Use of national clinical databases for informing and for evaluating health care policies

Abstract

Policy-makers and analysts could make use of national clinical databases either to inform or to evaluate meso-level (organisation and delivery of health care) and macro-level (national) policies. Reviewing the use of 15 of the best established databases in England, we identify and describe four published examples of each use. These show that policy-makers can either make use of the data itself or of research based on the database. For evaluating policies, the major advantages are the huge sample sizes available, the generalisability of the data, its immediate availability and historic information. The principal methodological challenges involve the need for risk adjustment and time-series analysis.

Given their usefulness in the policy arena, there are several reasons why national clinical databases have not been used more, some due to a lack of ‘push’ by their custodians and some to the lack of ‘pull’ by policy-makers. Greater exploitation of these valuable resources would be facilitated by policy-makers’ and custodians’ increased awareness, minimisation of legal restrictions on data use, improvements in the quality of databases and a library of examples of applications to policy.

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).