K Ritchie, S Downie, J Boynton, J Warner
NHS Quality Improvement Scotland 50 West Nile Street Glasgow G1 2N
Corresponding author: Mrs S Downie, NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP Email: susan.downie@nhshealthquality.org
SMJ 2005 50(4): 147-149
What is clinical governance?
Many health professionals have difficulty explaining the concept of 'clinical governance'. Simply stated, it is the system of checks and balances that NHS Boards put in place to ensure "corporate accountability for clinical performance".1 It can also be described as the mechanism for making sure that healthcare is safe and effective and which ensures that the public are also involved.
The term ‘clinical governance' first appeared in Scottish and English policy documents detailing the reforms to the health service following the election of the Labour government in 1997.2 ,3 Since then, it has been the driving force for quality improvement in UK healthcare and several papers and government publications have been issued to provide a meaningful definition of the concept.1,4, 5,6 While these papers do not use a single standard definition of clinical governance, several key themes are apparent which include:
•continuous quality improvement;
•patient focus and public involvement (PFPI); and
•risk management.
The early references to clinical governance, whilst identifying the key components of the concept, lack clarity of instruction as to how to achieve the systematic adoption of such activities. Further advice was subsequently issued describing outcomes and clarifying roles and responsibilities.7 ,8 ,9
How is clinical governance being implemented in NHSScotland?
NHS Quality Improvement Scotland (QIS) has responsibility for setting standards for clinical governance and risk management and for monitoring performance against these. Two rounds of performance review have been carried out since 2001, and the standards developed in 2002 have been revised to ensure that they reflect new evidence and the new organisational structures that have been introduced in NHSScotland.10 During the revision of the standards, NHS QIS undertook an interim review of the development and implementation of clinical governance and risk management, focusing on Board accountability for safe and effective care throughout its health system. The findings of the review showed that NHSScotland takes clinical governance and risk management seriously, and is committed to providing this assurance. It was also clear that, while there is work still to be done, clinical governance is beginning to develop from its relatively informal beginnings into a much more structured and cohesive system with the patient at the core of all activities.11 The next cycle of performance review against the revised standards will begin in May 2006.
What evidence is there that clinical governance is effective?
Quality improvement interventions
The Cochrane Effective Practice and Organisation of Care group has undertaken a number of systematic reviews of a variety of quality improvement strategies. Many of these strategies would be classified as clinical governance, under the banner of clinical effectiveness, ie evidence-based practice, dissemination of good practice and professional development.
Grimshaw et al (2001)12 identified 41 systematic reviews of these interventions. The reviews included interventions of the following types: continuing medical education, dissemination and implementation of guidelines, interventions to improve team working, patient-mediated interventions, audit and feedback, reminders and local opinion leaders.
Passive dissemination of educational materials, including clinical guidelines, was found to be generally ineffective. Audit and feedback and use of local opinion leaders were found to vary in effectiveness between different studies. Those interventions found to be generally effective included the use of educational outreach activities (defined as use of a trained person who meets with providers in their practice setting to provide information with the intent of changing the provider’s performance) and use of reminder systems. Overall multi-component interventions were found to be more effective than single interventions.
Although clinical governance has been championed by the central NHS administration, there are vocal opponents.13,14 One author concluded that there is little evidence that clinical governance produces clear benefits for patients but concedes that lack of evidence does not necessarily mean that clinical governance strategies are ineffective.15
Patient focus and public involvement
A report published by the Commission for Health Improvement in 200416 (now part of the Healthcare Commission) indicated that although there is considerable PFPI activity in the NHS, there is little evidence of associated service improvement. This is attributed to a number of factors including a lack of corporate commitment to implementation of PFPI, a concentration of effort on seeking views but insufficient action thereafter and not enough sharing of best practice both within and between organisations.
Two recent publications examined the benefits of PFPI in the planning, provision and monitoring of healthcare services.17,18 Ridley and Jones identified a range of different PFPI initiatives including involving people in defining and measuring quality of services and in looking at how services are performing. The authors agree that involving users in determining the quality of services is based on the principle that users are best placed to say what they want from services and whether or not this is being delivered. However, the review cautions that it is possible to be engaged in numerous involvement activities without really involving people if professionals continue to drive the agenda and make decisions about treatments and services without taking users’ views into account.17
‘Patient and public involvement in health: the evidence for policy implementation’ 18 clearly indicated the value of directly involving patients in their own care. There was evidence that patient satisfaction improves when patients are involved. This resulted from reduced anxiety levels, better relationships with healthcare professionals, a greater understanding of their personal needs and positive health effects. The conclusions regarding public involvement in the planning and monitoring of health services were perhaps slightly less positive: while the authors found that public involvement can influence the policies, plans and services of NHS organisations, they note that leadership, board commitment and inclusion in strategic planning are important for the success of public involvement. Those involved in primary care service planning believed that public involvement led to better understanding of healthcare needs, improved health services, less health inequality and health improvement.
Risk management
Risk management within health services differs from risk management in other types of organisations in that the process is focused on improving quality and protecting patients rather than on minimising the costs of risk and protecting the organisation.19
Published evidence of effectiveness of risk management systems to improve quality and reduce the number of adverse incidents experienced by patients is sparse. In one of the few studies where an association has been explored, Walshe and Dineen in 1998 assessed the impact of implementing clinical risk management strategies in NHS Trusts in England.20 The authors reported on three areas that clinical risk management might have an impact upon: the management of claims for clinical negligence; the influence on the clinical audit process; and reported changes in clinical practice. Although overall the introduction of risk management systems was not associated with any change in the way clinical negligence claims were managed, of those Trusts which were using clinical incident recording as an early identification method for potential claims many did indicate that this had altered the management of the claim.
The study also reported that in just over half of respondent Trusts, risk management systems had resulted in reported clinical incidents leading to at least one clinical audit. The authors describe the most encouraging finding of this study to be the reporting by 74% of Trusts of changes in clinical practice resulting from the risk management systems. Many of these changes included the introduction of new policies, procedures or guidelines to ensure consistency in the delivery of care.
There is evidence from other industries, including in particular the aviation industry, which links the introduction of risk management systems to improvements in safety and quality. The concepts demonstrated by the approach of other industries to risk management have succeeded in convincing clinicians that a systematic approach to risk management within a clinical governance framework is an appropriate method to improve patient safety.21
Conclusions
There has been considerable emphasis on clinical governance as a mechanism to improve quality in the NHS across the UK since its inception in 1997. There is a body of evidence that quality will improve when at least some aspects of the three main elements of clinical governance – clinical effectiveness, PFPI and risk management – are put in place, but it has been more difficult to identify evidence of effectiveness of the implementation of a system of clinical governance. This is unsurprising given the relative immaturity of clinical governance systems within NHS organisations and the difficulties in measuring the impact of one set of initiatives within the ever-changing environment that is healthcare. One approach might be for organisations to audit clinical governance activities against those that have shown clear evidence of quality improvement, to ensure that time and resources are being most appropriately directed.
The apparent gulf in understanding between policy makers and clinicians has caused difficulty in promoting clinical governance as a strategy for improving the quality of healthcare for all patients. It has been suggested that this is made worse by the lack of a common language.13,22 Perhaps this is what needs to be addressed in the first instance?
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