What impact does regulation have on the quality of healthcare?

This Health Foundation Viewpoint considers the extent to which regulation can improve, or support the improvement of, the quality of healthcare in the UK. It is based on a new report, Regulation and quality improvement: A review of the evidence by Sheila Leatherman and Kim Sutherland, undertaken as part of QQUIP, a five-year initiative of The Health Foundation. It also takes note of the experiences of our award holders working in the NHS.

This Health Foundation Viewpoint considers the extent to which regulation can improve, or support the improvement of, the quality of healthcare in the UK. It is based on a new report, Regulation and quality improvement: A review of the evidence by Sheila Leatherman and Kim Sutherland, undertaken as part of QQUIP, a five-year initiative of The Health Foundation. It also takes note of the experiences of our award holders working in the NHS.

The regulation of healthcare is one of the key components of NHS reform. The expansion of patient choice, the increasing use of the independent sector and the principle of payment following patients all create new challenges and require a new regulatory regime. The future regulation of health and adult social care in England sets out the Government’s proposed response to these challenges and a new structure for regulatory bodies. Significant changes have also been proposed for how healthcare professionals are regulated. However, regulation also involves significant direct and indirect costs, both for the regulator and those being regulated, and tends to increase in volume over time. The Better Regulation Commission has been set up to find ways to reduce this burden in England.

It is clear that decisions about how to regulate the reformed NHS should be based on the available evidence. However, Regulation and quality improvement shows that there is limited evidence to date about the impact regulatory regimes have on healthcare quality, with most of the current research based on observational studies or uncontrolled research. The report offers the most up-to-date insights into what we do know and the level of evidence about which regulatory mechanisms are worth pursuing in an attempt to improve healthcare quality.

Key points 

• Standards can be used to improve the quality of healthcare. Clinical outcomes measurement is necessary to assess whether standards have had the desired effect.
• It is important that targeting achievement in one area does not lead to worsening standards in others. Organisations need to be supported to meet targets appropriately.
• Healthcare policy makers, providers and patients need information about health outcomes in an accessible format in order to decide where to focus resources, improve quality and make informed choices.
• The low levels of participation in existing clinical audits needs to be addressed. This could be done by making participation a requirement for medical practice, through revalidation.
• Inspections play an important role in ensuring that standards are met. However, their impact depends on the methodology used, quality of the recommendation and people’s ability to implement.
• Existing UK regulation of medical professionals needs to change in line with the proposals outlined in Good Doctors, Safer Patients on local regulation, clinical audit and revalidation.
• Foundation Trust boards need to ensure the drive to pursue financial surpluses for re-investment does not lead to a reduction in the quality of healthcare.

Regulation and quality improvement takes a broad view of regulation as rules designed to control conduct. The report assesses the impact of regulation on organisations, individuals and the marketplace. This includes standards, targets, inspection, professional regulation, mandatory reporting and market regulation.

Standards

The evidence: Standards are used to set levels of expected performance or quality. They include best practice guidelines, minimum levels of performance and technology appraisal guidance. There is evidence to suggest that the coronary heart disease National Service Framework (NSF) in particular has been instrumental in improving the quality of care. Studies show that the use of statins following heart attack rose from 34 per cent of men and 48 per cent of women before the NSF was introduced, to 65 per cent and 67 per cent respectively afterwards.

Our view: The Health Foundation believes that standards such as the NSF and guidance from the National Institute for Health and Clinical Excellence can be used to improve the quality of care, particularly when supported by other mechanisms. Clinical outcomes measurement is also necessary to assess whether these standards have had the desired effect.

Targets

The evidence: Targets have been widely used in the NHS since 1997. Despite criticism that they have sometimes distorted clinical priorities, the evidence suggests that setting challenging targets, combined with other interventions, is effective. For instance, waiting time targets in England have led to an improvement that is markedly better than other parts of the UK, where targets are less stringent. However, the evidence also suggests that targets work best when they are modest in number and focused on specific objectives. For example, in 2004 a manageable set of 14 public service agreement targets for health in England were translated into 206 health targets and measures for NHS and Primary Care Trusts, which led to priorities becoming meaningless.

Our view: We believe that the right targets, used in an appropriate way, can improve health quality. However, it is important that systems and services are designed in a way that ensures achieving targets in one area does not lead to worsening standards in others. Health professionals and organisations also need support to meet targets appropriately, for example through training in mapping, measuring and testing processes. Our Safer Patients Initiative demonstrates how much can be achieved when hospitals set their own targets and are given the right technical support. For instance, the four hospitals involved are successfully reducing rates of ventilator pneumonia, central line infections and medication errors.

Inspection

The evidence: The UK has placed a large emphasis on inspection as a way to improve public services, with spending on this area more than doubling between 1997 and 2004. However, the evidence about inspection and its impact on the quality of healthcare is limited. There is some evidence that the prospect of inspection can encourage organisations to focus on measuring and improving their performance.

Our view: Inspections can play an important role in ensuring accountability and that minimum standards are met. In addition, when conducted in the right ways, they can be powerful tools for supporting quality improvement and can provide evidence of the need for additional resources or staff changes. However, we believe that their impact depends on the inspection methodology used, the quality of the resulting recommendation and people’s ability to implement them.

Professional regulation

The evidence: There is little evidence about the impact licensure has on quality. However, there is a substantial body of evidence that indicates a positive association between specialist certification and better patient outcomes. Research also suggests that professionally-led and publicly-reported regulation is more effective than employer-driven regulation. Furthermore, the revalidation of professionals works best when it is based on clear and objective standards, with participation from the relevant professional bodies.

Our view: It is clear that existing UK regulation of medical professionals needs to change. The Health Foundation supports the proposals outlined in Good Doctors, Safer Patients for local regulation, revalidation and the use of clinical audit data for specialist re-certification. The clinical community now needs to step up to the challenge of modernising the regulation of healthcare professionals.

Mandatory reporting

The evidence: Public reporting of clinical performance is at an early stage in the UK. The Healthcare Commission and the Society for Cardiothoracic Surgery in Great Britain and Ireland have led the way by publishing information about survival rates for patients after heart surgery from across the country. Very few research studies have assessed the impact of mandatory reporting of performance data on the quality of healthcare. However, the indications from the US are that publicly reporting performance can have a positive effect on care. There is also evidence that for reporting to be effective it needs to be mandatory and developed in a way that does not lead to providers or clinicians refusing to treat higher risk patients.

Our view: Healthcare policy makers, providers and patients need information about health outcomes in an accessible format in order to decide where to focus resources, improve quality and make informed choices. The Health Foundation believes that the efforts that have been made to record heart surgery survival rates should be replicated in other specialities. However, careful consideration is needed in deciding how performance is reported, particularly in areas such as mental health where it is harder to attribute outcomes to care. In all cases, measures should be developed in consultation with professionals and patients.

We support the recommendation in the Chief Medical Officer’s report Good Doctors Safer Patients to set up a clinical audit advisory group. However, we think this should go further and address the current lack of resources for the development and use of clinical quality measurement. In some areas of mental health, national measurement is funded on a subscription basis by participating Trusts. This model could be adopted by acute and general services. The low levels of participation in existing audits, which can be as low as 20 per cent, also needs to be addressed. This could be done by making participation a requirement for medical practice, through revalidation.

Market regulation

The evidence: There is some emerging evidence from the US on the impact of regulatory mechanisms and the health market. With its insurance-based system and greater expenditure on healthcare, the challenges facing the US in terms of market regulation are obviously very different to the NHS. Nevertheless, this evidence can still inform NHS reform in England, where market mechanisms are increasingly being introduced. The conversion of hospitals from public or non-profit to for-profit status has received much attention in the US. The evidence suggests that hospital conversion to for-profit status has had negative consequences for healthcare quality, such as increased mortality rates. However, there is little evidence about the impact of regulation in preventing this. Elsewhere, there is strong evidence that setting the rate of pay by service or by case (equivalent to the English payments by results) can constrain the growth of expenditure on healthcare, as can setting the rate by overall hospital expenditure.

Our view: The creation of Foundation Trusts in England is very different from the US experience of conversion from non-profit to for-profit status. However, vigilance is needed to ensure that the drive to pursue financial surpluses for re-investment does not reduce the quality of healthcare. We therefore support the introduction of the compliance framework for Foundation Trust boards, which sets out their responsibilities for health service quality and the action that can be taken if this falls below minimum standards.

The following views on regulation come directly from The Health Foundation’s award holders, who are working at the frontline of healthcare provision in the NHS.

“Following the Clinical Standards Advisory Group report and subsequent standards on cleft lip and palate, the numbers of surgical centres have reduced, the numbers of patients per surgeon have increased, services have responded more quickly to the birth of children with clefts and there are early indications that outcomes are improving.”--Dr Joyce Russell, Clinical Director, Cleft Lip and Palate Network

“My Trust routinely reports performance data, even though some of the targets reported on are not measured for mental health nationally. However, it is very hard to attribute mental health interventions to specific outcomes, as so many aspects of life in general impact on individuals’ mental wellbeing. There continues to be a desire to measure outcomes in mental health, and people have tried to agree appropriate outcomes to measure, but no one has succeeded.”--Rachel Newson, Associate Director, Norfolk and Waveney Mental Health Partnership

“Every inspection leads to recommendations and an action plan. However, the quality of the inspection methodology used has a significant impact on the helpfulness of the recommendations and the likely improvements achieved. A well-triangulated inspection can produce meaningful feedback to organisations and galvanise managers and practitioners into action, where before there might have been complacency or resistance.”--Rachel Newson, Associate Director, Norfolk and Waveney Mental Health Partnership