4.2 Introduction

The purpose of this chapter is to provide an overview of the development and use of clinical guidelines as a tool for decision making in clinical practice. Nurses have always developed and used tools to guide clinical decision making related to interventions in practice. Since Florence Nightingale (Nightingale 1860) gave us ‘notes’ on nursing in the late 1800s, nurses have continued to use tools, such as standards, policies and procedures, protocols, algorithms, clinical pathways and clinical guidelines, to assist them in making appropriate decisions about patient care that eventuate in the best desired patient outcomes.

Clinical guidelines have enjoyed growing popularity as a comprehensive tool for synthesising clinical evidence and information into user-friendly recommendations for practice. Historically, clinical guidelines were developed by individual experts or groups of experts by consensus, with no transparent process for the user to determine the validity and reliability of the recommendations. The acceptance of the evidence-based practice (EBP) movement as a paradigm for clinical decision making underscores the imperative for clinical guidelines to be systematically developed and based on the best available research evidence.

Clinicians are faced with the dilemma of choosing from an abundance of guidelines of variable quality, or developing new guidelines. Where do you start? How do you find an existing guideline to fit your practice? How do you know if a guideline is evidence-based, valid and reliable? Should you apply an existing guideline in your practice or develop a new guideline? How do you get clinicians to use the guidelines? How do you know if using the guideline will make any difference in care delivery or patient outcomes? Whatever the choice, the challenge lies in choosing or developing a clinical guideline that is credible as a decision-making tool for the delivery of quality, efficient and effective care. This chapter will address the posed questions through an exploration of the ins and outs of clinical guidelines, from development to application to evaluation.

4.3 What are clinical guidelines?

Before getting into this chapter on clinical guidelines, it is necessary to start with a definition to differentiate clinical guidelines from the myriad of other decision-making tools nurses use in practice (see Table 4.1). However, it is important to keep in mind that regardless of nomenclature (e.g. algorithm, clinical pathway), the process of the development of clinical decision-making tools should be equally as rigorous. Clinical guidelines are ‘systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific circumstances’ (Field & Lohr 1992). The broad purpose of clinical guidelines is to aid clinicians in providing quality care and to aid in the evaluation of that care against best practice.

Table 4.1 Examples of clinical decision-making tools used in practice

Algorithms are clinical guidelines prepared in a flowchart format. They typically describe the process and decisions, allow for alternative pathways and are involved in addressing a specific condition.

Clinical pathways are typically multidisciplinary management tools based on clinical information developed in other guidelines. They document the essential steps in a clinical process from hospital admission to discharge, detailing the timing of interventions to achieve identified outcomes.

Clinical guidelines are systematically developed statements to assist clinical and patient decisions about appropriate healthcare for specific clinical circumstances (Field & Lohr 1992).

Policies are written plans of an organisation’s official position, based on the organisation’s purpose and goals, on a specific health situation. They are intended to guide and determine decisions for improving a specific health situation.

Procedures are an established series of ordered steps for performing specific tasks, typically associated with an identified policy.

Protocols are rigid, prescribed statements. They describe in detail how the process of the most cost-effective care for a population of patients should be conducted, usually to expedite care for routine problems.

Standards are accepted discipline-based principles for patient care processes, developed to increase the probability of appropriate care.

Evidence-based guidelines have been promoted as one strategy for bridging the research–practice gap by translating research findings into feasible recommendations ready for integration into practice. The proliferation of guidelines in the past 15 years has been an attempt to address the problems of variability in practice and inappropriate practice, by gathering together in one place the best available evidence to support effective and efficient care. There is some evidence that guideline-driven care by medical, nursing and allied health professionals can be effective, in varying degrees, in changing the process and improving the outcome of care (Grimshaw & Russell 1993, Thomas et al 2003).

However, in order for guidelines to reach their full potential, they must be: developed with the end user in mind; developed using systematic and rigorous processes; developed simultaneously with dissemination and implementation strategies; and evaluated regularly to keep abreast of the ever-changing healthcare environment and new knowledge. With this in mind, clinicians must be aware that not all guidelines have been developed within the confines of the above criteria or without the impact of other influences inherent in the current processes. Some of the issues that can cloud the credibility and acceptance of a guideline as evidence-based include: conflicting or lack of research evidence; governance and composition of the guideline development committee; unanimity among committee stakeholders within the development process; lack of transparency in the consensus process; lack of independent external review; resource availability or constraints; and conflict of interests among stakeholders, industry and academia (Raine et al 2005, Sniderman & Furberg 2009). Guidelines must be critically appraised before they are accepted for use in practice; only then can guidelines effectively assist in clinical decision making, improve the quality of healthcare, guide resource allocation and reduce the legal risk of liability.

4.4 What are the characteristics of effective clinical guidelines?

Grilli et al (2000) evaluated 431 guidelines produced by professional specialty organisations between 1988 and 1998 for quality, based on three dimensions: description of stakeholder involvement in the development process; strategy for identifying evidence; and grading of recommendations. Only 5% of guidelines in the study met all three criteria for quality, which led to the conclusion that ‘explicit methodological criteria for the production of guidelines shared among public agencies, scientific societies, and patients’ associations need to be set up’ (Grilli et al 2000:103).

Although there is no internationally recognised and universally accepted framework for the development of clinical guidelines, guideline development organisations around the world are in agreement on certain key qualities required for guidelines to be effective. These key qualities include validity, reproducibility, representativeness, flexibility, adaptability, cost-effectiveness, applicability, reliability and usefulness (Field & Lohr 1992; NHMRC 1999, 2009; SIGN 2001). These key qualities should be considered when appraising existing national clinical guidelines before adaptation to local contexts, and when developing new guidelines. Guideline development methodology, and therefore guidelines, can be enhanced worldwide by the adoption of an internationally accepted conceptual framework, based on the recognised key qualities. In this way, internationally accepted standards for the collection and synthesis of evidence in developing effective guidelines can be established.

More recently, the World Health Organisation (WHO) commissioned a series of 16 reviews to address the need to use more rigorous processes for guideline development (Oxman et al 2006). Schünemann et al (2006) found no experimental research that compared the different components of guidelines. They did find many examples, surveys and other observational studies that compared the impact of different guideline development documents on guideline quality, and recommended integration of key components similar to those recommended by the National Health and Medical Research Council (NHMRC) in the late 1990s (NHMRC 1999).

In Australia, the NHMRC (1999, 2009) has incorporated recognised key qualities into nine guiding principles for effective guideline development. These nine principles have been adapted and presented as a conceptual framework for guideline development in Table 4.2.

Table 4.2 Conceptual framework for guideline development

Key qualities	Guideline development principles
Valid and reproducible	Guideline development should be outcome-focused.
	Guidelines should be based on best available evidence and describe the strength of the link between recommendation and outcome.
	Guideline evidence should be combined using the strongest method available to determine effect on clinical outcomes.
Representative	Guideline development teams should be multidisciplinary and include consumer representatives.
Flexible and adaptable	Guidelines should be flexible and adaptable to local conditions.
Cost-effective	Guidelines should be developed with thought to resource limits.
Reliable and applicable	Guidelines should be developed with thought to the target audience.
	Guidelines should be evaluated for effect, value, validity and usage.
	Guidelines should be reviewed and modified regularly to incorporate new evidence.

Source: Adapted from NHMRC’s nine guiding principles underlying the guideline development process (NHMRC 1999)

4.4.1 Principle 1: guideline development should be outcome-focused

Guidelines should be developed with inferences about specific clinical and economic outcomes. The validity of the guideline can then be assessed on how implementation of the recommendations compares with alternative treatment or management in achieving the projected outcomes.

4.4.2 Principle 2: guidelines should be based on best available evidence and describe the strength of the link between recommendation and outcome

Searching for and analysing research evidence is the most expensive and time-consuming component of evidence-based guideline development (Browman 2001), and may sometimes be an impetus for taking shortcuts in the process. Meticulous processes must be adhered to so that the credibility and validity of the guideline is assured. Systematic reviews, including a meta-analysis of results, are accepted by researchers as being at the top of the hierarchy of evidence pyramid. Despite this, a review of the use of systematic reviews in clinical guidelines found that only 3% of the references cited were systematic reviews (Grant et al 2000). The authority of systematic reviews of the literature depends a great deal on the care of the search conducted (Grilli et al 2000). Furthermore, conventionally, the gold standard of experimental research is a randomised controlled design, because randomisation strengthens the internal validity of the design and the findings. However, a randomised controlled design is not always appropriate or feasible in clinical practice when evaluating the effectiveness of complex interventions on change, in situations where contextual factors cannot be controlled and the nature of the intervention does not lend itself to standardisation (Osborne 2009). Thus, not all guideline recommendations can be underpinned by systematic reviews, and guideline developers can and should make recommendations that are specific to local contexts.

In addition to a careful search for evidence, the grading of that evidence is essential to discriminate evidence-based from consensus-based recommendations (Grilli et al 2000). The effectiveness of guidelines depends on the quality of the evidence upon which they are based. Guidelines should be accompanied by explicit details on how the research was judged for level of evidence, methodological quality, relevance to the research question and applicability to the target patient population. A guide to grading the recommendations based on the strength of the link between the evidence and the recommendation should be made evident.

4.4.3 Principle 3: guideline evidence should be combined using the strongest method available to determine effect on clinical outcomes

Good quality evidence is necessary but not enough when making recommendations (NHMRC 1999). The availability of evidence from one high-level study does not immediately mean a good clinical recommendation will result, due to issues such as small effect size or the use of non-clinical outcomes (NHMRC 1999). In addition, one of the difficulties in searching the literature is determining effect size where there is conflicting evidence. Where more than one study is available, appropriate combination of results into a meta-analysis may yield a truer picture of treatment effect. The guideline development team must be able to assess and combine not only the effect of interventions, but also the feasibility of implementation relevant to resources, and inequities that may arise in certain populations gaining access to the recommended treatment (NHMRC 1999).