which of the following characteristics of a clinical practice guideline is the best indicator that the recommendations are truly evidence-based?
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Clinical practice guideline development manual: A quality
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 ...
Otolaryngol Head Neck Surg. Author manuscript; available in PMC 2010 Jun 1.
Published in final edited form as:
Otolaryngol Head Neck Surg. 2009 Jun; 140(6 Suppl 1): S1–43.
doi: 10.1016/j.otohns.2009.04.015
PMCID: PMC2851142
NIHMSID: NIHMS180759
PMID: 19464525
Clinical practice guideline development manual: A quality-driven approach for translating evidence into action
Richard M. Rosenfeld, MD, MPH and Richard N. Shiffman, MD, MCIS
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The publisher's final edited version of this article is available at Otolaryngol Head Neck Surg
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Abstract
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.
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1 INTRODUCTION
If you use or develop clinical practice guidelines this manual will likely be of interest. “There are many paths to the top of the mountain,” suggests an old Chinese proverb, “but the view is always the same.”1 Although many paths lead to guidelines, we offer proven strategies for crafting a valid and action-ready product within twelve months. The driving force is quality improvement with a continuous effort to balance pragmatism with developmental rigor. The end product is a starting point for performance improvement.
This manual builds on an earlier publication2 by American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) to systematize internal guideline development. By following these principles the AAO-HNS published five multidisciplinary guidelines in five years, all within 12 months from conception to completion.3–7 Each guideline presented a fresh opportunity to test and refine prior efforts, necessitating a revised and greatly expanded manual only three years after initial publication. Our new manual not only summarizes this experience, but allows other organizations to assess and adapt the processes.
Our goals in publishing a revised manual are several. First, we sought to provide clinicians with a straightforward explanation of guidelines, considering the increasing prominence of guidelines as a quality metric. Second, we wanted a pragmatic resource, which accurately reflects current practices, to sustain consistent guideline development at the AAO-HNS. Last, we wanted to share our successful development process with the guideline community at-large to encourage an exchange of ideas and to promote best practices.
Guidelines are particularly important when wide regional variations exist in managing a condition. Similarly, the wide variability in guideline methodology, both within and between organizations, is precisely what mandates a systematic approach to guideline development. Despite a plethora of techniques reflected in published guidelines, we could not find a single, comprehensive “how-to” manual with a valid and pragmatic approach that could be readily implemented. This work is offered to address this void.
We thank the AAO-HNS for their trust, support, and flexibility throughout this fruitful collaboration, and sincerely hope that you may also benefit from the experience. We humbly acknowledge that ours is one of many paths to the mountain top, and look forward to further refinement based on reader feedback and ongoing experience.
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2 HOW TO USE THIS MANUAL
Throughout the manual we emphasize principles and practices, recognizing that both are needed to translate concepts into action. Principles underlying practices are always stated, to promote conceptual focus and clarity before getting sidetracked with implementation details. Practices are illustrated with examples from prior AAO-HNS guidelines to clarify how we chose to implement a principle, with the understanding that other development groups will need to modify the particulars to fit their organizational structure and resources.
Content that is offset from the remainder of the text is intended to emphasize a concept, insight, or principle, of special note or importance. This also serves to create visual breaks that improve readability, along with tables, bulleted lists, numbered lists, and frequent subheadings.
Evidence Based Clinical Practice Guidelines Quiz 9 Flashcards
Study with Quizlet and memorize flashcards terms like Which statement best describes how evidence-based clinical practice guidelines are mainly and most often used? A) To inform patients of the care they should expect B )To guide agencies in developing protocols specific to their setting C) As a standard for nurse performance appraisal D) As an educational tool for nurses and other providers, From the following possible methodological steps for producing evidence-based clinical practice guidelines, which combination includes widely accepted core principles? 1. They are carried out by members of the affected disciplinary groups 2. A systematic review identified or conducted prior to development of recommendations 3. Only studies with a sample size greater than 100 are considered 4. Recommendations are explicitly linked with supporting evidence 5. Recommendations are set forth only for those issues for which there are two or more randomized controlled trials A) 1, 2, 4 B) 1, 3, 5 C) 2, 4, 5 D) 1, 3, 4, Which of the following is the best reason for a project team that is updating a clinical protocol to start by looking for an evidence-based clinical practice guideline rather than individual studies? A) It is required for Medicare reimbursement B) It is the route to a clinical protocol preferred by accrediting organizations C) It could save time and effort D) An evidence-based clinical practice guideline can be used as is - without adaptation. and more.
Evidence Based Clinical Practice Guidelines Quiz 9
5.0 1 Review
Which statement best describes how evidence-based clinical practice guidelines are mainly and most often used?
A) To inform patients of the care they should expect
B )To guide agencies in developing protocols specific to their setting
C) As a standard for nurse performance appraisal
D) As an educational tool for nurses and other providers
Click card to see definition 👆
B )To guide agencies in developing protocols specific to their setting
Click again to see term 👆
From the following possible methodological steps for producing evidence-based clinical practice guidelines, which combination includes widely accepted core principles?
1. They are carried out by members of the affected disciplinary groups
2. A systematic review identified or conducted prior to development of recommendations
3. Only studies with a sample size greater than 100 are considered
4. Recommendations are explicitly linked with supporting evidence
5. Recommendations are set forth only for those issues for which there are two or more randomized controlled trials
A) 1, 2, 4 B) 1, 3, 5 C) 2, 4, 5 D) 1, 3, 4
Click card to see definition 👆
A) 1, 2, 4
Click again to see term 👆
1/10 Created by kayla_maslauskas
Terms in this set (10)
Which statement best describes how evidence-based clinical practice guidelines are mainly and most often used?
A) To inform patients of the care they should expect
B )To guide agencies in developing protocols specific to their setting
C) As a standard for nurse performance appraisal
D) As an educational tool for nurses and other providers
B )To guide agencies in developing protocols specific to their setting
From the following possible methodological steps for producing evidence-based clinical practice guidelines, which combination includes widely accepted core principles?
1. They are carried out by members of the affected disciplinary groups
2. A systematic review identified or conducted prior to development of recommendations
3. Only studies with a sample size greater than 100 are considered
4. Recommendations are explicitly linked with supporting evidence
5. Recommendations are set forth only for those issues for which there are two or more randomized controlled trials
A) 1, 2, 4 B) 1, 3, 5 C) 2, 4, 5 D) 1, 3, 4 A) 1, 2, 4
Which of the following is the best reason for a project team that is updating a clinical protocol to start by looking for an evidence-based clinical practice guideline rather than individual studies?
A) It is required for Medicare reimbursement
B) It is the route to a clinical protocol preferred by accrediting organizations
C) It could save time and effort
D) An evidence-based clinical practice guideline can be used as is - without adaptation.
C) It could save time and effort
An example of a false negative is:
A) A healthy person correctly identified as healthy
B) A healthy person incorrectly identified as diseased
C) A diseased person incorrectly identified as healthy
D) A diseased person correctly diagnosed as diseased
C) A diseased person incorrectly identified as healthy
If a test has a sensitivity of 100%, it means that:
A) It should not be as a screening test because it may have some false positives
B) The test identifies everyone with the disease and it never flags any healthy people as having the disease
C) The test identifies everyone with the disease but it may mistakenly flag some healthy people as having the disease
D) It sometimes yields false negatives
C) The test identifies everyone with the disease but it may mistakenly flag some healthy people as having the disease
An example of a true positive is:
A) A healthy person incorrectly identified as diseased
B) A diseased person incorrectly identified as healthy
C) A disease person correctly identified as having the disease
D) A healthy person correctly identified as healthy
C) A disease person correctly identified as having the disease
Which of the following characteristics of a clinical practice guideline is the best indicator that the recommendations are truly evidence-based?
A) A computerized database search was conducted before the recommendations were developed.
B) The producers used a levels of evidence hierarchy to characterize the types of supporting evidence
C)The producers of the guideline will say so and a reference list is provided.
D) The evidence for each recommendation is summarized and referenced.
D) The evidence for each recommendation is summarized and referenced.
Which of the following is an important feature of all evidence-based clinical practice guidelines?
A) They should be base on conclusions from meta-analysis
B) They should explicitly indicate the amount, level, and quality of evidence supporting each recommendation
C) They should link pathophysiology to clinical actions
D) They should be based on randomized clinical trials
B) They should explicitly indicate the amount, level, and quality of evidence supporting each recommendation
Which of the following panel profiles best portrays a panel that has what it takes to produce an evidence-based clinical practices guidelines?
Guidelines and Safety Practices for Improving Patient Safety
This chapter explains why clinical practice guidelines are needed to improve patient safety and how further research into safety practices can successfully influence the guideline development process. There is a description of the structured process by which...
Guidelines and Safety Practices for Improving Patient Safety
Walter Ricciardi & Fidelia Cascini
Chapter Open Access
First Online: 15 December 2020
25k Accesses 2 Citations
Abstract
This chapter explains why clinical practice guidelines are needed to improve patient safety and how further research into safety practices can successfully influence the guideline development process. There is a description of the structured process by which guidelines that aim to increase the likelihood of a higher score are created. Proposals are made relating to (a) the live updating of individual guideline recommendations and (b) tackling challenges related to the improvement of guidelines.
Keywords
Patient safety Healthcare quality Risk management Patient outcomes Adverse events Malpractice Clinical trials
Evidence-based medicine
Clinical practice
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1.1 Introduction
Actions to improve patient safety have shown widely varying degrees of effectiveness. Usually hospitals are focused on the occurrence of adverse events and the level of adversity to the patient in the contexts of insurance premiums and the costs of malpractice. Furthermore, even risk management units within hospitals focus on these factors, when comparing the performance of departments or wards. However, for the improvement of patient safety in clinical practice, a different approach is required, in which the prevention of patient harm and effectiveness of clinical actions is standardized and assessed on the basis of scientific evidence.
Recommendations that have been translated into guidelines are the best possible evidence-based solutions to clinical practice issues. However, it appears that there are very few clinical guidelines focused on patient safety, particularly in the risk management sector. Furthermore, when using clinical guidelines for quality and safety improvement, practices often seem to diverge. Higher quality and safer clinical practice are consequently difficult to achieve, share, and promote.
Existing knowledge of patient safety essentially covers the nosography of threats and causes of patient harm, as opposed to possible evidence-based solutions that can (a) prevent risks, (b) address healthcare incidents, and (c) which can be compared. This means that etiology, pathogenesis, and observations of safety issues in clinical departments, and, more broadly in healthcare organizations, are often investigated while proven solutions to patient safety issues are rarely discussed. To give an appropriate analogy, it is like saying that there are many papers that have examined perioperative complications, type of surgeries, and patient characteristics. However, no research is available on how the occurrence of these complications have been managed in different settings according to organizational and human factors.
It is essential that healthcare professionals acquire proficiency in producing evidence that can be used for making improvements to patient’s safety and managing the risks of adverse events. To successfully achieve this goal, the first step is for them to have a clear idea of what guidelines and practices are. Definitions of these terms will be the content of the first section of this chapter. Once these concepts have been introduced, the second section will show the current picture regarding patient safety and why a greater number of valuable clinical guidelines are needed. The third section will then consider possible solutions, lessons to apply in practice, and will explain how to prepare and update a guideline. The challenges we are facing along with the limits of the current guidelines will be considered at the end, which will assist in managing patient safety in future.
1.2 The Need to Understand Guidelines Before Improving Safety
The World Health Organization (WHO) regards guidelines as tools to help people to make decisions and particularly emphasize the concept of choosing from a range of interventions or measures. A WHO guideline is any document developed by the World Health Organization containing recommendations for clinical practice or public health policy. A recommendation tells the intended end-user of the guideline what he or she can or should do in specific situations to achieve the best health outcomes possible, individually or collectively. It offers a choice of different interventions or measures that are intended to have a positive impact on health and explains their implications for the use of resources. Recommendations help the user of the guideline make informed decisions on whether to undertake specific interventions or clinical tests, or if they should implement wider public health measures, as well as where and when to do so. Recommendations also help the user to select and prioritize across a range of potential interventions [1].
With a greater emphasis on clinical practice, the U.S. Institute of Medicine (IOM) defines guidelines as “statements that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options” [2]. This definition emphasizes that the foundation of a guideline is a systematic review of the scientific evidence bearing on a clinical issue. The strength of the evidence leads the clinical decision-making process through a set of recommendations. These concern the benefits and harms of alternative care options and address how patients should be managed, everything else being equal.
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