After reading this chapter, you should be able to:
• Describe what clinical practice guidelines are, their uses and their limitations
• Be aware of the major online resources for locating clinical practice guidelines
• Explain the major steps that are involved in the development of guidelines
• Appraise the quality of a clinical practice guideline to determine whether you should trust the recommendations that it contains
• Describe some of the issues related to using a clinical practice guideline
• Be aware of some of the legal issues associated with the use of guidelines
There are various forms of clinical guidance that recommend how to manage specific clinical conditions. This guidance is developed in different ways and can range from consensus-based documents compiled by an individual health agency to high quality evidence-based clinical practice guidelines which have undergone a much more rigorous development and review process. The latter is the type that we are interested in and will focus on in this chapter. However, we will also discuss how to assess the quality of a clinical practice guideline, as it is likely that you will come across many types of guidelines during your clinical practice.
In this chapter we will look at what clinical practice guidelines are, why they are used, where to search for guidelines, the steps involved in developing a guideline and how to appraise the quality of a guideline. We will also discuss some of the issues involved with using guidelines in clinical practice, including legal issues surrounding their use.
Until recently, the internationally accepted standard definition was that proposed by the United States Institute of Medicine (IOM) in 1992: clinical practice guidelines were:
systematically developed statements to assist health professional and patient decisions about appropriate health care for specific circumstances.1
In 2011 a subsequent report by the IOM proposed a new definition aimed at better reflecting the consensus developed over the past 20 years. The new definition is:
Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.2
According to this definition, a well-developed, trustworthy guideline contains rigorously compiled information and recommended actions to guide practice. It should be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key stakeholder groups, and be based on a systematic review of existing evidence, using an explicit and transparent process that minimises bias. It should consider important subgroups and patient preferences, clearly explain the relationship between alternative care options and health outcomes and provide ratings of both the quality of the evidence and the strength of the recommendations. Finally, it should be revised when important new evidence becomes available.2
Guidelines are designed to help health professionals and their patients reach decisions about the most appropriate ways to prevent, diagnose and treat the patient's presenting symptoms. For example, occupational therapists, physiotherapists, speech pathologists, doctors, nurses or other health professionals who work with people who are recovering from a stroke should find the National Stroke Foundation's ‘Clinical Guidelines for Stroke Management 2010’ useful for informing practice (available from www.strokefoundation.com.au/clinical-guidelines).
As we saw in Chapter 2, health professionals are continually exposed to an overwhelming amount of health research and there are thousands of new studies published each year. Keeping abreast of this enormous volume of information is not possible for busy health professionals, and the development of healthcare guidelines is one way in which information overload is being addressed. Guidelines are a useful tool for evidence-based practice as they help us to translate evidence into practice recommendations, which can then be applied to clinical situations.
Guidelines aim to help health professionals and patients make better decisions about health care. They aim to reduce variations in practice across health professionals for the same condition and improve patient outcomes. The development of guidelines—the act of amassing and scrutinising the relevant research about a specific topic and making research accessible to health professionals and patients—is part of evidence-based practice at the organisational level. The subsequent translation and use of guidelines in the clinical setting is more about evidence-based individual decision making, as well as the implementation of evidence into practice.
The number of clinical practice guidelines being produced has increased substantially over the last several years. A survey in 1993 identified 34 Australian clinical practice guidelines.3 A more extensive search in 2007 found over 300 clinical practice guidelines that had been produced for use in Australia in the previous five years,4 and many thousands of guidelines are now published in international guideline libraries.
Guidelines dealing with the same clinical condition may have differing recommendations about the care that should be provided. Sometimes this reflects a difference in quality of production, with some guidelines undergoing more-rigorous development processes than others. Differing recommendations may also arise because the guidelines have been developed for use in different settings, or with different population groups, or because of different views or approaches to valuing care outcomes.
Clinical guidelines are increasingly being used by health professionals. It is anticipated that their use will continue to become more common. The direct applicability to contemporary clinical practice is what makes a clinical guideline useful. As with other types of evidence, care needs to be taken to ensure that guidelines are of high quality, that the evidence that they use is relevant for the setting and population where they will be used, and that they are implemented effectively. Guidelines will not address all the uncertainties of current clinical practice and should be seen as only one strategy that can help improve the quality of patient care.5
Guidelines have a number of benefits. High quality guidelines differ from systematic reviews in that they provide recommendations for care based on a combination of scientific research evidence, clinical expertise and patient values. They often provide an overview of the prevention, diagnosis and management of a condition or the use of an intervention, and so have a broader scope than systematic reviews, which tend to focus on a single clinical question. Use of guidelines can save time, improve decisions about health care and produce better health outcomes.6–9
Guideline development is not easy and involves large amounts of time, money, expertise and effort. As the development process can be lengthy, there is a possibility that the evidence used in a guideline may not be the most current evidence by the time the guideline is finally published. Many guidelines do not provide clear information about conflicts of interest within the guideline development group and how these were handled during the guideline development process.
When considering using a guideline, the key word to remember is ‘guide’. Rigorously developed guidelines are the result of a comprehensive and systematic examination of the literature by a panel of experts with consumer input. This group considers how research findings should be applied in practice and aims to develop a useful, practical resource that can assist in the prevention, diagnosis and treatment of health conditions. However, guideline recommendations are not fixed protocols that must be followed. As with evidence-based practice in general, responsible and informed clinical judgment about the management of individual patients remains important. You need to work together with your patient to develop an intervention plan that is tailored to their specific needs and circumstances, and that is achievable, affordable and realistic.10
One of the potentially limiting factors about guidelines is that they generally tend to deal with a specific condition in isolation. However, in practice, patients often present with a range of comorbid conditions. Even when a patient presents without comorbidities, translating a guideline in practice still needs to take into account factors such as:
• individual patient preferences and desired outcomes
• the patient's readiness to change behaviours
• the likely harms and benefits of alternative courses of action
• the availability and affordability of any services, medications or other interventions that are recommended in the guidelines.
Patient factors will be discussed in more detail later in this chapter when we discuss using a clinical guideline in practice.
As well as clinical guidelines, there are other evidence-based practice products or aids that can help health professionals and patients to make decisions about care. Examples of these products include:
• ‘handbooks’, of which there are many and which differ from country to country. Some examples, primarily Australian ones, include:
• The Australian Medicines Handbook (https://shop.amh.net.au)
• The Asthma Management Handbook (www.nationalasthma.org.au/cms/index.php)
• Therapeutic Guidelines (www.tg.org.au)—covers over 3000 topics, which will mostly be of relevance to medical practitioners. Some of the guidelines are available through the Clinical Guidelines Portal which is described in the ‘Guideline-specific databases’ section of this chapter. The topics are also produced electronically (known as eTG) for either a computer or a handheld device.
• Decision support tools for health care (sometimes these are available for both patients and health professionals). More detail about decision aids is provided in Chapter 14.
• Practice software and smart-phones/handheld computers which incorporate, or have links to, evidence-based guidelines.
• Educational modules and information packs which are sent out to health professionals by national and state health departments.
• Online resources that have been developed to help clinicians find evidence-based information relevant to their needs (in addition to those that were mentioned in Chapter 3), such as:
• Some sites provide interactive topic-based information. For example, NICE Pathways brings together all related products from the United Kingdom's National Institute for Health and Clinical Excellence (NICE) so that users can quickly see all of NICE's recommendations on a specific clinical or health topic (pathways.nice.org.uk).
• Other sites provide information in response to specific clinical questions e.g. BestBETS (www.bestbets.org) are Best Evidence Topics (BETs), developed in the Emergency Department of Manchester Royal Infirmary, UK. These provide evidence-based answers to real-life clinical questions.
• EvidenceUpdates (plus.mcmaster.ca/EvidenceUpdates) is a free service arising from collaboration between the BMJ Group and McMaster University's Health Information Research Unit. This service scans over 120 clinical journals and carefully selects high quality papers. These are then rated for clinical relevance and newsworthiness by an international panel of practising doctors. There is a searchable database and an email alerting system (that can be filtered by specialty/discipline).
Guidelines can complement these other products when the information contained in them is aligned and consistent. Some of these products may contain guidelines and sometimes the products may share the same evidence base as the relevant guidelines. However, there is not always consistency across products. Situations can arise where there are discrepancies in the recommendations made in various products. When discrepancies occur, you need to decide which resource to use. Later in this chapter, we discuss how to evaluate the quality of guidelines so that you can choose the one with the highest quality that will be of the most use to your particular clinical situation.
It is probably clear to you by now that there are thousands of clinical guidelines across the health professions. The obvious question is: Where and how should you look for guidelines relevant to your patient/clinical situation? In general, there are two main electronic sources that can be used to locate clinical guidelines:
• large bibliographic databases (such as PubMed, Embase, CINAHL)
• guideline-specific databases (such as the Australian Clinical Practice Guidelines Portal, National Guideline Clearinghouse and the Guidelines International Network library).
Although the large bibliographic databases do contain some clinical guidelines, the problem is that only a small proportion of guidelines are published in journals. As a result, only a small proportion is indexed in the traditional databases. In addition, none of these bibliographic databases appraise the quality of guidelines, and it may be difficult to access more than just the abstract from their sites. However, if you decide to search the large bibliographic databases to locate guidelines, here are a few tips:
• PubMed: When searching for clinical guidelines in PubMed, you can select the limit ‘practice guideline’ under publication type.
• MEDLINE: Methodological search strategies for retrieving guidelines in MEDLINE (via Ovid) have been created11 and are summarised in Table 13.1, showing strategies that are aimed at locating all articles classified as a guideline and strategies that are aimed at locating methodologically sound guidelines. In the study that developed these search filters, all articles retrieved that met the definition of a clinical practice guideline were evaluated for methodological quality according to the following criteria if they were concerned with the development of a guideline:
TABLE 13.1:
Search strategies (hedges) for locating practice guidelines in MEDLINE (via Ovid)11
| Hedge | All classified guidelines | Methodologically sound guidelines |
| Best sensitivity | exp health services administration OR tu.xs. OR management.tw. | guideline:.tw. OR exp data collection OR recommend:.tw. guidelines.tw. OR practice guidelines.sh. OR recommend:.tw. |
| Best specificity | guideline:.tw. | guideline adherence.sh. OR physician's practice patterns.sh. practice guidelines.tw. OR practice guidelines.sh. |
| Best optimisation of sensitivity and specificity | guide:.tw. OR recommend:. tw. OR exp risk | exp “quality assurance (health care)” OR recommend:.tw. OR guideline adherence.sh. |
+ = explode; colon (:) = truncation; exp = explosion; sh = subject heading; tu = therapeutic use; tw = textword; xs = exploded subheading.
1. the article contained an explicit statement that described the process of developing the guideline, including methods of evidence assembly, method of review of studies and at least one of (a) the organisations and the individuals involved, (b) the methods of formulating guidelines and (c) the methods of reaching agreement or consensus; and
2. evidence was cited in support of at least one of the recommendations contained in the guideline.
If the article related to the application (as opposed to development) of a clinical guideline, the following criterion was used to evaluate the article's scientific merit: at least one of the exact guidelines was provided in a table, figure or text of the article.
Combine the methodological search strategies in Table 13.1 with your content terms (such as the keywords from your clinical question) when searching for clinical guidelines in MEDLINE.
• Embase: Embase has a thesaurus term ‘practice guideline’ which you can use as part of your search strategy; however, be aware that the term refers to more than just clinical practice guidelines.
• CINAHL: You can select the limit ‘practice guideline’ under publication type when searching in CINAHL.
Chapter 3 provides further details about these databases, as well as advice about how to use search strategies such as those shown in Table 13.1 when looking for evidence to answer a clinical question.
One of the best ways to find a clinical guideline can be by searching a guideline-specific database. Details about some of the major guideline-specific databases where guidelines can be found are provided below.
• Clinical Practice Guidelines Portal (Australia) (www.clinicalguidelines.gov.au)
This portal is maintained by the National Institute of Clinical Studies (NICS), an institute of the National Health and Medical Research Council (NHMRC). It provides links to clinical practice guidelines developed for use in Australian healthcare settings. To be included on the portal site, guidelines must have been produced within the last 5 years. At present the portal includes both guidelines that have been developed using systematic review processes and guidelines that do not use (or have documentation of) systematic literature reviews. A summary of key features of each guideline notes whether the guidelines are ‘evidence-documented’. The browsing function supports looking for guidelines by topic as well as by developer. The portal also links to a register of guidelines in development.
• National Guideline Clearinghouse (USA) (www.guideline.gov)
This database is maintained as a public resource by the Agency for Healthcare Research and Quality, USA Department of Health and Human Services. It contains guidelines from both USA-based and non-USA-based organisations, including guidelines from well-known guideline databases such as the Scottish Intercollegiate Guidelines Network (SIGN) and the New Zealand Guidelines Group. You can find guidelines by entering the topic you are interested in (using the National Library of Medicine's Medical Subject Headings (MeSH); www.nlm.nih.gov/mesh/2011/mesh_browser/MBrowser.html; see Box 3.1 in Chapter 3 for an explanation of MeSH) or by entering the name of the organisation or guideline developer. Guidelines must have been developed using a systematic literature search and review process and have been produced or reviewed within the past 5 years in order to be included on this site. The National Guideline Clearinghouse provides structured summaries of the guidelines, including information about availability and links to the developers' website. An interesting feature is the Guideline Comparison Utility, which gives users the ability to generate side-by-side comparisons of a combination of two or more guidelines. The Clearinghouse staff also prepare syntheses of selected guidelines that cover similar topic areas. In these syntheses, there is often a comparison of guidelines developed in different countries. This tool may assist health professionals by providing insight into the commonalities and differences in international health practices.
• National Health Service (NHS) Evidence (UK) (www.evidence.nhs.uk)
This database is managed by the UK's National Institute for Health and Clinical Excellence (NICE) and contains a large number of evidence resources, including guidelines. While some parts of the site are only available to people working within the NHS, most of the resources can be accessed by anyone and guidelines can be searched for by topic. An accreditation logo next to a guideline on the NHS Evidence site shows that the processes used by the organisation producing the guideline have been assessed as meeting NICE quality standards. Registering on the site enables you to save searches and results and be sent email updates of new evidence in your area of interest. All published NICE guidance is indexed by NHS Evidence and there are also guidelines from a variety of other sources. The guidelines on this site are also available at the website of the National Clinical Guideline Centre (www.ncgc.ac.uk), which is an easier site to search if it is primarily guidelines that you are looking for.
• Guidelines International Network (G-I-N) (www.g-i-n.net)
This is a global network with both organisational and individual members that aims to support collaboration on guideline development, adaptation and implementation. The Network has an International Guideline Library that contains more than 7500 guidelines, evidence reports and related documents, developed or endorsed by G-I-N member organisations. Anyone can access the library, but only network members can access the detailed information, save their searches, combine their searches or export the references to EndNote or RefMan.
• Turning Research Into Practice (TRIP) (www.tripdatabase.com)
The TRIP database was discussed in detail in Chapter 3. It is a search engine that searches a number of databases and thousands of sites for evidence relevant to clinical questions. The search results are grouped according to the type of evidence (for example, guideline). For guidelines, the search can be filtered further by choosing from Australia and New Zealand, Canada, UK, USA or ‘other’.
For some specialties and geographical regions, there are other smaller databases which collate guidelines. These include:
• Physiotherapy (PEDro—the Physiotherapy Evidence Database; www.pedro.org.au): contains evidence-based clinical guidelines of relevance to physiotherapy. Some guidelines are also of relevance to other health professions. PEDro was described in more detail in Chapter 3.
• Clinical Practice Rehabilitation Guidelines (www.health.uottawa.ca/rehabguidelines/en/login.php): contains web-based guidelines of relevance to rehabilitation health professionals.
• Canadian Medical Association Infobase—Clinical Practice Guidelines (www.cma.ca/cpgs): contains more than 1200 guidelines that were developed or endorsed by an authoritative medical or health organisation in Canada.
• Speech Pathology and Audiology (www.asha.org/members/ebp/compendium): the American Speech-Language-Hearing Association have collated guidelines of relevance to these professions.
• Oncology (www.nccn.org/index.asp): contains guidelines produced by the National Comprehensive Cancer Network.
The steps involved in developing an evidence-based clinical guideline typically consist of:
1. Identifying the scope of a guideline—providing an outline of the aspects of care within the designated topic area that the guideline will cover.
2. Forming a guideline development group—usually made up of health professionals with expertise in the clinical area, representatives of patients and carers and people who have technical expertise in guideline development methods and in systematic literature reviewing.
3. Gaining agreement about the specific clinical questions or problems that will be addressed by the guideline and that will guide the search for evidence.
4. Searching systematically for evidence and appraising its quality.
5. Discussing and agreeing the implications of the evidence for clinical practice.
6. Formulating draft recommendations.
7. Obtaining external review and feedback of the guideline.
8. Ongoing review and update of the guideline to ensure it remains based on the most current best available evidence—a timeframe of 3 years is often used.
What gives rise to the variable quality of guidelines is that differences occur in this development process, typically in the following areas:
• the specific clinical questions that guide the search for evidence
• the comprehensiveness of the search used to locate evidence (it should be a systematic search)
• the quality of the evidence reviewed
• the rigour of the processes used to assess/grade the evidence
• the mix of people reviewing the evidence
• the way in which conflicts of interest are identified and managed throughout the guideline development process
• decisions that are made about the desirability of different clinical outcomes
• assessments of the likelihood of harms and benefits of interventions and where the balance should fall
• the processes used to develop agreement on the final guideline recommendations
• the strength of guideline recommendations and the extent to which they are linked to evidence
• the process for obtaining review and feedback on the guideline and the modifications made to the guideline as a result.
Guides to guideline development have been published by a number of international guideline development groups, including the NICE and the SIGN12,13—refer to the websites that are provided in the reference list for this chapter.
With such a large number of clinical guidelines of varying quality available, you may be left wondering which guidelines you should, or should not, use in your clinical practice. You need to ask yourself the same question that we asked when appraising various study designs in earlier chapters of this book—‘Are the results of this study valid?’ When appraising clinical guidelines, the ‘results’ are the recommendations, so you are trying to determine whether you can trust the recommendations in a clinical guideline. As with the other types of evidence discussed in other chapters, it is important that you know how to appraise clinical guidelines and recognise the key features that discriminate high quality guidelines that can be used to guide practice from low quality clinical guidelines that should be used with caution. High quality guidelines can improve health care, but the adoption of low quality guidelines can lead to the use of ineffective interventions, the inefficient use of scarce resources and, most importantly, possible harm to patients.14,15
A number of instruments have been developed to help assess the quality of clinical practice guidelines.16 The most widely used of these has been the AGREE instrument. The original AGREE instrument17 was developed by an international group of guideline developers and researchers, the Appraisal of Guidelines Research and Evaluation (AGREE) collaboration. The Collaboration defined quality of guidelines as ‘the confidence that the potential biases of guideline development have been addressed adequately and that the recommendations are both internally and externally valid, and are feasible for practice’.
The original AGREE Instrument was published in 2003 but has now been further refined to strengthen its measurement properties and improve its useability. The new AGREE II instrument18 and instructions for its use can be downloaded for free from the AGREE Research Trust website (www.agreetrust.org). The AGREE II tool appraises guidelines based on how they score on 23 items, which are grouped into six major domains, followed by two global-rating overall assessment items. It is recommended that each guideline is assessed by at least two people (and preferably four) to increase the reliability of the assessment. Box 13.1 lists the domains and items of the AGREE II instrument. Each of the AGREE II items is rated on a 7-point scale (from 1 = strongly disagree to 7 = strongly agree) regarding the extent to which the guideline meets the particular item.
A quality score can then be calculated for each of the six AGREE II domains. Domain scores are calculated by summing up all the scores of the individual items in a domain and by scaling the total as a percentage of the maximum possible score for that domain. The six domain scores are independent and should not be aggregated into a single quality score. AGREE II asks for the assessor to make two overall assessments of the guideline—first, a judgment of the overall quality which takes into account the criteria considered in the assessment process; and second, a statement about whether the assessor would recommend use of the guideline.
Appraising the quality of the evidence that underpins the recommendations within a clinical practice guideline is a key part of the guideline development process. Some guideline recommendations are based on high quality evidence, while others are based on lower quality evidence that is more susceptible to bias, so it is important that users of guidelines are able to understand the strength of the evidence that supports any particular recommendation.19 Internationally, clinical practice guideline developers have in the past used a variety of systems to rate the quality of the evidence that underpins recommendations within the guideline and the strength of the recommendation that is being made.20 The different systems use varying combinations of letters and numbers to communicate the methodological quality of the underlying evidence and the strength of the recommendation. This variety of systems can be extraordinarily confusing for users of guidelines, since the same evidence and recommendation could be graded as ‘II-2, B’, ‘C+, 1’ or ‘strong evidence, strongly recommended’ depending on which system is used.21
Methods for grading evidence and rating the strength of recommendations are continuing to evolve. One method that has now been adopted by several organisations and journals (including the Cochrane Collaboration) is the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach.22 The working group that developed this system used the following definitions:
• the quality of evidence indicates the extent to which one can be confident that an estimate of effect is adequate to support a particular recommendation
• the strength of a recommendation indicates the extent to which one can be confident that adherence to the recommendation will do more good than harm.
The GRADE system takes several elements into account when judging quality of the evidence, including: study design (for example, is the study an observational study or a randomised controlled trial?); study quality (the detailed study methods and execution); consistency (the similarity of estimates of effects across studies); and directness (the extent to which the people, interventions, and outcome measures are similar to those of interest). Judgments about the strength of recommendations take into consideration the balance between desirable and undesirable consequences of alternative management strategies, as well as the quality of evidence, applicability and the certainty of the baseline risk.
The GRADE Working Group website (www.gradeworkinggroup.org) has a number of resources for people wanting to learn more about the GRADE system, with a comprehensive list of published papers, presentations and aids to using the GRADE system. The quality of evidence grading used by GRADE is as follows:21
• high—further research is very unlikely to change our confidence in the estimate of effect
• moderate—further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
• low—further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Within many countries, guideline organisations set standards for guideline development. For example, in Australia the NHMRC sets standards in clinical practice guideline development23 and can approve selected clinical practice guidelines developed by other organisations. To meet the NHMRC standards, clinical practice guidelines must:
• provide guidance on a clearly defined clinical problem based on an identified need
• be developed by a multidisciplinary group that includes relevant experts, end users and consumers affected by the clinical practice guideline
• include a transparent process for declaration and management of potential conflicts of interest by each member of the guideline development group
• be based on the systematic identification and synthesis of the best available scientific evidence
• make clear and actionable recommendations in plain English for health professionals practising in an Australian healthcare setting
• be easy to navigate for end-users
• undergo a process of public consultation and independent external clinical expert review
• incorporate a plan for dissemination, including issues for consideration in implementation.
The NHMRC standards cover requirements in seven domains;23 and within these domains, some items are mandatory if the guideline is to be approved by NHMRC while some are desirable but not mandatory. The NHMRC requires guideline developers to engage reviewers who will assess the guideline using the AGREE II instrument and requires use of either the GRADE approach or an NHMRC-approved evidence rating system to grade recommendations.24
The NHMRC approach requires grading of the evidence according to the following components:
• the evidence base, in terms of the number of studies, level of evidence and the quality of studies (that is, their risk of bias)
• the consistency of the study results between studies
• the potential clinical impact of the proposed recommendation (for example, effect size, precision of the effect size estimate, clinical significance, balance of risks and benefits)
• the generalisability of the body of evidence to the target population for the guideline
• the applicability of the body of evidence to the Australian healthcare context.
For each ‘body of evidence’ that is being evaluated, each of these components should be given a rating of A (excellent), B (good), C (satisfactory) or D (poor). Using this system, the developers of guidelines can then determine an overall grade, from A to D, for each of the recommendations that are contained in the guidelines, where:
A = Body of evidence can be trusted to guide practice.
B = Body of evidence can be trusted to guide practice in most situations.
C = Body of evidence provides some support for recommendation(s) but care should be taken in its application.
D = Body of evidence is weak and the recommendations must be applied with caution.
By now, it should be clear that there are many circumstances where you may wish to seek out a guideline to answer a clinical question. When searching for relevant guidelines, you should frame your clinical question of interest in a way that will help you to efficiently locate relevant information. The PICO method of formulating clinical questions, which was explained in Chapter 2, can also be used when searching for guidelines. Once you have located and appraised a guideline and decided that it is valid, as with other types of evidence, you then need to assess its applicability. That is, is the guideline applicable to your patient/clinical scenario? A key question that you need to ask is whether your patient is similar to the clinical population to which the guidelines apply. For example, your patient may have different risk factors to the clinical population who are the target group for the guidelines and, therefore, the guidelines cannot be applied to this patient. You should also consider whether the setting for health care is similar to the setting to which the guidelines apply. There are also organisational factors to bear in mind when considering implementing a guideline, such as whether the appropriate resources are available (for example, specialised equipment or staff with the necessary skills). Another issue to consider is whether the values that are associated with a guideline (either explicitly or implicitly) match the values of your patient or your community.19 Your patient may have different values, preferences and beliefs to those that were assumed in the guideline.
A clinical guideline is not a mandate for practice. Regardless of the strength of the evidence on which the guideline recommendations are made, it is the responsibility of the individual health professional to interpret their application for each particular situation. Application involves taking account of patient preferences as well as local circumstances.25 For example, while two patients may have exactly the same risks for a particular health condition, we should not assume that they will react in the same way to a suggestion about interventions which are recommended in the guideline. As the two patients are likely to have different values, beliefs and preferences, one patient may wish to proceed with the intervention that the guideline recommends, whereas the other patient may decide not to.
The use of clinical guidelines is not without some controversy. A large amount of human and financial resources have been devoted to developing guidelines on a wide range of topics, but production and dissemination of a guideline alone has limited effect on uptake by health professionals.26 It is clear that the effort and rigorous approach that goes into guideline development needs to be matched by similar investment of time and resource into guideline implementation. Implementing guideline recommendations often requires both a change in human behaviour and a change in the way systems work to deliver care, and this can be a difficult process. The process for implementing evidence into clinical practice, along with some of the barriers that may be encountered during the process and strategies for overcoming them, is discussed in Chapters 16 and 17.
Unfortunately there is a relative lack of high quality research evidence on the impacts of guideline implementation, but there is some evidence that, when implemented, use of guidelines can improve care processes and outcomes. Studies have documented improvements in specific areas of care such as cardiovascular disease and diabetes when guidelines are used.27–30 A systematic review of studies evaluating the effects of Dutch evidence-based guidelines both on the process and structure of care and on patient outcomes showed that guidelines can be effective in improving the process and structure of care, although the effects on patient health outcomes were studied far less and data were less convincing.31
We have seen that clinical guidelines are not a foolproof method of providing clinical care. Guidelines have, in the past, been criticised as being ‘recipe book medicine’ due to concerns that the rigid following of algorithms or care plans has the potential to de-skill health professionals. However, after reading this chapter, it should be clear that no matter how well clinical guidelines and their recommendations are linked to evidence, their interpretation and application should be guided by the health professional's clinical experience and judgment and the patient's preferences and values. Clinical guidelines are a standardised approach to care that apply to general conditions (such as a person who has had a stroke) and not necessarily to the particular clinical situation at hand (for example, a 43-year-old woman who has had a cerebellar infarction and also has diabetes, osteoarthritis and a history of smoking). Therefore, health professionals should interpret the guidelines within the context of an individual patient's circumstances.
The legal issues that surround the use of clinical guidelines can vary greatly between countries because of different laws that exist in each country. Under common law in Australia, minimum acceptable standards of clinical care derive from responsible customary practice, not from guidelines. In England and Wales, the National Health Service Executive has stated that clinical guidelines cannot be used to mandate, authorise or outlaw treatment options.32 While clinical guidelines may be used as evidence in court (either supporting or not supporting the actions of the health professional involved), they are unlikely to alter the usual evidentiary processes in litigation as, currently, the testimony of experts is used to help the courts to decide what is reasonable and accepted practice.33 In other words, court decisions about whether a health professional provided reasonable care and skill are typically based on expert opinion rather than the contents of a clinical guideline. So, while guidelines may be introduced into courts by expert witnesses as evidence of accepted and customary standards of care, they cannot, as yet, be introduced as a substitute for expert testimony.
Although guidelines currently do not set legal standards for clinical care, they provide the courts with a benchmark by which to judge clinical conduct.34 Because evidence-based clinical guidelines can set normative standards for practice, departure from them may require some explanation.34 In clinical situations where there is a serious departure from guidelines, this will need to be well documented in the patient's clinical records. The documentation should emphasise that the departure from the guidelines, and the possible consequences of this, have been thoroughly discussed and understood by the patient and the relevant clinical, or other (for example, patient choice), reasons for this departure provided.
1. Institute of Medicine. In: Field M, Lohr K, eds. Guidelines for clinical practice: from development to use. Washington DC: National Academy Press, 1992.
2. Institute of Medicine. In: Graham R, Mancher M, Wolman D, et al, eds. Clinical practice guidelines we can trust. Washington DC: National Academy Press, 2011.
3. Ward, J, Grieco, V. Why we need guidelines for guidelines: a study of the quality of clinical practice guidelines in Australia. Med J Aust. 1996; 165:574–576.
4. Buchan, H, Currie, K, Lourey, E, et al. Australian clinical practice guidelines: a national study. Med J Aust. 2010; 192:490–494.
5. Feder, G, Eccles, M, Grol, R, et al. Clinical guidelines: using clinical guidelines. BMJ. 1999; 318:728–730.
6. Menendez, R, Torres, A, Zalacain, R, et al. Guidelines for the treatment of community-acquired pneumonia: predictors of adherence and outcome. Am J Respir Crit Care Med. 2005; 172:757–762.
7. Fonarow, G, Abraham, W, Albert, N, et al. Association between performance measures and clinical outcomes for patients hospitalised with heart failure. JAMA. 2007; 297:61–70.
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