the group of patients with an RT recommendation 1 year later showed that nearly all of the patients did indeed receive RT, except for patients who declined it. The centers' explanations for missed targets are discussed in the certification and guideline commissions, and this may lead to a revision of the QIs involved. This was the case, for example, with the QI for stating resection and safety margins. Other guideline-derived QIs show similarly good implementation of the content of the 2008 guideline [18] in clinical routine over the yearsdsuch as SLNE alone in patients with pN0 and without preoperative treatment. A total of 97.8% of the centers fulfilled this requirement. The six centers that did not meet the target value stated that in addition to the marked sentinel node they had also removed lymph nodes with suspicious palpatory findings intraoperatively during lymph-node sampling, but without performing an axillary dissection. Another example of the implementation of a new, guideline-recommended form of treatment is the recommendation for 1 year of trastuzumab therapy in patients with HER2epositive results after a primary diagnosis of breast cancer. In 2012, this treatment had become an established standard, and only older patients or patients with comorbidities and contraindications did not receive a recommendation for it. In addition to guideline-derived QIs, it can be seen that different national requirements lead to relatively large variation in the QIs for some indicators. For example, six of the 11 sites in which
