Use of national clinical databases for informing and for evaluating health care policies
Introduction
In some countries, national clinical databases have been developed over the past decade. Many have been established for clinical audit (the routine assessment of the quality of care of health care providers). In England there are over 50 covering a wide range of clinical areas [1]. In addition, there are national databases containing clinical data that were established primarily for other purposes, such as cancer registries set up to determine disease incidence and survival. Although national clinical databases vary in their design, organisation, the extent of the dataset collected and the quality of the data [2], [3], they share three features: the intention to achieve participation by all relevant health care providers; data are collected on individual patients (rather than aggregated); and their output can identify providers (usually hospitals but occasionally clinical teams or individual practitioners). Their scope is usually defined in terms of a condition (e.g. diabetes, heart failure) or an intervention (e.g. cardiac surgery). Some, however, focus on a service that provides care for a range of conditions (e.g. adult critical care, pain clinics).
In England, the databases vary as to the size and composition of the datasets they collect. Some are quite small with only 10–20 variables whereas others have over 100. They usually include data on patient's socio-demographic characteristics, their primary condition (and maybe its severity), secondary conditions (comorbidities), treatments (such as surgical procedures), details of service use (such as length of hospital stay, case discussed by a multi-disciplinary team) and outcomes (such as improvements in health status, complications). The quality of the databases varies as regards provider participation rates, patient recruitment rates, data completeness, and data validity and reliability.
There is no consistent terminology for those responsible for running national databases either within England or internationally. Terms include database supplier, owner, custodian, controller, steward, processor, and manager. Each one focuses on slightly different functions reflecting variation in the way databases are organised. We have opted for ‘database custodian’ as an umbrella term for the responsibility for establishing, managing and ensuring the quality of a database. In England, custodians are usually composed of a combination of clinicians (particularly doctors), methodologists (e.g. statisticians, epidemiologists), administrative staff (e.g. IT, project management) and patient or public representatives. They are often located within a professional association (e.g. medical royal college) or a university, though some are independent organisations. Funding is either from central government or from subscriptions from participating providers. While ownership and control of the aggregated data in a national database may rest with the custodian, it may instead be held by the funder (i.e. central government). In either case, access to the data must be granted by the data controller and meet information governance regulations regarding patient confidentiality.
While the value of national clinical databases for stimulating quality improvement is well-recognised [4], as is their use at the micro-level for evaluating health technologies, it is unclear whether much use has been made of them at the meso-level for informing and evaluating the organisation and delivery of services or at the macro-level of national policy.
Our aim was to demonstrate, through several case studies in England, the potential value of national clinical databases to managers and policy-makers, and to make recommendations as to how more use could be made of them in the policy arena. Our objectives were to: identify examples of how national clinical databases have been used by policy-makers to inform and determine health care policies; identify examples of their application in evaluating policies; and suggest ways in which greater use might be made of these databases by policymakers in all countries. Our focus was on meso (institutional) and macro (national, system-level) policies, deliberately excluding micro-level policy about clinical practice (such as individual treatment decisions).
Section snippets
Materials and methods
We restricted the review to 15 of the longest established national clinical databases in England (listed in Appendix A) which tend to be in cancer, heart disease and surgery rather than in long term conditions. Examples of their use to inform policy were identified by reviewing the references cited in national policy documents that related to the clinical areas covered by the 15 databases. The policy documents considered were those available on the Department of Health website which had been
Use of databases to inform policies
- 1.
Adult critical care
In September 2005, the Department of Health (Emergency Care) published Quality Critical Care [5] which provided policy advice to commissioners and providers as to how to achieve good quality care. The document built on policy recommendations published in 2000, Comprehensive Critical Care [18], reinforcing the case for an expansion in the number of critical care beds and to ensure critical care was fully integrated in hospitals by means of outreach services, planned transfer
Discussion
Little use has been made of national clinical databases for either informing or evaluating policies in England. Despite a thorough (though not exhaustive) search, we were able to identify only a few examples of either usage and these were restricted to a small number of the 15 databases we focused on. Where databases have been used, they have proved to be of value to policy-makers, suggesting that they are an under-exploited resource.
Conclusions
There are four ways to stimulate greater use of national clinical databases in those countries in which they exist. First, steps could be taken to encourage greater awareness of the databases that are available and their characteristics. An earlier attempt to achieve this in the UK was the development of the Directory of Clinical Databases (DoCDat) [2] but this foundered after several years due to the withdrawal of support from the statutory body responsible for providing health care
Acknowledgements
This work was funded by the Department of Health Policy Research Programme as part of the Policy Research Unit in Policy Innovation Research. The views expressed are those of the authors and not necessarily the Department of Health.
References (24)
- et al.
Consequences of discharges from intensive care at night
Lancet
(2000) - et al.
Trends in head injury outcome from 1989 to 2003 and the effect of neurosurgical care: an observational study
Lancet
(2005) - Department of Health. List of national clinical audits for inclusion in Quality Accounts 2012–13....
- et al.
Directory of clinical databases: improving and promoting their use
Quality and Safety in Health Care
(2003) - et al.
Cross-sectional survey of multi-centre clinical databases in the United Kingdom
BMJ
(2004) - Improving Health Care Quality. Fact sheet. AHRQ Publication No. 02-P032, September 2002. Agency for Healthcare Research...
Quality critical care: beyond ‘comprehensive critical care’
(2005)The National Service Framework for renal services. Part 1: Dialysis and transplantation
(2004)National stroke strategy
(2007)NHS blood and transplant commercial review
(2011)
What determines geographical variation in rates of acceptance onto renal replacement therapy in England
Journal of Health Services Research and Policy
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