Impact of a board certification system and implementation of clinical practice guidelines for pancreatic cancer on mortality of pancreaticoduodenectomy
The aim of this study was to clarify the impact of a board certification system and the implementation of clinical practice guidelines for pancreatic cancer (PC) on the mortality of pancreaticoduodenectomy in Japan.
Methods
By a web questionnaire survey via the National Clinical Database (NCD) for departments participating in the NCD, quality indicators (QIs) related to the treatment for PC, namely the board certification systems of various societies and the adherence to clinical practice guidelines for PC, were investigated between October 2014 and January 2015. A multivariable logistic regression analysis was performed to evaluate the relationship between the QIs and mortality of pancreaticoduodenectomy.
Results
Of 1415 departments that registered at least 1 pancreaticoduodenectomy between 2013 and 2014 in NCD, 631 departments (44.6%), which performed pancreaticoduodenectomy for a total of 11,684 cases, answered the questionnaire. The mortality of pancreaticoduodenectomy was positively affected by the board certification systems of the Japanese Society of Gastroenterological Surgery, Japanese Society of Hepato-Biliary-Pancreatic Surgery, Japanese Society of Gastroenterology, and Japanese Society of Medical Oncology as well as by institutions that used magnetic resonance imaging of ≥ 3 T for the diagnosis of PC in principle.
Conclusions
The measurement of the appropriate QIs is suggested to help improve the mortality in pancreaticoduodenectomy. Masamichi Mizuma and Hiroyuki Yamamoto equally contributed
Hinweise
Publisher's Note
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Abkürzungen
ADL
Activity of daily life
AOR
Adjusted odds ratio
APTT
Activated partial thromboplastin time
ASA
American Society of Anesthesiologists
BMI
Body mass index
CA
Celiac artery
CI
Confidence interval
CT
Computed tomography
JSGE
Japanese Society of Gastroenterology
JSGS
Japanese Society of Gastroenterological Surgery
JSHBPS
Japanese Society of Hepato-Biliary-Pancreatic Surgery
JSMO
Japanese Society of Medical Oncology
JSS
Japan Surgical Society
MRI
Magnetic resonance imaging
NCD
National Clinical Database
PD
Pancreaticoduodenectomy
PT-INR
Prothrombin time- international normalized ratio
QI
Quality indicator
SMA
Superior mesenteric artery
WBC
White blood cell
Introduction
Quality indicators (QIs) are utilized to measure the quality of care, which can be defined as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge” [1]. The quality of care has been reported to be evaluated from three aspects: “structure”, “process” and “outcome” [2]. For example, board-certified experts are an indicator of structure. In addition, diagnostic methods or treatments recommended in a clinical practice guideline correspond to process indicators. The evaluation and improvement of the quality of care in each institution ultimately lead to the uniform accessibility of medical care nationwide. Therefore, assessing the quality of care using QIs is very important.
The registration of surgical cases in the National Clinical Database (NCD), which is linked to the board certification system of some surgical societies, began in 2011. Most surgical cases (90%-95%) performed in Japan are included in the NCD [3]. Approximately 10,000 cases of pancreaticoduodenectomy (PD), classified as having a high degree of difficulty in the surgical difficulty category defined by the Japanese Society of Gastroenterological Surgery (JSGS), are registered per year on NCD [4]. Risk models of the eight main procedures, including PD, were created using NCD data [5‐12] and are used in the risk calculator on the NCD web site, which is available in clinical settings. PD is still a high-risk procedure, and the operative mortality and morbidity need improvement. The evaluation of QIs related to PD is thought to contribute to the improvement of the surgical outcome.
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A questionnaire survey of the board certification system and the implementation of clinical practice guidelines for cancers of the esophagus, stomach, colorectum, liver, pancreas, biliary tract, lung and breast was conducted using the NCD to investigate their impact on the surgical mortality by a study group for “the utilization of high-accuracy organ cancer registration in the clinical practice guidelines and medical specialist training” and was supported by a grant from the Ministry of Health, Labour and Welfare of Japan. The results concerning esophageal and colon cancers have been recently reported [13, 14].
The present study aimed to elucidate the impact of the board certification system and the adherence to the clinical practice guideline for pancreatic cancer on mortality of PD.
Methods
Web questionnaire using the NCD registration system
The questionnaire form was created with the NCD registration system. The questionnaire survey of the QIs related to the treatment for pancreatic cancer was performed via the NCD web page between October 1, 2014, and January 31, 2015. The QIs of the questionnaire, which were chosen by discussion among experts on pancreatic diseases (MM, MU, TS and MG), are shown in Table 1. Q1–16, mainly asking whether or not there is a board-certified expert in each society related to the treatment of pancreatic cancer, were created as structure indicators. Q3 regarding board-certified institutions of the Japanese Society of Hepato-Biliary-Pancreatic Surgery (JSHBPS) was answered separately for Training Institutions A and B. In the application for the board certification system of JSHBPS, Training Institutions A and B need to perform 50 and 30 high-level hepato-biliary-pancreatic surgeries annually, as defined by the JSHBPS, respectively [15]. Board-certified experts of the Japanese Society of Gastroenterology (JSGE) or Japanese Society of Medical Oncology (JSMO), who are not necessarily surgeons, may participate in preoperative care for PD. Thus, the board certification systems of the JSGE and JSMO were considered for the questionnaire because they may affect the outcomes of PD. Q17–22 were selected as process indicators from Clinical Questions (CQs) of Clinical Practice Guidelines for Pancreatic Cancer Based on Evidence-Based Medicine 2013 [16]. The subjects of the questionnaire were a total of 1415 departments that performed at least 1 case of PD between 2013 and 2014, including a total of 20,183 PD cases in this study (Fig. 1).
Table 1
Questionnaire items related to the treatment of pancreatic cancer
Structure indicator
Q1
Is your institution accredited by or related to the Japan Surgical Society (JSS)?
Q2
Is your institution certified by the Japanese Society of Gastroenterological Surgery (JSGS)?
Q3
Is your institution a board-certified training institution (Hepatobiliary-Pancreatic field) of the Japanese Society of Hepato-Biliary-Pancreatic Surgery (JSHBPS)?
Q4
Is your institution certified by or related to the Japanese Society of Gastroenterology (JSGE)?
Q5
Is your institution an accredited training facility of the Japanese Society of Medical Oncology (JSMO)?
Q6
Does your institution register cases of pancreatic cancer in the Japan Pancreatic Cancer Registry of the National Clinical Database (NCD)?
Q7
Does your institution have a board-certified instructor of JSS?
Q8
Does your institution have an expert surgeon of gastroenterological surgery board-certified by JSGS?
Q9
Does your institution have an instructor of gastroenterological surgery board-certified by JSGS?
Q10
Does your institution have a board-certified expert surgeon (Hepatobiliary-Pancreatic field) by JSHBPS?
Q11
Does your institution have an instructor (Hepatobiliary-Pancreatic field) board-certified by JSHBPS?
Q12
Does your institution have a gastroenterologist board-certified by JSGE?
Q13
Does your institution have an instructor of gastroenterology board-certified by JSGE?
Q14
Does your institution have an oncologist board-certified by JSMO?
Q15
Does your institution have an instructor of oncology board-certified by JSMO?
Q16
Does your institution have a General Clinical Oncologist certified by the Japanese Board of Cancer Therapy?
Process indicator
Q17
Are contrast media used in CT or MRI to diagnose pancreatic cancer?
Q18
Is MRI of 3 T or more performed to diagnose pancreatic cancer?
Q19
Is radical resection performed for cases with Stage 0–IVa* pancreatic cancer without invasion of SMA or CA? Or does your institution refer them to other institutions for radical resection?
*General Rules for the Study of Pancreatic Cancer the 6th Edition (the 3rd English Edition) by Japan Pancreas Society
Q20
Is S-1 monotherapy performed as the first choice in adjuvant chemotherapy for pancreatic cancer
Q21
Is chemoradiotherapy or chemotherapy performed as the first-line therapy for locally advanced unresectable pancreatic cancer?
Q22
Is either gemcitabine monotherapy, gemcitabine plus erlotinib combination therapy, or S-1 monotherapy performed as the first-line chemotherapy for locally advanced unresectable or metastatic pancreatic cancer?
CA celiac artery, CT computed tomography, JSGE Japanese Society of Gastroenterology, JSGS Japanese Society of Gastroenterological Surgery, JSHBPS Japanese Society of Hepato-Biliary-Pancreatic Surgery, JSMO Japanese Society of Medical Oncology, JSS Japan Surgical Society, MRI magnetic resonance imaging, NCD National Clinical Database, SMA superior mesenteric artery
Fig. 1
The flow chart of the patient selection process
×
Operative mortality for each QI
Responses to the QI questionnaire were obtained from 631 departments (44.6%), which performed 11,684 pancreaticoduodenectomies (57.9%) during the study period. These PD cases were analyzed using the NCD database. Operative death was observed in 292 cases (2.5%) (Fig. 1). Operative death was defined as any death within the index hospitalization period up to 90 days after surgery or any death after discharge within 30 days after surgery. The operative mortality was analyzed for each QI of the questionnaire.
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The multivariable logistic regression analysis
The relationship between each QI of the questionnaires and operative death was analyzed by multivariable logistic regression models fitted with a generalized estimating equation, considering the clustering of patients by the hospital level. According to a previous report on the risk model using the NCD [5], the following variables were used to adjust risk factors by the patient background: age, respiratory distress (any), the activity of daily life (ADL) within 30 days before surgery (any assistance), angina, weight loss > 10%, American Society of Anesthesiologists (ASA) performance status grade ≥ Class 3, Brinkman index > 400, body mass index (BMI) > 25 kg/m2, serum creatinine > 3 mg/dl, platelet count < 120,000/μl, prothrombin time- international normalized ratio (PT-INR) > 1.1, white blood cell (WBC) count > 11,000/μl and activated partial thromboplastin time (APTT) > 40 s. Q1 and Q17 were excluded from the multivariable analysis because very few departments answered “no” and “Not performed in principle”, respectively.
Statistical analyses
The STATA 15 software program (STATA Corp., College Station, TX, USA) was used for all statistical analyses. The significance of categorical variates was calculated using the chi-square test or Fisher’s exact test. The risk-adjusted odds ratio (AOR) and 95% confidence interval (CI) were calculated in multivariable logistic regression analyses. P < 0.05 was considered statistically significant.
This specific project was approved by the Ethics Committee of Fukushima Medical University (No. 1057).
Results
Patient demographics and crude operative mortality
The crude operative mortality was investigated for each risk factor according to the previous report of the risk model for PD (Table 2) [5]. All risk model variables except for a Brinkman index > 400 were significantly correlated with operative death.
Table 2
Preoperative factors and crude operative mortality rates
Variables
Operative death (n = 292)
Alive (n = 11,392)
p value
N
%
N
%
Age (years)
< 0.001
≤ 59
14
4.8
1726
15.2
60–64
24
8.2
1558
13.7
65–69
56
19.2
2132
18.7
70–74
68
23.3
2541
22.3
75–79
70
24.0
2134
18.7
≥ 80
60
20.5
1301
11.4
Respiratory distress (any)
5
1.7
82
0.7
0.067*
ADL within 30 days before surgery (any assistance)
25
8.6
263
2.3
< 0.001
Angina
12
4.1
118
1.0
< 0.001
Weight loss > 10%
30
10.3
634
5.6
0.001
ASA ≥ Class 3
87
29.8
1244
10.9
< 0.001
Brinkman index > 400
96
32.9
3511
30.8
0.452
BMI > 25 kg/m2
78
26.7
1789
15.7
< 0.001
Creatinine > 3 mg/dl
13
4.5
79
0.7
< 0.001
Platelet < 120,000/μl
19
6.5
352
3.1
0.001
PT-INR > 1.1
55
18.8
1308
11.5
< 0.001
WBC > 11,000/μl
13
4.5
260
2.3
0.015
APTT > 40 s
20
6.8
433
3.8
0.008
ADL activity of daily life, APTT activated partial thromboplastin time, ASA American Society of Anesthesiologists, BMI body mass index, PT-INR prothrombin time-international normalized ratio, WBC white blood cell
*Fisher's exact test
The response distribution and crude operative mortality for each QI
Tables 3 and 4 indicate the response distribution and crude operative mortality rate in each QI for the structure and process indicators, respectively.
Table 3
The response distributions and relationship between each quality indicator and the crude operative mortality: structure indicator
Questionnaire item
Department (N)
Operative death (n = 292)
Alive (n = 11,392)
Total
Mortality rate
N
%
N
%
N
%
Q1 Institution accredited by or related to JSS
p = 0.162*
No
7
2
0.7
39
0.3
41
0.4
4.88%
Accredited
527
274
93.8
10,908
95.8
11,182
95.7
2.45%
Related
97
16
5.5
445
3.9
461
3.9
3.47%
Q2 Institution certified by JSGS
p < 0.001
Yes
493
256
87.7
10,626
93.3
10,882
93.1
2.35%
No
138
36
12.3
766
6.7
802
6.9
4.49%
Q3 A JSHBPS board-certified training institution
p < 0.001
No
473
163
55.8
4370
38.4
4533
38.8
3.60%
Training Institution A
96
81
27.7
5223
45.8
5304
45.4
1.53%
Training Institution B
62
48
16.4
1799
15.8
1847
15.8
2.60%
Q4 Institution certified by or related to JSGE
p < 0.001
No
112
35
12.0
716
6.3
751
6.4
4.66%
Accredited
425
230
78.8
10,010
87.9
10,240
87.6
2.25%
Related
94
27
9.2
666
5.8
693
5.9
3.90%
Q5 An accredited training facility of JSMO
p < 0.001
Yes
180
116
39.7
6201
54.4
6317
54.1
1.84%
No
451
176
60.3
5191
45.6
5367
45.9
3.28%
Q6 Registration in the Japan Pancreatic Cancer Registry of NCD
p = 0.574
All cases registered
449
210
71.9
8400
73.7
8610
73.7
2.44%
Some cases registered
113
45
15.4
1768
15.5
1813
15.5
2.48%
Not registered
69
37
12.7
1224
10.7
1261
10.8
2.93%
Q7 A JSS board-certified instructor
p = 1.000*
Yes
600
289
99.0
11,250
98.8
11,539
98.8
2.50%
No
31
3
1.0
142
1.2
145
1.2
2.07%
Q8 A JSGS board-certified expert surgeon of gastroenterological surgery
p = 0.408*
Yes
605
287
98.3
11,255
98.8
11,542
98.8
2.49%
No
26
5
1.7
137
1.2
142
1.2
3.52%
Q9 A JSGS board-certified instructor of gastroenterological surgery
p = 0.081
Yes
559
274
93.8
10,925
95.9
11,199
95.8
2.45%
No
72
18
6.2
467
4.1
485
4.2
3.71%
Q10 A JSHBPS board-certified expert surgeon
p < 0.001
Yes
120
89
30.5
4688
41.2
4777
40.9
1.86%
No
511
203
69.5
6704
58.8
6907
59.1
2.94%
Q11 A JSHBPS board-certified instructor
p < 0.001
Yes
241
164
56.2
7938
69.7
8102
69.3
2.02%
No
390
128
43.8
3454
30.3
3582
30.7
3.57%
Q12 A JSGE board-certified gastroenterologist
p = 0.004
Yes
560
270
92.5
10,923
95.9
11,193
95.8
2.41%
No
71
22
7.5
469
4.1
491
4.2
4.48%
Q13 A JSGE board-certified instructor of gastroenterology
p < 0.001
Yes
411
210
71.9
9310
81.7
9520
81.5
2.21%
No
220
82
28.1
2082
18.3
2164
18.5
3.79%
Q14 A JSMO board-certified oncologist
p = 0.001
Yes
179
113
38.7
5574
48.9
5687
48.7
1.99%
No
452
179
61.3
5818
51.1
5997
51.3
2.98%
Q15 A JSMO board-certified instructor of oncology
p = 0.004
Yes
191
120
41.1
5650
49.6
5770
49.4
2.08%
No
440
172
58.9
5742
50.4
5914
50.6
2.91%
Q16 A General Clinical Oncologist certified by the Japanese Board of Cancer Therapy
p = 0.232
Yes
563
276
94.5
10,928
95.9
11,204
95.9
2.46%
No
68
16
5.5
464
4.1
480
4.1
3.33%
JSGE Japanese Society of Gastroenterology, JSGS Japanese Society of Gastroenterological Surgery, JSHBPS Japanese Society of Hepato-Biliary-Pancreatic Surgery, JSMO Japanese Society of Medical Oncology, JSS Japan Surgical Society, NCD National Clinical Database
*Fisher's exact test
Table 4
The response distributions and relationship between each quality indicator and the crude operative mortality: process indicator
Questionnaire item
Department no.
Operative death (n = 292)
Alive (n = 11,392)
Total
Mortality rate
N
%
N
%
N
%
Q17 Contrast media in CT or MRI to diagnose pancreatic cancer
p = 0.258*
Performed in principle
592
281
96.2
10,931
96.0
11,212
96.0
2.51%
Not performed in principle
2
1
0.3
154
1.4
155
1.3
0.65%
Doctor's discretion
37
10
3.4
307
2.7
317
2.7
3.15%
Q18 MRI of 3 T or more to diagnose pancreatic cancer
p < 0.001
Performed in principle
285
119
40.8
6330
55.6
6449
55.2
1.85%
Not performed in principle
217
101
34.6
2843
25.0
2944
25.2
3.43%
Doctor's discretion
129
72
24.7
2219
19.5
2291
19.6
3.14%
Q19 Radical resection for cases with Stage 0–IVa* pancreatic cancer without invasion of SMA or CA, or referral to other institutions for radical resection
* General Rules for the Study of Pancreatic Cancer the 6th Edition (the 3rd English Edition) by Japan Pancreas Society
p = 0.018
Performed in principle
463
238
81.5
9880
86.7
10,118
86.6
2.35%
Not performed in principle
34
14
4.8
490
4.3
504
4.3
2.78%
Doctor's discretion
134
40
13.7
1022
9.0
1062
9.1
3.77%
Q20 S-1 monotherapy as the first choice in adjuvant chemotherapy for pancreatic cancer
p = 0.001
Performed in principle
305
157
53.8
7205
63.2
7362
63.0
2.13%
Not performed in principle
95
36
12.3
1389
12.2
1425
12.2
2.53%
Doctor's discretion
231
99
33.9
2798
24.6
2897
24.8
3.42%
Q21 Chemoradiotherapy or chemotherapy as the first-line therapy for locally advanced unresectable pancreatic cancer
p = 0.549
Performed in principle
413
215
73.6
8701
76.4
8916
76.3
2.41%
Not performed in principle
35
15
5.1
535
4.7
550
4.7
2.73%
Doctor's discretion
183
62
21.2
2156
18.9
2218
19.0
2.80%
Q22 Either gemcitabine monotherapy, gemcitabine plus erlotinib combination therapy, or S-1 monotherapy as the first-line chemotherapy for locally advanced unresectable or metastatic pancreatic cancer
p = 0.291
Performed in principle
391
199
68.2
7644
67.1
7843
67.1
2.54%
Not performed in principle
31
10
3.4
630
5.5
640
5.5
1.56%
Doctor's discretion
209
83
28.4
3118
27.4
3201
27.4
2.59%
CA celiac artery, CT computed tomography, MRI magnetic resonance imaging, SMA superior mesenteric artery
*Fisher's exact test
As shown in Qs2–5, the board-certified institutions of the JSGS, JSHBPS, JSGE, and JSMO showed a significantly lower mortality rate than the non-certified institutions (p < 0.001). Regarding QIs related to board-certified experts or instructors, institutions having an expert surgeon and instructor board-certified by the JSHBPS (p < 0.001), a gastroenterologist and instructor board-certified by the JSGE (p = 0.004 and p < 0.001), and an oncologist and instructor board-certified by the JSMO (p = 0.001 and p = 0.004) showed significantly lower operative mortality than others (Table 3).
However, regarding QIs for process indicators, departments that used magnetic resonance imaging (MRI) of ≥ 3 T for the diagnosis of pancreatic cancer in principle (p < 0.001), performed radical resection for pancreatic cancer or referred the case to other institutions for radical resection in principle (p = 0.018) and performed S-1 adjuvant therapy for pancreatic cancer in principle (p = 0.001) showed a significantly lower operative mortality rate than others (Table 4). In Q18, 285 departments (45.2%) responded with “Performed in principle” concerning the use of MRI of ≥ 3 T for the diagnosis of pancreatic cancer.
Results of the multivariable logistic regression analysis
Figure 2 and 3 show the AOR and 95% CI for each structure and process-related QI according to a multivariable logistic regression analysis with risk-adjustment using patient-level risk factors.
Fig. 2
Relationship between each structure indicator and the AOR in PD. a Q2: Institution certified by the JSGS. b Q3: A training institution board-certified by the JSHBPS. c Q4: Institution certified by or related to the JSGE. d Q5: An accredited training facility of the JSMO. e Q6: Registration in the Japan Pancreatic Cancer Registry of the NCD. f Q7: A board-certified instructor of the JSS. g Q8: An expert surgeon of gastroenterological surgery board-certified by the JSGS. h Q9: An instructor of gastroenterological surgery board-certified by the JSGS. i Q10: An expert surgeon board-certified by the JSHBPS. j Q11: An instructor board-certified by the JSHBPS. k Q12: A gastroenterologist board-certified by the JSGE. l Q13: An instructor of gastroenterology board-certified by the JSGE. m Q14: An oncologist board-certified by the JSMO. n Q15: An instructor of oncology board-certified by the JSMO. o Q16: A General Clinical Oncologist certified by the Japanese Board of Cancer Therapy
Fig. 3
Relationship between each process indicator and the AOR in PD. a Q18: MRI of ≥ 3 T to diagnose pancreatic cancer. b Q19: Radical resection for cases with Stage 0–IVa* pancreatic cancer without invasion of SMA or CA, or referral to other institutions for radical resection. c Q20: S-1 monotherapy as the first choice in adjuvant chemotherapy for pancreatic cancer. d Q21: Chemoradiotherapy or chemotherapy as the first-line therapy for locally advanced unresectable pancreatic cancer. e Q22: Either gemcitabine monotherapy, gemcitabine plus erlotinib combination therapy, or S-1 monotherapy as the first-line chemotherapy for locally advanced unresectable or metastatic pancreatic cancer
×
×
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The AOR was significantly higher in institutions not certified by the JSGS (1.78 [1.19–2.66], p < 0.001) or JMSO (1.69 [1.29–2.21], p < 0.001) than in those that were certified (Fig. 2a, d). Compared with institutions that were not board-certified by the JSHBPS, JSHBPS board-certified training institution A showed a significantly lower AOR (0.49 [0.37–0.66], p < 0.001). In contrast, there was no significant difference between the JSHBPS board-certified training institution B and the institutions that were not board-certified (Fig. 2b). Although institutions accredited by the JSGE showed a significantly lower AOR (0.50 [0.34–0.74], p < 0.001) than those not certified by or related to the JSGE, related institutions showed no significant difference (Fig. 2c). Institutions with an expert surgeon or instructor board-certified by the JSHBPS (Fig. 2i, j), a gastroenterologist or instructor of gastroenterology board-certified by the JSGE (Fig. 2k, l), and an oncologist or instructor of oncology board-certified by the JSMO (Fig. 2m, n) showed significantly lower AOR values than those without them.
Regarding the use of MRI of ≥ 3 T for the diagnosis of pancreatic cancer (Q18), both “Not performed in principle” and “Doctor’s discretion” were significantly poor risk factors (p < 0.001 and p = 0.01) (Fig. 3a). Regarding radical resection (Q19) and S-1 adjuvant chemotherapy (Q20), “Doctor’s discretion” showed a significantly higher AOR than “Performed in principle”. “Not performed in principle” showed no significant difference in Q19 and Q20 (Fig. 3b, c).
Discussion
The present study revealed the following three points using questionnaires and the data of the NCD: (1) Mortality of PD was positively affected by the institution certification systems of the JSGS, JSHBPS, JSGE and JSMO. (2) Institutions with an expert or instructor board-certified by the JSHBPS, JSGE or JSMO showed a low PD mortality. (3) The mortality of PD was low in institutions that used MRI of ≥ 3 T for the diagnosis of pancreatic cancer in principle. These findings suggest to be useful as a QI for PD in Japan.
According to the NCD, the operative mortality of PD between 2011 and 2012 was reported to be lowest in training institution A (board-certified by the JSHBPS) followed by institution B and non-certified institutions. In addition, the participation of an expert surgeon or instructor who was board-certified by the JSHBPS in PD resulted in a lower operative mortality compared to that with no such participation [17]. The current study, which analyzed NCD data collected between 2013 and 2014, also showed a similar impact of the board certification system of the JSHBPS on the operative mortality of PD. The board certification system of the JSHBPS is suggested to be a good QI in PD for pancreatic cancer.
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In contrast, regarding the board certification system of the JSGS, the present study indicated no marked correlation between the operative mortality and the presence of a board-certified expert surgeon or instructor. A previous report showed that the number of expert surgeons board-certified by the JSGS was a surrogate marker of the operative mortality in eight main procedures, including PD [18]. The present study’s lack of an investigation of the number of expert surgeons board-certified by the JSGS might have been associated with the absence of a correlation with the operative mortality. In our study, a favorable outcome of PD was observed in institutions board-certified by the JSGE or JSMO. Furthermore, institutions with experts board-certified by the JSGE or JSMO who did not necessarily participate directly in PD still showed a significantly lower operative mortality for PD than in those without. These results suggest that institutions that specialize in gastroenterology or oncology have more favorable outcomes from surgery due to an indirect effect, as gastroenterologists and oncologists are involved in preoperative care, including oncological judgement, chemotherapy and nutritional management, for patients scheduled for PD. Therefore, these results imply that systematic multidisciplinary approach for preoperative care improves the safety of PD. There are no reports on the relationship between the operative mortality of PD and the board certification systems of the JSGE or JSMO. These are novel findings as factors related to the operative mortality of PD.
To our knowledge, there have been no reports concerning the implementation of clinical practice guidelines for pancreatic cancer, including associations with the mortality of PD. In the present study, institutions using MRI of ≥ 3 T in principle for the diagnosis of pancreatic cancer had a significantly lower mortality rate of PD than those who did not or did so only at the doctor’s discretion (Q18). Although adherence to Q18 was low compared with other QIs, this might be due to the considerable number of institutions unable to perform MRI of ≥ 3 T. Since possession of an MRI machine of ≥ 3 T depends on a hospital’s financial standing, the results of Q18 may reflect the effects of the hospital volume. Interestingly, the present study showed that QIs in radical resection (Q19) and S-1 adjuvant chemotherapy (Q20) had higher AORs for “Doctor’s discretion” than for “Performed in principle”. In a previous study in this project concerning esophageal cancer, similar results were found in some QIs [13]. These findings suggest the importance of organizational compliance with clinical practice guidelines for pancreatic cancer.
Despite patient selection bias due to old age, which may be considered a factor of non-operative indication, especially in elderly patients with comorbidity, this study demonstrated that age was a significant risk factor for mortality in PD, as previously reported [5]. Mortality following PD for elderly patients with pancreatic cancer has been reported to be affected by specific comorbidities (chronic obstructive pulmonary disease, chronic kidney disease, dementia and sepsis) as patient factors [19]. The present study was conducted with risk adjustment for various patient factors, including the age, as described in the Methods section. However, as a structure indicator, a previous report showed that non-teaching hospitals have a higher risk of PD mortality for elderly patients with pancreatic cancer than teaching hospitals [20]. The present study clarified the correlation between the mortality of PD and board certification systems of various academic societies as structure indicators. Thus, the assessment of structural indicators is crucial for reducing the mortality of PD.
The utilization of administrative claims data in Japan for the wide-scale measurement of QIs in the treatment of various cancers, namely colorectal, lung, stomach, liver, breast, prostate and cervical cancer, has been reported [21]. When comparing NCD data with administrative claims data, the advantage is that the impact of QIs on surgical outcomes can be analyzed, as in the current study project [13]. At clinical settings in Japan, the NCD Breast Cancer Registry is used to assess the QIs recommended by the clinical practice guidelines. Registered NCD users can compare the implementation rates of the QIs in their institutes with those of the national average on the NCD web site, which helps eliminate cancer care disparity. Thus, the NCD is a useful tool for evaluating QIs related to each type of cancer.
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The limitations of this study are similar to those previously described [13]. First, we cannot exclude respondents’ bias in the questionnaire surveys. The respondents were users registered in the NCD and not necessarily representative of the department. In other words, the answers may not necessarily reflect the policies of the department. Second, we received no answer from more than half of the institutions. There may be differences in the implementation rate of QIs or the mortality of PD between respondents and non-respondents. Third, there may have been selection bias for the QIs, which were selected by discussion among experts of pancreatic diseases, as mentioned above. Finally, PD cases with diseases other than pancreatic cancer were included in this study.
In conclusion, the mortality of PD was positively impacted by the institutional certification systems of the JSGS, JSHBPS, JSGE and JSMO. Institutions with an expert or instructor who was board-certified by the JSHBPS, JSGE or JSMO showed a lower mortality rate of PD than those without such a staff member. Furthermore, institutions performing MRI of ≥ 3 T for the diagnosis of pancreatic cancer showed a lower mortality from PD than others. The NCD is a useful tool for evaluating the quality of cancer care, especially for analyzing the impact of QIs on surgical outcomes.
Acknowledgements
The authors thank all of the departments and societies related to the NCD for their cooperation in this study. The authors also thank Drs. M. Mori, K. Sugihara, K. Hirata, M. Nagino, T. Ohta, H, Konno, T. Sobue, A. Nashimoto, K. Kotake, N. Kokudo, M. Yamamoto, M. Tanaka, M. Sato, H. Tokuda and Y. Kitagawa for their cooperation. This work was supported by a grant from the Ministry of Health, Labour and Welfare of the Japan (201221064A) and by a grant from Japan Society for the Promotion of Science (16K10437 and 19K09111).
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Conflict of interest
Hiroyuki Yamamoto and Hiroaki Miyata are affiliated with the Department of Healthcare Quality Assessment at the University of Tokyo. The department is a social collaboration department supported by grants from the National Clinical Database, Johnson & Johnson K.K., and Nipro Co. Other authors have no conflicts of interest.
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Impact of a board certification system and implementation of clinical practice guidelines for pancreatic cancer on mortality of pancreaticoduodenectomy
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