Guidelines are designed
to support the decision-making processes in patient
. The content of a guideline is based on a systematic
review of clinical evidence - the main source for evidence-based
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.
| Clinical protocols can be
seen as more specific than guidelines, defined in geater
detail. Protocols provide "a comprehensive set of
rigid criteria outlining the management steps for a single
clinical condition or aspects of organisation""
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.
and international clinical guidelines organisations
sources of guidelines
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
"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.
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
guideline development methodology
50: A guideline developer's handbook (SIGN Publication
No. 50). Published February 2001 Last updated October
|| 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
|"This document sets out the
process through which the Institute will commission,
approve and disseminate clinical guidelines."
Guideline Implementation (Translating guidelines
Wollersheim H, Burgers J, Grol R.
Clinical guidelines to improve patient care.
Neth J Med. 2005 Jun;63(6):188-92.
[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.
| " 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
| " "
Grol R, Grimshaw J. Evidence-based
implementation of evidence-based medicine. Jt
Comm J Qual Improv. 1999 Oct;25(10):503-13.
| " 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.
|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.
| " 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.
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.
| 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
| 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.
| " 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
| 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
||" 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.
| 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.
"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.
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.
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.
|links: guideline quality appraisal and evaluation tools and resources
|links: guideline applications for PDAs [OC]
|Entry on OpenClinical: 2001
Redesigned: 1 July 2004 Last main updates: 31 July 2004; 17 April 2005; [09 June 2005]; 11 January 2006