Guidelines are designed to support the decision-making processes in patient care . The content of a guideline is based on a systematic review of clinical evidence - the main source for evidence-based care.

The movement towards evidence-based healthcare has been gaining ground quickly over the past few years, motivated by clinicians, politicians and management concerned about quality, consistency and costs. CPGs, based on standardised best practice, have been shown to be capable of supporting improvements in quality and consistency in healthcare. Many have been developed, though the process is time- and resource-consuming. Many have been disseminated, though largely in the relatively difficult to use format of narrative text. As yet they have not had a major impact on medical practice, but their importance is growing.

• To describe appropriate care based on the best available scientific evidence and broad consensus;
• To reduce inappropriate variation in practice;
• To provide a more rational basis for referral;
• To provide a focus for continuing education;
• To promote efficient use of resources;
• To Act as focus for quality control, including audit;
• To highlight shortcomings of existing literature and suggest appropriate future research.

Computerised guidelines encode evidence-based recommendations for and can automatically generate recommendations about what medical procedures to perform tailored for an individual patient. Computerised guidelines offer benefits over and above those offered by paper-based guidelines:

• They offer a readily accessible reference, providing selective access to guideline knowledge.
• They help reveal errors in the content of a guideline;
• They help improve the clarity of a guideline, e.g. in decision criteria and clinical recommendations;
• They help offer better descriptions of patient states;
• They can automatically propose timely, patient-specific decision support and reminders.

Field MJ, Lohr KN (Eds). Guidelines for clinical practice: from development to use. Institute of Medicine, Washington, D.C: National Academy Press, 1992. Field MJ, Lohr KN (Eds). Clinical Practice Guidelines: Directions for a New Program, Institute of Medicine, Washington, DC: National Academy Press, 1990.

Providers of the standard definition of CPGs: "Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." (Field & Lohr 1990. page 38).

Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J. Potential benefits, limitations, and harms of clinical guidelines. BMJ. 1999 Feb 20;318(7182):527-30. [PubMed]   [PubMed Central]

" Summary points: Clinical guidelines are an increasingly familiar part of clinical practice They have potential benefits and harms Rigorously developed evidence based guidelines minimise the potential harms Clinical guidelines are only one option for improving the quality of care "

The guideline development process

Scottish Intercollegiate Guidelines Network SIGN guideline development methodology SIGN 50: A guideline developer's handbook (SIGN Publication No. 50). Published February 2001 Last updated October 2002.

SIGN 50 main documents: Introduction; Selection of guideline topics; The guideline development group; Systematic literature review; Forming guideline recommendations; Consultation and peer review; Presentation and dissemination; Implementation; Audit and review.

Clinical guidelines development process - UK NHS National Institute for Clinical Excellence [NICE]

"This document sets out the process through which the Institute will commission, approve and disseminate clinical guidelines."

Guideline Implementation (Translating guidelines into practice)

Wollersheim H, Burgers J, Grol R. Clinical guidelines to improve patient care. Neth J Med. 2005 Jun;63(6):188-92. [PubMed]   [Neth J Med]

" The aim of clinical guidelines is to improve quality of care by translating new research findings into practice. There is evidence that the following characteristics contribute to their use: inclusion of specific recommendations, sufficient supporting evidence, a clear structure and an attractive lay out. In the process of formulating recommendations, implicit norms of the target users should be taken into account. Guidelines should be developed within a structured and coordinated programme by a credible central organisation. To promote their implementation, guidelines could be used as a template for local protocols, clinical pathways and interprofessional agreements. "

Davis DA, Taylor-Vaisey A. Translating guidelines into practice. A systematic review of theoretic concepts, practical experience and research evidence in the adoption of clinical practice guidelines. CMAJ. 1997 Aug 15;157(4):408-16. [PubMed]   [CMAJ]

" OBJECTIVE: To recommend effective strategies for implementing clinical practice guidelines (CPGs). DATA SOURCES: The Research and Development Resource Base in Continuing Medical Education, maintained by the University of Toronto, was searched, as was MEDLINE from January 1990 to June 1996, inclusive, with the use of the MeSH heading "practice guidelines" and relevant text words. STUDY SELECTION: Studies of CPG implementation strategies and reviews of such studies were selected. Randomized controlled trials and trials that objectively measured physicians' performance or health care outcomes were emphasized. DATA EXTRACTION: Articles were reviewed to determine the effect of various factors on the adoption of guidelines. DATA SYNTHESIS: The articles showed that CPG dissemination or implementation processes have mixed results. Variables that affect the adoption of guidelines include qualities of the guidelines, characteristics of the health care professional, characteristics of the practice setting, incentives, regulation and patient factors. Specific strategies fell into 2 categories: primary strategies involving mailing or publication of the actual guidelines and secondary interventional strategies to reinforce the guidelines. The interventions were shown to be weak (didactic, traditional continuing medical education and mailings), moderately effective (audit and feedback, especially concurrent, targeted to specific providers and delivered by peers or opinion leaders) and relatively strong (reminder systems, academic detailing and multiple interventions). CONCLUSIONS: The evidence shows serious deficiencies in the adoption of CPGs in practice. Future implementation strategies must overcome this failure through an understanding of the forces and variables influencing practice and through the use of methods that are practice- and community-based rather than didactic "

Entwistle M and Shiffman RN. Turning Guidelines into Practice: Making It Happen With Standards. Health Care and Informatics Review Online [HCRO]. March 2005. [Editorial/overview - HCRO] [part 1 - HCRO]   [part 2 - HCRO]

" Successful delivery of the knowledge incorporated into guidelines requires a systemic approach which integrates knowledge with workflow using existing clinical information systems. Electronic clinical decision support (ECDS) systems are the means through which the knowledge embedded in guidelines can be managed and delivered effectively. Barriers to the success of guideline-based ECDS are multiple and include: guideline-related obstacles, both extrinsic to the guideline (organisational and provider specific obstacles) and intrinsic to the guideline (such as failure to meet adequate standards in guideline development and format, identification and summary of evidence, and formulation of recommendations) electronic decision support issues which include such factors as: the extreme complexity of integrated decision support systems; poor alignment of the goals of different players; complex technical requirements; complex content requirements. Initiatives with the goal of "improving the guidelines" include the AGREE[ b ] instrument for guideline quality appraisal, the GuideLine Implementability Appraisal (GLIA) instrument which predicts barriers to implementation and the COGS (Conference on Guideline Standardization) checklist of necessary components of practice guidelines. Numerous projects in "guideline translation" have taken place worldwide, each using different approaches in guideline representation architecture and implementation. These attempts have advanced the process of transforming clinical knowledge expressed in a guideline to a computable format but the absence of commonly agreed standards has created major difficulties for guideline implementers and decision-support systems designers. Standards are now seen as essential to improvements in the process of "guideline transformation" for ECDS and underpin a further critical requirement – the need for ECDS, which has typically been viewed as a software application, to be considered from a wider systems perspective. ... "

Grol R. Implementing guidelines in general practice care. Qual Health Care. 1992 Sep;1(3):184-91. [PubMed]   []

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Grol R, Grimshaw J. Evidence-based implementation of evidence-based medicine. Jt Comm J Qual Improv. 1999 Oct;25(10):503-13. [PubMed]   []

" BACKGROUND: The slow and haphazard process of translating research findings into clinical practice compromises the potential benefits of clinical research. Most quality improvement (QI) initiatives are based on the beliefs of decision makers rather than on the growing theoretical and empirical knowledge about organizational and provider behavior change. If future QI activities are to improve the translation of evidence into practice, they should be based on an understanding of the different models and strategies for implementing research evidence and the evidence base supporting their use. Evidence-based medicine should be complemented by evidence-based implementation. THE EVIDENCE FOR DIFFERENT STRATEGIES OF IMPLEMENTING CHANGE: A general framework for changing practice based on theoretical perspectives and research evidence considers a variety of theoretical approaches and their contribution to an understanding of provider behavior change. The framework summarizes evidence from systematic reviews of provider behavior change, which suggest the potential of several dissemination and implementation strategies that are effective under certain conditions. Passive dissemination approaches are largely ineffective; specific strategies to implement research-based recommendations appear to be necessary to ensure practice change. Multifaceted interventions that address specific barriers to change are more likely to lead to changes in practice. PRACTICAL, FIVE-STAGE FRAMEWORK: A practical, five-stage framework for changing practice, which is illustrated with experiences from a comprehensive program on implementing evidence-based clinical guidelines in primary care, includes development of a concrete proposal for change; analysis of the target setting and group to identify obstacles to change; linking interventions to needs, facilitators, and obstacles to change; development of an implementation plan; and monitoring progress with implementation. "

Thomson R, Lavender M, Madhok R. How to ensure that guidelines are effective. BMJ. 1995 Jul 22;311(6999):237-42. [PubMed]   [BMJ]

Summary points: "Guidelines are a way to support effective clinical practice; There is a growing body of literature on the factors that influence the effectiveness of guidelines; Reference to these factors will enhance the likelihood of achieving the objectives of guidelines; The use of this series of reflective questions rooted in this literature will support the effective development, dissemination, implementation, and review of guidelines. " Conclusion: "McKeown states: "Medicine must be prepared to face the tests which are inescapable in private enterprise and which it is almost unique among public activities in having evaded hitherto: Is our work well done? Is it worth doing? and Does it pay its way"40 The process that leads from selecting a topic to having an impact on patient care is complex and full of potential pitfalls. None the less, there is a growing body of research evidence on appropriate approaches. We have reviewed this literature and produced a series of reflective questions to help incorporate this knowledge into practice. We believe that the potential for guidelines to influence the quality of patient care is considerable, particularly when aligned with the process of audit and quality assurance, in the setting of the purchaser-provider interaction, and within an overall culture of continuous quality improvement. "

Haynes RB. Using informatics principles and tools to harness research evidence for patient care: evidence-based informatics. Medinfo. 1998;9 Pt 1:suppl 33-6. [PubMed]   []

" With the huge worldwide investment in biomedical research during the past 50 years, there are many important advances in health care knowledge each year. Unfortunately, it commonly takes over 20 years for even the most important of these advances to be widely integrated into clinical practice. Many potentially remediable factors are responsible for this dilemma in research transfer, including defective continuing education for health professionals and patients; increasingly complex medical regimens; diminishing resources for health care; and inadequate evidence management. The principles and procedures of health informatics can help overcome some of these barriers to research transfer, particularly such evidence management tasks as retrieving, processing, summarizing, disseminating and applying evidence for clinical care. Evidence retrieval has been improved by better indexing and electronic search engines, by improved access from clinical and other settings, and by integration of evidence into clinical decision support systems. Evidence processing has been greatly accelerated by streamlined methods of critical appraisal of research and by centralization of these procedures for the development of current awareness publications and cumulative "best evidence" databases. The Cochrane Collaboration has revolutionized the summarization (systematic review) of evidence. The internet has provided access to patients, practitioners, and policy makers, alike. Direct-from-patient automated data collection promises to move the connection between evidence and practice to a higher level. In all of these innovations, health care practice is most likely to be enhanced by intertwining best evidence with best informatics techniques. "

Michie S, Johnston M. Changing clinical behaviour by making guidelines specific. BMJ. 2004 Feb 7;328(7435):343-5. [PubMed]   [BMJ]

" The problems of getting people to act on evidence based guidelines are widely recognised.1 An overview of 41 systematic reviews found that the most promising approach was to use a variety of interventions including audit and feedback, reminders, and educational outreach.1 The effective interventions often involved complicated procedures and were always an addition to the provision of guidelines. None of the studies used the simplest intervention—that is, changing the wording of the guidelines. We examine the importance of precise behavioural recommendations and suggest how some current guidelines could be improved. ... "

Computer-based clinical care and clinical performance

Hunt DL, Haynes RB, Hanna SE, Smith K. Effects of computer-based clinical decision support systems on physician performance and patient outcomes: a systematic review. JAMA. 1998;280:1339-46. [PubMed]    [ ]

Review of 68 controlled trials of CDSS (meeting specified criteria) on physician performance and patient outcomes. Conclusion: "Published studies of CDSSs are increasing rapidly, and their quality is improving. The CDSSs can enhance clinical performance for drug dosing, preventive care, and other aspects of medical care, but not convincingly for diagnosis. The effects of CDSSs on patient outcomes have been insufficiently studied."

Johnston M, Langton K, Hayes B, Mathieu A. Effects of computer-based clinical decision support systems on clinician performance and patient outcome. A critical appraisal of research. Annals of Internal Medicine 1994; 120: 133-142. [PubMed]

" OBJECTIVE: To review the evidence from controlled trials of the effects of computer-based clinical decision support systems (CDSSs) on clinician performance and patient outcomes. DATA SOURCES: The literature in the MEDLARS, EMBASE, SCISEARCH, and INSPEC databases was searched from 1974 to the present. Conference proceedings and reference lists of relevant articles were reviewed. Evaluators of CDSSs were asked to identify additional studies. STUDY SELECTION: 793 citations were examined, and 28 controlled trials that met predefined criteria were reviewed in detail. DATA EXTRACTION: Study quality was assessed, and data on setting, clinicians and patients, method of allocation, computer system, and outcomes were abstracted and verified using a structured form. Separate summaries were prepared for physician and patient outcomes. Within each of these categories, studies were classified further according to the primary purpose of the CDSS: drug dose determination, diagnosis, or quality assurance. RESULTS: Three of 4 studies of computer-assisted dosing, 1 of 5 studies of computer-aided diagnosis, 4 of 6 studies of preventive care reminder systems, and 7 of 9 studies of computer-aided quality assurance for active medical care that assessed clinician performance showed improvements in clinician performance using a CDSS. Three of 10 studies that assessed patient outcomes reported significant improvements. CONCLUSIONS: Strong evidence suggests that some CDSSs can improve physician performance. Additional well-designed studies are needed to assess their effects and cost-effectiveness, especially on patient outcomes. "

Shiffman RN, Liaw Y, Brandt CA, Corb GJ. Computer-based guideline implementation systems: a systematic review of functionality and effectiveness. J Am Med Inform Assoc 1999 Mar-Apr;6(2):104-14 [PUBMED]    [PubMed Central]

" In this systematic review, the authors analyze the functionality provided by recent computer-based guideline implementation systems and characterize the effectiveness of the systems. Twenty-five studies published between 1992 and January 1998 were identified. Articles were included if the authors indicated an intent to implement guideline recommendations for clinicians and if the effectiveness of the system was evaluated. Provision of eight information management services and effects on guideline adherence, documentation, user satisfaction, and patient outcome were noted. All systems provided patient-specific recommendations. In 19, recommendations were available concurrently with care. Explanation services were described for nine systems. Nine systems allowed interactive documentation, and 17 produced paper-based output. Communication services were present most often in systems integrated with electronic medical records. Registration, calculation, and aggregation services were infrequently reported. There were 10 controlled trials (9 randomized) and 10 time-series correlational studies. Guideline adherence improved in 14 of 18 systems in which it was measured. Documentation improved in 4 of 4 studies. "

Shea S, DuMouchel W, Bahamonde L. A meta-analysis of 16 randomized controlled trials to evaluate computer-based clinical reminder systems for preventive care in the ambulatory setting. J Am Med Inform Assoc. 1996 Nov-Dec;3(6):399-409. [PubMed]    [PubMed Central]

Meta-analysis of all 16 randomized, controlled trials of computer-based reminder systems in ambulatory settings found in the literature in the period 1966-1994. Conclusion: "Evidence from randomized controlled studies supports the effectiveness of data-driven computer-based reminder systems to improve prevention services in the ambulatory care setting."

Clinical guideline programs

Burgers JS, Grol R, Klazinga NS, Makela M, Zaat J; AGREE Collaboration. Towards evidence-based clinical practice: an international survey of 18 clinical guideline programs. Int J Qual Health Care. 2003 Feb;15(1):31-45. [PubMed]   [Int J Qual Health Care]

" OBJECTIVE: To describe systematically the structures and working methods of guideline programs. DESIGN: Descriptive survey using a questionnaire with 32 items based on a framework derived from the literature. Answers were tabulated and checked by participants. STUDY PARTICIPANTS: Key informants of 18 prominent guideline organizations in the United States, Canada, Australia, New Zealand, and nine European countries. MAIN OUTCOME MEASURES: History, aims, methodology, products and deliveries, implementation, evaluation, procedure for updating guidelines, and future plans. RESULTS: Most guideline programs were established to improve the quality and effectiveness of health care. Most use electronic databases to collect evidence and systematic reviews to analyze the evidence. Consensus procedures are used when evidence is lacking. All guidelines are reviewed before publication. Authorization is commonly used to endorse guidelines. All guidelines are furnished with tools for application and the Internet is widely used for dissemination. Implementation strategies vary among different organizations, with larger organizations leaving this to local organizations. Almost all have a quality assurance system for their programs. Half of the programs do not have formal update procedures. CONCLUSIONS: Principles of evidence-based medicine dominate current guideline programs. Recent programs are benefiting from the methodology created by long-standing programs. Differences are found in the emphasis on dissemination and implementation, probably due to differences in health care systems and political and cultural factors. International collaboration should be encouraged to improve guideline methodology and to globalize the collection and analysis of evidence needed for guideline development. "

Shaneyfelt TM, Mayo-Smith MF, Rothwangl J. Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature. JAMA. 1999 May 26;281(20):1900-5. [PubMed]   []

" CONTEXT: Practice guidelines play an important role in medicine. Methodological principles have been formulated to guide their development. OBJECTIVE: To determine whether practice guidelines in peer-reviewed medical literature adhered to established methodological standards for practice guidelines. DESIGN: Structured review of guidelines published from 1985 through June 1997 identified by a MEDLINE search. MAIN OUTCOME MEASURES: Mean number of standards met based on a 25-item instrument and frequency of adherence. RESULTS: We evaluated 279 guidelines, published from 1985 through June 1997, produced by 69 different developers. Mean overall adherence to standards by each guideline was 43.1% (10.77/25). Mean (SD) adherence to methodological standards on guideline development and format was 51.1% (25.3%); on identification and summary of evidence, 33.6% (29.9%); and on the formulation of recommendations, 46% (45%). Mean adherence to standards by each guideline improved from 36.9% (9.2/25) in 1985 to 50.4% (12.6/25) in 1997 (P<.001). However, there was little improvement over time in adherence to standards on identification and summary of evidence from 34.6% prior to 1990 to 36.1 % after 1995 (P = .11). There was no difference in the mean number of standards satisfied by guidelines produced by subspecialty medical societies, general medical societies, or government agencies (P = .55). Guideline length was positively correlated with adherence to methodological standards (P = .001). CONCLUSION: Guidelines published in the peer-reviewed medical literature during the past decade do not adhere well to established methodological standards. While all areas of guideline development need improvement, greatest improvement is needed in the identification, evaluation, and synthesis of the scientific evidence. "