Jpn J Extra-Corporeal Technology 42（1）：1 − 7, 2015

A data analysis trial of the National Perfusion Registry
in a pilot test
Tetsuya Kamei 1），Makoto Hibiya 1），Kiyoshi Yoshida 2），Shoji Kubota 3），Hiroya Kano 4）
Koji Takai 5），Shoichi Takado 6），Yoshiaki Koyama 7），Chihiro Saito 1），Kyoichi Kemmoku 8）
Abstract
The Japanese Society of Extra-Corporeal Technology in Medicine has been conducting open tests based on a
database of extracorporeal circulation cases since May 2013. The society collected data from the tests conductedby the end of December 2013 twice, and organized and analyzed the second collected data.
The number of data samples collected was 507. Roller-type and centrifugal pumps accounted for 19.5 and 80.5%of the total number of pumps used, respectively. Regarding venous drainage methods, gravity, vacuum-assisted,
pump-assisted, and a combination of gravity and vacuum-assisted venous drainage accounted for 61.9, 11.4, 5.1, and21.5%, respectively. The rate of using the pre-bypass filter was 32.5%. The error rates in data validation for multiple-choice and descriptive items were 0.8 and 18.9%, respectively. This suggests that the rate of cases excluded
was 15.0%. However, when items were limited to those similar to the PERForm items adopted by the International
Consortium for Evidence-Based Perfusion ( ICEBP), the rate of excluded cases was 4.5%.
In the case of data from different institutions, items involving input errors and defects varied among institutions.
In the case of data from the same institutions, input errors and defects were identified in the same items. However,
we had asked the institutions to review input data, and there was a significant decrease in the number of systematic errors. This suggests that data input can be more accurate through the validation and assessment of data.
As data related to the same items are input according to the definitions in each institution and data frommultiple institutions are analyzed, the results can be applied to assessment standards using actual data.
Key words：extracorporeal circulation，database，case registry，heart-lung machine

Ⅰ．Introduction

central role in the promotion of extracorporeal circu-

In recent years, there has been an increase in thelation using heart-lung machines - a basic life-sustain-

demand for health care based on scientific evidence.

ing/management method in the field of cardiovascu-

The International Consortium for Evidence-Basedlar surgery, and its techniques. 1）

Perfusion ( ICEBP) aims to establish evidence-based

Emphasis has been placed on scientific evidencecare in extracorporeal circulation, develop its guide-in randomized controlled trials ( RCTs) and clinicallines through international collaboration, and play astudies including meta-analyses. On the other hand,1）Fujita Health University School of Health Sciences

Corresponding author：Makoto Hibiya

2）Osaka University Hospital

Faculty of Clinical Engineering, School of Health3）Asahikawa City Hospital

Sciences, Fujita Health University4）Kobe University Hospital

1-98, Dengakugakubo, Kutsukake-cho, Toyoake,5）Nagoya Medical Center

Aichi, 470-1192, Japan6）University of Toyama Hospital
7）Saitama Children’s Medical Center［Received December 31, 2014：Accepted February 4, 2015］8）Saitama Medical University

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clinical epidemiological studies, which are a similarin August, and those between July and December

observation-based clinical research method that uses

are retrieved in February the following year. The

common medical records, involve the creation of

tabulation and analysis results are published in data

databases of medical records and other patient infor-

manager meetings held at education seminars (inmation and analyze significant amounts of data stored

spring) and academic conferences.
1）Institutions included in the study

in these databases. With the aim of establishing asystem of databases of extracorporeal circulation

As ethical consideration is required when institu-

cases based on the latter analysis method, the ICEBP

tions involved in extracorporeal circulation operatecreated a database in collaboration with a clinical casedatabases of extracorporeal circulation cases, thedatabase developed by cardiac surgeons in the State

following ethical considerations were made: the projectof Michigan and initiated the collection of data.

2）

was implemented with the approval of the JaSECT

The Japanese Society of Extra-Corporeal Technol-

ethics committee; methods for the implementation ofogy in Medicine ( JaSECT) created a database of ex-

the project and other information were published on

tracorporeal circulation cases, consisting of the items

the Internet to encourage the institutions to undergo

required to be input for their registration publishedethics screening.

by the ICEBP that reflect the analysis results of a

We asked the institutions to participate in the2010 national survey of the status of extracorpore-project according to the following procedures since

al circulation.

their understanding is essential:

3）

On the basis of this database, the

JaSECT conducted input-matching tests in four in-①Consent provided by the clinical engineer-

stitutions in Japan for four months since December

ing section and clinical departments of cardiac
surgery of the institutions

2012, using records of same cases that occurred in theinstitutions. The results of these tests suggest that:②Request for screening submitted to the ethics

the input of data of one clinical case requires approx-

committees of the institutions and their or theirimately 20 minutes, items related to defective data

directors’ approvalshould be presented in an objective manner, and it is③Notification of the implementation of the study

necessary for each institution to develop an instruc-sent to the users of the institutions continuously

tion manual for accurate data input. 4）

instead of obtaining informed consent④Recruitment of data managers

On the basis of the test results, we revised the
database input form and manual, and conducted open

⑤Registration of participation in the project

tests for eleven months from May 2013 using thesubmitted to the committee on the development

revised form and manual. We collected data input byof the guidelines⑥Purchase of the software FileMaker Pro® andthe institutions by the end of December 2013. The
present paper presents the results of tabulation andlearning the method for its use

analyses conducted for each item.

⑦Downloading the manual for the handling of theextracorporeal circulation case database and its

Ⅱ．Methods

understanding

1．Open tests⑧Preparation of the manual to quote data frommedical and extracorporeal circulation records

The open tests, positioned as preliminary tests forthe extracorporeal circulation case database project,2）Extracorporeal circulation case databasewere scheduled to be conducted based on the same

The extracorporeal circulation case database wasprocedures as those for the actual operation of thecreated using FileMaker Pro® because the software

database project. The committee for the develop-

operates on both Windows® and Mac OSX® - twoment of the guidelines, an organization in charge ofcommon operating systems, independent of the user’s

the implementation of the project, provided an expla-

PC environment. It also has high affinity with spread-nation of the project for the JaSECT representative

sheet and statistical software, which is an advantage

assembly and projects of local communities.

for individuals in charge of data collection.

Data stored in each institution are collected twice

The database involves the following five fields: basic

a year. Data between January and June are collectedpatient information, circuits and priming fluids, fluid2

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Jpn J Extra-Corporeal Technology 42（1），2015

volume management ( In/Out), and inspection data

analyzed again.

management. It consists of a total of 177 input items:

All files collected by the institutions were linked to

46 multiple-choice and 131 descriptive (requiring

each other, and the institution numbers and initials

numerical values) items. A function of the databaseof patients were deleted. Following this, data wereautomatically inputs data into the required items (ifanalyzed using JMP®.

any) according to the procedure for the implemen-

The registry data were output in Excel® format.

tation of extracorporeal circulation, established by

The data were visually examined, and the summa-

the institution. Therefore, the number of items to be

rized data for each institution were examined using

entered manually using a keyboard was expected to

JMP®, followed by the aggregation of input data

be reduced by half.

that included possible defects and errors. Data that

The database has indicators on the input screen to

did not follow the definition of data input including

allow the user to identify missing data (if any) in eachthe following ones were regarded as error data:

field and item visually.

the maximum measurement input into an item field

3）Data collection

being lower than the minimum measurement, andThe data stored in each institution were output tothe minimum measurement input into an item fielddata collection files created using FileMaker Pro ,being lower than the maximum measurement. ( Dataand collected through the Internet.

involving one of these two types of error were counted®

The exclusive web mail system for JaSECT

as an error incident.)

members was used for data collection. This system

Ⅲ．Results

allows terminal-to-terminal transmission using the SSL
cipher communication system, and ensures security
to prevent unauthorized online data acquisition.

Fifteen institutions participated in the data collection test. The number of collected data samples

The data managers of the institutions logged into

was 507. As the number of participants increased,

the system and sent an email with necessary accom-

the number of registered cases increased (Fig.1).

panying files to a designated address. The individuals

There were 305 males (60.2%) and 202 females

in charge of data collection downloaded the attached(39.8%). The mean age of the patients at the time offiles from the system, and stored them on a PC whose

surgery was 69.5±12.1 years old (68.4±11.9 for males

security had been established.

and 71.3±12.1 for females). Regarding the types of4）Disclosure of analysis data

surgery, the CABG, CABG+Valve, CABG+other

The collected data were analyzed using JMP®

surgical procedures, Valve, aortic surgery, and other(SUS), and the analysis results were published insurgical methods accounted for 9.1, 11.0, 1.6, 44.6,

a data manager conference. In this conference, the26.8, and 5.5% of the total, respectively. The rate ofdata managers reported the total analysis results andpatients with congenital disorders was 1.4%. A total

those obtained from each institution based on all data,of 83.0% of the patients were discharged to theirusing paper or electronic media.

homes, and 10.7% were transferred to other hospitals.

2．Subjects and methods

The rate of patients who died in the institutions wasFifteen institutions that had been eligible for the

6.3% (n=506). Table 1 presents the male-female ratio,

care registry as of December 2013 were selected foracid-base balance management, time of extracorpo-

the present study according to the above-mentioned

real circulation, and interrupting time according toprocedures. Data registered by the end of December

the type of surgery.

2013 were collected and analyzed in February 2014,

Regarding the circuit configuration, roller- andand published in a data manager conference held incentrifugal-type arterial blood pumps accounted forJune 2014. As defects in data and input errors were19.5 and 80.5% of the total, respectively. Open-air- andidentified in the process of tabulation, we instructed

closed-type reservoirs accounted for 98.2 and 0.8%

the data managers who had participated in the con-of the total, respectively. The rate of patients who

ference to review the registered data by the time of

did not use a reservoir was 1.0%. Regarding the typethe next data collection. In August 2014, the regis-of venous drainage, gravity, vacuum-assisted, pump-tered data in the same period were collected andassisted, a combination of gravity and vacuum-assist-

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600

150

500

120

400

90

300

60

200

30

100

0

Cumulative number of cases

Number of cases per month

180

0
May

June

July

August September October November December
Year 2013

Fig.1

Table 1Monthly and cumulative numbers of registered cases

Male-female ratio, acid-base balance management, time of extracorporeal circulation, and interrupting time(according to the type of surgery)
CABG
＋
Valve

CABG

Cases

pH management

CPB Time（min）

Aorta

Congenital（Adult）

Other

46

56

8

226

136

7

28

Percentage of cases

9.1

11.1

1.6

44.6

26.8

1.4

5.5

（％）

78.3

60.7

75.0

54.9

65.4

57.1

42.9

Female （％）

Male

21.7

39.3

25.0

45.1

34.6

42.9

57.1

α Stat （％）

97.8

58.9

37.5

62.8

79.4

71.4

50.0

pH Stat （％）

0.0

21.4

25.0

19.5

8.1

28.6

42.9

Both

（％）

2.2

19.7

37.5

17.7

12.5

0.0

7.1

Total

（mean±SD）

139±50235±86223±114166±57221±8555±16184±93

Clump （mean±SD）29±45145±56131±73113±41110±71

27±7

94±55

Number items that require data input and the error rate (specific to fields)
Input method

Error ratio

Valve

Number of cases

Table 2

Number of entry

CABG
＋
Other

Field
C

D

E

Total

A

B

Multiple-choice

7

13

20

6

0

46

Numerical entry

7

4

31

34

55

131

Multiple-choice

0.0％

0.8％

0.0％

0.0％

0.0％

0.8％

Numerical entry

0.6％

0.0％

3.2％

0.0％

15.2％

18.9％

ed, and a combination of gravity and pump-assisted

dium was collected following the completion of extra-

venous drainage accounted for 61.9, 11.4, 5.1, 21.5 andcorporeal circulation.

0.1% of the total, respectively. The rate of the use of

When data validation was conducted, data defects

a pre-bypass filter was 32.5%. In 18.7% of the cases,

were identified in only one case: the examiner was

biocompatible coating was performed for all circuits

unable to input the data and status of discharge of aincluding cannulas. The coating was implemented forpatient because he was still hospitalized at the time ofall (excluding cannula) circuits limited components ofdata collection. Data of cases in which the input defi-

circuits, and no circuits in 53.1, 27.8, and 0.4% of thenition was not followed were submitted by all institu-

cases, respectively.

tions. The mean rate of data input not in accordance

In 97.6% of the cases, blood in the pericardiumwith the definition was 15.7±10.0%.

was returned from the sucker circuit directly to the

The error rates for multiple-choice and descriptive

reservoir. In 96.1% of the cases, blood in the pericar-

items were 0.8 and 18.9%, respectively ( Table 2). This4

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Jpn J Extra-Corporeal Technology 42（1），2015

suggests that the rate of cases excluded was 15.0%.

and the error rate for the same items as those of the

However, when items were limited to those similar to

STS database (six items: hospital identification, time

the PERForm items adopted by the ICEBP, the rateof extracorporeal circulation, interrupting time, datesof excluded cases was 4.5%.

of birth, hospitalization, and discharge) was 8%. 2）
However, when items were limited to those of the

Ⅳ．Discussion

extracorporeal circulation case database in Japan

In Japan, there are 570 institutions with a systemthat are similar to those of the PERForm adopted

for the implementation of extracorporeal circula-by Paugh, et al., the rate of excluded cases was 4.5%.

tion, and 529 of them conducted it for one or more

Since the most common type of error is simple typing

patients during the year 2011.

In May 2013, anerrors, as suggested by the results of the present

open test involving databases of extracorporeal cir-study, the error rate can be decreased by setting theculation cases was initiated, and a total of 20 insti-

range of numerical values that can be input to thetutions initiated case registration (fifteen by the end

form or adopting multiple-choice systems so that ir-of December 2013 and five by the end of December

relevant data cannot be input. Furthermore, since2014). The percentage of institutions that implement-

regular data collections and assessments based on

ed a system for databases of extracorporeal circula-the data, scheduled to be continued, are expected totion cases was only 3.8%, although the comparison

reduce defects and errors in data as well as increase

between two different periods may not be reliable.

the accuracy, improvement to reduce the error rate

The results of the present study were obtained bycan be accomplished from a logical point of view.

5）collecting data of clinical cases that had occurred

Regarding data collected in February 2013, in thein a limited number of institutions during a specificcase of data from different institutions, items involving

period of time, and, therefore, they may not correctly

input errors and defects varied among institutions.

represent the current status in Japan. However, since

In the case of data from the same institutions, input

the clinical departments of the institutions that par-errors and defects were identified in the same items.

ticipated in the study are involved in the Japan Adult

To address this problem, we had asked the institu-

Cardiovascular Surgery Database ( JACVSD) andtions to review input data, and there was a significant

the aggregation results are reported to each institu-

improvement in the second collected data, includingtion twice a year, the institutions can compare thesea decrease in the number of systematic errors. This

results with their own aggregation results obtainedsuggests that earlier and more accurate data input

from the database of extracorporeal circulation cases

can be implemented by asking institutions scheduled

for the objective promotion of actions to improve ex-

to participate in the case registration project totracorporeal circulation technology.

submit data obtained during the few months since

The rate of clinical cases excluded from the present

their registration and examining/assessing the data.

study was 15.0%, and most of the excluded cases wereAs data related to the same items are input

related to items that required the input of numericalaccording to the definitions in each institution andvalues. According to a study conducted by Paugh,data from multiple institutions are organized, theet al., the rate of cases excluded from the aggrega-

results can be applied to assessment standards using

tion due to defects in data and other causes was 2%,

actual data.

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Appendices

Extracorporeal circulation care registration input forms

Center, Sapporo Cardiovascular Center〈Acknowledgement〉
The present study was conducted with the support of the◦Toshifumi Matsumoto, National Hospital Organization
Obihiro National Hospitalbudget allocated by the committee for the development of theguidelines of the JaSECT and a 2014 research grant for thefaculty staff of Fujita Health University (Research Subject: A◦Shoji Kubota, Asahikawa City Hospital

study on the methods for analyses of extracorporeal circulationcase registry data).

◦Mitsuru Sago, Medical Corporation Choshinkai Toyohashi

We would like to express our sincere appreciation to the◦Masatoshi Kojima, Social Medical Corporation Daiyukai,◦Kouichi Kanai, Hidaka-kai Group, Hidaka Hospital
Heart Center
Daiyukai General Hospitalinstitutions that participated in the extracorporeal circulation
database project and data managers for their cooperation with

◦Katsuhiro Otsubo, Ichinomiya Municipal Hospitalthe study:◦Saori Ishida, Fujita Health University Hospital◦Akio Aramichi, Medical Corporation Sun Plaza Shin-Sapporo◦Yasuko Enya, Regional Independent Administrative
Corporation Gifu Prefectural General Medical Center

Cardiovascular Hospital◦Tetsuya Kakizaki, Medical Corporation Sapporo Heart6

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