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Clinical guidelines can lead to improved health care, but many guidelines are not effectively implemented. We examine what is involved in implementing guidelines and the evidence about the commonest and most effective methods for doing this, illustrated with clinical examples from paediatric practice where possible. Although the evidence for what works is incomplete, it provides some important pointers for clinicians who are nowadays faced with numerous guidelines.
Clinical practice guidelines are systematically developed statements which assist clinicians and patients in making decisions about the appropriate management of specific conditions and situations with the aim of improving the quality of health care.1 They provide guidance or advice, rather than instructions, and are aids to and not substitutes for clinical judgment. Ideally they are evidence-based, but some may be based on clinical consensus.
There is a strong expectation that well-developed clinical guidelines will contribute to improved standards of clinical practice and outcomes. However the literature abounds with examples of guidelines not being fully or effectively implemented.2–5 The time and resources devoted to guideline development and their potential impact on health care are then wasted. Implementation is not just a “brief interlude between a bright idea and opening the door for service”;6 it is a process not an event. There has been extensive research on guideline implementation which shows that this process is complex but the evidence about what works remains incomplete.7
A central directive alone does not lead to the widespread implementation of even evidence-based health care. In 2005 the Chief Executive of the National Institute for Health and Clinical Excellence (NICE) acknowledged that more needed to be done to secure full implementation of its guidelines.8 A number of national organisations that develop and circulate guidelines now issue outline guidance on implementation, for example NICE, SIGN (Scottish Intercollegiate Guideline Network), the RCPCH (Royal College of Paediatrics and Child Health).9–11 However, translating national and locally-developed guidelines and guidance on implementation into clinical practice is a challenge for paediatricians and their employers, which has implications for the bodies that develop guidelines. This article describes and discusses the process of implementing guidelines, highlighting evidence from systematic reviews and overviews about the commonest and most effective interventions, and illustrating the application of these with an emphasis on paediatric practice.
The stages of the implementation process have been well described and those identified by NICE are shown in box 1.
Box 1 The Process for implementing clinical guidelines (adapted from How to put NICE guidance into practice9)
Consider relevance of guideline
Decide if individual or collaborative approach needed
Identify a clinical lead and network
Baseline assessment of current practice, obstacles, resources
Select interventions and develop an action plan
Implement action plan
Audit and evaluate implementation
Review and evaluate guideline
Although this provides a practical framework, its apparent simplicity is deceptive. In their extensive systematic literature review published in 2005, Greenhalgh et al12 concluded that successful implementation depends on many factors, which include:
the nature of guidelines (their advantages, complexity, flexibility, etc);
the individual clinicians (their motivation, competing demands, knowledge, etc);
the local organisation (existing structures, networks, systems, decision making, priorities, resources, etc);
the interventions (leadership, training, audit and feedback, etc).
There are many possible ways of achieving implementation and no single method has been shown to be effective under all circumstances. Systematic reviews and literature overviews have identified good evidence for what does not work, reasonable evidence for what does work, but many unanswered questions,3,7,13 and there are few randomised controlled trials that address these issues. Successful guideline implementation requires a strategy that has taken account of the evidence about implementation.
KEY EVIDENCE ABOUT IMPLEMENTING GUIDELINES
Much has been published on the development of guidelines. Their characteristics influence how well they are implemented. For example, those that have a good evidence base and are clear, not complex and do not require a lot of change are more likely to be implemented.3,14 The status of guidelines also affects implementation but is not enough to secure this. The dearth of clear evidence on the effectiveness of many paediatric guidelines may influence how they are perceived by busy clinicians.15
In a review of systematic reviews Grol et al found conflicting evidence about whether guidelines developed locally are more likely to be effective than guidelines developed nationally.13 If clinicians can adapt them for local circumstances without deviating from the underlying evidence this has the potential benefit of encouraging ownership while taking account of local systems and resources. Although locally-developed guidelines have intrinsic advantages, successful widespread implementation of both national and local guidelines is likely to need a similar systematic approach.
Leadership, responsibility and accountability
In their systematic review of health service innovations, Greenhalgh et al concluded that, although the evidence is sparse, it strongly indicates that innovations require one or more professionals to lead, support and drive them through.12 In practice, responsibility for implementing new guidelines is often unclear and relies on the somewhat arbitrary initiative of individual clinicians or groups of clinicians. SIGN and other national bodies state that responsibility for the comprehensive implementation of guidelines lies jointly with clinicians and their local organisations.9,10 Accountability in guideline implementation is often less clear and making Trusts accountable for the implementation of some NICE guidance (Technology Appraisals) is likely to augment the role of individuals and clinical groups and lead to better outcomes.
The adoption of new guidelines often involves change both in clinicians’ behaviour and in local systems. Understanding and effectively managing change are important elements of successful implementation. The literature on changing behaviour shows that this is a process requiring initial intention to change, planning of strategies to bring this about, action and then maintenance of the change.16 In general, if people perceive that change is needed, and advantages outweigh disadvantages, it is more likely to happen. Advice that is imposed is not usually valued and is more likely to be rejected.17 Individuals may begin with good intentions but then encounter difficulties and revert to earlier behaviour; this does not mean that the process has failed, as it often takes more than one attempt to alter old beliefs and habits. An overview of literature on the management of change found that new practices are more likely to be assimilated if they fit with existing systems, are accompanied by dedicated time and resources, and there are systems and skills to evaluate their impact.18 This is illustrated by an audit of the implementation of 12 pieces of NICE guidance across 58 Trusts (acute, mental health and primary care) which found that NICE guidance was more likely to be accepted when strongly supported by professionals, when there were no increased or unfunded costs as disincentives and there were good systems for checking progress.19 In practice therefore, implementation is often a gradual and faltering process. It needs organisational support and leadership that fosters understanding, participation and a sense of ownership among clinicians.
Most systematic reviews conclude that effective implementation strategies are multifaceted but the number and combination of interventions required is not clear. According to a major recent systematic review of 235 studies evaluating guideline implementation,7 there is no evidence that effectiveness increases with the number of interventions, and although the possibility that single interventions may be as effective as multiple interventions seems unlikely, this has not been excluded altogether. The Cochrane Effective Practice and Organisation of Care (EPOC) group has described common interventions that can contribute to an implementation strategy.7 These are shown in box 2 and are discussed in more detail.
Box 2 Classification of professional interventions in guideline implementation from Cochrane Effective Practices Organisation of Care7
Identifying and addressing barriers to change
Inclusion of local professionals
Education and training
Local opinion leaders
Patient mediated interventions
An audit system and feedback
Disseminating guidelines is an essential first step in implementation but systematic reviews and literature overviews show that dissemination on its own has little or no impact on implementation.3,13,14 This is illustrated by a North American study which found that simply disseminating guidelines for the diagnosis of attention deficit disorder in primary care did not change clinical practice.20 Similarly, following an extensive programme of disseminating and raising awareness of new British Thoracic Society asthma guidelines, a survey of doctors and nurses in primary care found that although most knew that guidelines had been launched, their knowledge of the content, including even key recommendations, was limited.21 Other studies have shown that not all target professionals are aware of guidelines or do not have access to them when needed.3,22,23 Electronic methods have facilitated the dissemination of full copies of guidelines although in practice summaries may be more useful so long as full copies are available when needed. For example, a survey of community and hospital-based physicians in North America found a strong preference for guidelines in the form of algorithms on patients’ notes.24
Identifying and overcoming barriers
There is substantial evidence from systematic reviews that an assessment of local obstacles and strengths contributes to a successful implementation strategy.7,13 There may be obstacles to do with the clinicians involved (for example, their knowledge, willingness to cooperate and change practice, other demands), the environment (for example, structures, organisational priorities, resources) or the guideline itself (for example, its complexity, evidence base, rarity of the condition involved). In a systematic review of literature describing barriers to guideline adherence Cabana et al found that barriers in one setting may not be present in another and so decisions have to be based on an assessment of local circumstances.25
The introduction of information and new practices requires resources and a lack of these can be a barrier.7 A systematic review of 235 studies of implementation strategies found that the economics of disseminating and implementing guidelines have been examined in only a minority of studies, that there were rarely existing budgets to support these and costs can be substantial.26
Training and education
Training and educational approaches are important but there is considerable evidence that on their own they do not result in the widespread implementation of new practices.3,13,14 The method of delivery of training is important; passive talks have little effect, whereas interactive approaches such as problem solving or discussion of scenarios are potentially more successful.27,28 Focusing on beliefs and misconceptions is another important element of training aimed at changing practice. Recent systematic reviews suggest that providing training in clinical settings (outreach) can increase its effectiveness, but may be costly.3,7
A randomised controlled trial of interactive training of doctors on asthma guidelines showed that two years later the interactively trained doctors were more likely than controls to practice according to the guidelines and received higher scores from the parents of the children who were their patients, who in turn had fewer emergency hospital visits.29
There is broad agreement that reminders about guidelines are among the most effective interventions, especially if they target the clinical consultation and become part of this process.8,14,30 Reminders may take the form of guideline summaries, proformas or algorithms in patients’ notes, and electronic or personal prompts in clinical settings.
For example, a study of the effectiveness of guidelines for the in-patient management of bronchiolitis showed that compliance with treatment guidelines was higher following the introduction of nurse specialists who regularly reminded clinicians about the guidelines.31 However reminders need to be sustained until the new recommendations become routine practice. A study by Hay et al demonstrated that prompts to clinicians on alternate months about the availability of guidelines for the management of gastrointestinal haemorrhage in adults led to greatly increased guideline compliance, from 30% to 70%, during the prompted months.32 Compliance fell to baseline during control months and there was no evidence of sustained change at the end of the intervention period. This shows both the limitations of a single intervention and the contribution that audit can make to the process.
Opinion leaders and coordinators
There is little rigorous evidence for the effectiveness of local opinion leaders, whose primary role is influencing colleagues without taking overall responsibility.13,30 However a clinical coordinator who actively manages the implementation process can make a significant contribution. This is illustrated by a study of surveillance for Barrett’s oesophagus, an adult pre-malignant condition. Disseminating guidelines and the results of an audit of current practice to clinicians did not change practice, but the introduction of clinical coordinators greatly improved adherence to guidelines.33
Audit and review
There is good evidence that audit and quality assurance activities are essential elements of a successful implementation strategy.3,14 Sheldon et al showed that NICE guidelines are more likely to be implemented when organisations have good systems for tracking the implementation process.19 Without audit, incorrect assumptions may be made that dissemination has been complete or that practice has changed.22,23 A systematic review of evaluations of different strategies found that audit with feedback to clinicians has some impact on future practice.8
The content of guidelines also needs to be reviewed periodically. A local audit of national consensus-based paediatric guidelines for investigations following urinary tract infections showed that guidelines had been widely and fully implemented but provided evidence that some of the recommendations being followed were not appropriate and that the guidelines needed to be revised.34
Children and parents
There is evidence that providing patients with information about healthcare interventions, such as in clinical guidance, may both change their expectations and clinicians’ behaviour.14,35 NICE guidance states that patients (and presumably parents) can help ensure that NICE guidance is used appropriately by clinicians.36 For example Pathman found that if parents knew and asked about certain vaccines (acellular pertussis or hepatitis A) doctors were more likely to give these.37
Applying the evidence: examples of successfully implemented paediatric guidelines
Considering the numbers of guidelines that have been issued, there are not many published studies reporting the successful implementation of paediatric guidelines, but there are some good examples. Most are descriptive studies reporting successful outcomes following multiple interventions. Although some studies include data showing the inadequacy of a single intervention, they do not explain the choice and relative impact of the individual interventions that were used, which probably reflects the uncertainties that remain about these issues.
For example, guidelines for the age of referral of children with undescended testes were successfully implemented in Northampton after previous studies had shown that simply circulating recommendations to doctors did not change the age at which children were referred. Implementation was achieved by multiple interventions including analysis of possible barriers, circulating the results of an audit of the existing referral ages and the new policy to hospital and primary care staff, interactive educational events, reminders in health records, information leaflets for parents, an administrative support system and ongoing audit. After implementation, median age at surgery fell from 4.0 to 2.0 years.38
Powel et al39 provide another example. A new guideline for the treatment of acute asthma in children in an Accident and Emergency (A&E) department was implemented effectively through multidisciplinary consultation, interactive educational sessions on-site with emphasis on the rationale, potential problems, skills necessary, and opportunities to shape the guideline, accompanied by written materials and newsletters.
Parents were informed in advance through information leaflets at hospital visits and local media. Evaluation showed that practice had changed for 95% of children presenting with acute asthma, which contrasted with the effects of simply disseminating guidelines in another study reported by Child et al.40 The authors considered that the key to success was considerable planning and following a structured strategy for translating evidence into clinical practice.
Armon et al showed that locally developed guidelines for the management of three of the most common problems presenting to a paediatric A&E department were successfully implemented through a combination of interventions.41 These were: initial consultation with local staff, on-site teaching about the system, prompts at the time of consultation, laminated copies of guideline algorithms in patients’ notes, access to full guidelines and audit. The outcomes were improvements in the quality of care and documentation, reduced invasive investigations, more appropriate treatment and reduced time in A&E.
Implementing guidelines aimed at a wider multidisciplinary system is a more complex process, even when they are developed locally. Cornette et al described the successful implementation of regional guidelines for neonatal stabilisation before transfer.42 These were introduced through initial audit, extensive consultation with clinicians so as to modify guidelines if necessary and maximise ownership, dissemination in booklets and online, outreach training focused on attitudes and skills, ongoing site visits by nurse facilitators, reminders, induction of new staff and ongoing audit. Evaluation showed that guidelines were being used and were highly valued by staff, referrals were appropriate and time spent at the local hospital was reduced. The study illustrates the considerable time and resources that may be needed for successful implementation.
Applying the evidence: what to do in practice
There are several common stages to the successful implementation of guidelines, which include pragmatic decisions about which of the possible interventions are most appropriate and feasible in the local circumstances. The most efficient approach in particular circumstances is still uncertain and those taking responsibility need to take account of the evidence about the strengths and limitations of different approaches.
Although guidelines are intended to aid clinical decision-making, some are directives—for example, Working Together to Safeguard Children 200643 makes it mandatory for guidelines for the management of unexpected childhood deaths to be implemented in England and Wales by April 2008. Multi-agency guidelines on this subject were introduced across Sussex in 199944 and the process of implementation is used here to illustrate the practical application of some of the possible interventions. The Sussex chronology is outlined in box 3.
Box 3 Sussex Unexplained Child Death Protocol44 chronology of implementation
Mid to late 1990s: development of local multi-agency guidelines by police, health, and coroners in response to local needs.
1999: guidelines endorsed and circulated in child protection procedures of three ACPC (Area Child Protection Committee) areas.
Retrospective audit identified gaps in dissemination and implementation leading to further interventions.23
2006: prospective audit in one LSCB (Local Safeguarding Children Board) area confirmed compliance with guidelines.
Widespread implementation requires a local system that considers and responds to new guidelines; this may be the clinical governance panel, clinical networks for conditions such as epilepsy, diabetes, oncology or autism, or the Local Safeguarding Children Board (LSCB), etc. After a decision to adopt guidelines, the next step is to establish who will devise, lead and manage an implementation strategy and action plan. Professionals affected by the guideline must be represented from an early stage in discussions between clinicians, managers and budget holders. In Sussex, the three Area Child Protection Committees (ACPCs) gave the guidelines recognised status and provided a system that bridged multi-agency practice and facilitated discussions.
Identify possible obstacles and strengths
There are local variations in practice, knowledge, interest and resources. An important early step is an assessment of local circumstances to identify strengths, such as existing systems and expertise, and possible obstacles, such as professionals’ differing knowledge, perceptions and competing demands. This provides a basis for judgements about interventions and the best use of resources. In Sussex there were early discussions with the coroners, whose authority and independence were potential barriers. They were then closely involved in guideline development. Some senior clinical staff in A&E had understandable reservations and it emerged that there was no policy with the Ambulance Service about whether babies who had died should be taken to A&E departments. Discussions with staff about the reasons behind the guidelines and their practical implications helped both to resolve these obstacles and to formulate other aspects of implementation. Some paediatricians’ doubts about elements of the guidelines were overcome through similar discussions, practical support from colleagues and continuing review and evaluation of outcomes. The relative infrequency of these events was a potential obstacle that had to be taken into account.
It is essential to identify everyone who should have access to a copy of the guidelines, and to decide whether to circulate full copies or summaries and how to ensure speedy access when needed. This needs careful planning and orchestration. It is cheaper to distribute guidelines electronically to individuals, supplemented with summaries and full copies in the clinical settings where they are needed, and to make use of established and familiar systems where possible. In Sussex the existing systems of the ACPCs and their procedures provided an extant mechanism for disseminating and raising awareness of the guidelines. In addition to dissemination, awareness needs to be raised and reinforced through meetings, case discussions, ward rounds and other clinical opportunities. Information should also be included in induction programmes for new staff.
SELECTING OTHER INTERVENTIONS
It is important that all those for whom guidelines are produced understand their purpose and benefits and have opportunities to discuss the practical implications. Information alone is not enough to change practice and training is not a panacea for implementation. Training should target key professionals but not be exclusive. It should take an interactive approach, making use of clinical scenarios and discussions, rather than just lectures, and should incorporate understanding of what influences behaviour. Some training may be more efficient if held in clinical settings and staff turnover has to be anticipated. In Sussex, as the guidelines apply to an uncommon event and so are not used frequently, it was not practical to run training events for all staff. A local multidisciplinary conference raised some awareness but training is mainly through discussion in staff meetings, multidisciplinary case presentations and audit feedback meetings in the different departments. This is supplemented by training in breaking bad news and working with bereavement.
Wherever possible an implementation strategy should include reminders such as a summary of guideline recommendations, care pathway or algorithm and prompts about guidelines in clinical records and electronic systems or by on-site professionals at the time of clinical contact. Clinicians are more likely to make use of guidelines if these are immediately available and provide useful information at times of patient contact. In Sussex a simple proforma was introduced to A&E departments and is an appendix in the guidelines. This prompts staff about important aspects of history taking, and provides a checklist of recommended medical investigations that have been authorised by local coroners. This overcame the uncertainties, delays and inconsistencies in investigations that were identified in the first local audit. The proforma is routinely copied to the pathologist and coroner and provides a summary that can be audited prospectively. Professional feedback has been positive. The Sussex Police and Sussex Ambulance services established a system of centralised electronic prompts about the guidelines for officers called to an unexpected child death.
The implementation process as a whole requires leadership and coordination, which may be enhanced if lead professionals in the settings in which guidelines apply, such as wards, clinics or A&E department, hold responsibility for some aspects. In Sussex, senior clinical staff in A&E departments play an essential role in establishing and maintaining a system so that guidelines are routinely brought to the attention of clinicians who may be unfamiliar with their own and others’ roles and responsibilities. Police, paediatricians and coroners have maintained joint oversight and gather and audit data prospectively.
Parents and carers
Providing parents and, if appropriate, children, with information about guidelines can also contribute to implementation. In Sussex leaflets given to parents following the unexpected death of a child include general information about the multi-agency process. Experience has suggested that additional written information about local arrangements would be helpful for some parents.
A serious implementation strategy requires audit with a feedback loop to be part of the process from an early stage and should anticipate that new practices may take some years to establish. Successful implementation also means that guidelines become intrinsic to the system, but continue to be updated and informed by it. In Sussex an initial retrospective audit after three years revealed gaps in dissemination, awareness and implementation. Professionals in some agencies who were familiar with the new guidelines had assumed incorrectly that other agencies were following the same procedures. Responsibility and accountability for taking forward implementation were unclear in some localities. Steps were taken to bring these discrepancies to the attention of clinicians and a subsequent prospective audit in one ACPC area showed full compliance with guidelines.
The implementation of clinical guidelines is most likely to be successful when there is a locally devised and managed multifaceted strategy that involves more than just dissemination and passive training. There is no single efficient and effective approach. Paediatricians and their Trusts need to develop ways of jointly and systematically responding to the steady flow of new guidelines. It seems that national bodies that issue guidelines increasingly recognise that their implementation can be complex, but the full implications of this may still be underestimated by some and accountability is often unclear. It might be that even evidence-based practices will only be implemented fully when supported by political, financial and human resource systems at national and local level.45
Particular thanks to Ben Skinner from Brighton and Sussex University Hospitals Trust Library and to Ann Skinner at the Mackeith Centre, Royal Alexandra Children’s Hospital.
Competing interests: None.