ASE Guideline Development Manual

 

ASE Guideline Development Manual

Developed by Merri L. Bremer, M.Ed., RN, RDCS, FASE, Marielle Scherrer-Crosbie, MD, PhD, FASE, Federico Asch, MD, FASE, Allan L. Klein, MD, FASE, Amer M. Johri, MD, MSc, FASE

Introduction

The American Society of Echocardiography (ASE) Guidelines have become an essential, useful, and integral part of the practice of echocardiography.  As echocardiographic technology and utilization continue to advance, an overwhelming amount of new information is being generated, requiring organized analysis, synthesis, and conversion into specific recommendations.  The contents of a guideline is based on systematic evaluation of best available evidence as well as expert consensus.

ASE Guidelines are designed to support decision-making in the use of echocardiography as an imaging modality.  Ideally, the Guidelines will reduce inappropriate variation in practice, provide a focus for continuing education, highlight limitations of existing literature, and provide direction for future research.  In addition, ASE Guidelines support achievement of ASE Strategic Goals.

 

Table of Contents

ASE Guideline Committee Charges…………………………………………………………. 2

Purpose and Scope of Manual…………………………………………………………………. 2

Guideline Categories and Timelines…………………………………………………………. 2

Guideline Proposal Template…………………………………………………………………… 2

Document Development and Review Process…………………………………………… 3

Writing Group Members…………………………………………………………………………. 5

Writing Group Responsibilities……………………………………………………………….. 5

Recommendations for Developing and Writing a Guideline……………………….. 5

References……………………………………………………………………………………………. 11

 

ASE Guideline Committee Charges:

1. Review and edit new standards documents for consistency and alignment with society’s standards and values.
2. Supervise and advise taskforces and councils that are developing standards and training documents (Chair).
3. Identify areas in need of standardization as well as potential leaders to direct the development of guidelines or standards documents.
4. Review documents led by other societies that seek endorsement by the ASE.
5. Commission documents that affirm ASE’s position as the authoritative resource on cardiovascular ultrasound.
6. Review existing ASE documents to assess update requirements.
7. Suggest ways to disseminate guidelines to members, physicians, the public and private payers (specific task related to goal).
8. Routinely monitor working group progress to ensure timely delivery of documents (Chair).

Members of the committee cannot serve as chair/lead author on any ASE writing groups during their time of committee service.

Purpose and Scope of Manual

This manual is intended to serve as a guide and reference for authors, writing group chairs, and members.  Information and guidance are provided on document development and review process, expectations from the writing group chair and members, collaborating with other societies, and proposal/writing group development recommendations.

Guideline Categories and Timelines

Timelines are started after the ASE Guidelines Committee and Executive Committee have approved the Guideline proposal and invited the members of the writing group.

1. Technique-based imaging (one year timeline)
2. Disease-based imaging (15 month timeline)
3. Cardiac structure and function (one year timeline)
4. Quality/Education (one year timeline)
5. Focused Updates (9 month timeline)

In order to keep all documents updated, the Guidelines Committee will evaluate on a yearly basis the need for document update by critically reviewing each document that has been in print for four years or more. The goal will be to have by year five either an updated document or a decision that such update was not yet needed. This report will be presented to the Executive Committee on a yearly basis for their review/approval.

Guideline Proposal Template (link)

Document Development and Review Process

1. The writing group chair will be asked to provide a list of proposed writing group members. Upon approval of the proposed writing group, invitations to authors and other Societies must originate from the ASE President and Guidelines Committee Chair, not the Writing Group chair or members.
2. Writing Group members should represent communities of interest for the topic being addressed. In particular, careful consideration should be given to representation from different ASE Councils and Task Forces, as appropriate to the topic. Recommendations on such representation should be considered by the writing group Chair but may also come from the Guidelines Committee or Executive Committee.
3. The Writing Group should represent diverse institutions and geographic regions (nationally and internationally).  No more than two members (including the Chair) from a single institution should be included on a given writing group. Specific exceptions will be considered by the Guidelines Committee Chair in case challenges arise as the document writing process moves forward, or specific expertise is required.
4. All invited authors will be required to complete ASE’s conflict-of-interest form prior to joining the writing group, disclosing all relationships that pertain to the document topic. More than half of the writing group should have no relationships to disclose.  It is preferred that the writing group chair have no major conflicts or financial interests to disclose. Exceptions may be made when expertise is required to enhance the document that is not otherwise available.
5. Collaborations with other societies require approval by the ASE Executive Committee. There are varying levels of collaborations:
   Joint documents with organizations such as EACVI may indicate a partnership with equal sharing of responsibilities.  These documents would have co-chairs from each society, an equal number of authors, and co-publication.  However, only one society will own the copyright and that will be determined by the leaders of both societies prior to their agreement to collaborate.  The society owning the copyright will have their chair listed as the first author and will also publish first.
   Endorsing societies will be invited to submit author nominees, from which the writing group chair will select the appropriate authors representing that society, being mindful of expertise and geographic/institutional diversity.
6. Smaller Writing Groups (5-10) are typically more agile and easier to build consensus.
7. At least one sonographer must be included.
8. Writing groups should consider including mid-career group members to provide writing group experience.
9. Recognize that collaboration with other Societies may extend the time required for document development, review, and approval.
10. When listing the writing group in the document, it is recommended that authors be listed in this order:  Chair, Co-Chair (if applicable), alphabetical listing of authors

 

Writing Group Responsibilities

Chair

1. Propose Writing Group membership to the ASE Guidelines Committee Chair and Executive Committee. This list should be accompanied by the document outline, to facilitate the critical consideration of expert and council representatives based on the scope of work.
   • Once the initial Writing Group has been established, additional authors may be required depending on the appropriate division of writing tasks.
2. Determine scope and objectives of document (expert consensus versus evidence-based recommendations)
3. Communicate with ASE Liaison/ Executive Committee/Guidelines Chair if document scope changes or additional members are desired
4. Coordinate development of document outline
5. Determine writing assignments based on proposal outline,
6. Define and coordinate appropriate and comprehensive literature review
   • Ensure document under development is consistent with other relevant publications and ASE Guideline documents, or why change is needed
7. Review JASE author/publication requirements and ensure appropriate use within the document
8. If the document has been approved as a collaboration with EACVI, the Chair should review and abide by the current version of “Collaborative Documents Process: American Society of Echocardiography and European Association of Cardiovascular Imaging,” available from the ASE Guidelines Committee Chair or staff liaison.
9. Manage document development
   • Draft development
   • Facilitate consensus
   • Manage meetings and document progress – keep document on schedule
   • Send quarterly status report to ASE Liaison and Guidelines Committee Chair
   • Schedule six month conference call with ASE Liaison and Guidelines Committee Chair
   • Coordinate response to external review
   • Coordinate development of executive summary and implementation tools
   • Ensure the Guideline follows the Template described in the Recommendations for Development and Writing of a Guideline (page 5 below).
10. Report on a quarterly basis the status and progress of the document, and the achievement of goals as described in the document development timeline (figure in page 3). This will take place in the form of conference calls with the Guidelines Committee Chair and ASE Liaison. To facilitate fluent communication, additional conference calls or reports will be scheduled whenever the Writing Group or Guidelines Chairs consider it necessary.

 

Writing Group Committee member

1. Participate in planning discussions and agree to writing assignments
2. Adhere to COI/disclosure policy
3. Write and edit assigned sections in a timely manner
4. Review and approve as requested

 

Recommendations for Writing and Developing a Guideline

Background
Members of the Guidelines and Standards Committee were asked to provide their top guidelines in terms of content and clarity.   The comments and studies listed were compiled and reviewed to determine the common elements found in these documents.  A recommendation for guideline production was formulated based on this list of guidelines and suggestions gleaned from published critical appraisal of guidelines by other Societies (References [1] and[2]).

ASE guidelines picked by committee for clarity and/or content:
Recommendations for Cardiac Chamber Quantification by Echocardiography in Adults (2015)[3]
Expert Consensus for Multimodality Imaging Evaluation of Adult Patients during and after Cancer Therapy (2014) [4]

Goal
“Guidelines are aimed at presenting all the relevant evidence on a particular clinical topic/issue in order to help physicians weigh the benefits and risks of a particular diagnostic or therapeutic procedure.  They should be helpful in everyday clinical medical decision-making.”[1]  Expert consensus may also be provided, particularly for topics with limited evidence.

Selection of Topics
Preferred topics are those where there is a clear need for standardization of practices through application of guidelines that would assist physicians, sonographers, and other health professionals on health issues, epidemiology, prevention, management, health policies, techniques, etc.  Topics can be ranked and reviewed by the Guidelines Committee.  Updates are a high priority when new data has emerged and should be considered for review every 4-5 years. As described in “Guideline Categories and Timelines,” the Guidelines Committee will evaluate on a yearly basis the need for document update, by critically looking into each published document that is 4 years old or older. The goal will be to have by year 5 either an updated document or a decision that such update was not needed. This report will be presented to the Executive Committee on a yearly basis for their review/approval.

Current Core Topics (ASE)
3D Echocardiography; Cardio-Oncology; Cardiovascular Sonography; Chamber Quantification; Contrast Echocardiography; Diastolic Function; Disease-Based; Doppler Echocardiography; Echo-Guided Interventions; Focused Cardiac Ultrasound; Multimodality; Pediatric/Congenital/Fetal; Perioperative/TEE; Reporting/Quality; Research; Resynchronization/Mechanics; Stress Echocardiography; Training; Valves; Vascular Ultrasound

Key Writing Tips

1. Ethical Principles
   • Authors must strive to maintain high ethical principles, avoid bias, and declare conflicts of interest
   • Ensure patient confidentiality is preserved: all identifiers are to be removed from still frames and videos
2. Document Length
   • Long enough to adequately cover the topic, but short enough to be interesting and useful to the reader. Recommendation is <7000 words if possible, although the length depends upon category and type of document.
   • Avoid redundancy within the document
   • Gain group consensus regarding non-duplication before writing sections
3. Content
   • Guidelines Review Articles: The writing of Guidelines is different from the writing of a review. Although authors must strive to include the most meaningful literature, they should use the references to make a series of recommendations rather than summarize each paper.  If a literature review is deemed essential, consider including it as a table.
   • Guidelines Expert Consensus Statements: Guidelines are evidence-based recommendations. Expert Consensus Statements are appropriate when sufficient data may be lacking but an expert opinion is needed.
   • Reference previous documents (especially ASE documents) instead of re-establishing the primary value of a modality. In this regard, special attention should be given to the revision of previously published ASE documents and assure consistency among them.
   • Provide conclusions and recommendations when appropriate, and clearly define recommendations as evidence-based versus expert consensus
   • Provide bulleted highlights /recommendations at the end of each section of the document
   • Provide an Executive Summary at the end of the document
   • Protocols may best be provided in links or appendixes
4. Formatting
   • Visually summarize key points in tables, diagrams, etc.
   • Figures, algorithms, and decision trees are useful if feasible
   • Use of videos in ASE guideline documents provides additional educational value and is highly encouraged.

Recommended Template of ASE Guideline:

1. Description of Writing Group
   1. Describe the type of professional and other stakeholders involved with the developmental process and evaluate for potential or existing bias
   2. Multi-society and authoritative recommendations increase credibility for appropriate topics, but may substantially extend the time required for document development, review, and approval. All multi-society collaborations require prior approval from the Executive Committee.
2. Table of Contents
3. Overview/Introduction (300 word limit)
   1. Explain why the guideline is being developed at this time
      1. Detailed rationale
      2. Provide epidemiologic information
      3. Clearly refer to changes or discrepancies in older versions
   2. Include scope and limitation of the guideline
      1. Include the following text: “The purposes of this guideline document are as follows:”
      2. Include a numbered list of purposes
      3. Intended audience for the Recommendations

4. Methods
   1. Evidence gathering and review process
      1. Only peer reviewed published literature should be considered
      2. Avoid citation of abstracts, unpublished results (trial data – unless formally presented at a major conference and the final draft of the manuscript is available)
   2. Explicit description of review methodology: narrative versus non-systematic gathering of literature, include search criteria and databases used

5. Formatting of Recommendations
   1. Each section/paragraph of the Guideline body should have the purpose of supporting one or several Recommendations
   2. The Recommendations should be qualified either by level of evidence (if possible) or advantages and disadvantages
   3. Each Recommendation should be:
      1. Clear and concise
      2. Unbiased
      3. Reflect information needed in everyday practice.
   4. Provide bulleted highlights /recommendations at the end of each section of the document.

6. Body of Guideline (suggested formats)
   1. Technique-based Guideline (i.e. 3D, contrast, stress, strain)
      1. Overall summary of the guideline
      2. Definition and theoretical basis of the technique
      3. Methodology
         1. Protocols are encouraged when applicable and may be included in either the body of the text or an appendix (acquisition, analysis, interpretation)
         2. Equipment, sensitivity, specificity, comparison with other diagnostic tools/techniques.
      4. Advantages: historical context, advancement
      5. Pitfalls: Explain the limitations of the technique
      6. Safety issues: comparison with other techniques
      7. Cost issues: is there data?
      8. Clinical applications: Include figures/algorithms/decision trees.
      9. Summarize/highlight recommendations at the end of each section

    

• Disease-based Guideline (i.e. Radiotherapy, HOCM, Pericardial Disease)

1. Overall summary of the Guideline
2. Definition: Describe disease, scope of the problem, epidemiology, and known data

• Consider describing the echo/multi-modality evaluation of each aspect of the disease separately
  1. Systolic/diastolic function, valvular function, chamber dimension, hemodynamics

• Diagnosis, prognosis, monitoring, role in treatment and intervention, risk stratification, screening

1. Clinical applications: Detail different evaluation algorithms from simple to complex. Include figures/algorithms/decision trees.
2. Advantages
3. Pitfalls

• If multimodality, each modality can be explored separately or one after the other for each indication
• Summarize/highlight recommendations at the end of each section

 

1. Cardiac Structure or Function-based Guideline (i.e. valvular regurgitation, right ventricle, pericardium, aorta, chambers)
1. Overall summary of the Guideline
2. Definition: Normal values, provide reference tables
• Methodology:
  1. Techniques and algorithms used to assess the structure or the finding
  2. The techniques can be first described generally and then detailed for each indication
  3. Advantages and disadvantages/pitfalls of the different approaches
  4. If multimodality, each modality can be treated separately or treated one after the other for each indication.
1. Clinical applications: Figures/algorithms/decision tree/tables
2. Summarize/highlight recommendations at the end of each section

 

1. Quality/Education Guideline (i.e. standardization of labs, reporting, training of sonographers, accreditation)
   1. Overall summary and objectives of the guideline
   2. Definition: Detail gap in knowledge or quality
• Literature review
1. Proposed methodology or solutions
2. Clinical application (if appropriate): Figures/algorithms/decision tree/tables
3. Summarize/highlight recommendations at the end of each section

 

7. Special Considerations
   1. Consider providing information or recommendations related to quality assurance, cost, safety, special populations (elderly, women, pediatric)
   2. Consider including areas of ongoing research that may change recommendations

 

8. Executive Summary (1000 word limit)
   1. List Primary Recommendations (one paragraph for each recommendation)
   2. Summary table of Primary Recommendations

 

9. Implementation Tools (protocols, report templates, etc.) which can be provided in the body of the document or an appendix are strongly recommended by the ASE Board of Directors

 

 

10. Required Disclaimer for Guidelines Documents

NOTICE AND DISCLAIMER:  This report is made available by ASE as a courtesy reference source for its members. This report contains recommendations only and should not be used as the sole basis to make medical practice decisions or for disciplinary action against any employee.  The statements and recommendations contained in this report are primarily based on the opinions of experts, rather than on scientifically-verified data. ASE makes no express or implied warranties regarding the completeness or accuracy of the information in this report, including the warranty of merchantability or fitness for a particular purpose. In no event shall ASE be liable to you, your patients, or any other third parties for any decision made or action taken by you or such other parties in reliance on this information. Nor does your use of this information constitute the offering of medical advice by ASE or create any physician-patient relationship between ASE and your patients or anyone else.

 

 

References

 

[1]   Recommendations for guidelines production.  2010.  European Society of Cardiology.

Ref Type: Report

[2]   Methodology manual and policies from the ACCF/AHA task force on practice guidelines.  2010.  American college of cardiology foundation and american heart associations, Inc.

Ref Type: Report

[3]   Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr 2010; 23: 685-713.

[4]   Zoghbi WA, Enriquez-Sarano M, Foster E, Grayburn PA, Kraft CD, Levine RA, Nihoyannopoulos P, Otto CM, Quinones MA, Rakowski H, Stewart WJ, Waggoner A, Weissman NJ. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr 2003; 16: 777-802.

[5]   Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, et al. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr 2015;28:1-39.

 

[5]     Plana JC, Galderisi M, Bara A, Ewer MS, Ky B, Scherrer-Crosbie M, et al. Expert consensus for multimodality imaging evaluation of adult patients during and after cancer therapy: a report from the American Society of Echocardiography and the European Association of Cardiovascular Imaging . J Am Soc Echocardiogr 2014;27:911-39.

 

 

 

Contacts:

Federico M. Asch, Guidelines Committee Chair, fmasch@gmail.com

Rhonda Price, Chief Standards Officer (Staff Liaison to writing groups and Guidelines Committee), rprice@asecho.org, 919-297-7159

 

 

 

[NOTE TO ARISSA – THE FOLLOWING IS INFORMATION TO BE LINKED.  JUST PREPARE THE PREVIOUS CONTENT FOR NOW]

Information to be linked to the document:

Links for guideline development manual:

 

 

 

 

 

 

ASE QUALITY GOAL

Improve the global dissemination and implementation of cardiovascular ultrasound quality in all clinical settings.

Strategies:

Continue to define quality and standardize cardiovascular ultrasound practice in all clinical settings.

Increase Dissemination of cardiovascular quality standards across the globe.

Facilitate Implementation of cardiovascular ultrasound quality globally.

Define Focused cardiovascular ultrasound quality for all clinical settings.

 

ASE GOALS (2015-2018)

Goal 1:  Attract all users of CV ultrasound by creating quality and value

Strategy:  Assess needs and create a menu of items that are attractive to the Structural Heart Team

Strategy:  Expand ASE’s global presence

Strategy:  Assess needs and create a menu of items that are attractive to POC users

Strategy:  Assess needs and create a menu of items that are attractive to medical students

 

Goal 2:  Promote the value of CV ultrasound to be well-known by patients, payers and healthcare providers

Strategy:  Redesign our web and digital presence

Strategy:  Develop educational campaign for patients

Strategy:  Develop educational campaign for payers

Strategy:  Develop educational campaign for healthcare providers

Strategy:  Create an effective media campaign

 

Goal 3:  Facilitate the development and application of novel CV ultrasound technology

Strategy:  Collaborate and partner with technology innovators and other organizations

Strategy:  Serve as an innovation incubator

Strategy:  Create infrastructure to assess new technology and its incremental value through assessment of patient outcomes

 

Goal 4:  Create a governance structure that is representative of our membership and supports an efficient and effective organization

Strategy:  Redesign ASE and ASEF board structures to facilitate engagement and strategic decision-making

Strategy:  Improve training of Committees and Councils to increase communications and create dedicated volunteer workforces representing ASE

Strategy:  Document and provide transparency to Council operations and move toward standardizing to allow for additional growth

 

 

 

 

 

 

 

 

 

 

 

______________________________________________________________________________

 

Guideline Proposal Template:

 

New Document Proposal

 

Title: 

 

Perceived need

 

Guideline Category

• Imaging Modality/Technique-based (one year timeline)
  • Guideline template (link)
• Quality/Training (one year timeline)
  • Guideline template (link)
• Evolving Technology or Application (one year timeline)
  • Guideline template (link)
• Disease/Condition/Multimodality Imaging (15 month timeline)
  • Guideline template (link)

 

Other relevant publications

 

Other relevant ASE guideline documents

 

Summary and bulleted outline of content

1. Introduction to Guideline
   1. Background
   2. Perceived Need

 

 

 

 

Suggested Writing Group

Writing Group Chair:

 

ASE MD members:

 

ASE Sonographer members (at least one required):

 

Other Society members (if applicable):

 

Alternates:

 

Once the initial writing group has been established, additional authors may be required depending on the appropriate division of writing tasks.

 

Proposed Timeline

 

Month	Activity	Goal(s)
	Planning	Define topic and group membership
	Planning
	Conference call	Discuss purpose, timeline, and scope
	Literature review	Identify existing guidelines and pertinent literature

 

Proposed Publication

• JASE
• Other: _______

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Procedures for co-published guidelines (JASE)

• Societies to agree, before the article is sent to the publisher for production, which party will own copyright. The copyright holder will serve as the lead journal.  ASE to inform Elsevier contacts of this decision and provide contact info for the other journal.
• The lead journal will publish the article first. The other journal may publish in the same month but not earlier than the lead journal.
• The lead journal will grant rights to the other journal substantially as follows. If JASE is the lead journal, the agreement will be handled by the publisher.  If JASE is not the lead journal, the agreement should be sent to the publisher and journal manager at Elsevier.  The agreement should be issued as soon as possible after acceptance of the manuscript by the lead journal.
• Non-exclusive worldwide license for the full term of copyright to publish the article in all media including electronic and microfilm, the right to use the material in conjunction with computer-based electronic information retrieval systems, and the right to print and sell reprints of the article
• The right to use a figure from the article on the cover of the issue in which the article appears
• The lead journal will handle copyediting, typesetting, and proofreading. Proofs will be sent to the corresponding author.  In case of additional proofreading requirements they should be stated when the manuscript is put into production.
• Once the article is in final form and ready for publication, the lead journal will provide to the other journal a PDF of the final article, original image files, and a final XML file for use in typesetting. The other journal may typeset to match journal design, but no changes may be made to the text, except addition of a title page footnote that provides appropriate copyright notice acknowledging the lead journal.
• When the article is put into production, the lead journal will notify the other journal of the estimated online and print publication dates. The lead journal will keep the other journal informed if these dates change.

Elsevier contacts:

Jane Grochowski, Publisher, JASE, j.grochowski@elsevier.com

Lily Palladino, Journal Manager, JASE, l.palladino@elsevier.com