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ScienceDirect EJSO 40 (2014) 1387e1390

www.ejso.com

Editorial

Quality Assurance in Surgical Oncology the EURECCA platform Quality assurance awareness is rapidly expanding in Surgical Oncology, where surgery is still offering the most effective curative cancer treatment. By monitoring cancer treatment outcomes, new tools will be generated to aid our advancement and assist us to minimise complications and increase rates of survival. In the era of modern cancer care; audits and registries are available for almost all tumour types. Most disciplines have embraced the knowledge that ‘structured data collection, combined with feedback’, delivers very valuable information that allows us to change internal organisational structures. As the pioneers in auditing, surgeons have been able to improve their results by actively reviewing outcome data and centralizing complex surgical procedures.1 Personalised medicine is coined as ‘the right treatment, for the right person, at the right time’, is a significant shift from ‘one-size-fits all’ medicine to a ‘tailor-made’ individualised approach which will and ought to be, the future of medicine. Now that we are beginning to understand how each tumour might be unique and each patient is an exclusive host, we need to acquire new, validated tools to identify who benefits from specific treatments. Due to the fact that cancer treatment registries are not homogenous this is more for selections in clinical trials; this may be creating more cons than pros for specific patient groups, as, cancer registries show, how the increasing use of palliative treatments in Stage IV patients does not in fact necessarily result in improved patient outcomes. These registries also produce several reports asking for further investigation in the selection process.2 The European Society of Surgical Oncology challenges surgeons to take the lead on Quality Assurance e a dynamic process where quality indicators, case-mix adjustments and high-end benchmarking are still open for debate. Not all issues are resolved regarding data collection or feedback; identifying the most robust quality indicators is not an easy task, when the number of retrieved information remains inevitably limited. Despite the fact that different EU countries have been using different data collection techniques, as well as different versions of the TNM classification (posing a significant challenge to the international comparison of cancer http://dx.doi.org/10.1016/j.ejso.2014.08.478 0748-7983/Ó 2014 Published by Elsevier Ltd.

outcomes) it has been possible to identify minimal data sets for several tumour types, which have been shared between different international registries. This is the foundation for proper population-based research.3,4 Capturing the most relevant factors influencing outcomes following cancer treatments remains a ‘test case’. Traditional outcome parameters are incidence, mortality, overall survival, disease-free survival, and cancer-specific survival. Nowadays, surgeons are also interested in feedback on postoperative complications, i.e. complete resection, leakages and reoperations, each of which might influence long-term outcomes. From a patient perspective, what is most important, is making the process of collecting data on more subjective outcomes mandatory; i.e. compliance with treatment, quality of life, chronic pain, body image changes, organ dysfunction (sexual, intestinal, bladder) and rehabilitation after cancer treatment. With the current advances in cancer treatment, survivorship and quality of life are crucially important patient-centred issues to be scrutinized. In the present climate of financial restrictions, policy makers, consumers and patients lobbies are also interested in cost-effectiveness and financial implications of the entire system. It is definitively a physicians’ responsibility to identify the most suitable, patient-friendly and costeffective treatment modality for each individual patient; as much as it’s in the right of the community to be informed about marginally advantageous and perhaps excessively expensive treatment options. Our priority is to identify and promote safe, effective, efficient, timely, equitable, patient-centred cancer care; a treatment plan that achieves optimal outcomes e effective pathways of care which will respect and aim to be based on tailor-made approaches. A critical appraisal is mandatory to fulfil our responsibility and provide adequate advice to the community. Clinical trials versus population-based observational research Clinical trials are an important source of evidence for treatment recommendations; they represent the foundation

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for the development evidence-base clinical guidelines. There are, never the less, several important limitations to the conclusions derived from randomised trials; these should be taken into account before extrapolating such findings into standards of treatment for the general population. When less than 1% of all cancer patients are treated within clinical trials, it is legitimate to suspect a selection bias; this might generate unsuitable results for those patients who do not meet the inclusion criteria. Patients with different combinations of comorbidities, rare tumour characteristics or simply old age are often excluded from randomised clinical trials. Elderly cancer patients, as well as the youngest ones, are at risk of either under- or over-treatment. The largest number of tumours peaks at an old age and elderly patients present the worst cancer-specific survival. Interestingly, even when older patients are included into methodologically accurate clinical trials, they are not representative of older patients from the general population.5 Furthermore, when using well validated decision making tools such as “Adjuvant! Online”, it appears that, even these tools are not capable of accurately predicting overall survival or recurrence rates in the elderly subgroup.6 Randomised clinical trials’ inclusion and exclusion criteria are there to ensure that a population is homogeneously and that statistical significance can be reached for the study population. An accurate selection of the study group implies a smaller sample size in order to achieve 80% power. Patient selection, such as age or comorbidity, may thus result in a selection bias. Another point of concern is the publication bias. All unpublished negative trials will eventually have an impact on the design of clinical guidelines: on one side negative results are undisclosed and kept in the dark; on the other, published trials might be excessively weighted when a metaanalysis is conducted. The definition of national guidelines is heavily influenced by the outcomes of national investigations, while different countries usually tend to develop different cancer treatment guidelines. An example of this comes from the TME trial studying the value of preoperative short-term radiotherapy in combination with a total mesorectal excision (TME) and reporting a better local control. Consequently, the 2008 Dutch rectal cancer guidelines endorsed preoperative radiotherapy for rectal cancer. However, the 12-year follow up study on these patients demonstrated a reduced 10-year local recurrence incidence without an overall survival benefit between the two randomised groups.7 Patterns of care in rectal cancer among several European countries demonstrate how rectal cancer patients in the Netherlands are receiving an excess of radiotherapy when compared to other countries, without shortterm survival benefits.8 Uniform data collection is mandatory to bring light on the value of adjuvant chemotherapy after curative surgery: this is not recommended as a standard in the Netherlands, whilst it is in other EU countries. A comparison between

the two treatment options according to geographical areas would clarify the value of such a treatment option, provided that the data is collected consistently and coherently. It is thus likely that, large observational populationbased registries, with complete and accurate information, may provide a better reflection of the quality of cancer management and its outcomes when compared to furthering the number of randomised trials. Ideally, population-based research should be designed as a comparison between different geographical areas, each one presenting individual treatment plans. To optimise population-based observational research, we will most likely head towards realtime data entry, where the information is prospectively collected “as it happens”. It is thus advisable to promote international prospective observational research and propose the re-evaluation of such investigations to a higher level of evidence than randomised controlled trials. However, large observational population-based research requires uniform data collection. Population-based registries e Where do we stand? Several EU-funded projects i.e. Eurocourse, EUROCARE and EUROCHIP, show considerable differences in the way the data is collected, the collected items and the budget for registration. Moreover, all these different data collections show significant variation in cancer outcomes across the EU for individual tumour groups.9,10 The relevance of this kind of research is obvious and should not be project dependent. Surgical Oncologists are fully aware of the absolute need for a coherent and standardized collection of prospective international data which is essential to establish collaborative population-based research. Large prospective population-based observational databases are the foundation of future clinical research. The EURECCA initiative EURECCA, the European Registration of Cancer Care, is a fast growing platform of health care professionals, epidemiologists and patients, aiming at improving cancer outcomes. Quality assurance awareness and high quality patient-centred care are both key priorities. Absolute priorities are: a) developing uniform, prospective registries and b) providing guidance and feedback. Moreover, e-learning modules and other educational initiatives are being developed to increase awareness of minimal standards of cancer care. EURECCA promotes a multidisciplinary approach in a complex and dynamic oncological landscape; EURECCA supports patients and health care professionals by providing the infra-structure and facilitating the establishment of minimal standards of high quality cancer care. EURECCA relies on recognized opinion leaders in several areas of cancer care who are committed to the success of the project. For the time being, within the EURECCA platform we have four active tumour site groups:

Editorial / EJSO 40 (2014) 1387e1390

colorectal, breast, oesophago-gastric and hepato-pancreatobiliary cancers. Prostate cancer group and lung cancer are currently initiated. EURECCA’s colorectal group was founded by Cornelis van de Velde in 2007 as an ESSO/ ECCO initiative. More information about the organisational structure and performance of the EURECCA project can be found through www.canceraudit.eu and the URL http:// www.essoweb.org/eursso/quality-assurance/eureccaproject.html. EURECCA endeavours to establish international harmonized comparisons; as a spider in a web of organisations it connects to all and seeks for synergy of combined forces. As an example, an exciting project to be launched at the 34th Congress of the European Society of Surgical Oncology, Liverpool 29e31 of October 2014, is the analysis of large cohorts of the oldest olds (80 years or more) surgically treated for rectal and colon cancer across 8 European countries, which will provide a significant outlook across the operative approach and adjuvant therapies in this age group. An international database of patients with complete remission after neoadjuvant treatment for rectal cancer is being designed to allow an international web-based prospective accrual and data comparison. Its launch is planned for May 2015. A prospective international registry of nipple-sparing mastectomies will also be initiated soon as an international web-based data collection. The importance of auditing Registration of patient characteristics and treatment outcomes will allow insights into physicians and institutional performance; it will also generate tools to improve internal structures. Despite the fact that cancer registries have been collecting such data for a long time, there is a lack of agreement on the standardization of international data collection and this seems to hamper any valuable international

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comparison. Since international comparisons seem to be powerful generators of health care improvement, a structured data collection has become a top priority. Auditing, by means of standardized data collection, analysis and feedback, is a powerful instrument to improve performance, not just in health care issues. Careful auditing has overtly changed the standards of care of rectal cancer patients across Western Europe. An important question remains; how we can capture good quality population-based cancer care data in Europe and how can we do better? Real-time dashboard outputs of cancer care would give us valuable information to improve and intervene rapidly when cancer care can be improved. Although quality assurance and audit is embedded in the health care system of most high-income Northern European countries, a huge variation in the patterns of care can still be found. The potential to positively impact on cancer care at a European level should become more obvious to policy makers, while European commission programs should prioritise registries of clinical cancer care. EURECCA, a unique collaboration between patients, health care professionals and epidemiologists has the ability to become the interface combining forces and improving cancer care across Europe. Interested in taking part? All types of cancer registries and regional/national clinical audits are welcome to participate to the EURECCA platform: ‘a better future requires international cancer registration’. Please join in! Petra G. Boelens, MD, PhD, Surgical Oncologist, CEO EURECCA. Riccardo A. Audisio, MD, President-elect ESSO, Chair EURECCA Breast group. Cornelis J.H. van de Velde, MD, PhD, President EURECCA, Past-president ESSO and ECCO.

EURECCA tumour site group

EURECCA Board, Chairs of Surgery

Research support centre at the Department of Surgery, LUMC

Contact www.canceraudit.eu www.essoweb.org

EURECCA General

Founder/President: Cornelis van de Velde CEO: Petra Boelens Chair of Surgery: Pawel Mroczkowski

CEO: Petra Boelens, Epidemiology: Valery Lemmens

[email protected]

Anne Breugom, Marloes Swets, Esther Bastiaannet, GJ Liefers Wobbe de Steur, Esther Bastiaannet, Henk Hartgrink Mandy Kiderlen, Esther Bastiaannet, GJ Liefers Noor de Leede Noor de Leede

[email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected]

Executive Board Colorectal cancer Oesophageal gastric cancer Breast cancer Pancreatic cancer Liver primary and secondary cancer Prostate cancer Lung cancer

Chair of Surgery: Bill Allum Chair of Surgery: Riccardo Audisio Chair of Surgery: Bert Bonsing Chair of Surgery: Graeme Poston Chair of Urology: Theo de Reijke Chair of Surgery: Michel Wouters

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References 1. Breugom AJ, Boelens PG, van den Broek CB, et al. Quality assurance in the treatment of colorectal cancer: the EURECCA initiative. Ann Oncol 2014;25(8):1485–92. 2. Klaver YL, Lemmens VE, Creemers GJ, Rutten HJ, Nienhuijs SW, de Hingh IH. Population-based survival of patients with peritoneal carcinomatosis from colorectal origin in the era of increasing use of palliative chemotherapy. Ann Oncol 2011;22(10):2250–6. 3. de Steur WO, Henneman D, Allum WH, et al. Common data items in seven European oesophagogastric cancer surgery registries: towards a European upper GI cancer audit (EURECCA Upper GI). Eur J Surg Oncol 2014;40(3):325–9. 4. van Gijn W, van den Broek CB, Mroczkowski P, et al. The EURECCA project: data items scored by European colorectal cancer audit registries. Eur J Surg Oncol 2012;38(6):467–71. 5. van de Water W, Kiderlen M, Bastiaannet E, et al. External validity of a trial comprised of elderly patients with hormone receptor-positive breast cancer. J Natl Cancer Inst 2014;106(4):dju051.

6. de Glas NA, van de Water W, Engelhardt EG, et al. Validity of adjuvant! Online program in older patients with breast cancer: a population-based study. Lancet Oncol 2014;15(7):722–9. 7. van Gijn W, Marijnen CA, Nagtegaal ID, et al. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial. Lancet Oncol 2011;12(6):575–82. 8. van den Broek CB, Kolfschoten NE, van Gijn W, et al. The EURECCA initiative e differences in treatment and short term outcome of rectal cancer. Eur J Cancer 2011;47(Suppl. 1):418.. [Ref Type: Abstract]. 9. De Angelis R, Sant M, Coleman MP, et al. Cancer survival in Europe 1999e2007 by country and age: results of EUROCARE-5ea population-based study. Lancet Oncol 2014;15(1):23–34. 10. Siesling S, Kwast A, Gavin A, Baili P, Otter R. Availability of stage at diagnosis, cancer treatment delay and compliance with cancer guidelines as cancer registry indicators for cancer care in Europe: results of EUROCHIP-3 survey. Int J Cancer 2013;132(12): 2910–7.

Quality assurance in surgical oncology the EURECCA platform.

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