The purposes of this chapter:
- To put clinical audit into a historical and policy context.
- To discuss the key issues in clinical audit at the present time.
THE HISTORICAL POLICY CONTEXT
Clinical audit has a relatively recent history. Although the practice of comparing clinical practice against standards may go back to the nineteenth century, early steps in medical audit, as it was then known, mainly took place in the USA and in the UK from the 1970s onwards (see, for example, for the UK context, articles published in the British Medical Journal from 19801). Subsequently it is in the UK that clinical audit has perhaps become most widely recognised as a distinct form of clinical quality measurement and improvement, partly as a result of being actively supported centrally within the National Health Service (NHS) system. However, it is important to emphasise that clinical audit is a quality improvement methodology that is applicable anywhere, within any healthcare system, and the revision of this book is designed to offer an impetus to the conduct of clinical audit by healthcare professionals worldwide.
Clinical audit is extensively used in the USA, albeit often not clearly identified with this title, where the term usually used is chart audit. It is compulsory for doctors in France,2 is practised widely across Europe, and is established practice in Commonwealth countries (especially Australia), and now worldwide to a greater or lesser degree (as, for example, in the developing world).3–6
In the UK, the 1990s saw a surge in activity to evaluate and promote clinical audit, led by the Department of Health. That activity was captured in reviews of the time,7 and was followed by a spate of introspection about the role and value of the process.8–12 This period led directly to the first edition of this book and other activity around 2000 to make clinical audit more effective.
The publication of the inquiry into the failings at the Bristol Royal Infirmary (BRI) in the UK played a major role in highlighting the potential value of clinical audit.13 The publication in 2002 of the first edition of Principles of Best Practice in Clinical Audit captured the findings of the inquiry, and was the culmination of that period of ‘energising’ audit, but it also marked the point when clinical audit began to be regarded as not just the activity of clinicians (as hitherto), but also a valuable tool in management. Up until that time, the idea of external scrutiny of clinical practice had not been fully accepted, so clinical audit had been regarded as largely a professional practice for and by doctors, with limited use of the results by managers and even less use of it by patients.
In 2002, when this book was first published, a wider concept termed clinical governance had emerged in the UK as the touchstone of the period, expressing the need to ensure that clinical processes were managed and overseen by the organisa-tions within which care took place in an effective, integrated way with other matters. This was a managerial viewpoint on what needed to be done, namely that service delivery would be effective if it was ‘managed.’ It did not emphasise quality per se, as this was assumed. Although initially it was felt by some that this overarching concept would give clinical audit a new impetus,11,14 in practice it had the effect of marginalising audit.
This is because during this period the focus moved from ‘clinical audit’ as a separate theme, as this was seen as just one process within clinical governance as a whole. National resources went into supporting effective clinical governance at management level, which in turn involved clinical audit. As a consequence of the emergence of the broader concept of governance, clinical audit staff at local level were moved into other areas; there was limited national support for audit, and the responsibility for national audits moved sequentially between a variety of UK health organisa-tions, from the National Institute for Health and Clinical Excellence (NICE) to the Commission for Healthcare Audit and Improvement (CHI), and to the Healthcare Commission, like a relay baton. Interest in clinical audit, as measured by studies published in academic journals, declined sharply.
By 2007 it was clear that clinical audit in the UK was in the doldrums. Internationally clinical audit was being overtaken and overlooked as a leading quality improvement (QI) method by the focus on patient engagement, prevention of mistakes, untoward events, and improvement of safety. Newer types of quality improvement were emerging, with whole new organisations promoting these but not promoting clinical audit. There were new ideas about how to collect data and measure change against it, such as clinical dashboards.
However, clinical audit was still happening. In the UK it was still a requirement in professional codes and on academic syllabuses. There were still over 20 national audits funded by the Department of Health in England, a system not replicated outside the UK, where national audit is often unfunded and often occurs only in single cycles. As well as this programme there were still keen individuals who were developing and refining audit practice in centres such as the Royal College of Psychiatrists and the Royal College of Physicians. Luckily for clinical audit, the belief that it was central to the NHS as part of the drive for ‘quality’ had also not been lost in the Department of Health in England.
In the UK, from around 2007 there began a new fashioning of what mattered in running health services, which was also taking place worldwide. The current driving principle is quality, best expressed in England by the Next Stage review High Quality Care for All.15 This movement has several elements and systems to improve quality, of which clinical audit is one strand.
The Healthcare Quality Improvement Partnership (HQIP) now manages the revitalisation of clinical audit in England for the Department of Health. HQIP is a consortium that reflects a partnership between patient interest groups and professional bodies, including those for medicine and nursing. This new book is the expression of this renewed energy about clinical audit. However, the views in the book reflect the views of HQIP and the authors, not those of the Department of Health.
KEY ISSUES AND CONTEXTS FOR CLINICAL AUDIT IN THE 'TWENTY-TENS'
Why do we need a new handbook on clinical audit? Reviewing the first edition of this book in 2002, Walshe wrote:
The continuing failure of clinical audit in many NHS organisations is not a failure of knowledge, which this book might help to address. It is primarily a failure of leadership and organisational culture, something which this book cannot really help to solve.16
At one level, this statement is correct. Many people working in healthcare know the basics of clinical audit methodology. However, it is dangerous to assume that there is a firm link between knowing and doing. Audit practice still suffers from the same methodological faults and practice errors as it always has done, and best practice, and encouragement to follow it, need to be set out clearly over and over again. Adherence to proper methodology is the cornerstone of effective audit.
In addition, it is not possible to pretend that clinical audit has not changed, that new ideas do not need to be embraced, that new issues have not emerged, or that the context of healthcare has not altered. All of these things are true. Since 2002, new quality approaches have emerged, and there is a need to both refine and re- state the importance and value of the audit method in this wider context. We shall return to this throughout this chapter.
Nonetheless, the broader point made by Walshe in 2002, namely that audit requires leadership and managerial commitment, remains valid today. There is only so much that an individual clinician or team can do to make the full spread of changes that audit has recommended. In a sense this is what the introduction of clinical governance sought to achieve, but in practice it did not manage to make the link between management and clinical practice adequately. This new edition seeks to reinforce the need to ensure engagement of senior management, especially senior clinicians, in the processes for oversight of audit, and the need for managerial oversight of any programme, as recommended by Bullivant and Corbett- Nolan (see HQIP’s website,17 and summary in Appendix 5 of this volume). If healthcare governing bodies, at least in England, as part of the requirements of central government are expected to maintain oversight of clinical audit, in recognition of its value, Walshe’s concerns may well be addressed by centrally determined requirements. However, to make practice of clinical audit amongst clinicians and audit professionals effective, guidance is essential, and a manual of best practice is needed more than ever.
Other factors in healthcare policy, most of which are global issues, under the broad heading of ‘quality’, form a backdrop to and influence the renewed focus on clinical audit. In this chapter we shall review some of these issues, along with others that are specific to clinical audit, as a means of stimulating debate about the future of audit within this context.
There has been continuing convergence and emphasis on the role of guidelines and standards and, in the UK, NICE has been central to this. NICE guidelines are widely recognised as being among the very best in the world, and they form the basis for many standards that are used in clinical audit. The role of NICE, and its expertise in producing definitive standards, has enabled clinical audit to be based on a body of evidence that can easily be agreed upon to audit. This has meant that increasingly those who design audits have been able to draw on existing standards rather than seeking to draft these themselves. As a result, the subsidiary activity adopted by some national audits in defining standards for care as part of what they do may become less prominent. This is important in the context of the discussion about what audit is for (which is dealt with in detail below).
The second major issue has been the continuing rise of processes variously referred to as regulation, inspection, registration or accreditation, depending on their unique aspects. Each of these processes seeks to examine an area of clinical care, or an entire provider, such as a hospital, for the purposes of some kind of recognition or award. This can be from central government, or from an insuring body, or from some international accreditation body to deliver assurance to an insurer. In the UK, this work has expanded hugely since the publication of the first edition of this book, with a new regulator emerging in 2009 which has quality explicit in its title – the Care Quality Commission.
Discussion of this area would need a chapter or more in itself, but the purpose of introducing it here is simply to emphasise that clinical audit has a relationship to these processes. Audit data is a useful source of evidence in measuring compliance with the standards they use. However, clinical audit can examine complex issues in detail, and the level at which the standards are set for these regulatory processes, although they vary enormously, may well be much lower than the standards against which clinical audit seeks to assess care, and much less detailed. Nonetheless, the rise of such processes establishes how important audit is as a source of data for regulators. In an earlier era, audit data were not used ...