The Japanese Intensive care PAtient Database (JIPAD): A national intensive care unit registry in Japan

Journal Pre-proof The Japanese Intensive care PAtient Database (JIPAD): A national intensive care unit registry in Japan

Hiromasa Irie, Hiroshi Okamoto, Shigehiko Uchino, Hideki Endo, Masatoshi Uchida, Tatsuya Kawasaki, Junji Kumasawa, Takashi Tagami, Hidenobu Shigemitsu, Eiji Hashiba, Yoshitaka Aoki, Hiroshi Kurosawa, Junji Hatakeyama, Nao Ichihara, Satoru Hashimoto, Masaji Nishimura, for the JIPAD Working Group in the Japanese Society of Intensive Care Medicine PII:

S0883-9441(19)30765-8

DOI:

https://doi.org/10.1016/j.jcrc.2019.09.004

Reference:

YJCRC 53371

To appear in:

Journal of Critical Care

Please cite this article as: H. Irie, H. Okamoto, S. Uchino, et al., The Japanese Intensive care PAtient Database (JIPAD): A national intensive care unit registry in Japan, Journal of Critical Care(2018), https://doi.org/10.1016/j.jcrc.2019.09.004

This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

© 2018 Published by Elsevier.

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Journal Pre-proof Title: The Japanese Intensive care PAtient Database (JIPAD): A national intensive care unit registry in Japan

Authors:

Department of Anesthesiology, Kurashiki Central Hospital, Okayama, Japan

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Hiromasa Irie a, Hiroshi Okamoto b, Shigehiko Uchino c, Hideki Endo d, Masatoshi Uchida e, Tatsuya Kawasaki f, Junji Kumasawa g, Takashi Tagami h, Hidenobu Shigemitsu i, Eiji Hashiba j, Yoshitaka Aoki k, Hiroshi Kurosawa l, Junji Hatakeyama m, Nao Ichihara d, Satoru Hashimoto n, and Masaji Nishimura o, for the JIPAD Working Group in the Japanese Society of Intensive Care Medicine

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1-1-1 Miwa, Kurashiki, Okayama 710-8602, Japan [email protected]

Department of Critical Care Medicine, St. Luke's International Hospital, Tokyo, Japan

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9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan [email protected]

Intensive Care Unit, Department of Anesthesiology, Jikei University School of Medicine, Tokyo, Japan

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3-19-18 Nishi-Shinbashi, Minato-ku, Tokyo 105-8471, Japan [email protected] d

Department of Healthcare Quality Assessment, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan [email protected] (Hideki Endo) [email protected] (Nao Ichihara)

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Department of Emergency and Critical Care Medicine, Dokkyo Medical University, Tochigi, Japan 880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, Japan

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Journal Pre-proof [email protected] f

Department of Pediatric Critical Care, Shizuoka Children’s Hospital, Shizuoka, Japan 860 Urushiyama, Aoi-ku, Shizuoka, Shizuoka 420-8660, Japan [email protected]

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Department of Critical Care Medicine, Sakai City Medical Center, Osaka, Japan 1-1-1 Ebaraji-cho, Nishi-ku, Sakai, Osaka 593-8304, Japan [email protected]

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1-7-1 Nagayama, Tama, Tokyo 206-8512, Japan

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[email protected]

Department of Intensive Care Medicine, Graduate School of Medicine, Tokyo Medical and Dental University, Tokyo, Japan

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Department of Emergency and Critical Care Medicine, Nippon Medical School Tama Nagayama Hospital, Tokyo, Japan

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1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan [email protected]

Division of Intensive Care, Hirosaki University Hospital, Aomori, Japan

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j

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53 Honcho, Hirosaki, Aomori 036-8203, Japan [email protected] k

Department of Anesthesiology and Intensive Care, Hamamatsu University School of Medicine, Shizuoka, Japan 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3125, Japan [email protected]

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Department of Pediatric Critical Care Medicine, Hyogo Prefectural Kobe Children’s Hospital, Hyogo, Japan 1-6-7 Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan [email protected]

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Department of Emergency and Critical Care Medicine, Yokohama City Minato Red Cross Hospital, Kanagawa, Japan

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Journal Pre-proof 3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa 231-8682, Japan [email protected] n

Department of Anesthesiology and Intensive Care Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan [email protected]

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The President of the Japanese Society of Intensive Care Medicine

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3-32-7 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

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[email protected]

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Corresponding author: Hiromasa Irie

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Mailing address: Department of Anesthesiology, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama 710-8602, Japan

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Tel: +81-86-422-0210

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Email: [email protected]

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Fax: +81-86-421-3424

Abstract: 198 words

Entire manuscript: 4,433 words Number of Table: 5 Number of Figure: 3 Supplementary file: Table S1, Figure S1

Competing interests MN consults for Nihon Kohden Corporation, Getinge Group Japan K.K., and Total Medical Supply Corporation. The other authors declare that they have no competing interests.

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Abstract Purpose: The Japanese Intensive care PAtient Database (JIPAD) was established to construct a high-quality Japanese intensive care unit (ICU) database.

Materials and methods: A data collection structure for consecutive ICU admissions in

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adults (≥16 years) and children (≤15 years) has been established in Japan since 2014. We

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herein report a current summary of the data in JIPAD for admissions between April 2015 and

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March 2017.

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Results: There were 21,617 ICU admissions from 21 ICUs (217 beds) including 8,416

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(38.9%) for postoperative or procedural monitoring, defined as adult admissions following

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elective surgery or for procedures and discharged alive within 24 h, 11,755 (54.4%) critically ill adults other than monitoring, and 1,446 (6.7%) children. The standardized mortality ratios

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(SMRs) based on the Acute Physiology and Chronic Health Evaluation (APACHE) III-j, APACHE II, and Simplified Acute Physiology Score II scores in adults ranged from 0.387 to 0.534, whereas the SMR based on the Paediatric Index of Mortality 2 in children was 0.867.

Conclusion: The data revealed that the SMRs based on general severity scores in adults were low because of high proportions of elective and monitoring admission. The development of a new mortality prediction model for Japanese ICU patients is needed.

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Keywords: database, national registry, ICU admission, monitoring, standardized mortality

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ratio, mortality prediction model

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1. Introduction

The advancement of clinical databases is undoubtedly essential for clinical medicine. Highquality databases can make a large contribution to the improvement of clinical practice, patient outcome, management of health services, and audits [1, 2]. Such databases are also

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rich resources for clinical research to generate new insights that can provide clinicians

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important information regarding clinical decision-making, such as estimates of patient

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outcomes, accurate diagnoses, and interventions [1]. However, despite the advantages

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afforded by clinical databases, several considerations need to be addressed regarding the

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management of databases: the construction of an effective data registration system, the selection and definition of data items to be collected, the minimization of workloads for data

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acquisition, the guarantee of data quality and security, the establishment of ethical rules for

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data utilization, the placement of a feedback system to motivate participants for data collection, and funding [2, 3].

The same applies to the field of intensive care medicine. Many national registries addressing critically ill patients have been successfully developed around the world [4–8]. For example, the Australian and New Zealand Intensive Care Society (ANZICS) Adult Patient Database (APD) is widely recognized as one of the largest intensive care unit (ICU) databases, collecting more than two million patients since 1992 [9]. The Australian and New Zealand Paediatric Intensive Care Registry (ANZPICR) also successfully holds

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approximately 170,000 records of pediatric patients, collected since 1997 [9]. The Case Mix Programme by the Intensive Care National Audit & Research Centre (ICNARC) in the United Kingdom has a high-quality dataset recorded from approximately 1.8 million patients for over 20 years [10]. However, in Japan, there has been only one cohort study of 5,107 consecutive patients admitted to Japanese ICUs in 22 hospitals, comparing the utilization and

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outcomes of ICU admissions between Japan and the United States [11]. In this study,

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conducted in 2002, the numbers of ICU admissions and participating hospitals were small,

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and the data were obtained from 1993 to 1995, which does not represent the current national

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critical care system in Japan. In addition, there were no national ICU databases in Japan at the time, making it vital to construct a Japanese ICU database as a national registry.

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The Japanese Intensive care PAtient Database (JIPAD) was established by the

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Japanese Society of Intensive Care Medicine (JSICM) to construct a high-quality ICU database as a national registry with the goal of improving the quality of care and pursuing the development of intensive care medicine in Japan. The aim of this report was to describe the activity of the JIPAD project and its methodology of data collection as a national ICU database and to review the characteristics of critical care services in Japan.

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2. Materials and methods

2.1.Framework of JIPAD

The JIPAD project began in 2011 with the launch of a working committee in JSICM to construct a Japanese ICU database. In 2012, JSICM reached an agreement with the ANZICS

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Centre for Outcome and Resource Evaluation (CORE) to form a partnership in terms of

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mutual activities, including the JIPAD project. Data collection on consecutive admissions

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started in 2014 in accordance with a data dictionary formally issued, following a pilot study

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among five institutions in 2013. The first annual report describing a summary of the ICU

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database (with nine participating institutions) was published in 2015 [12]. The core members

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of JIPAD visited ANZICS CORE and ICNARC in 2015 and 2016, respectively, to learn about

registry.

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their well-established organization systems, management, and database quality as a national

In 2017, the JIPAD Working Group, consisting of 15 medical doctors, was established as a subsidiary body of the ICU Functional Assessment Committee in JSICM to facilitate the management of the project. The JIPAD project is now mainly managed by the JIPAD Working Group. All members of the JIPAD Working Group share tasks regarding the project, including coordination and development of data collection systems, data administration (preservation, verification, and analysis), contacting participants, responding to inquiries, publishing reports, taking responsibility for data usage, and performing audits.

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Each member of the working group is an expert who works in the field of intensive care medicine, with various backgrounds represented, such as adult and pediatric intensivists, emergency surgeons, anesthesiologists, and researchers focused on healthcare quality assessments.

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The JIPAD project is conducted by the JIPD Working Group, which is under the

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auspices of JSICM, the primary funder of JIPAD. In 2017, we also received a research grant

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(Health Labour Sciences Research Grant) from the Ministry of Health, Labour and Welfare.

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Development of the data collection software program was funded through these means.

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Although each participating ICU needs to pay for FileMaker® Pro (FileMaker Inc., Santa Clara, CA, USA) itself, the data collection software program is available to participating

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ICUs for free, and each institution imposes no fees for participation in JIPAD.

2.2.Data collection

The JIPAD project was approved by the ICU Functional Assessment Committee of JSICM on March 1, 2013. The collection and registration of data in each participating ICU were conducted after receiving approval from the ethics committee of the respective institutions with an opt-out policy from patients, their relatives, or proxies. The need for written informed consent was waived.

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Data on all adults (≥16 years) and children (≤15 years) admitted to ICUs except for neonates admitted to neonatal ICUs are collected. Collected data include the following: 1) patient demographics, 2) information before ICU admission, 3) the diagnosis at ICU admission, 4) physiological data, 5) treatment in the ICU, and 6) outcome. In total, 90 and 54 data items from all adult and pediatric patients, respectively, are collected. Severity scores,

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including the Acute Physiology and Chronic Health Evaluation (APACHE) III score [13], the

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APACHE II score [14], the Simplified Acute Physiology Score (SAPS) II score [15], and the

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Paediatric Index of Mortality (PIM) 2 predicted mortality [16], are calculated. We revised the

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data collection form in April 2018, adding several new items, including the worst Sequential Organ Failure Assessment (SOFA) score [17] and pediatric SOFA score [18] within 24 h of

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ICU admission, as well as PIM3 [19] for children. Consequently, the number of data items on

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adults and children increased to 98 and 66, respectively, starting in April 2018 (Supplementary Table S1). Chronic organ insufficiency was defined based on the APACHE II, III, and SAPS II scores.

2.3.Data collection tools FileMaker® Pro (FileMaker Inc.) is used for data collection because each participating ICU can also use this software as a registry for its own institution. We developed three components using the software: JIPAD Global, JIPAD Local, and JIPAD Internal. JIPAD

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Global serves as a central data server to which all data from each participating ICU are registered, with only data administrators and members of the analyzing committee of the JIPAD Working Group being granted access. JIPAD Local is a basic element of the JIPAD input system that can directly connect to JIPAD Global through the Internet and also be used as a patient registry in each ICU. JIPAD Internal also can be used as a patient registry, but it

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cannot connect to the Internet. Instead, it is installed on personal computers (PCs) within the

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electronic intra-hospital medical record network of the participating ICU. All data in JIPAD

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Internal can be easily transferred to JIPAD Local via the application (JIPAD Bridge) as an

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encrypted file, enabling data to be registered to the server for institutions concerned about security vulnerabilities with the direct connection of electronic medical records (EMRs) to

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the Internet. Each participating ICU can choose using either JIPAD Local or JIPAD Internal

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for registering data, according to the institution’s preference. In addition to JIPAD Local and JIPAD Internal supporting manual input, vendors of EMR systems have developed applications to enable automated data transfer from the EMR to the database with CommaSeparated Value (CSV) files and/or an Open Database Connectivity (ODBC) gateway, thus facilitating the input of data to JIPAD Local and/or JIPAD Internal without errors. Figure 1 shows an overview of JIPAD Global, Local, and Internal. The central server with the Firewall system included with FileMaker® Server (FileMaker Inc.) was established at a secure data center in the northern part of Japan. All data

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were encrypted and uploaded to the central server via the Secure Sockets Layer (SSL) protocol. The central server identifies only registered PCs, so no other devices can connect to the server. Identifiable personal information, such as the patient’s name, hospital name, and hospital medical record number, are removed, and a unique code for each ICU admission and

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2.4.Ensuring the validity and credibility of data

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institution for JIPAD are assigned when data are uploaded to the central server.

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At the start of data collection, each participating ICU must undergo the following two steps,

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which is carried out under the guidance of the JIPAD Working Group: 1) the site visit, and 2)

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the query system. The objectives of the site visit by the Working Group are as follows: 1) to

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check the current status of preparation for data collection in the participating ICU, 2) to offer suggestions on accurate data collection and workload reduction, and 3) to allow the participating ICU and the Working Group to become better acquainted.

Subsequently, the participating ICU that received the site visit must undergo queries to ensure the validity and credibility of their collected data, via the following steps: 1) each participating ICU uploads data for 10 admissions to the server, 2) a member of the Working Group verifies these data and replies with comments concerning input errors, 3) the participating ICU confirms the comments and re-uploads the data after any necessary

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corrections are made, 4) both the participating ICU and a member of the Working Group continue this process until there are no input errors in any of the uploaded data. Once ICUs have completed this query step, and the reliability of data from the ICUs has been accepted by the Working Group, they can freely begin registering their data to the central server based on the data dictionary, which is periodically revised by the Working Group. After that, the

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data checking committee of the Working Group checks the registered data and provides

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feedback to each participating ICU on its data quality several times a year.

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Data managers, who are responsible for the data collection at each participating ICU,

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include doctors, nursing staff, and clerical staff. If the data manager in the participating ICU changes for some reason, the new manager (not the ICU) must complete the query process

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again and be re-approved for participation in JIPAD by the Working Group. The member of

checking its data.

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the JIPAD Working Group who is placed in charge of a particular ICU is responsible for

2.5.Reporting feedback

Uploaded data are analyzed by the JIPAD Working Group, and annual reports are sent to all participating institutions every year. The annual report includes not only patient demographics, ICU treatment, severity scores, and outcomes for all admissions but also

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information such as the standardized mortality ratio (SMR), duration of ICU stay, SMR funnel plots, and distribution maps for comparing to other institutions as a benchmark. Each participating ICU can readily use these benchmark data in JIPAD without any restrictions. In contrast, all raw data, including those from other institutions, are available after permission is obtained from the ICU Functional Assessment Committee in JSICM following a reasonable

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request, e.g. for research purposes.

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2.6.Data summary presentation

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The data that were registered in the 2015 and 2016 fiscal years (from April 2015 to March

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2017) were summarized. For this summary, only data on patients from ICUs where all

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consecutive admissions had been registered in each fiscal year were analyzed. The patients were divided into three groups: monitoring, critically ill adults, and children. In Japan, the proportion of ICU admissions for postoperative monitoring has been reported to be high [11, 12]. Accordingly, we classified adult patients (≥16 years old) who were admitted to the ICU after elective surgery or for ICU procedures and discharged alive within 24 h as being admitted for ‘monitoring’. Critically ill adults and children were adults other than monitoring and patients aged 15 years old or younger, respectively. Finally, SMRs were calculated as the observed hospital mortality divided by the predicted mortality based on the APACHE III(-j), APACHE II, SAPS II scores, and as the observed ICU mortality divided by the predicted

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mortality based on PIM2.

Data were presented as medians and interquartile ranges (IQRs) or numbers and percentages. Coronary artery bypass graft (CABG) was presented separately from cardiovascular disease because CABG is excluded when calculating the APACHE III and II

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Foundation for Statistical Computing, Vienna, Austria).

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scores [20]. Statistical analyses were performed using the R software, version 3.4.1 (The R

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3. Results

3.1.Characteristics of ICU admissions in JIPAD

There were 21,617 admissions in the 2015 and 2016 fiscal years from 21 ICUs with 217 beds (Table 1 and Figure 2), including 8,416 (38.9%) admitted for postoperative or ICU procedural

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monitoring, 11,755 (54.4%) as critically ill adults, and 1,446 (6.7%) as children. The patient

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demographics are shown in Table 2. There were 15,995 (74.0%) ICU admissions directly

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from the operating room, and elective surgery was the most common admission classification

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among overall admissions. In patients with chronic disease before ICU admission,

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immunosuppression was most frequently observed, being noted in 1109 (5.1%), followed by

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maintenance dialysis in 1053 (4.9%) and metastatic cancer in 833 (3.9%). The median APACHE III, APACHE II, and SAPS II scores were 51, 13, and 26 points, respectively, and

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the median PIM2 predicted mortality was 1.0%. Invasive mechanical ventilation was employed in 8,203 (37.9%) admissions for a median 0.8 days (Table 3). Renal replacement therapy was performed in 1930 (8.9%) admissions, of which 865 (4.0%) were intermittent cases and 1,065 (4.9%) required continuous renal replacement therapy.

Cardiovascular disease was the most frequent primary disease necessitating ICU admission, being suffered in 5,658 (26.2%) admissions, followed by gastrointestinal disease in 4,410 (20.4%) and respiratory disease in 3,796 (17.6%); in contrast, the most common disease group in those admitted for monitoring was respiratory disease (Table 4). More than

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40% of children were admitted to the ICUs because of cardiovascular disease.

3.2.ICU and hospital outcome

Of all 21,617 admissions, 18,051 (83.5%) were discharged alive from the ICUs to the general

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wards (Table 5). ICU and hospital mortality was 3.6% and 7.7%, respectively. Critically ill

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adults had the highest ICU and hospital mortality among the three groups (ICU mortality:

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0%, 6.3%, and 3.0% and hospital mortality: 0.7%, 13.0%, and 5.2% in monitoring

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admissions, critically ill adults, and children, respectively). The median length of ICU stay

3.3.SMRs

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respectively.

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was 0.8, 2.5, and 1.7 days in the monitoring admissions, critically ill adults, and children,

The SMRs based on the APACHE III-j, APACHE II, and SAPS II scores in all adults were 0.471 (95% confidence interval [CI]: 0.447–0.497), 0.387 (0.367–0.408), and 0.428 (0.405– 0.451), and those in critically ill adults were 0.534 (0.505–0.563), 0.466 (0.441–0.492), and 0.470 (0.445–0.496), respectively, whereas the SMR based on PIM2 in children was 0.867 (0.617–1.186) (Figure 3). The receiver operating characteristic curves of the four scores (hospital mortality prediction for APACHE III-j, APACHE II, and SAPS II scores in all adults

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and critically ill adults, and ICU and hospital mortality prediction for PIM2 in children) are

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also shown in Figure 3.

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4. Discussion

4.1.Summary of the data

In this study, information provided by JIPAD revealed the following characteristics of ICU patients in Japan: 1) the proportions of admissions for postoperative or ICU procedural

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monitoring, critically ill adults who stayed in the ICU for more than 24 h, and children were

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39%, 54%, and 7%, respectively; 2) 63% of all admissions were elective, and 74% were from

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the operating room; 3) cardiovascular disease was most frequently observed in both critically

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ill adults and children, whereas respiratory disease was most common in monitoring

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admissions; 4) the ICU and hospital mortality was 3.6% and 7.7%, respectively; and 5) the

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SMRs based on all scores in adults ranged from 0.387 to 0.534, whereas the SMR based on

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the PIM2 in children was 0.867.

4.2.Significance of JIPAD

The primary purposes of the JIPAD project are to improve the quality of care and facilitate the advance of intensive care medicine by collecting medical information from ICU patients in Japan. Comparisons among ICUs, hospitals, and countries can also be achieved by offering data feedback as a benchmark, including such information as patient outcomes and mortality. Another important purpose of this database is to allow researchers and clinicians to promote

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clinical research and obtain new insights in the field of intensive care medicine.

To achieve these goals, a highly organized and structured system of data collection is required for both administrators and participants. Whitney et al. [21] described the distinction between the activities that are carried out before data collection (quality assurance

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procedures) and those during and after data collection (quality control procedures) for the

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data quality in longitudinal studies. Arts et al. [3] proposed that data collection procedures

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could be divided into two structures (procedures handled by central sites and those handled

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by local sites), which could then be further subdivided into three phases (procedures to

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prevent inaccurate data during the set up and organization of the registry, detection of errors during data collection, and corrections and actions for data quality improvement). JIPAD has

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been developed in line with these proposed frameworks and timeframes, and both the JIPAD

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Working Group and each participating ICU have actively played their own role in constructing a good-quality Japanese ICU database since the project began. Collected data are regularly monitored and corrected by dedicated members who are trained and familiar with the data collection system of JIPAD, so that the validation and credibility of data are guaranteed.

However, some difficulties still undermine the mission of the JIPAD project. Human resources have been a major problem for each institution since the project started, and neither the JIPAD Working Group nor the participating ICUs have dedicated staff. Funding has also

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been insufficient for maintaining and improving both the tangible materials (equipment, server, and network environment) and intangible resources (personnel, information, and software program).

This database also can function as a basic dataset for future research. A high-volume

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database enables clinicians and researchers to conduct various analyses, such as subgroup

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analyses in patients in specific categories [22] or with certain disorders [23]. In addition,

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research using a database can reduce the workload and cost because the demographic data are

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already available when the research is planned [1]. As all participants of JIPAD are allowed

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to use all data for their clinical research, this database is expected to provide good

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opportunities for studies in the future.

4.3.The comparison with other ICU registries

Although similarity exists between JIPAD and other national ICU databases in terms of providing benchmark feedback to improve the quality of critical care and promoting clinical research, the governance structures and data quantities vary. The ANZICS CORE Registries was developed under the auspices of ANZICS more than 20 years ago, and data were collected on 158 ICUs with 151,767 admissions for adults annually in 2015/2016 [24] and 29 ICUs with 11,024 admissions for children in 2016 across Australia and New Zealand [25].

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ICNARC is a charitable organization established in 1994 that is independent of the Intensive Care Society in the United Kingdom and funded by the participating hospitals and research grants from the British government and other funding agencies [26]. A total of 248 ICUs participated in the ICNARC Case Mix Programme to collect data on 170,900 adult admissions between April 1, 2015, and March 31, 2016 [27]. The Dutch National Intensive

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Care Evaluation (NICE) foundation reported that the annual numbers of participating

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institutions and adult patients admitted to the ICU in the Netherlands were 85 and 90,115 in

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2014, respectively [7].

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According to the above reports, the ICU and hospital mortality was reported to be 5.2% and 8.1% in ANZICS [24], and 14.0% and 20.1% in ICNARC [27], respectively. In

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JIPAD, the ICU and hospital mortality was 3.6% and 7.7%, respectively, and the SMRs based

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on the general severity scores (APACHE III, APACHE II, and SAPS II) in adults ranged from 0.387 to 0.534. ANZICS also described, in its annual report, that the proportion of planned admissions after elective surgery was 42.6% in 2015/2016 [24]. ICNARC reported that the proportion of planned admissions following elective/scheduled surgery was 19.7% between April 1, 2015, and March 31, 2016 [27]. In the NICE foundation, the proportion of admissions after elective surgery in 2016 was 36.4% [28]. In JIPAD, by contrast, the proportions of admissions related to elective surgery and elective admission were 64.0% and 62.6%, respectively, and 38.9% of all patients were admitted to the ICUs for postoperative

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procedural monitoring.

The difference in the background of ICU admissions between JIPAD and other ICU registries, particularly the proportion of elective surgery and elective admission, was presumed to be associated with the low ICU and hospital mortality and SMRs in JIPAD.

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Compared to urgent or emergency surgery, the mortality following elective surgery is

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reported to be better. Kahan et al. [29] found that the crude mortality within 30 days after

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elective surgery among patients admitted to the ICUs in 27 countries was 2.4%, which was

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lower than the ICU and hospital mortality reported by ANZICS and ICNARC. A seven-day

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cohort study of surgery by Pearse et al. [30] showed that the odds ratios of the in-hospital mortality in urgent and emergency surgery for elective surgery were 1.71 (95% CI: 1.52–

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1.91) and 3.20 (95% CI: 2.77–3.70), respectively. Accordingly, the high proportion of

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admissions after elective surgery in our cohort might have resulted in the low SMRs based on general severity scores in adults.

Information on the number of ICU beds per inhabitant would also be useful for comparisons with other countries. In ANZICS, there are 9.04 and 5.31 ICU beds per 100,000 capita [24] in Australia and New Zealand, respectively. According to a report by Rhodes et al. [31], the average of number of critical care beds in Europe (31 countries) from July 2010 to July 2011 was 11.5 (8.2 in the United Kingdom) per 100,000 capita. In contrast, there were approximately 5 ICU beds per 100,000 capita in Japan according to a report from the

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Ministry of Health, Labour and Welfare in 2017 (a total of 6,298 ICU beds and 126,000,000 inhabitants in Japan), showing that the number of ICU beds per inhabitant is much lower than in other countries. One major feature of Japanese ICUs is that the proportion of admissions for elective postsurgical care and procedural monitoring is high despite the number of ICU beds per inhabitant being lower than in other countries. The reasons for this are not clear at

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present, partly due to the lack of information on the number of postoperative recovery rooms

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or post-anesthetic care units in Japan.

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ANZICS CORE developed its own mortality prediction model (Australian and New

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Zealand Risk of Death [ANZROD]) [20], and ICNARC has also developed a risk model to predict acute hospital mortality for adult critical care patients in the United Kingdom

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(ICNARCH-2014) [32], as their SMRs based on the general severity scores tend to deviate

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away from the value of one. Likewise, the development of a new mortality prediction model for Japanese adult admissions is warranted due to the relatively low SMRs in JIPAD.

4.4.Strengths and weaknesses

There are several strengths associated with JIPAD. This is the first national ICU registry in Japan. Compared to ANZICS CORE and ICNARC, JIPAD covers patients of all ages, including adults and children admitted to the ICUs, which allows not only adult but also

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pediatric or mixed ICUs to collect data using the same database. That also enables us to seamlessly analyze data on patients of all ages. Our automated data collection system makes it possible for each participating ICU to reduce their workload and improve the completeness and validity of data. In our electronic registration system, there are very few missing data concerning patient demographics, information before ICU admission, ICU treatment, and the

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outcome because the data cannot be uploaded to the central server unless the input of all data

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to the input form, except for laboratory data within 24 h of ICU admission, is completed.

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Despite the limited staff resources and dour financial circumstances, the administration of

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this project has advanced smoothly thanks to the inclusion of specialists with different backgrounds in the JIPAD Working Group and corresponding managers in the participating

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ICUs motivated to participate in JIPAD using a cost-saving software program and

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components developed ourselves. This database has been successfully administered thanks to the co-operative efforts of individuals involved in the JIPAD project.

However, several weaknesses of JIPAD should also be noted. First, unlike ICNARC [33], all data that are registered to the server are not checked and corrected. It will be challenging for us to maintain and improve the data quality in the future when more ICUs participate. Second, as automated data collection systems are not used in all institutions, the workloads for data collection may differ among participating ICUs, leading to variability in data completeness. Third, some useful data items (e.g. comorbidities such as hypertension

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and diabetes mellitus, and laboratory and/or physiological data beyond 24 h after ICU admission) remain uncollected at present. The data variables included in this registry should be re-evaluated to ensure their appropriateness and rearranged periodically. Fourth, since this report included only approximately 3.5% of all Japanese ICU beds, we are not sure if our current cohort is truly representative of all ICU patients in Japan. Finally, the numbers of

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participating ICUs and patients registered to the database are lower than in other national ICU

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databases like ANZICS CORE, ICNARC, or NICE. Although the numbers of registered

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admissions and participating ICUs have been gradually increasing since the start of the

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JIPAD is needed.

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project (Supplementary Figure S1), further recruitment of new participating institutions for

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5. Conclusions

JIPAD has been constructed to improve the quality of care and facilitate the further development of intensive care medicine in Japan. This database has been constructed through the voluntary efforts of individuals in both the JIPAD Working Group and participating ICUs,

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being a basic dataset for future clinical research. The data of JIPAD showed that the ICU and

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hospital mortality was 3.6% and 7.7%, respectively, and the proportion of elective

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postoperative and procedural monitoring was higher than in other countries. As the SMRs

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based on the general severity scores in adult patients were low, the development of a new

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future.

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mortality prediction model for patients admitted to the ICUs in Japan is needed in the near

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Funding

The JIPAD project has been funded by the Japanese Society of Intensive Care Medicine and Health Labour Sciences Research Grant by the Ministry of Health, Labour and Welfare.

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Competing interests

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MN consults for Nihon Kohden Corporation, Getinge Group Japan K.K., and Total Medical

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Supply Corporation. The other authors declare that they have no competing interests.

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Ethics approval and consent to participate

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The JIPAD project was approved by the ICU Functional Assessment Committee of the Japanese Society of Intensive Care Medicine on March 1, 2013. The collection and registration of data in each participating ICU were conducted after receiving approval from the ethics committee of the respective institutions with an opt-out policy from patients, their relatives or proxies. The need for written informed consent was waived. This study was conducted in accordance with the Declaration of Helsinki.

Availability of data and materials

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The datasets used and/or analyzed during the current report are available from the corresponding author on reasonable request.

Authors’ contributions

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HI was a major contributor to writing the manuscript. SU helped organize and draft this

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manuscript. HO and HE analyzed the data and interpreted the results. HI, SU, MU, JK and JH

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contributed to data collection and ensuring data credibility. TK, TT, HS, EH, YA, HK, NI,

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SH, and MN contributed to the interpretation of the results and revision of the manuscript.

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HS helped proofread the English of this manuscript. SH, and MN organized the JIPAD

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project. All authors have read and approved the final manuscript and agreed to submit it.

Acknowledgements

The authors wish to thank all institutions participating in JIPAD for their contribution to the data collection on which this report is based.

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and outcomes for patients with cirrhosis admitted to the United Kingdom critical care units. Crit Care Med 2018;46:705–12. https://doi.org/10.1097/CCM.0000000000002961. [23] Al-Bassam W, Kubicki M, Bailey M, Walker L, Young P, Pilcher DV, et al. Characteristics, incidence, and outcome of patients admitted to the intensive care unit with myasthenia gravis. J Crit Care 2018;45:90–4. https://doi.org/10.1016/j.jcrc.2018.01.003. [24] The Australian and New Zealand Intensive Care Society Centre for Outcome and Resource Evaluation (ANZICS CORE). Adult Patient Database Activity Report 2015/2016, https://www.anzics.com.au/wp-content/uploads/2018/08/ANZICS-CORE-

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APD-Activity-Report-2015-16.pdf Accessed 26 Jan 2019; 2016 [Accessed 3 Feb 2019]. [25] The Australian and New Zealand Intensive Care Society Centre for Outcome and Resource Evaluation (ANZICS CORE). Report of the Australian and New Zealand Paediatric Intensive Care Registry 2016, https://www.anzics.com.au/wpcontent/uploads/2018/08/ANZPICR-Annual-Report-2016.pdf; 2017 [Accessed 3 Feb

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[26] The Intensive Care National Audit & Research Centre (ICNARC). Annual Report and

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[27] The Intensive Care National Audit & Research Centre (ICNARC) Key statistics from the

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Case Mix Programme - adult, general critical care units (1 April 2015 to 31 March 2016), https://www.icnarc.org/DataServices/Attachments/Download/a30185e2-0e19-e711-80e61402ec3fcd79; 2017 [Accessed 26 Jan 2019]. [28] Nationale Intensive Care Evaluatie. Basisgegevens IC units voor het jaar 2016 (in Dutch), https://www.stichtingnice.nl/datainbeeld/public?subject=BASIC&year=2016&hospital=-1&icno=0; 2019 [Accessed 20 Mar 2019]. [29] Kahan BC, Koulenti D, Arvaniti K, Beavis V, Campbell D, Chan M, et al., for The

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International Surgical Outcomes Study (ISOS) group. Critical care admission following elective surgery was not associated with survival benefit: prospective analysis of data from 27 countries. Intensive Care Med 2017;43:971–9. https://doi.org/ 10.1007/s00134-0164633-8. [30] Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, et al., for the European

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Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after

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surgery in Europe: a 7 day cohort study. Lancet 2012;380:1059–65. https://doi.org/

[31] Rhodes A, Ferdinande P, Flaatten H, Guidet B, Metnitz PG, Moreno RP. The variability

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of critical care bed numbers in Europe. Intensive Care Med 2012;38:1647–53.

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https://doi.org/10.1007/s00134-012-2627-8. [32] Ferrando-Vivas P, Jones A, Rowan KM, Harrison DA. Development and validation of the new ICNARC model for prediction of acute hospital mortality in adult critical care. J Crit Care 2017;38:335–9. https://doi.org/10.1016/j.jcrc.2016.11.031. [33] The Intensive Care National Audit & Research Centre (ICNARC). Case Mix Programme (CMP) Process guide for audit staff Top tips for navigating the CMP process, https://www.icnarc.org/Our-Audit/Audits/Cmp/Resources; 2019 [Accessed 15 Feb 2019].

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Figure Captions/ Legends Figure 1: Overview of the data collection system in JIPAD.

JIPAD: Japanese Intensive care PAtient Database, ODBC: Open Database Connectivity, CSV:

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Comma-Separated Value, SSL: Secure Sockets Layer

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Figure 2: Geographical distribution of ICUs participating in JIPAD in the 2015 and 2016

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fiscal years.

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JIPAD: Japanese Intensive care PAtient Database

Figure 3: Standardized mortality ratios based on the APACHE III, APACHE II, and SAPS II

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scores in all adults and critically ill adults and on the PIM2 in children (A). Receiver operating characteristics curves of hospital mortality prediction for the APACHE III-j, APACHE II, and SAPS II scores in all adults (B) and critically ill adults (C) and of ICU and hospital mortality prediction for the PIM2 in children (D).

APACHE: Acute Physiology and Chronic Health Evaluation, SAPS: Simplified Acute Physiology Score, PIM: Paediatric Index of Mortality, ICU: intensive care unit, AUC: Area under the receiver operating characteristic curve

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Journal Pre-proof Table 1: ICUs participating in JIPAD Fiscal year 2015 (from April 2015 to March 2016) Type of hospital University University University University National Private Public Public University

Number of ICU beds 6 6 20 14 6 10 6 8 10

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Number of ICU beds 6 6 20 14 6 10 6 8 11 8 16 18 8 10 6 12 6 16 12 8

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Type of hospital University University University University National Private Public Public University Private University University University Public National University Public Private Private Public

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Hospital No. 1 2 3 4 5 6 7 8 10 11 12 13 14 15 16 17 18 19 20 21

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Fiscal year 2016 (from April 2016 to March 2017)

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Hospital No. 1 2 3 4 5 6 7 8 9

Type of ICU General Pediatric General General General General General General General

Type of ICU General Pediatric General General General General General General General Emergency General General General General General General General General Emergency General

A total of 21 ICUs (217 ICU beds) contributed data in the two-year study period. One hospital (No. 9) did not participate in the 2016 fiscal year. ICU: intensive care unit, JIPAD: Japanese Intensive care PAtient Database

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Journal Pre-proof Table 2: Demographic data on ICU admissions between April 2015 and March 2017 Characteristics Age (year) Male sex Height (cm) Weight (kg) Admission classification Elective surgery Emergency surgery Non-operative Admission type Elective Emergency ICU procedure Admission source Operating room Emergency department Ward Other care units Transferred from another hospital Emergency calls RRT/MET Code blue Hospital to ICU admission Readmission to ICU After cardiac resuscitation Chronic organ insufficiency AIDS

All admissions (n = 21617) 68 [56, 77] 13124 (60.7) 160 [152, 167] 56 [47, 66]

Monitoring (n = 8416) 69 [59, 76] 4990 (59.3) 161 [154, 168] 58 [50, 67]

13831 (64.0) 2752 (12.7) 5034 (23.3)

8368 (99.4) 0 (0.0) 48 (0.6)

13533 (62.6) 8059 (37.3) 25 (0.1)

8400 (99.8) 0 (0.0) 16 (0.2)

Critically ill adults (n = 11755) 71 [60, 79] 7320 (62.3) 160 [153, 167] 57 [48, 66]

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Children (n = 1446) 1 [0, 6] 814 (56.3) 80 [61, 111] 10 [6, 19]

4471 (38.0) 2633 (22.4) 4651 (39.6)

994 (68.7) 117 (8.1) 335 (23.2)

4130 (35.1) 7621 (64.8) 4 (0.0)

1003 (69.4) 438 (30.3) 5 (0.3)

8354 (99.3) 2 (0.0) 60 (0.7) 0 (0.0) 0 (0.0)

6563 (55.8) 3029 (25.8) 1865 (15.9) 150 (1.3) 148 (1.2)

1078 (74.5) 110 (7.6) 172 (11.9) 14 (1.0) 72 (5.0)

292 (1.4) 159 (0.7) 3 [2, 7] 918 (4.2) 493 (2.3)

0 (0.0) 0 (0.0) 4 [3, 7] 109 (1.3) 4 (0.0)

269 (2.3) 151 (1.3) 3 [1, 7] 684 (5.8) 461 (3.9)

23 (1.6) 6 (0.4) 3 [2, 8] 125 (8.6) 28 (1.9)

8 (0.0)

2 (0.0)

6 (0.1)

0 (0.0)

15995 (74.0) 3141 (14.5) 2097 (9.7) 164 (0.8) 220 (1.0)

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Journal Pre-proof Heart failure Respiratory failure Liver failure Liver cirrhosis AL/MM Lymphoma Metastatic cancer Immunosuppression Maintenance dialysis Severity score APACHE III Predicted mortality (%) APACHE II Predicted mortality (%) SAPS II Predicted mortality (%) PIM2 Predicted mortality

288 (1.3) 311 (1.4) 102 (0.5) 300 (1.4) 152 (0.7) 136 (0.6) 833 (3.9) 1109 (5.1) 1053 (4.9)

54 (0.6) 58 (0.7) 4 (0.0) 76 (0.9) 12 (0.1) 32 (0.4) 444 (5.3) 340 (4.0) 234 (2.8)

51 [38, 68] 6.4 [2.7, 18.2] 13 [10, 18] 11.2 [6.0, 23.5] 26 [18, 38] 7.2 [2.9, 21.3] 1.0 [0.3, 2.2]

41 [33, 51] 3.4 [1.9, 6.7] 11 [9, 14] 7.1 [4.5, 11.7] 19 [14, 25] 3.3 [1.7, 6.5] NA

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210 (1.8) 196 (1.7) 93 (0.8) 224 (1.9) 134 (1.1) 103 (0.9) 382 (3.2) 757 (6.4) 818 (7.0)

24 (1.7) 57 (3.9) 5 (0.3) 0 (0.0) 6 (0.4) 1 (0.1) 7 (0.5) 12 (0.8) 1 (0.1)

61 [46, 80] 12.3 [4.6, 33.2] 16 [12, 21] 17.9 [9.0, 36.2] 34 [25, 46] 15.3 [6.5, 37.0] NA

NA NA NA NA NA NA 1.0 [0.3, 2.2]

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Data are presented as the median [interquartile range] or number (%). There were no missing values for any variables. ICU: intensive care unit, Hospital to ICU admission: Days from hospital admission to ICU admission, RRT/MET: rapid response team/ medical emergency team, AIDS: acquired immunodeficiency syndrome, AL/MM: acute leukemia/ multiple myeloma, APACHE: Acute Physiology and Chronic Health Evaluation, SAPS: Simplified Acute Physiology Score, PIM: Pediatric Index of Mortality, NA: not applicable.

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Journal Pre-proof Table 3: ICU treatment Treatment Arterial catheterization Central venous catheterization Invasive mechanical ventilation Mechanical ventilation days NPPV Surgical tracheostomy Percutaneous tracheostomy ICU admission to tracheostomy (days) IABP Veno-arterial ECMO Veno-venous ECMO IRRT CRRT RRT for AKI Plasma exchange PMX-DHP Other blood purification therapy

All admissions (n = 21617) 19398 (89.7) 9848 (45.6) 8203 (37.9) 0.8 [0.4, 3.4] 1003 (4.6) 319 (1.5) 156 (0.7) 11 [7, 17] 342 (1.6) 134 (0.6) 33 (0.2) 865 (4.0) 1065 (4.9) 858 (4.0) 101 (0.5) 156 (0.7) 31 (0.1)

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Monitoring (n = 8416) 8057 (95.7) 2656 (31.6) 962 (11.4) 0.3 [0.2, 0.5] 31 (0.4) 2 (0.0) 4 (0.0) 1 [1, 2] 8 (0.1) 0 (0.0) 0 (0.0) 82 (1.0) 5 (0.1) 7 (0.1) 4 (0.0) 0 (0.0) 1 (0.0)

Critically ill adults (n = 11755) 10249 (87.2) 6481 (55.1) 6364 (54.1) 1.1 [0.5, 3.8] 942 (8.0) 289 (2.5) 152 (1.3) 10 [7, 17] 334 (2.8) 113 (1.0) 25 (0.2) 783 (6.7) 1033 (8.8) 824 (7.0) 79 (0.7) 154 (1.3) 25 (0.2)

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Children (n = 1446) 1092 (75.5) 711 (49.2) 877 (60.7) 0.9 [0.2, 4.4] 30 (2.1) 28 (1.9) 0 (0.0) 12 [8, 26] 0 (0.0) 21 (1.5) 8 (0.6) 0 (0.0) 27 (1.9) 27 (1.9) 18 (1.2) 2 (0.1) 5 (0.3)

Data are presented as the median [interquartile range] or number (%). There were 25 missing values (0.1%) for the duration from ICU admission to tracheostomy among all admissions. All other variables had no missing values. ICU: intensive care unit, NPPV: non-invasive positive pressure ventilation, IABP: intraaortic balloon pumping: ECMO: extracorporeal membrane oxygenation. I(C)RRT: intermittent (continuous) renal replacement therapy, AKI: acute kidney injury, PMX-DHP: polymyxin B-immobilized fiber columndirect hemoperfusion.

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Journal Pre-proof Table 4: Disease group at ICU admission Disease group All admissions (n = 21617) Cardiovascular 5658 (26.2) Coronary artery bypass graft 639 (2.9) Gastrointestinal 4410 (20.4) Respiratory 3796 (17.6) Neurology 3374 (15.6) Musculoskeletal 1172 (5.4) Genitourinary 795 (3.7) Trauma 495 (2.3) Metabolic 394 (1.8) Gynecology 388 (1.8) Hematological 56 (0.3) Other 440 (2.0)

Monitoring (n = 8416) 1241 (14.8) 113 (1.3) 1920 (22.8) 1964 (23.3) 1605 (19.1) 652 (7.7) 507 (6.0) 24 (0.3) 136 (1.6) 249 (3.0) 0 (0.0) 5 (0.1)

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Data are presented as the median [interquartile range] or number (%).

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Coronary artery bypass graft is presented separately from cardiovascular disease [20]. There were no missing values for any variables. ICU: intensive care unit.

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Critically ill adults (n = 11755) 3819 (32.5) 524 (4.4) 2356 (20.0) 1546 (13.2) 1498 (12.8) 435 (3.7) 270 (2.3) 451 (3.8) 249 (2.1) 139 (1.2) 51 (0.4) 417 (3.6)

Children (n = 1446) 598 (41.4) 2 (0.1) 134 (9.3) 286 (19.8) 271 (18.7) 85 (5.9) 18 (1.2) 20 (1.4) 9 (0.6) 0 (0.0) 5 (0.4) 18 (1.2)

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Journal Pre-proof Table 5: ICU and hospital outcome Variables ICU outcome Ward Other care units Home To another hospital Death ICU stay (days) To ward with MV Hospital outcome Survival To another hospital Death Hospital stay (days)

All admissions (n = 21617)

Monitoring (n = 8416)

Critically ill adults (n = 11755)

Children (n = 1446)

18051 (83.5) 2641 (12.2) 46 (0.2) 100 (0.5) 779 (3.6) 1.0 [0.8, 2.9] 1157 (5.4)

7899 (93.9) 510 (6.1) 0 (0.0) 7 (0.0) 0 (0.0) 0.8 [0.7, 0.9] 16 (1.7)

8900 (75.7) 2006 (17.0) 44 (0.4) 69 (0.6) 736 (6.3) 2.5 [1.4, 4.8] 990 (15.6)

1252 (86.6) 125 (8.6) 2 (0.1) 24 (1.7) 43 (3.0) 1.7 [0.8, 4.6] 151 (17.3)

16350 (75.6) 3603 (16.7) 1664 (7.7) 22 [13, 40]

7670 (91.2) 684 (8.1) 62 (0.7) 17 [11, 29]

7434 (63.2) 2794 (23.8) 1527 (13.0) 27 [16, 49]

1246 (86.2) 125 (8.6) 75 (5.2) 19 [12, 48]

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Data are presented as the median [interquartile range] or number (%). There were no missing values for any variables. ICU: intensive care unit, MV: mechanical ventilation.

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Journal Pre-proof Highlights: 

The Japanese Intensive care PAtient Database (JIPAD) project started in 2014.



The primary aim of JIPAD is to improve the quality of intensive care in Japan.



A total of 21 ICUs (217 beds) contributed to this report examined in the two years.



In Japanese ICUs, the proportion of elective and monitoring admissions was high.



The standardized mortality ratios based on severity scores in adults were low.

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Figure 1

Figure 2

Figure 3