Feature—HSR Methodology
Development and implementation of a high-quality clinical database: the Australian and New Zealand Intensive Care Society Adult Patient Database

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Abstract

Objective

To describe the development of a binational intensive care database.

Setting

One hundred thirty-eight intensive care units (ICUs) in Australia and New Zealand.

Methods

A structure was developed to enable ICUs to submit data for central and local analysis. Reports were developed to allow comparison with similar ICU types and against published mortality prediction models. The database was evaluated according to (a) the criteria of the Directory of Clinical Databases (DoCDat) and (b) a proposed framework for data quality assurance in medical registries.

Results

Between January 1987 and December 2003, 444 147 data sets were collected from 121 (72.5%) of 167 Australian and 10 (37.0%) of 27 New Zealand ICUs. Data sets from more than 60 000 ICU admissions were submitted in 2003. Overall hospital mortality was 14.5%. The mean quality level achieved according to DoCDat criteria was high as was performance against a proposed framework for data quality. The provision of no-cost software has been vitally important to the success of the database.

Conclusion

A high-quality ICU database has successfully been implemented in Australia and New Zealand and is now used as a routine quality assurance and peer review tool. Similar developments may be both possible and desirable in other countries.

Introduction

The development of high-quality clinical databases is increasingly recognized as being integral to the practice, management, research, and audit of clinical services [1]. One of the main advantages of a national database is the ability to capture large amounts of information across a wide spectrum of diagnoses or interventions, making meaningful subgroup analysis possible [1]. This is especially important in the field of intensive care, involving the admission of a large number of patients with a wide range of heterogeneous diagnoses, pathologies, and clinical care locations. There are other reasons for wanting to examine national activity. Patients are often cared for in a variety of types of intensive care units (ICUs) and, in Australia and New Zealand especially, critical care services may be provided in tertiary settings as well as in nonspecialized regional hospitals. Distances between centers are often very large and there may be geographical or other barriers to the transfer of patients between different levels of care. Private and public funding models may also result in differences in clinical practice. Finally, intensive care is expensive, consuming an estimated $AUD 500 million to $AUD 1 billion in Australia per annum [2]. It therefore behooves all clinicians, managers, and health care providers to constantly evaluate the results of this expenditure to ensure that goals and expectations are being met.

Until the early 1990s, there was no national database of intensive care activity in Australia. Many publications regarding ICU outcome were appearing in the international literature at that time, and a number of illness severity scoring systems were being developed and used [3], [4], [5], [6]. Members of the Australian and New Zealand Intensive Care Society (ANZICS) therefore sought to develop a binational database of admission details for all ICU patients. Although the project was commenced in 1992, retrospective data available from some institutions went back to 1987 and have continued to the present time.

It is important for database users to have some assurance of its quality and associated processes and there are now a number of methods for the assessment of large clinical databases. The Directory of Clinical Audit Databases (DoCDat) was established in the UK in July 2001 to provide a catalogue of clinical databases to researchers and clinicians and to allow evaluation according to well-defined criteria [7], [8]. The developed criteria can be considered in three major categories: the ability of the database to represent the population that it purports to describe, the completeness of the data contained within the database, and the consistency and accuracy of data collected. Others have also proposed methods for ensuring data quality in medical registries and the framework proposed by Arts et al [9] is intended to serve as a reference during the establishment of databases or registries and to allow identification of areas for improvement in data quality.

This paper describes the history and development of the ANZICS Adult Patient Database (APD) and evaluates its performance according to the DoCDat criteria and the framework proposed by Arts et al [9].

Section snippets

Development

A number of individual Australian and New Zealand ICUs began collecting severity of illness and patient outcome data in their own databases after the initial descriptions of the Acute Physiology and Chronic Health Evaluation (APACHE) system by Knaus et al [10] in 1981 and the subsequent development of APACHE II in 1985 [3]. In 1990, it was decided to capture this information in a binational database. A core data set based on APACHE II was agreed upon and the important components of the project

Methods

The APD was assessed according to (a) the DoCDat criteria and (b) the framework proposed by Arts et al [9]. DoCDat criteria were obtained from http://www.lshtm.ac.uk/docdat/PDF_files/data_manual.pdf. Each criterion was rated on a scale of 1 to 4 by 5 people independently (2 clinicians and 3 ANZICS employees) (Table 1).

The framework of Arts et al [9] was broken down into 3 categories and each category was applied to the central coordinating center and to local sites (Table 2).

Contributing units

At December 31, 2003, 131 units in Australia and New Zealand had contributed data to the Central Database. The type, location, and number of ICU admissions to these units are shown in Table 3. Patients do not have an “opt out” option; however, ICUs have an “opt in” option. More than 78% of existing Australian ICUs and 37% of New Zealand ICUs have contributed to the database at some time in the past 16 years (Fig. 1). These units represent approximately 60% of all public and private sector ICUs

Assessment using framework of procedures (Arts et al)

The APD fulfilled all criteria within the framework, with the exception of 5 items. Four relate to the central coordinating center (ie, perform site visit, train new participants, perform site visits for data quality audit, and check interobserver and intraobserver variability) and one relates to local sites (train [new] data collectors).

Discussion

The ANZICS APD has grown from humble origins into the largest single ICU data repository in the world, now housing over 450 000 intensive care episodes and covering 72.5% of all current admissions to Australian ICUs. It also captures data from 37% of New Zealand ICUs and a small number of units in other countries with ANZICS members, notably Hong Kong. The APD has effectively evolved from the “ground up.” Unlike most other outcome assessment tools, often well-funded research projects with

Conclusions

The ANZICS APD has its origins in 1987. Its evolution has been slow and hampered by funding difficulties, but it is now the world's largest single repository of intensive care data. It has met the initial goal of providing a significant quality assurance tool and a national intensive care information resource, now capturing most intensive care episodes in Australia. Centrally and peripherally generated reports help provide individual ICUs and health care providers with a greater understanding

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