National quality improvement policies and strategies in European healthcare systems.

OBJECTIVE: This survey provides an overview of the development of policies and strategies for quality improvement in European healthcare systems, by mapping quality improvement policies and strategies, progress in their implementation, and early indications of their impact. STUDY DESIGN: A survey of quality improvement policies and strategies in healthcare systems of the European Union was conducted in 2005 for the first phase of the Methods of Assessing Response to Quality Improvement Strategies (MARQuIS) project. PARTICIPANTS: The survey, completed by 68 key experts in quality improvement from 24 European Union member states, represents their views and accounts of quality improvement policies and strategies in their healthcare systems. PRINCIPAL FINDINGS: There are substantial international and intra-national variations in the development of healthcare quality improvement. Legal requirements for quality improvement strategies are an important driver of progress, along with the activities of national governments and professional associations and societies. Patient and service user organisations appear to have less influence on quality improvement. Wide variation in voluntary and mandatory coverage of quality improvement policies and strategies across sectors can potentially lead to varying levels of progress in implementation. Many healthcare organisations lack basic infrastructure for quality improvement. CONCLUSIONS: Some convergence can be observed in policies on quality improvement in healthcare. Nevertheless, the growth of patient mobility across borders, along with the implications of free market provisions for the organisation and funding of healthcare systems in European Union member states, require policies for cooperation and learning transfer.

Learning from MARQuIS: future direction of quality and safety in hospital care in the European Union.

This article summarises the significant lessons to be drawn from, and the policy implications of, the findings of the Methods of Assessing Response to Quality Improvement Strategies (MARQuIS) project--a part of the suite of research projects intended to support policy established by the European Commission through its Sixth Framework Programme. The article first reviews the findings of MARQuIS and their implications for healthcare providers (and particularly for hospitals), and then addresses the broader policy implications for member states of the European Union (EU) and for the commission itself. Against the background of the European Commission's Seventh Framework Programme, it then outlines a number of future areas for research to inform policy and practice in quality and safety in Europe. The article concludes that at this stage, a unique EU-wide quality improvement system for hospitals does not seem to be feasible or effective. Because of possible future community action in this field, attention should focus on the use of existing research on quality and safety strategies in healthcare, with the aim of combining soft measures to accelerate mutual learning. Concrete measures should be considered only in areas for which there is substantial evidence and effective implementation can be ensured.

Milk amyloid A: correlation with cellular indices of mammary inflammation in cows with normal and raised serum amyloid A.

This study compared concentrations of amyloid A in bovine milk with the cell-based indicators of intramammary inflammation, somatic cell count and California Mastitis Test. Mammary quarter data pertaining to 180 cows were categorised according to concentrations of serum amyloid A in the cow of origin. Ranked correlation, ranked regression and receiver operator characteristics all demonstrated acceptable agreement between milk amyloid A concentrations and cell-based indices. There were some indications of reduction in this agreement, in cows with raised concentrations of serum amyloid A. However, there were also indications that serum amyloid A did not significantly influence milk amyloid A. The results of the current study indicate that milk amyloid A exhibits good correlation with established cell-based indicators of intramammary inflammation.

Rules and guidelines in clinical practice: a qualitative study in operating theatres of doctors' and nurses' views.

BACKGROUND: The current orthodoxy within patient safety research and policy is characterised by a faith in rules based systems which limit the capacity for individual discretion, and hence fallibility. However, guidelines have been seen as stifling innovation and eroding trust. Our objectives were to explore the attitudes towards guidelines of doctors and nurses working together in surgical teams and to examine the extent to which trusting relationships are maintained in a context governed by explicit rules. METHODS: Fourteen consultant grade surgeons of mixed specialty, 12 consultant anaesthetists, and 15 nurses were selected to reflect a range of roles. Participant observation was combined with semi-structured interviews. RESULTS: Doctors' views about the contribution of guidelines to safety and to clinical practice differed from those of nurses. Doctors rejected written rules, instead adhering to the unwritten rules of what constitutes acceptable behaviour for members of the medical profession. In contrast, nurses viewed guideline adherence as synonymous with professionalism and criticised doctors for failing to comply with guidelines. CONCLUSIONS: While the creation of a "safety culture" requires a shared set of beliefs, attitudes and norms in relation to what is seen as safe clinical practice, differences of opinion on these issues exist which cannot be easily reconciled since they reflect deeply ingrained beliefs about what constitutes professional conduct. While advocates of standardisation (such as nurses) view doctors as rule breakers, doctors may not necessarily regard guidelines as legitimate or identify with the rules written for them by members of other social groups. Future safety research and policy should attempt to understand the unwritten rules which govern clinical behaviour and examine the ways in which such rules are produced, maintained, and accepted as legitimate.

Achieving progress through clinical governance? A national study of health care managers' perceptions in the NHS in England.

BACKGROUND: A national cross sectional study was undertaken to explore the perceptions concerning the importance of, and progress in, aspects of clinical governance among board level and directorate managers in English acute, ambulance, and mental health/learning disabilities (MH/LD) trusts. PARTICIPANTS: A stratified sample of acute, ambulance, and mental health/learning disabilities trusts in England (n = 100), from each of which up to 10 board level and 10 directorate level managers were randomly sampled. METHODS: Fieldwork was undertaken between April and July 2002 using the Organisational Progress in Clinical Governance (OPCG) schedule to explore managers' perceptions of the importance of, and organisational achievement in, 54 clinical governance competency items in five aggregated domains: improving quality; managing risks; improving staff performance; corporate accountability; and leadership and collaboration. The difference between ratings of importance and achievement was termed a shortfall. RESULTS: Of 1916 individuals surveyed, 1177 (61.4%) responded. The competency items considered most important and recording highest perceived achievement related to corporate accountability structures and clinical risks. The highest shortfalls between perceived importance and perceived achievement were reported in joint working across local health communities, feedback of performance data, and user involvement. When aggregated into domains, greatest achievement was perceived in the assurance related areas of corporate accountability and risk management, with considerably less perceived achievement and consequently higher shortfalls in quality improvement and leadership and collaboration. Directorate level managers' perceptions of achievement were found to be significantly lower than those of their board level colleagues on all domains other than improving performance. No differences were found in perceptions of achievement between different types of trusts, or between trusts at different stages in the Commission for Health Improvement (CHI) review cycle. CONCLUSIONS: While structures and systems for clinical governance seem well established, there is more perceived progress in areas concerned with quality assurance than quality improvement. This study raises some uncomfortable questions about the impact of CHI review visits.

Serum amyloid A in the serum and milk of ewes with mastitis induced experimentally with Staphylococcus epidermidis.

Mastitis was induced experimentally in ewes with Staphylococcus epidermidis, and the concentrations of serum amyloid A (SAA) in milk and serum, and the somatic cell counts and bacteria in the milk were determined for up to 10 weeks in two experiments, each examining five infected and five control ewes. The somatic cell counts peaked eight hours after infection and preceded an increase in SAA in milk. A maximum concentration of 6460 microg/ml SAA was recorded in milk from the infected sheep, compared with a mean concentration of 1.4 microg/ml in the control sheep. The mean peak concentration of SAA in serum (206.8 microg/ml) occurred earlier (one day after infection) than in milk. The serum concentration of SAA in the healthy animals ranged from 0 to 29.4 microg/ml. There was no correlation between the concentrations of SAA in serum and milk.

Markers of experimental acute inflammation in the Wistar Han rat with particular reference to haptoglobin and C-reactive protein.

C-reactive protein (CRP), haptoglobin (Hp) and fibrinogen (Fbgn) are acute phase reactants (APRs), the blood levels of which increase during acute inflammation. However, although the levels of these APRs are used to monitor inflammation in man, their usefulness and sensitivity as markers of inflammation in rodents are less clear. We therefore wished to evaluate, in a comparative fashion, a prototype immunoassay for serum CRP, a commercial assay for serum Hp, and an automated assay for Fbgn, using a model of acute inflammation in the rat. Additionally, pro-inflammatory cytokines and serum protein fractions were also measured. The model of inflammation used was the intraperitoneal injection of Freund's complete adjuvant (FCA). In a concluding experiment, findings with Hp in the FCA rat model were validated in a toxicologically relevant study involving the induction of acute hepatic inflammation using the model hepatotoxicant carbon tetrachloride (CCl(4)). Female Wistar Han rats were treated with a single injection of FCA in a dose-response study (1.25-10.0 ml/kg, sampling at 36 h) and two time-course studies (over 40 h and 21 days). In a final experiment, rats were dosed with CCl(4) at 0.8 ml/kg and sampled over a 17-day period. In FCA and CCl(4) experiments, serum/plasma was prepared and tissues taken at autopsy for histological assessment (CCl(4) study only). In the dose-response study, serum CRP, Hp and plasma Fbgn were increased at all FCA dose levels at 36 h post-dosing. Serum alpha(2) and beta(1) globulin fractions were also increased, while albumin levels were decreased. In the 40-h time-course study, CRP levels peaked at 25-40 h post-dosing, to approximately 120% of control (as 100%). Hp levels increased to a maximum at 25 and 40 h post-dosing with values greater than 400% of control, and alpha(2) and beta(1) globulin fractions peaked at 30 and 40 h post-dosing to 221 and 187% of control, respectively. Increased serum interleukin-6 (IL-6) and interleukin-1beta (IL-1beta) levels peaked at 20 h (11-fold) and 25 h (19-fold), respectively. In a 21-day time-course study, no increased CRP levels were measured despite elevated levels of Hp, which peaked at 36 h (approximately 7-fold above control), and remained elevated up to 21 days. IL-6 and IL-1beta levels peaked at 12 h (19-fold) and 24 h (28-fold), respectively. Liver histopathology of animals treated with CCl(4) showed centrilobular hepatocellular degeneration and necrosis (most significant at 36 h) with an inflammatory response (most significant at 48 h). Resolution of the lesion was complete by 4 days post-dosing. Serum alanine aminotransferase, aspartate aminotransferase and glutamate dehydrogenase levels peaked at 36 h post-dosing. Hp levels increased maximally at 48 h (426% of control). We conclude that serum CRP is a poor marker of acute inflammation in the rat in comparison with serum Hp and plasma Fbgn. Between Hp and Fbgn, serum Hp is shown to be the most sensitive and useful marker of acute inflammation.

Effectiveness of quality improvement: learning from evaluations.

The effectiveness of many quality improvement interventions has been studied, and research suggests that most have highly variable effects which depend heavily on the context in which they are used and the way they are implemented. This has three important implications. Firstly, it means that the approach to quality improvement used in an organisation probably matters less than how and by whom it is used. Rather than taking up, trying, and then discarding a succession of different quality improvement techniques, organisations should probably choose one carefully and then persevere to make it work. Secondly, future research into quality improvement interventions should be directed more at understanding how and why they work--the determinants of effectiveness--rather than measuring whether they work. Thirdly, some element of evaluation should be incorporated into every quality improvement programme so that its effectiveness can be monitored and the information can be used to improve the systems for improvement.

The external review of quality improvement in health care organizations: a qualitative study.

OBJECTIVE: To explore the use of external approaches to quality improvement in health care organizations, through a descriptive evaluation of the process and impact of external reviews of clinical governance arrangements at health care provider organizations in the National Health Service (NHS) in England. DESIGN: A qualitative study, involving the use of face-to-face and telephone interviews with senior managers and clinicians in health care provider organizations and with members of a regional clinical governance review team. SETTING: The West Midlands region of England, in which there are 47 NHS trusts (health care provider organizations). STUDY PARTICIPANTS: A total of 151 senior clinicians and managers at NHS trusts in the West Midlands and 12 members of a specially constituted regional clinical governance review team. INTERVENTION: Clinical governance review visits which were undertaken by the regional clinical governance review team to all NHS trusts between April 1999 and February 2000. Interviews with senior managers and clinicians took place before and after the review visits had taken place; interviews with members of the clinical governance review team took place when they had undertaken most of their visits. RESULTS: The prospect of external review produced mixed reactions in health care provider organizations, and preparing for such a review was a substantial and time-consuming task. The review itself was often productive, although differences in attitudes and expectations between health care provider organizations and review team members created tensions, especially when the results of the review were reported back. External reviews rarely generated wholly new knowledge, were more confirmatory than revelatory, and did not usually lead to major changes in policy, strategy or practice. CONCLUSIONS: External review systems are widely used in health care to promote quality improvement in health care provider organizations, but their effectiveness is little researched and the optimal design of systems of external review is not well understood. More attention to the design and impact of external review would help to maximize its benefits and minimize costs and adverse effects.

NHS reorganisation. Cause and effect.

In a survey of 304 chief executives, three-quarters felt the Shifting the Balance reorganisation would delay the delivery of the NHS plan over the next year. A quarter felt the delay would be severe. 55 per cent expressed negative views about the reorganisation. On average, chief executives were spending a quarter of their time implementing the reforms. Almost half were concerned about PCTs' ability to cope with an enlarged set of responsibilities. More than half (59 per cent) of chief executives thought their job would change as the result of the reorganisation. A quarter thought they were less likely to be working in the NHS.

Evidence-based management: from theory to practice in health care.

The rise of evidence-based clinical practice in health care has caused some people to start questioning how health care managers and policymakers make decisions, and what role evidence plays in the process. Though managers and policymakers have been quick to encourage clinicians to adopt an evidence-based approach, they have been slower to apply the same ideas to their own practice. Yet, there is evidence that the same problems (of the underuse of effective interventions and the overuse of ineffective ones) are as widespread in health care management as they are in clinical practice. Because there are important differences between the culture, research base, and decision-making processes of clinicians and managers, the ideas of evidence-based practice, while relevant, need to be translated for management rather than simply transferred. The experience of the Center for Health Management Research (CHMR) is used to explore how to bring managers and researchers together and promote the use of evidence in managerial decision-making. However, health care funders, health care organizations, research funders, and academic centers need wider and more concerted action to promote the development of evidence-based managerial practice.

Organisational strategies for changing clinical practice: how trusts are meeting the challenges of clinical governance.

OBJECTIVES: To describe the use, perceived effectiveness, and predicted future use of organisational strategies for influencing clinicians' behaviour in the approach of NHS trusts to clinical governance, and to ascertain the perceived benefits of clinical governance and the barriers to change. DESIGN AND SETTING: Whole population postal survey conducted between March and June 1999. SUBJECTS: Clinical governance leads of 86 NHS trusts across the South West and West Midlands regions. METHOD: A combination of open questions to assess the use of strategies to influence clinician behaviour and the barriers to clinical governance. Closed (yes/no) and Likert type ratings were used to assess the use, perceived effectiveness, and future use of 13 strategies and the predicted outcomes of clinical governance. RESULTS: All trusts use one or more of 13 strategies categorised as educational, facilitative, performance management, and organisational change methods. Most popular were educational programmes (96%) and protocols and guidelines (97%). The least popular was performance management such as use of financial incentives (29%). Examples of successful existing practice to date showed a preference for initiatives that described the use of protocols and guidelines, and use of benchmarking data. Strategies most frequently rated as effective were facilitative methods such as the facilitation of best practice in clinical teams (79%), the use of pilot projects (73%), and protocols and guidelines (52%). The least often cited as effective were educational programmes (42%) and training clinicians in information management (20%); 8% found none of the 13 strategies to be effective. Predicted future use showed that all the trusts which completed this section intended to use at least one of the 13 strategies. The most popular strategies were educational and facilitative. Scatterplots show that there is a consistent relationship between use and planned future use. This was less apparent for the relationship between planned use and perceived effectiveness. Barriers to change included lack of resources, mainly of money and staff time, and the need to address cultural issues, plus infrastructure support. The anticipated outcomes of clinical governance show that most trusts expect to influence clinician behaviour by improving patient outcomes (78%), but only 53% expect it to result in better use of resources, improved patient satisfaction (36%), and reduced complaints (10%). CONCLUSIONS: Clinical governance leads of trusts report using a range of strategies for influencing clinician behaviour and plan to use a similar range in the future. The choice of methods seems to be related to past experience of local use, despite equivocal judgements of their perceived effectiveness in the trusts. Most expect to achieve a positive impact on patient outcomes as a result. It is concluded that trusts should establish methods of learning what strategies are effective from their own data and from external comparison.

Litigation authority. For our eyes only.

The NHS Litigation Authority has a great deal of information on individual doctors that should be made available to trusts in order to ensure patient safety. The authority is so focused on managing clinical negligence cases that it neglects its wider mission to serve the NHS. The authority should be reformed to make it more accountable.

Regulating U.S. nursing homes: are we learning from experience?

The quality of care in U.S. nursing homes has been a recurrent matter of public concern and policy attention for more than thirty years. A complex regulatory system of state licensure and federal certification is in place, but problems of poor quality and neglect and abuse of patients still appear to be endemic. This paper describes how the current system of regulation developed, examines its impact, and draws on the wider literature on regulation to outline some characteristics that may have detracted from its effectiveness and contributed to its disappointing results. Future regulatory reform should pay more attention to the lessons of regulation in other settings and make more use of research and formative evaluation.