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The handle http://hdl.handle.net/1887/55893 holds various files of this Leiden University dissertation.
Author: Busweiler, L.A.D.
Title: Evaluating quality of care and setting future goals in oesophagogastric cancer treatment
Issue Date: 2017-11-29
Ch ap te r
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Introduction and outline of this thesis
INTRODuCTION AND OuTLINE OF THIS THESIS
Cancer care is increasingly recognized as a major worldwide challenge given its global, financial, social, and health implications1. The prevalence of cancer, primarily a disease of aging, is increasing. Together with rapid innovations in technology and treatments strategies, this puts a heavy burden on current health care. Moreover, the need to satisfy patients’ ex- pectations and the use of pay-for-performance models for the reimburse- ment of health care providers require a critical review of current practice.
This demand for performance has become a major issue for today’s healthcare system and has spurred the development of many national and international quality improvement initiatives2,3.
Evaluating quality in cancer care
In 2007, the Signalling Committee Cancer of the Dutch Cancer Society evaluated quality of cancer care in the Netherlands4. In their report ‘Qual- ity of Cancer Care’ the committee concluded that the overall quality of care for cancer patients in the Netherlands was high, though reducing variation between hospitals could lead to further improvement. Intro- ducing quality standards for organisation of care on the one hand, and monitoring and benchmarking patient outcomes between providers on the other hand, were suggested as strategies to reduce variation and to improve quality of care.
Where benchmarking is common in most branches, this is not the case for health care. Benchmarking made its first appearance in the healthcare system in the mid 1990’s and involves a sustained effort to measure outcomes, compare these outcomes against those of other organizations, learn how those outcomes were achieved, and apply the lessons learned in order to improve3. To do so, useful, reliable and up-to-date information is essential.
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Following international examples of successful clinical audits, in 2009 the Dutch Surgical Colorectal Audit (DSCA) was initiated5. With this audit colorectal cancer surgeons were among the first to embrace a nationwide clinical registry and implement clinical benchmarking in the Netherlands.
Shortly after, a second national audit on the quality of surgery for upper gastrointestinal (GI) cancer was initiated6.
Cancer of the upper GI tract
Cancer of the upper GI tract includes both oesophageal cancer and gastric cancer. In the Netherlands, the incidence of oesophageal cancer increased during the last two decades7, whilst the incidence of gastric cancer de- creased8. Approximately 2,200 patients are diagnosed with oesophageal cancer, and 1,200 patients are diagnosed with gastric cancer, each year.
Despite significant improvements in diagnostic modalities and treatment, prognosis remains dismal with 5-year survival rates around 20 per cent7,8.
Multimodality treatment
In Western countries, surgery combined with multimodality therapy has become standard of care for patients with advanced oesophagogastric cancer. In several studies performed in Europe and the United States, the benefits of multimodal therapy on both disease free and overall survival have been shown9-13. However, international consensus on the best multimodal approach has not yet been reached. According to Dutch treatment guidelines, all patients with potentially curable oesophageal or oesophagogastric-junction cancer (above T1) should be treated with preoperative chemoradiotherapy10,14. For patients with non-metastasized resectable gastric cancer (excluding stage I) perioperative chemotherapy is recommended9,15.
High-risk surgery and centralization
Although the treatment of both oesophageal cancer and gastric cancer requires a multidisciplinary approach, surgical resection remains the cornerstone of curative treatment. Oesophagectomies and gastrectomies for cancer are complex surgical procedures with considerable morbidity and mortality16-20. Next to technical skills needed to perform the opera- tion, careful patient selection with accurate staging and risk assessment are essential21. Moreover, early recognition and timely management of serious complications once they occur, are needed to prevent the patient from dying postoperatively. This requires the presence of an experienced surgical team working in the context of a well-structured multidisciplinary environment with excellent hospital facilities, appropriate consultative and critical care staff, experienced nursing staff and perioperative clinical pathways22-25. To increase the experience and expertise of surgical teams, minimum volume standards were introduced by the professional society, the Association of Surgeons in the Netherlands (ASN). For oesophageal cancer surgery, a minimum volume standard was set at 20 resections per hospital per year in 2011. For gastric cancer surgery, a minimum volume of ten resections per hospital per year in 2012, and 20 resections per hospital per year as of 2013, was required.
The Dutch upper GI Cancer Audit
After the initiation of the DSCA in 2009, the Dutch Institute for Clinical Auditing (DICA) was founded in 2011 with the objective to facilitate and organize the initiation of nationwide audits in a uniform format. In the same year, the Dutch Upper GI Cancer Audit (DUCA) group began a nationwide registration of all patients with oesophageal or gastric can- cer who underwent surgery with the intent of a surgical resection with or without preoperative therapy. The main purpose of the DUCA was to improve the quality of care for these patients by providing (surgical) teams with reliable, benchmarked information on process and (case mix-
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adjusted) outcome parameters regarding their patients. The initiation and implementation of the DUCA, together with an overview of the first results, are described in Chapter 26.
Hospital comparisons
Reducing hospital variation was recommended by the Signalling Com- mittee Cancer for further quality improvement. In order to display such variation in hospital performance, a widely used graphical aid is the funnel plot26. This plot shows the outcome of interest (vertical axis) per hospital using 95.0 per cent or 99.8 per cent control limits. Those hos- pitals that fall outside these control limits can be identified as potential outliers and could be subject for an in-depth investigation. Identifying such outliers becomes a challenge when evaluating high complex and low volume surgery, like resections for oesophageal and gastric cancer monitored in the DUCA. Minimum volume standards are set, but annual volumes vary considerably between hospitals6. In Chapter 3, alternative statistical approaches using funnel plots that can be used for displaying variation in hospital performance within the context of clinical auditing are described27.
International benchmarking
In several European countries, registries for collecting detailed clinical information about patients treated for oesophagogastric cancer have been started. For instance, the Swedish National Register for Oesophageal and Gastric Cancer (NREV) was launched in 2006 and the British National Oesophago-Gastric Cancer Audit (NOGCA) started collecting detailed information about this group of patients in 201128,29. These clinical audit systems on oesophagogastric cancer care provide opportunities for benchmarking on a European level30,31. In a previous study, postoperative mortality for patients with gastric cancer in the Netherlands was high com- pared with that in other European countries32. In Chapter 4, a comparison
is made between the results from the DUCA and those from the NREV33. Are there any differences between patient and treatment characteristics and how do the surgical outcomes as registered in the DUCA compare to those in the Swedish registry?
Textbook outcome
In previous years, quality measurements for outcome of complex surgical procedures have focussed on readily available and easily understand- able parameters, such as procedural volume, in-hospital mortality and duration of postoperative hospital stay34-37. This provides information on a single parameter and the multidimensional aspect of the whole surgical process is not valued. As proposed by the Institute of Medicine, health care should be safe, effective, patient-centred, timely, efficient and equitable38. For patients undergoing potentially curative oesophago- gastric cancer surgery, the surgical process can be considered safe if no adverse outcomes (mortality and morbidity) have occurred, and effective if complete tumour removal and adequate lymphadenectomy have been achieved. This information is gathered in the composite measure textbook outcome (Chapter 5)39.
Failure-to-rescue
Failure-to-rescue (FTR) is a relatively new quality parameter and was first described in patients undergoing coronary artery bypass graft (CABG) sur- gery by Silber et al40. FTR is defined as the mortality rate among patients with post interventional complications. In general, timely recognition and effective management of postoperative complications may have a great positive effect on prevention of postoperative mortality. This might be even more true for postoperative management of oesophagogastric can- cer patients, as it concerns a relatively frail group of patients, after major surgery, who are prone to quick clinical deterioration once a complication has occurred. In Chapter 6 trends in postoperative outcomes are evalu-
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ated and a comparison is made between patients with oesophageal and those with gastric cancer41. Can differences in FTR rates after oesophageal cancer resections versus those after gastric cancer resections be explained by differences in patient, tumour and treatment characteristics?
Composite hospital volume
In the Netherlands, both oesophageal and gastric cancer resections are performed by certified gastro-intestinal surgeons. One could infer a mutual benefit of combining these procedures in specialized centers. In Dutch treatment guidelines, it is described that gastric cancer surgery is preferrably centralized towards hospitals with broad experience in oesophageal cancer surgery. A dedicated multidisciplinary team with well-trained surgeons, operative teams familiar with these procedures, dedicated anaesthesiologists, a specialized Intensive Care Unit and an experienced nursing staff at the hospital ward might result in better out- comes. If placed under a broader scope, the quality of gastric cancer sur- gery might also benefit from shared experience with other high complex upper GI cancer resections such as pancreatectomies. Is such a composite hospital volume associated with improved postoperative outcomes for patients undergoing surgery for gastric cancer? (Chapter 7)42
REFERENCES
1. Lyerly HK, Abernethy AP, Stockler MR, et al. Need for global partnership in cancer care: perceptions of cancer care researchers attending the 2010 australia and Asia pacific clinical oncology research development workshop. J Oncol Pract 2011;7(5):
324-329.
2. Berwick DM. Era 3 for Medicine and Health Care. Jama 2016;315(13): 1329-1330.
3. Ettorchi-Tardy A, Levif M, Michel P. Benchmarking: a method for continuous qual- ity improvement in health. Healthc Policy 2012;7(4): e101-119.
4. Wouters MW, Jansen-Landheer ML, van de Velde CJ. The Quality of Cancer Care initiative in the Netherlands. Eur J Surg Oncol 2010;36 Suppl 1: S3-s13.
5. Van Leersum NJ, Snijders HS, Henneman D, et al. The Dutch surgical colorectal audit. Eur J Surg Oncol 2013;39(10): 1063-1070.
6. Busweiler LA, Wijnhoven BP, van Berge Henegouwen MI, et al. Early outcomes from the Dutch Upper Gastrointestinal Cancer Audit. Br J Surg 2016;103(13): 1855-1863.
7. Dikken JL, Lemmens VE, Wouters MW, et al. Increased incidence and survival for oesophageal cancer but not for gastric cardia cancer in the Netherlands. Eur J Cancer 2012;48(11): 1624-1632.
8. Dassen AE, Dikken JL, Bosscha K, et al. Gastric cancer: decreasing incidence but stable survival in the Netherlands. Acta Oncol 2014;53(1): 138-142.
9. Cunningham D, Allum WH, Stenning SP, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med 2006;355(1):
11-20.
10. van Hagen P, Hulshof MC, van Lanschot JJ, et al. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med 2012;366(22): 2074-2084.
11. Ychou M, Boige V, Pignon JP, et al. Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial. J Clin Oncol 2011;29(13): 1715-1721.
12. Macdonald JS, Smalley SR, Benedetti J, et al. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastro- esophageal junction. N Engl J Med 2001;345(10): 725-730.
13. Sjoquist KM, Burmeister BH, Smithers BM, et al. Survival after neoadjuvant che- motherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol 2011;12(7): 681-692.
14. Oncoline. Guideline Treatment Gastric Carcinoma. http://www.oncoline.nl/
maagcarcinoom [accessed 21 June 2017].
Chapter 1
16
15. Oncoline. Guideline Treatment Oesophageal Carcinoma. http://www.oncoline.nl/
oesofaguscarcinoom [accessed 21 June 2017].
16. Connors RC, Reuben BC, Neumayer LA, et al. Comparing outcomes after trans- thoracic and transhiatal esophagectomy: a 5-year prospective cohort of 17,395 patients. J Am Coll Surg 2007;205(6): 735-740.
17. Bailey SH, Bull DA, Harpole DH, et al. Outcomes after esophagectomy: a ten-year prospective cohort. Ann Thorac Surg 2003;75(1): 217-222.
18. Damhuis RA, Meurs CJ, Dijkhuis CM, et al. Hospital volume and post-operative mortality after resection for gastric cancer. Eur J Surg Oncol 2002;28(4): 401-405.
19. Ikeguchi M, Oka S, Gomyo Y, et al. Postoperative morbidity and mortality after gas- trectomy for gastric carcinoma. Hepatogastroenterology 2001;48(41): 1517-1520.
20. Lepage C, Sant M, Verdecchia A, et al. Operative mortality after gastric cancer resection and long-term survival differences across Europe. Br J Surg 2010;97(2):
235-239.
21. Grotenhuis BA, van Heijl M, Zehetner J, et al. Surgical management of submu- cosal esophageal cancer: extended or regional lymphadenectomy? Ann Surg 2010;252(5): 823-830.
22. Ghaferi AA, Dimick JB. Importance of teamwork, communication and culture on failure-to-rescue in the elderly. Br J Surg 2016;103(2): e47-51.
23. Sheetz KH, Dimick JB, Ghaferi AA. Impact of Hospital Characteristics on Failure to Rescue Following Major Surgery. Ann Surg 2016 Apr;263(4):692-7.
24. Ghaferi AA, Birkmeyer JD, Dimick JB. Hospital volume and failure to rescue with high-risk surgery. Med Care 2011;49(12): 1076-1081.
25. Nguyen NT, Paya M, Stevens CM, et al. The relationship between hospital vol- ume and outcome in bariatric surgery at academic medical centers. Ann Surg 2004;240(4): 586-593; discussion 593-584.
26. Spiegelhalter DJ. Funnel plots for comparing institutional performance. Stat Med 2005;24(8): 1185-1202.
27. Busweiler LA, Schouwenburg MG, Amodio S, et al. Alternative methods displaying variation in hospital performance in oesophageal cancer surgery using funnel plots. Submitted.
28. Health and Social Care Information Centre. National Oesophago-Gastric Cancer Audit (NOGCA). http://www.hscic.gov.uk/org [accessed 21 October 2015].
29. Linder G, Lindblad M, Djerf P, et al. Validation of data quality in the Swedish National Register for Oesophageal and Gastric Cancer. Br J Surg 2016;103(10):
1326-1335.
30. de Steur WO, Henneman D, Allum WH, et al. Common data items in seven Euro- pean oesophagogastric cancer surgery registries: towards a European upper GI cancer audit (EURECCA Upper GI). Eur J Surg Oncol 2014;40(3): 325-329.
31. Messager M, de Steur WO, van Sandick JW, et al. Variations among 5 European countries for curative treatment of resectable oesophageal and gastric cancer:
A survey from the EURECCA Upper GI Group (EUropean REgistration of Cancer CAre). Eur J Surg Oncol 2016;42(1): 116-122.
32. Dikken JL, van Sandick JW, Allum WH, et al. Differences in outcomes of oesopha- geal and gastric cancer surgery across Europe. Br J Surg 2013;100(1): 83-94.
33. Busweiler LA, Jeremiasen M, Wijnhoven BP, et al. International benchmarking in oesophageal and gastric cancer surgery using Swedish and Dutch quality regis- tries. Submitted.
34. Birkmeyer JD, Siewers AE, Finlayson EV, et al. Hospital volume and surgical mortal- ity in the United States. N Engl J Med 2002;346(15): 1128-1137.
35. Chowdhury MM, Dagash H, Pierro A. A systematic review of the impact of volume of surgery and specialization on patient outcome. Br J Surg 2007;94(2): 145-161.
36. Dikken JL, Dassen AE, Lemmens VE, et al. Effect of hospital volume on postop- erative mortality and survival after oesophageal and gastric cancer surgery in the Netherlands between 1989 and 2009. Eur J Cancer 2012;48(7): 1004-1013.
37. Wouters MW, Gooiker GA, van Sandick JW, et al. The volume-outcome relation in the surgical treatment of esophageal cancer: a systematic review and meta- analysis. Cancer 2012;118(7): 1754-1763.
38. Institute of Medicine Committee on Quality of Health Care in America. Crossing the Quality Chasm: a New Health System for the 21st Century. National Academies Press, National Academy of Sciences:Washington, 2001.
39. Busweiler LA, Schouwenburg MG van Berge Henegouwen MI, et al. Textbook outcome as a composite measure in oesophagogastric cancer surgery. Br J Surg 2017;104(6): 742-750.
40. Silber JH, Rosenbaum PR, Schwartz JS, et al. Evaluation of the complication rate as a measure of quality of care in coronary artery bypass graft surgery. JAMA 1995;274(4): 317-323.
41. Busweiler LA, Henneman D, Dikken JL, et al. Failure-to-rescue in patients undergo- ing surgery for esophageal or gastric cancer. Eur J Surg Oncol 2017 Oct;43(10):1962- 1969.
Chapter 1
18
42. Busweiler LAD, Dikken JL, Henneman D, et al. The influence of a composite hos- pital volume on outcomes for gastric cancer surgery: A Dutch population-based study. J Surg Oncol. 2017 May;115(6):738-745.
