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Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development.

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this third paper we discuss the issues of: reviewing, reporting, and publishing guidelines; updating guidelines; and the two emerging issues of enhancing guideline implementability and how guideline developers should approach dealing with the issue of patients who will be the subject of guidelines having co-morbid conditions.

Clinical practice and public health guidelines are important tools for translating research findings into practice with the aim of assisting health practitioners as well as patients and consumers in health behavior and healthcare decision-making. Numerous programs for guideline development exist around the world, with growing international collaboration to improve their quality. One of the key features in developing trustworthy guidelines is that recommendations should be based on high-quality systematic reviews of the best available evidence. The review process used by guideline developers to identify and grade relevant evidence for developing recommendations should be systematic, transparent and unbiased. In this paper, we provide an overview of current international developments in the field of practice guidelines and methods to develop guidelines, with a specific focus on the role of systematic reviews. The Guidelines International Network (G-I-N) aims to stimulate collaboration between guideline developers and systematic reviewers to optimize the use of available evidence in guideline development and to increase efficiency in the guideline development process. Considering the significant benefit of systematic reviews for the guideline community, the G-I-N Board of Trustees supports the international prospective register of systematic reviews (PROSPERO) initiative. G-I-N also recently launched a Data Extraction Resource (GINDER) to present and share data extracted from individual studies in a standardized template. PROSPERO and GINDER are complementary tools to enhance collaboration between guideline developers and systematic reviewers to allow for alignment of activities and a reduction in duplication of effort.

BACKGROUND

Because there is increasing concern that economic data are not used in the clinical guideline development process, our objective was to evaluate the extent to which economic analyses are incorporated in guideline development.

METHODS

We searched medline and HealthSTAR databases to identify English-language clinical practice guidelines (1996–1999) and economic analyses (1990–1998). Additional guidelines were obtained from The National Guidelines Clearinghouse Internet site available at . Eligible guidelines met the Institute of Medicine definition and addressed a topic included in an economic analysis. Eligible economic analyses assessed interventions addressed in a guideline and predated the guideline by 1 or more years. Economic analyses were defined as incorporated in guideline development if 1) the economic analysis or the results were mentioned in the text or 2) listed as a reference. The quality of economic analyses was assessed using a structured scoring system.

RESULTS

Using guidelines as the unit of analysis, 9 of 35 (26%) incorporated at least 1 economic analysis of above-average quality in the text and 11 of 35 (31%) incorporated at least 1 in the references. Using economic analyses as the unit of analysis, 63 economic analyses of above-average quality had opportunities for incorporation in 198 instances across the 35 guidelines. Economic analyses were incorporated in the text in 13 of 198 instances (7%) and in the references in 18 of 198 instances (9%).

CONCLUSIONS

Rigorous economic analyses may be infrequently incorporated in the development of clinical practice guidelines. A systematic approach to guideline development should be used to ensure the consideration of economic analyses so that recommendations from guidelines may impact both the quality of care and the efficient allocation of resources.

Background

Clinical practice guidelines are an important element of evidence-based practice. Considering an often complicated body of evidence can be problematic for guideline developers, who in the past may have resorted to using levels of evidence of individual studies as a quasi-indicator for the strength of a recommendation. This paper reports on the production and trial of a methodology and associated processes to assist Australian guideline developers in considering a body of evidence and grading the resulting guideline recommendations.

Methods

In recognition of the complexities of clinical guidelines and the multiple factors that influence choice in health care, a working group of experienced guideline consultants was formed under the auspices of the Australian National Health and Medical Research Council (NHMRC) to produce and pilot a framework to formulate and grade guideline recommendations. Consultation with national and international experts and extensive piloting informed the process.

Results

The FORM framework consists of five components (evidence base, consistency, clinical impact, generalisability and applicability) which are used by guideline developers to structure their decisions on how to convey the strength of a recommendation through wording and grading via a considered judgement form. In parallel (but separate from the grading process) guideline developers are asked to consider implementation implications for each recommendation.

Conclusions

The framework has now been widely adopted by Australian guideline developers who find it to be a logical and intuitive way to formulate and grade recommendations in clinical practice guidelines.

Background

To be useful, clinical practice guidelines need to be evidence based; otherwise they will not achieve the validity, reliability and credibility required for implementation.

Methods

This paper compares the methods used in gathering, analysing and linking of evidence to guideline recommendations in ten current hypertension guidelines.

Results

It found several guidelines had failed to implement methods of searching for the relevant literature, critical analysis and linking to recommendations that minimise the risk of bias in the interpretation of research evidence. The more rigorous guidelines showed discrepancies in recommendations and grading that reflected different approaches to the use of evidence in guideline development.

Conclusion

Clinical practice guidelines as a methodology are clearly still an evolving health care technology.

Background—There is currently a political enthusiasm for the development and use of clinical guidelines despite, paradoxically, there being relatively few healthcare issues that have a sound research evidence base. As decisions have to be made even where there is an undetermined evidence base and that limiting recommendations to where evidence exists may reduce the scope of guidelines, thus limiting their value to practitioners, guideline developers have to rely on various different sources of evidence and adapt their methods accordingly. This paper outlines a method for guideline development which incorporates a consensus process devised to tackle the challenges of a variable research evidence base for the development of a national clinical guideline on risk assessment and prevention of pressure ulcers.

Method—To inform the recommendations of the guideline a formal consensus process based on a nominal group technique was used to incorporate three strands of evidence: research, clinical expertise, and patient experience.

Results—The recommendations for this guideline were derived directly from the statements agreed in the formal consensus process and from key evidence-based findings from the systematic reviews. The existing format of the statements that participants had rated allowed a straightforward revision to "active" recommendations, thus reducing further risk of subjectivity entering into the process.

Conclusions—The method outlined proved to be a practical and systematic way of integrating a number of different evidence sources. The resultant guideline is a mixture of research based and consensus based recommendations. Given the lack of available guidance on how to mix research with expert opinion and patient experiences, the method used for the development of this guideline has been outlined so that other guideline developers may use, adapt, and test it further.

Key Words: guidelines; guideline development; formal consensus process; nominal group technique; pressure ulcers

Objectives: To investigate whether clinical practice guidelines in different countries take ethnic differences between patients into consideration and to assess the scientific foundation of such ethnic specific recommendations.

Design: Analysis of the primary care sections of clinical practice guidelines.

Setting: Primary care practice guidelines for type 2 diabetes mellitus, hypertension, and asthma developed in the USA, Canada, the UK, and the Netherlands.

Main outcome measures: Enumeration of the ethnic specific information and recommendations in the guidelines, and the scientific basis and strength of this evidence.

Results: Different guidelines do address ethnic differences between patients, but to a varying extent. The USA guidelines contained the most ethnic specific statements and the Dutch guidelines the least. Most ethnic specific statements were backed by scientific evidence, usually arising from descriptive studies or narrative reviews.

Conclusion: The attention given to ethnic differences between patients in clinical guidelines varies between countries. Guideline developers should be aware of the potential problems of ignoring differences in ethnicity.

Objectives

We set out to review and compare guidelines to prevent catheter-associated urinary tract infection (CAUTI), examine the association between recent federal initiatives and CAUTI guidelines, and recommend practices for preventing CAUTI that are associated with strong evidence and are consistent across guidelines.

Background

Catheter-associated urinary tract infections are the most common healthcare-associated infection, and a cause of significant morbidity and mortality in critically ill patients.

Methods

A search of the English-language literature for guidelines in the prevention of adult CAUTI, published between 1980 and 2010, was conducted in Medline and the National Guideline Clearinghouse.

Results

Many recommendations were consistent across 8 guidelines, including limited use of urinary catheters, the insertion of catheters aseptically, and the maintenance of a closed drainage system. The weight of evidence for some endorsed practices was limited, and different grading systems made comparisons across recommendations difficult. Federal initiatives are closely aligned with the 4 most recent guidelines.

Conclusion

Additional research into the prevention of CAUTI is needed, as is a harmonization of guideline grading systems for recommendations.

Background

Evidence-based clinical practice guidelines support clinical decision-making by making recommendations to guide clinical practice. These recommendations are developed by integrating the expertise of a multidisciplinary group of clinicians with the perspectives of consumers and the best available research evidence. However studies have raised concerns about the quality of guideline development, and particularly the link between research and recommendations. The reasons why guideline developers are not following the established development methods are not clear.

We aimed to explore the barriers to developing evidence-based guidelines in eleven hospitals in Australia, Indonesia, Malaysia, the Philippines and Thailand, so as to better understand how evidence-based guideline development could be facilitated in these settings. The research aimed to identify the value clinicians place on guidelines, what clinicians want in guidelines developed in hospital settings and what factors limit rigorous evidence-based guideline development in these settings.

Methods

Semi-structured, face-to-face interviews were undertaken with senior and junior healthcare providers (nurses, midwives, doctors, allied health) from the maternal and neonatal services of the eleven participating hospitals. Interviews were audio-recorded, transcribed and a thematic analysis undertaken.

Results

Ninety-three individual, 25 pair and eleven group interviews were conducted. Participants were clear that they want guidelines that are based on evidence and updated regularly. They were also clear that there are major barriers to this. Most of the barriers were shared across countries, and included lack of time, lack of skills in finding, appraising and interpreting evidence, lack of access to relevant evidence and difficulty arranging meetings and achieving consensus.

Barriers that were primarily identified in Australian hospitals include cumbersome organisational processes and a feeling that guidelines are being developed for bureaucratic ends. Barriers that were primarily identified in South East Asian hospitals include difficulty accessing evidence due to limited resources available for computers, internet and journal subscriptions and limited skills in computing and English.

Conclusions

The clinicians in these eleven very different hospitals want evidence-based guidelines. However they are frustrated by guideline development processes that are enormously time, skill and resource intensive. They feel strongly that "there's got to be a better way".

The fact that the great majority of the identified barriers were shared across settings may provide an opportunity to develop a more pragmatic way of developing guidelines that can be applied in many contexts.

Background

Guidelines translate best evidence into best practice. A well-crafted guideline promotes quality by reducing healthcare variations, improving diagnostic accuracy, promoting effective therapy, and discouraging ineffective – or potentially harmful – interventions. Despite a plethora of published guidelines, methodology is often poorly defined and varies greatly within and among organizations.

Purpose

This manual describes the principles and practices used successfully by the American Academy of Otolaryngology – Head and Neck Surgery to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for action-ready recommendations with multi-disciplinary applicability. The development process, which allows moving from conception to completion in twelve months, emphasizes a logical sequence of key action statements supported by amplifying text, evidence profiles, and recommendation grades that link action to evidence.

Conclusions

As clinical practice guidelines become more prominent as a key metric of quality healthcare, organizations must develop efficient production strategies that balance rigor and pragmatism. Equally important, clinicians must become savvy in understanding what guidelines are – and are not – and how they are best utilized to improve care. The information in this manual should help clinicians and organizations achieve these goals.

Background

Risk-stratified treatment recommendations facilitate treatment decision-making that balances patient-specific risks and preferences. It is unclear if and how such recommendations are developed in clinical practice guidelines (CPGs). Our aim was to assess if and how CPGs develop risk-stratified treatment recommendations for the prevention or treatment of common chronic diseases.

Methods

We searched the United States National Guideline Clearinghouse for US, Canadian and National Institute for Health and Clinical Excellence (United Kingdom) CPGs for heart disease, stroke, cancer, chronic obstructive pulmonary disease and diabetes that make risk-stratified treatment recommendations. We included only those CPGs that made risk-stratified treatment recommendations based on risk assessment tools. Two reviewers independently identified CPGs and extracted information on recommended risk assessment tools; type of evidence about treatment benefits and harms; methods for linking risk estimates to treatment evidence and for developing treatment thresholds; and consideration of patient preferences.

Results

We identified 20 CPGs that made risk-stratified treatment recommendations out of 133 CPGs that made any type of treatment recommendations for the chronic diseases considered in this study. Of the included 20 CPGs, 16 (80%) used evidence about treatment benefits from randomized controlled trials, meta-analyses or other guidelines, and the source of evidence was unclear in the remaining four (20%) CPGs. Nine CPGs (45%) used evidence on harms from randomized controlled trials or observational studies, while 11 CPGs (55%) did not clearly refer to harms. Nine CPGs (45%) explained how risk prediction and evidence about treatments effects were linked (for example, applying estimates of relative risk reductions to absolute risks), but only one CPG (5%) assessed benefit and harm quantitatively and three CPGs (15%) explicitly reported consideration of patient preferences.

Conclusions

Only a small proportion of CPGs for chronic diseases make risk-stratified treatment recommendations with a focus on heart disease and stroke prevention, diabetes and breast cancer. For most CPGs it is unclear how risk-stratified treatment recommendations were developed. As a consequence, it is uncertain if CPGs support patients and physicians in finding an acceptable benefit- harm balance that reflects both profile-specific outcome risks and preferences.

Background

Evidence-based guidelines have the potential to improve healthcare. However, their de-novo-development requires substantial resources – especially for complex conditions, and adaptation may be biased by contextually influenced recommendations in source guidelines. In this paper we describe a new approach to guideline development – the systematic guideline review method (SGR), and its application in the development of an evidence-based guideline for family physicians on chronic heart failure (CHF).

Methods

A systematic search for guidelines was carried out. Evidence-based guidelines on CHF management in adults in ambulatory care published in English or German between the years 2000 and 2004 were included. Guidelines on acute or right heart failure were excluded. Eligibility was assessed by two reviewers, methodological quality of selected guidelines was appraised using the AGREE instrument, and a framework of relevant clinical questions for diagnostics and treatment was derived. Data were extracted into evidence tables, systematically compared by means of a consistency analysis and synthesized in a preliminary draft. Most relevant primary sources were re-assessed to verify the cited evidence. Evidence and recommendations were summarized in a draft guideline.

Results

Of 16 included guidelines five were of good quality. A total of 35 recommendations were systematically compared: 25/35 were consistent, 9/35 inconsistent, and 1/35 un-rateable (derived from a single guideline). Of the 25 consistencies, 14 were based on consensus, seven on evidence and four differed in grading. Major inconsistencies were found in 3/9 of the inconsistent recommendations. We re-evaluated the evidence for 17 recommendations (evidence-based, differing evidence levels and minor inconsistencies) – the majority was congruent. Incongruity was found where the stated evidence could not be verified in the cited primary sources, or where the evaluation in the source guidelines focused on treatment benefits and underestimated the risks. The draft guideline was completed in 8.5 man-months. The main limitation to this study was the lack of a second reviewer.

Conclusion

The systematic guideline review including framework development, consistency analysis and validation is an effective, valid, and resource saving-approach to the development of evidence-based guidelines.

ABSTRACT Good guidelines will help us to take evidence into practice. In a survey among Dutch orthopedic surgeons, development and use of evidence-based guidelines was perceived as one of the best ways of moving from opinion-based to evidence-based orthopedic practice. The increasing number of guidelines means that knowing how to make a critical appraisal of guidelines is now a key part of every surgeon’s life. This is particularly true because guidelines use varying systems to judge the quality of evidence and the strength of recommendations. In this manuscript we discuss what a guideline is, where we can find guidelines, how to evaluate the quality of guidelines, and finally provide an example on the different steps of guideline development. Thus, we show that good guidelines are a summary of the best available evidence and that they provide a graded recommendation to help surgeons in evidence-based practice.

A key mandate of the Canadian Thoracic Society (CTS) is to promote evidence-based respiratory care through clinical practice guidelines (CPGs). To improve the quality and validity of the production, dissemination and implementation of its CPGs, the CTS has revised its guideline process and has created the Canadian Respiratory Guidelines Committee to oversee this process. The present document outlines the basic methodological tools and principles of the new CTS guideline production process. Important features include standard methods for choosing and formulating optimal questions and for finding, appraising, and summarizing the evidence; use of the Grading of Recommendations Assessment, Development and Evaluation system for rating the quality of evidence and strength of recommendations; use of the Appraisal of Guidelines for Research and Evaluation instrument for quality control during and after guideline development and for appraisal of other guidelines; use of the ADAPTE process for adaptation of existing guidelines to the local context; and use of the GuideLine Implementability Appraisal tool to augment implementability of guidelines. The CTS has also committed to develop guidelines in new areas, an annual guideline review cycle, and a new formal process for dissemination and implementation. Ultimately, it is anticipated that these changes will have a significant impact on the quality of care and clinical outcomes of individuals suffering from respiratory diseases across Canada.

Background

Clinical practice guidelines have the potential to facilitate the implementation of evidence into practice, support clinical decision making, specify beneficial therapeutic approaches, and influence public policy. However, these potential benefits have not been consistently achieved. The limited impact of guidelines can be attributed to organisational constraints, the complexity of the guidelines, and the lack of usability testing or end-user involvement in their development. Implementability has been referred to as the perceived characteristics of guidelines that predict the relative ease of their implementation at the clinical level, but this concept is as yet poorly defined. The objective of our study is to identify guideline attributes that affect uptake in practice by considering evidence from four disciplines (medicine, psychology, management, human factors engineering) to determine the relationship between the perceived characteristics of recommendations and their uptake and to develop a framework of implementability.

Methods

A realist-review approach to knowledge synthesis will be used to understand attributes of guidelines (e.g., its text and content) and how changing these elements might impact clinical practice and clinical decision making. It also allows for the exploration of 'what works for whom, in what circumstances, and in what respects'. The realist review will be structured according to Pawson's five practical steps in realist reviews: (1) clarifying the scope of the review, (2) determining the search strategy, (3) ensuring proper article selection and study quality assessment, (4) extracting and organising data, and (5) synthesising the evidence and drawing conclusions. Data will be synthesised according to a two-stage analysis: (1) we will extract and define all relevant guideline attributes from the different disciplines, then create a shortlist of unique attributes and investigate their relationships with uptake, and (2) we will compare and contrast the attributes and guideline uptake within each and between the four disciplines to create a robust framework of implementability.

Discussion

Creating guidelines that are designed to maximise uptake may be a potentially effective and inexpensive way of increasing their impact. However, this is best achieved by a comprehensive framework to inform the design of guidelines drawing on a range of disciplines that study behaviour change. This study will use a customised realist-review approach to synthesising the literature to better understand and operationalise a complex and under-theorised concept.

Background: Heterogeneity in aspects of development, structure and context of oncology guidelines was not evaluated. We analysed and critically examined its implications.

Materials and methods: Nine cancer clinical practice guidelines were selected on the basis of popularity among oncologists. The relevant Web sites and publications on three tumours were examined and characteristics grouped in the data domains: producing organisation, methodology, guideline structure and content, implementation and evaluation and scientific agreement.

Results: ASCO, ESMO, NICE, SIGN, START, NHMRC, NCI, NCCN and CCO guidelines were examined. Development was initiated by stakeholders or authorised bodies, run by task forces with varying degrees of multidisciplinarity, with rare endorsement of external guidelines. Recommendation formulation was on the basis of evidence, shaped via interactive processes of expert review and public consultation-based modifications. Guidelines varied in comprehensiveness per tumour type, number, size, format, grading of evidence, update and legal issues. Orientation for clinic use or as reference document, end-users and binding or elective nature also varied. Standard dissemination strategies were used, though evaluation of adoption and of impact on health outcomes was implemented with considerable heterogeneity.

Conclusions: Heterogeneity in development, structure, user and end points of guidelines is evident, though necessary in order to meet divergent demands. Crucial for their effectiveness are adherence to methodological standards, a clear definition of what the guideline intends to do for whom and a systematic evaluation of their impact on health care.

Background

Healthcare decision makers face challenges when using guidelines, including understanding the quality of the evidence or the values and preferences upon which recommendations are made, which are often not clear.

Methods

GRADE is a systematic approach towards assessing the quality of evidence and the strength of recommendations in healthcare. GRADE also gives advice on how to go from evidence to decisions. It has been developed to address the weaknesses of other grading systems and is now widely used internationally. The Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence (DECIDE) consortium (http://www.decide-collaboration.eu/), which includes members of the GRADE Working Group and other partners, will explore methods to ensure effective communication of evidence-based recommendations targeted at key stakeholders: healthcare professionals, policymakers, and managers, as well as patients and the general public. Surveys and interviews with guideline producers and other stakeholders will explore how presentation of the evidence could be improved to better meet their information needs. We will collect further stakeholder input from advisory groups, via consultations and user testing; this will be done across a wide range of healthcare systems in Europe, North America, and other countries. Targeted communication strategies will be developed, evaluated in randomized trials, refined, and assessed during the development of real guidelines.

Discussion

Results of the DECIDE project will improve the communication of evidence-based healthcare recommendations. Building on the work of the GRADE Working Group, DECIDE will develop and evaluate methods that address communication needs of guideline users. The project will produce strategies for communicating recommendations that have been rigorously evaluated in diverse settings, and it will support the transfer of research into practice in healthcare systems globally.

Background

In 2004, the Netherlands Society of Cardiology released the current guideline on cardiac rehabilitation. Given its complexity and the involvement of various healthcare disciplines, it was supplemented with a clinical algorithm, serving to facilitate its implementation in daily practice. Although the algorithm was shown to be effective for improving guideline adherence, several shortcomings and deficiencies were revealed. Based on these findings, the clinical algorithm has now been updated. This article describes the process and the changes that were made.

Methods

The revision consisted of three phases. First, the reliability of the measurement instruments included in the 2004 Clinical Algorithm was investigated by evaluating between-centre variations of the baseline assessment data. Second, based on the available evidence, a multidisciplinary expert advisory panel selected items needing revision and provided specific recommendations. Third, a guideline development group decided which revisions were finally included, also taking practical considerations into account.

Results

A total of nine items were revised: three because of new scientific insights and six because of the need for more objective measurement instruments. In all revised items, subjective assessment methods were replaced by more objective assessment tools (e.g. symptom-limited exercise instead of clinical judgement). In addition, four new key items were added: screening for anxiety/depression, stress, cardiovascular risk profile and alcohol consumption.

Conclusion

Based on previously determined shortcomings, the Clinical Algorithm for Cardiac Rehabilitation was thoroughly revised mainly by incorporating more objective assessment methods and by adding several new key areas.

Background

In 2004, the Netherlands Society of Cardiology released the current guideline on cardiac rehabilitation. Given its complexity and the involvement of various healthcare disciplines, it was supplemented with a clinical algorithm, serving to facilitate its implementation in daily practice. Although the algorithm was shown to be effective for improving guideline adherence, several shortcomings and deficiencies were revealed. Based on these findings, the clinical algorithm has now been updated. This article describes the process and the changes that were made.

Methods

The revision consisted of three phases. First, the reliability of the measurement instruments included in the 2004 Clinical Algorithm was investigated by evaluating between-centre variations of the baseline assessment data. Second, based on the available evidence, a multidisciplinary expert advisory panel selected items needing revision and provided specific recommendations. Third, a guideline development group decided which revisions were finally included, also taking practical considerations into account.

Results

A total of nine items were revised: three because of new scientific insights and six because of the need for more objective measurement instruments. In all revised items, subjective assessment methods were replaced by more objective assessment tools (e.g. symptom-limited exercise instead of clinical judgement). In addition, four new key items were added: screening for anxiety/depression, stress, cardiovascular risk profile and alcohol consumption.

Conclusion

Based on previously determined shortcomings, the Clinical Algorithm for Cardiac Rehabilitation was thoroughly revised mainly by incorporating more objective assessment methods and by adding several new key areas.

Background:

This article describes the evidence review and guideline development method developed for the Clinical Preventive Guidelines for Immigrants and Refugees in Canada by the Canadian Collaboration for Immigrant and Refugee Health Guideline Committee.

Methods:

The Appraisal of Guidelines for Research and Evaluation (AGREE) best-practice framework was combined with the recently developed Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to produce evidence-based clinical guidelines for immigrants and refugees in Canada.

Results:

A systematic approach was designed to produce the evidence reviews and apply the GRADE approach, including building on evidence from previous systematic reviews, searching for and comparing evidence between general and specific immigrant populations, and applying the GRADE criteria for making recommendations. This method was used for priority health conditions that had been selected by practitioners caring for immigrants and refugees in Canada.

Interpretation:

This article outlines the 14-step method that was defined to standardize the guideline development process for each priority health condition.

Background

Clinical practice guidelines are not uniformly successful in influencing clinicians' behaviour toward best practices. Implementability refers to a set of characteristics that predict ease of (and obstacles to) guideline implementation. Our objective is to develop and validate a tool for appraisal of implementability of clinical guidelines.

Methods

Indicators of implementability were identified from the literature and used to create items and dimensions of the GuideLine Implementability Appraisal (GLIA). GLIA consists of 31 items, arranged into 10 dimensions. Questions from 9 of the 10 dimensions are applied individually to each recommendation of the guideline. Decidability and Executability are critical dimensions. Other dimensions are Global, Presentation and Formatting, Measurable Outcomes, Apparent Validity, Flexibility, Effect on Process of Care, Novelty/Innovation, and Computability. We conducted a series of validation activities, including validation of the construct of implementability, expert review of content for clarity, relevance, and comprehensiveness, and assessment of construct validity of the instrument. Finally, GLIA was applied to a draft guideline under development by national professional societies.

Results

Evidence of content validity and preliminary support for construct validity were obtained. The GLIA proved to be useful in identifying barriers to implementation in the draft guideline and the guideline was revised accordingly.

Conclusion

GLIA may be useful to guideline developers who can apply the results to remedy defects in their guidelines. Likewise, guideline implementers may use GLIA to select implementable recommendations and to devise implementation strategies that address identified barriers. By aiding the design and operationalization of highly implementable guidelines, our goal is that application of GLIA may help to improve health outcomes, but further evaluation will be required to support this potential benefit.

Background

To assess the methodological rigour and transparency of reporting in clinical practice guidelines for the management of allergic rhinitis (AR).

Methods

We systematically searched MEDLINE, TRIP database (including the National Guidelines Clearinghouse) and professional society websites for guidelines about the management of AR published after the year 2000. We assumed that older guidelines would no longer influence current clinical practice. If the guideline was updated after 2000 we assessed the most recent version. We included all guidelines published in English and endorsed by an international or national government agency or professional group, irrespective of country of origin or publication status. Two reviewers independently screened search results using predefined eligibility criteria and assessed the rigour of development and reporting of included guidelines using the AGREE II instrument (www.agreetrust.org).

Results

Our search revealed 432 records of which 34 full text articles were assessed for eligibility. Nine documents fulfilled our criteria–3 international and 6 national guidelines from Japan, Singapore, South Africa, UK and the USA. Overall methodological rigour and reporting of guidelines about the management of AR was variable—from fulfilling most AGREE II criteria to almost none. There was no association between the methodological rigour and time of publication or the target scope of the guideline (national versus international). Across all guidelines the most rigorously reported domain was “clarity of presentation” (median score 53%), mainly due to fair presentation of different management options (item 16), followed by “scope and purpose” (median score 42%). The least rigorously addressed was “applicability” domain with median score of 2% across all guidelines. Median scores for domains “stakeholder involvement”, “rigour of development” and editorial independence” were 17%, 15% and 25%, respectively. The ARIA guidelines (2010 update) achieved the highest scores in 5 out of 6 domains and the lowest score on any domain was 60%.

Conclusions

Guideline users should be aware of the variability in quality of development and reporting of guidelines for the management of AR. They should choose higher quality guidelines to inform their practice. For many guidelines there is much room for improvement, in particular in the domains of applicability and implementation.

Introduction

Evidence-based recommendations are needed to guide the acute management of the bleeding trauma patient, which when implemented may improve patient outcomes.

Methods

The multidisciplinary Task Force for Advanced Bleeding Care in Trauma was formed in 2005 with the aim of developing a guideline for the management of bleeding following severe injury. This document presents an updated version of the guideline published by the group in 2007. Recommendations were formulated using a nominal group process, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) hierarchy of evidence and based on a systematic review of published literature.

Results

Key changes encompassed in this version of the guideline include new recommendations on coagulation support and monitoring and the appropriate use of local haemostatic measures, tourniquets, calcium and desmopressin in the bleeding trauma patient. The remaining recommendations have been reevaluated and graded based on literature published since the last edition of the guideline. Consideration was also given to changes in clinical practice that have taken place during this time period as a result of both new evidence and changes in the general availability of relevant agents and technologies.

Conclusions

This guideline provides an evidence-based multidisciplinary approach to the management of critically injured bleeding trauma patients.

Purpose:

Clinical practice guidelines play a critical role in guiding the evidence-based clinical practice of urology. We describe a systematic approach to critical appraisal of urology guidelines.

Materials and Methods:

Based on a focused clinical question derived from a clinical scenario, we identified a relevant clinical practice guideline that we critically appraised using the Users’ Guide to the Medical Literature framework as to whether the results are valid, what are the results, and can they be applied to the care of an individual patient.

Results:

A clinical practice guideline by the National Institute for Clinical Excellence on the use of sunitinib as the first line treatment for patients with metastatic renal cell carcinoma was identified. The guideline development process was found to be appropriately rigorous and included an explicit rating of the quality of evidence. The recommendations were clearly stated and appeared applicable to the specific patient in the clinical scenario.

Conclusions:

Clinical practice guidelines should be developed using rigorous evidence-based methodology. Urologists should have the skills and knowledge to critically appraise a guideline before applying it to the care of their patients.