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L.A.D. Busweiler1,2_{, M.G. Schouwenburg}1,2_{, M.I. van Berge Henegouwen}3_{, N.E. Kolfschoten}1_, P.C. de Jong4_{, T. Rozema}5_{, B.P.L. Wijnhoven}6_{, R. Van Hillegersberg}7_{, M.W.J.M. Wouters}1,8_{, J.W.} van Sandick8_{, on behalf of the Dutch Upper Gastrointestinal Cancer Audit (DUCA) group.}

1_{Dutch Institute for Clinical Auditing, Leiden}

2_{Department of Surgery, Leiden University Medical Centre, Leiden} 3_{Department of Surgery, Academic Medical Centre, Amsterdam} 4_{Department of Medical Oncology, St Antonius Hospital, Nieuwegein} 5_{Department of Radiation Oncology, Institute Verbeeten, Tilburg} 6_{Dept. of Surgery, Erasmus Medical Centre, Rotterdam}

7_{Department of Surgery, University Medical Centre Utrecht, Utrecht}

8_{Department of Surgical Oncology, Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital,} Amsterdam

ABSTRACT

Background: Quality assurance is acknowledged as a crucial factor in the assessment of oncological surgical care. The aim of this study was to develop a composite measure of multiple outcome parameters defined as ‘textbook outcome’, to assess quality of care for patients undergoing oesophagogastric cancer surgery.

Methods: Patients with oesophagogastric cancer, operated on with the intent of curative resection between 2011 and 2014, were identified from a national database (Dutch Upper Gastrointestinal Cancer Audit). Text- book outcome was defined as the percentage of patients who underwent a complete tumour resection with at least 15 lymph nodes in the resected specimen and an uneventful postoperative course, without hospital readmission. Hospital variation in textbook outcome was analysed after adjustment for case-mix factors.

Results: In total, 2748 patients with oesophageal cancer and 1772 with gastric cancer were included in this study. A textbook outcome was achieved in 29.7 per cent of patients with oesophageal cancer and 32.1 per cent of those with gastric cancer. Adjusted textbook outcome rates varied from 8.5 to 52.4 per cent between hospitals. The outcome param- eter ‘at least 15 lymph nodes examined’ had the greatest negative impact on a textbook outcome both for patients with oesophageal cancer and for those with gastric cancer.

Conclusion: Most patients did not achieve a textbook outcome and there was wide variation between hospitals.

INTRODuCTION

Quality assurance is acknowledged as a crucial factor in the assessment of oncological surgical care. In 2010, the Quality of Cancer Care initiative of the Dutch Cancer Society was made responsible for the evaluation of quality of cancer care in the Netherlands1_{. It was concluded that the over-}

all quality of care for patients with cancer in the Netherlands was high, although reduction in variation between hospitals could lead to further improvement. Introducing quality standards for procedural volume and organization of care, on the one hand, and monitoring and comparing patient outcomes between providers, on the other, were suggested to re- duce variation and improve the quality of cancer care1_{. In 2011, the Dutch}

Upper Gastrointestinal Cancer Audit (DUCA) group initiated a nationwide registry of all patients with oesophageal or gastric cancer in whom a surgical resection is planned2_{. The DUCA was set up as a surgical qual-}

ity improvement programme by providing surgical teams with reliable, weekly updated and benchmarked information on the quality of care they provide. However, debate remains on which parameters best reflect surgi- cal quality. According to the Donabedian paradigm, parameters can be re- lated to structure, process or outcome of healthcare, and each has unique advantages and limitations3–5_{. Over the past few years, quality assessment}

for complex surgical procedures has focused on procedural volume in relation to outcome measures such as surgical mortality6–9_{. This provides}

information only on a single parameter, and the multidimensional aspect of the whole surgical process is not valued. The aim of this study was to develop a composite measure of multiple outcome parameters, defined as a ‘textbook outcome’, in patients undergoing surgery for oesophago- gastric cancer. Hospital variation regarding this new composite measure was analysed.

METHODS

The data set was retrieved from the DUCA, a national surgical outcome registry including all patients with primary or recurrent oesophageal or gastric cancer in the Netherlands who undergo surgery with the intent of resection. Patients with non-epithelial tumours are not included in the registry. No ethical approval or informed consent was required for this study, under Dutch law. Case ascertainment for the DUCA in 2013 was estimated at 97.8 per cent of all primary oesophageal cancer resections and 96.2 per cent of all primary gastric cancer resections, as registered in the Netherlands Cancer Registry2_.

Patients

All patients with oesophagogastric cancer who underwent surgery with the intent of curative resection for oesophageal or gastric cancer, regis- tered in the DUCA between 2011 and 2014, were included. Patients with carcinoma in situ were excluded. A minimum number of items for a patient to be considered eligible for analyses included: information on tumour location, date of birth, date of surgery, nature of surgery as defined at the end of the operation (potentially curative resection, palliative resection or no resection) and the patient’s status 30 days after surgery and/or at time of discharge.

Parameters and definitions

A selection of relevant outcome parameters reflecting an uneventful course was determined by expert opinion within the DUCA scientific committee and placed in chronological order: radical resection accord- ing to the surgeon at the end of surgery, no intraoperative complication, tumour-negative resection margins, at least 15 lymph nodes retrieved and examined, no severe postoperative complication, no reintervention, no readmission to the ICU or medium-care unit, no prolonged hospital

stay (21 days or less), no postoperative mortality, and no readmission after discharge from hospital. A textbook outcome was achieved when all ten parameters were realized. In the first 3 years of the audit, the definition of the Royal College of Pathologists was used to describe a microscopically radical resection (R0)10,11_{. In 2014, this was changed to the definition of the}

College of American Pathologists (CAP)12,13_{. According to the CAP, resection}

margins are considered positive when tumour cells are present within the surgical margin, whereas the Royal College of Pathologists also includes tumour cells within 1mm of this margin14_{. Postoperative complications}

of grade II or higher according to the Clavien–Dindo classification15 _were

considered severe. A reintervention was defined as a reoperation, or an endoscopic or radiological reintervention. Postoperative mortality was defined as death during the initial hospital stay and/or within 30 days after the day of surgery.

Statistical analysis

National results for a textbook outcome were calculated both for patients with oesophageal cancer and for those with gastric cancer, and results for different years of registration were compared using the X2 _{test for trend.}

The overall proportion of patients for each separate outcome parameter included in a textbook outcome was described, together with the pro- portion of patients in whom each consecutive outcome parameter was realized, provided that all previous criteria were met. This was also calcu- lated at a hospital level. A univariable analysis was performed. Potential patient (age, sex, BMI, ASA grade, Charlson Co-morbidity Index score16_,

previous abdominal or intrathoracic surgery) and tumour-specific risk factors (clinical TNM stage (7th _edition)17_{, tumour location) for a textbook}

outcome were selected from the data set and, together with treatment characteristics (neoadjuvant therapy, type of resection, surgical approach, urgency of the procedure, additional organ resection owing to extensive tumour infiltration and urgency of the procedure), were compared be-

tween patients with and those without a textbook outcome by means of the χ2 test. A multivariable logistic regression model was employed to study the associations between selected patient, tumour and treatment characteristics, and a textbook outcome. All co-variables used in the multivariable analyses were analysed in discrete categories. For discrete co-variables with more than two categories, the lowest or normal value was chosen as the reference level (age, BMI, Charlson Co-morbidity Index score, tumour stage). For non-ordinal co-variables with more than two cat- egories, the reference category was based on guidelines (chemotherapy for gastric cancer, chemoradiotherapy for oesophageal cancer) or group size (tumour location, type of resection). Missing items were excluded or analysed in a separate group if exceeding 5.0 per cent. Finally, to analyse hospital variation in textbook outcome, casemix-adjusted hospital results were calculated. All available patient and tumour characteristics were used for case mix adjustment, and were entered in a multivariable logistic regression model. No process or treatment characteristics were included for adjustment in this analysis. Individual hospital results were displayed using funnel plots and effects shown as a sequence of 95 per cent confi- dence intervals. To minimize statistical artefacts as a result of small sample sizes, hospitals with fewer than 21 oesophageal resections or fewer than 21 gastric resections over the first 4-year interval were excluded from this analysis. Statistical analyses were performed in PASW® Statistics version 21.0 (IBM, Armonk, New York, USA).

RESuLTS

A total of 2748 patients with oesophageal cancer and 1772 with gastric cancer were included. A textbook outcome was realized in 817 patients (29.7 per cent) with oesophageal cancer and 569 (32.1 per cent) with gastric cancer (Figure 1). The outcome parameter ‘at least 15 lymph nodes

examined’ resulted in a decrease in textbook outcome for both patients with oesophageal cancer and those with gastric cancer. At least 15 lymph nodes were found in the resected specimen in 1650 patients (60.0 per cent) with oesophageal cancer and in 1012 (57.1 per cent) with gastric cancer. There were differences between patients with oesophageal or gas- tric cancer for some individual variables. Results for all individual outcome parameters included in a textbook outcome for both oesophageal and gastric cancer are shown in Figure 1.

Between 2011 and 2014, textbook outcome rates improved significantly, for both patients with oesophageal cancer (from 24.2 per cent in 2011 to 35.1 per cent in 2014; P <0.001) and those with gastric cancer (from 22.5 to 40.0 per cent respectively; P <0.001).

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Curative resection * No intraoperative complication

Tumour negative resection margins

≥ 15 lymph nodes in resected specimen No severe postoperative complication † No reintervention

No readmission ICU/MCU No prolonged hospital stay (≤ 21 days)

No postoperative mortality

No readmission ≤ 30 days after discharge Textbook outcome

% of patients

Oesophageal cancer (per parameter) Gastric cancer (per parameter) Oesophageal cancer (cumulative) Gastric cancer (cumulative)

Figure 1. Textbook outcome: a composite measure of outcome parameters in patients undergoing surgery for oesopha- geal or gastric cancer (2011–2014). *As determined by the surgeon at the end of surgery. †Postoperative complications grade III or higher according to the Clavien Dindo classification are considered severe. MCU, medium-care unit.

Patient, tumour and treatment characteristics

Differences in patient, tumour and treatment characteristics between patients with and those without a textbook outcome are shown in Table 1. Significant differences in age, BMI, ASA grade, Charlson Co-morbidity Index score, use of neoadjuvant therapy, type of resection, surgical ap- proach and an additional resection owing to tumour invasiveness were observed in patients with a textbook outcome for both oesophageal and gastric cancer. No clinically relevant differences were found between patients with and those without a textbook outcome for diagnostic modalities, such as ultrasonography, CT, PET-CT, endoscopic ultrasound examination with and without biopsy, and diagnostic laparoscopy (data not shown).

Multivariable analysis

Factors that were independently associated with a textbook outcome for patients with oesophageal cancer were age, BMI, Charlson Co-morbidity Index score, type of resection, surgical approach and additional organ resection owing to extensive tumour infiltration (Table 2). For patients who underwent a resection for gastric cancer, ASA grade, Charlson Co-morbidity Index score, clinical tumour stage, tumour location, neo- adjuvant therapy and an additional organ resection owing to extensive tumour infiltration were significantly associated with a textbook outcome (Table 2).

Figure 2 shows textbook outcome rates for individual hospitals after adjustment for case mix. Adjusted textbook outcome rates ranged from 8.5 to 45.5 per cent for hospitals performing resections for oesophageal cancer (Figure 2a), and from 11.4 to 52.4 per cent for hospitals undertak- ing resections for gastric cancer (Figure 2b).

Table 1. Patient, tumour and treatment characteristics for patients with or without a textbook outcome Oesophageal cancer

P‡

Gastric cancer

P‡ textbook outcome textbook outcome

No Yes No Yes (n=1931) (n=817) (n=1203) (n=569) Patient variables   Age (years) 0-64 44.4 48.8 0.001 30.2 37.3 0.001 65-74 39.7 40.8 33.6 34.8 75+ 15.4 10.0 36.2 27.6 unknown 0.5 0.4 0.1 0.4 Sex male 77.1 78.5 0.435 62.5 62.4 0.961 female 22.9 21.5 37.5 37.6 unknown 0.1 0.0 0.0 0.0 BMI (kg/m2) <18.5 3.5 1.6 0.028 4.1 3.2 0.014 18.5-24 41.0 43.7 45.0 45.7 25-29 37.3 37.7 32.1 37.3 ≥ 30 16.2 15.9 13.3 11.2 unknown 2.0 1.1 5.6 2.6

ASA classification I-II 73.6 80.8

<0.001 65.9 74.7 0.001 III+ 25.1 18.2 32.8 24.3 unknown 1.2 1.0 1.2 1.1 Charlson Comorbidity Index score 0 47.0 55.3 <0.001 43.3 51.0 0.001 1 25.6 26.2 22.8 23.2 ≥ 2 27.4 18.5 33.9 25.8 Previous surgery no 67.4 70.7 0.104 58.1 65.6 0.004 yes 32.2 28.5 41.4 34.4 unknown 0.4 0.7 0.5 0.0 Tumour variables   Clinical tumour stage* I 14.0 13.0 0.054 17.0 23.4 0.001 II 23.3 25.3 33.2 35.1 III 50.7 53.4 9.6 6.7 IV 0.8 0.6 1.9 0.7 X / unknown 11.2 7.7 38.4 34.1

Table 1. (continued)

Oesophageal cancer

P‡

Gastric cancer

P‡ textbook outcome textbook outcome

No Yes No Yes (n=1931) (n=817) (n=1203) (n=569) location oesophagus upper/middle oesophagus 13.2 11.3 0.212 - - lower oesophagus 57.3 60.8 - -

gastro oesophageal junction 28.6 27.4 - -

unkown 0.9 0.5 - - location stomach fundus - - 10.0 7.2 0.001 corpus - - 29.4 31.8 antrum/pylorus - - 44.2 50.1 total stomach - - 6.2 4.0 residual/anastomosis - - 5.2 1.8 unknown - - 5.1 5.1 Treatment variables neoadjuvant therapy none 10.7 7.7 0.027 48.9 35,0 <0.001 chemotherapy 9.4 9.9 48.4 63.3 chemoradiotherapy 79.1 81.8 1.7 1.2 unknown / other 0.9 0.6 1.0 0.6 Type of resection oesophagus transhiatal oesophagectomy 31.8 <0.001 - - transthoracic esophagectomy 52.5 65.7 - - other 2.4 2.4 - - no resection 6.1 0.0 - - unknown 0.7 0.1 - - Type of resection stomach total gastrectomy - - 34.7 42.7 <0.001 partial gastrectomy - - 48.5 56.8 other - - 1.7 0.4 no resection - - 14.0 0.0 unknown - - 1.4 0.2 Approach open 56 42.5 0.004 77.7 74.3 0.018 minimal invasive† 44.3 57.5 21.9 25.7 Urgency elective 99.5 99.6 0.718 95.3 96.8 0.123 emergency 0.5 0.4 4.7 3.2

Table 1. (continued)

Oesophageal cancer

P‡

Gastric cancer

P‡ textbook outcome textbook outcome

No Yes No Yes (n=1931) (n=817) (n=1203) (n=569) additional resection due to tumour invasiveness no 90.8 97.8 <0.001 77.4 91.4 <0.001 yes 3.7 1.5 10.9 8.3 unknown 0.1 0.0 0.0 0.2

Values are percentages. *TNM system (7th edn). †Determined at start of surgical procedure, including conversions. ‡χ2 test

0% 10% 20% 30% 40% 50% 60% 70% 0 50 100 150 200 250 300 350

Adjusted % patients with a textbook outcome

Hospital volume, oesophageal cancer (2011-2014) Hospital Mean 95% CI 99% CI a. 0% 10% 20% 30% 40% 50% 60% 70% 0 20 40 60 80 100 120

Adjusted % patients with a textbook outcome

Hospital volume, gastric cancer (2011-2014) b.

Figure 2. Hospital variation in case mix-adjusted percentages of a textbook outcome among patients undergoing resec- tion of a. oesophageal or b. gastric cancer

Table 2. Multivariable logistic regression analysis identifying patient, tumour and treatment characteristics predictive of a textbook outcome

Oesophageal cancer Gastric cancer

Patient variables  

Age (years) 0–64 1.00 (reference)  1.00 (reference) 

65–74 0.99 (0.82, 1.20) 0.97 (0.73, 1.28) ≥ 75 0.69 (0.52, 0.92) 0.94 (0.69, 1.30)

Sex M 1.00 (reference)  1.00 (reference)

F 0.97 (0.78, 1.21) 0.95 (0.75, 1.20)

BMI (kg/m2_{) 18.5–24 1.00 (reference) 1.00 (reference)}

< 18.5 0.39 (0.21, 0.74) 0.98 (0.53, 1.80) 25–29 0.92 (0.76, 1.11) 1.04 (0.82, 1.33) ≥ 30 0.90 (0.71, 1.17) 0.79 (0.55, 1.13)

ASA grade I–II 1.00 (reference)   1.00 (reference) 

≥ III 0.81 (0.64, 1.02) 0.74 (0.56, 0.96) Charlson Comorbidity Index score 0 1.00 (reference)  1.00 (reference) 1 0.93 (0.75, 1.15) 0.93 (0.70, 1.24) ≥ 2 0.70 (0.55, 0.89) 0.74 (0.55, 0.98)

Previous surgery No 1.00 (reference) 1.00 (reference)

Yes 0.92 (0.76, 1.12) 0.87 (0.69, 1.11)

Tumour variables      

Clinical tumour stage* I 1.00 (reference) 1.00 (reference)  

II 1.20 (0.89, 1.65) 0.76 (0.56, 1.05) III 1.11 (0.84, 1.48) 0.61 (0.38, 0.99) 0.46 (0.14, 1.49) IV 0.83 (0.28, 2.44) X / unknown 0.73 (0.49, 1.07) 0.78 (0.57, 1.06 Location Oesophagus

Lower oesophagus 1.00 (reference) – Upper/middle oesophagus 0.80 (0.60, 1.06) – Gastro-oesophageal junction 0.98 (0.80, 1.21) – Location Stomach Antrum/pylorus – 1.00 (reference) Fundus – 0.76 (0.48, 1.19) Corpus – 0.92 (0.70, 1.20) Total stomach – 0.63 (0.36, 1.10) Residual/anastomosis – 0.46 (0.22, 0.98)

Cumulative percentages of patients with a textbook outcome for two individual hospitals involved in the surgical treatment of patients with oesophageal cancer are shown as illustrative examples in Figure 3. The number of lymph nodes in the resected specimen also remained an important obstacle in achieving a textbook outcome at hospital level. The two hospitals achieved similar results (a textbook outcome in 43.4 and 45.1 per cent of patients in hospitals A and B respectively), but in a different manner.

Table 2. (continued)

Oesophageal cancer Gastric cancer

Treatment variables      

Neoadjuvant therapy Chemoradiotherapy 1.00 (reference)   0.68 (0.25, 2.26) None 0.91 (0.64, 1.28) 0.75 (0.52, 0.89) Chemotherapy 1.48 (1.08, 2.04) 1.00 (reference) Type of resection

Oesophagus 

Transthoracic esophagectomy 1.00 (reference)   – Transhiatal esophagectomy 0.79 (0.64, 0.98) –

Other 0.29 (0.17, 0.48) –

Type of resection Stomach

Partial gastrectomy – 1.00 (reference)

Total gastrectomy – 1.03 (0.78, 1.35)

Other – 0.02 (0.01, 0.10)

Surgical approach Open 1.00 (reference)   1.00 (reference)

Minimally invasive† 1.60 (1.31, 1.94) 1.11 (0.84, 1.45)

Urgency Elective 1.00 (reference)   1.00 (reference) 

Emergency 1.17 (0.29, 4.70) 1.08 (0.58, 2.00) additional resection due to tumour

invasiveness

No 1.00 (reference)   1.00 (reference)  Yes 0.42 (0.22, 0.81) 0.66 (0.44, 0.98) Values in parentheses are 95 per cent confidence intervals. *TNM system (7th edn). †Determined at start of surgical pro- cedure, including conversions. ‡According to Table 1.

DISCuSSION

This study has confirmed that the quality of the surgical process for pa- tients with oesophageal or gastric cancer is multidimensional, and that additional information can be generated when multiple desired outcome parameters are combined in a single composite outcome measure (text- book outcome). A textbook outcome was achieved in 29.7 per cent of pa- tients with oesophageal cancer and in 32.1 per cent of those with gastric cancer, and improved during the study period. The outcome parameter ‘at least 15 lymph nodes examined’ had the greatest negative impact on

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Curative resection * No intraoperative complication

Tumour negative resection margins

≥ 15 lymph nodes in resected specimen No severe postoperative complication †

No reintervention No readmission ICU/MCU No prolonged hospital stay (≤ 21 days)

No postoperative mortality No readmission ≤ 30 days after discharge

Textbook outcome

% of patients

DUCA Hospital A Hospital B

Figure 3. Individual-hospital analysis for a textbook outcome in patients undergoing surgery for oesophageal cancer (2011–2014). *As determined by the surgeon at the end of surgery.†Postoperative complications grade III or higher ac- cording to the Clavien Dindo classification are considered severe. DUCA, Dutch Upper Gastrointestinal Cancer Audit; MCU, medium-care unit.

the textbook outcome both for patients with oesophageal cancer and for those with gastric cancer. After adjustment for casemix, important hospital variation was observed regarding textbook outcome.

Outcomes such as postoperative mortality, morbidity, microscopic radi- cality and number of retrieved lymph nodes are often used to reflect the quality of care in oesophagogastric cancer surgery18,19_{. Overall, results for}

individual outcome parameters described in this study – postoperative mortality (4.3 and 5.5 per cent for oesophageal and gastric cancer re- spectively), severe postoperative complications (16.9 and 11.7 per cent) and tumour-negative resection margins (91.3 and 84.9 per cent) – cor- responded well with other contemporary results20,21_.

As proposed by the Institute of Medicine22_{, healthcare should be safe,}

effective, patient-centred, timely, efficient and equitable. For patients undergoing potentially curative oesophagogastric 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. These goals were represented in the composite measure textbook outcome.

A textbook outcome has also been described for patients with colorectal cancer23_{. This composite measure places individual outcome parameters}

within a broader context and approaches quality of care from a system perspective. It raises the bar by claiming that anything less than complete care is incompatible with the pursuit of excellence24,25_{. A better under-}

standing of different factors that lead to success or failure during the surgical process might potentially lead to further improvement in quality of care.

A textbook outcome can also be used as a tool for informing patients’ choices between hospitals, as this measure is easier to interpret than try- ing to identify the trend in many individual performance indicators26,27_.

Developing an application that enables the user to adjust both sequence and weight given to the individual parameters used in a textbook out- come, based on personal preferences, could result in a more informed hospital choice.

Finally, a textbook outcome also has statistical advantages when it comes to investigating hospital variation for highly complex and low-volume sur- gical procedures such as oesophagogastric cancer resections28_{. By using a}

broader parameter involving various items, it was possible to discriminate between hospitals performing above or below average.

There are some limitations relating to textbook outcome. A textbook outcome can be used in addition to individual quality indicators (item- by-item measurement) but it is not designed to replace them, as it does not take into account the unequal influence of different parameters on patient outcome or experience. The audited aspects of the surgical process limit the choice of desired parameters used for this measure. The

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