Introduction
(Use the links below to navigate through the information.)

Purpose of Manual
(Use links below to navigate through the information.)
Document Commissioning and Development
Peer Review
SACC Review and Approval
Publication and Revision

Introduction
The American Heart Association (AHA) is pleased to make public our processes and policies for developing AHA scientific documents. We've developed scientific documents for more than 50 years and published them in one or more of the AHA journals.  Such documents include scientific statements, guidelines, science advisories, statistical advisories/alerts, policy recommendations, conference proceedings, performance measures, and clinical data standards. 

Guidelines
The Institute of Medicine defines a guideline as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”[1] The AHA often develops practice guidelines in conjunction with the American College of Cardiology (ACC), but also may develop them alone or in partnership with other organizations as appropriate.  All guidelines adhere to the levels of evidence and classes of recommendation as established by the ACC/AHA Guidelines Task Force. [2] , [3] AHA also publishes emergency cardiovascular care guidelines developed through the AHA Committee on Emergency Cardiovascular Care (ECC).[4]The ECC guidelines adhere to levels of evidence and classes of recommendation derived from the ACC/AHA levels mentioned previously. All guidelines undergo peer review and are reviewed and approved by the AHA SACC.

Readers are referred to the Methodology Manual for ACC/AHA Guideline Writing Committees [5] for more information specific to ACC/AHA practice guideline development.

Science Advisory
The purpose of an AHA Science Advisory is to provide rapid, clear and consistent AHA positioning on scientific issues. Advisories are statements on an evolving, prominent scientific issue of great interest to the public and to health professionals. All AHA Science Advisories undergo peer review and are reviewed and approved by the AHA SACC.

Statistical Advisories/Alerts
The purpose of an AHA Statistical Advisory/Alert is to provide a rapid and clear picture about urgent statistical issues related to cardiovascular disease and stroke. Statistical advisories/alerts are AHA positioning statements of great interest to the public and to heath professionals. All AHA Statistical Advisories/Alerts undergo review by the Statistical Committee of the Council on Epidemiology and Prevention and are reviewed again and approved by the AHA SACC.

Policy Recommendations (or Policy Statements)
The AHA convenes expert panel working groups to study timely issues such as quality health care, stroke center identification, disease management, and other topics as appropriate. These panels examine the complex issues around their topics, issue recommendations, and considerations for clinical and public policy. These reports are reviewed by the AHA SACC before publication.

Conference Proceedings
AHA conferences disseminate new and emerging scientific knowledge and stimulate discussion of implications for future research and the application of knowledge. AHA often sponsors conferences with other societies or organizations, such as the National Heart, Lung, and Blood Institute; the Centers for Disease Control and Prevention; the ACC; and the American Diabetes Association, among others. Experts assembled at such conferences work together to address a common topic, such as scientific issues related to the definition of the metabolic syndrome,[6] and publish their results in conference proceedings.  Conference proceedings reflect the opinion of the conference participants and not necessarily of the AHA. However, conference proceedings are reviewed by the AHA SACC before publication to be certain that they are not contradictory to the AHA mission and to evaluate agreement or disagreement with AHA statements or guidelines in development.

Clinical Data Standards
The AHA works with the ACC to develop clinical data standards under the guidance of the ACC/AHA Task Force on Clinical Data Standards. Clinical data standards are sets of standardized elements and corresponding definitions that can be used in a variety of data collection efforts. The hope is that these standards will improve the ability to compare clinical outcomes between various trials and registries and to facilitate data management in future trials and registries.  These standardized definitions also may improve quality-of-care assessment and clinical performance measures.

Performance Measures
The AHA and the ACC, under the leadership of the ACC/AHA Task Force on Performance Measures, have launched an initiative to develop performance measures for healthcare providers for certain cardiovascular diseases and procedures. This effort is intended to promote the implementation of clinical evidence guidelines.  Performance measures are derived from practice guidelines and are intended to provide practitioners with tools for measuring the quality of care they provide, by defining specific, measurable elements of care. By assessing performance on these elements, although such elements are not all inclusive, practitioners can identify opportunities for improvement.

The present manual is intended for anyone, including writing groups, healthcare specialists, scientists, etc., who is interested in the methodologies and processes AHA uses to create scientific documents.  This manual is organized into a series of steps:

A visual representation is also available.

AHA also encourages readers to read the ACC/AHA Manual for Guideline Writing Committees.

Document Commissioning and Development
All AHA scientific documents begin with an idea. That idea can originate with AHA volunteers, scientific staff, expert panels, scientific leaders, healthcare providers or others. The “champion” of the idea works with an AHA staff scientist to develop the idea into a proposal.

The AHA Manuscript Oversight Committee, a committee of AHA volunteers, commissions all AHA scientific documents. Proposed scientific papers are evaluated by the AHA Manuscript Oversight Committee and commissioned if approved. A manuscript commission form is required for all proposals. Proposals must be thorough and must include:

• The mapping of the proposed statement to the overall AHA strategic plan for  reducing coronary heart disease, stroke and risk by 25 percent by 2010
• Potential collaborators (including AHA councils and interdisciplinary working groups [IWGs] and outside societies)
• An environmental scan, including a brief literature review
• A subject summary and need for the paper
• A lay summary
• The audience for the paper
• Potential authors, including the proposed lead author
• A preliminary timeline for completion of the document

Other elements are part of a complete proposal, and the AHA staff assists potential authors in completing these details on the manuscript commission form.

Prior to MOC review, the commissioning form is circulated to all Council and Interdisciplinary Working Group (IWG) Chairs to see if their Council/IWG is interested in cosponsoring the paper.

If a council/IWG chooses to cosponsor the manuscript, they are asked if they wish to participate at:

a)        a leadership level (major cosponsor, co-chair writing group, have more than one member on writing group), or

b)        a participant level (can name a person to the writing group).

MOC will review the proposed chair(s) and proposed potential members for the writing group at their monthly meeting.  This will include individuals suggested by the initiating council and individuals added by councils/IWGs wishing to co-sponsor or participate in the writing group.  The writing group chair(s)’s COI will be reviewed and a decision will be made to accept the proposed chair(s) or to recommend a different chair.  MOC will give preliminary approval to writing group members. MOC will also approve or disapprove outside organizations which are proposed to be cosponsors or endorsers.

As part of this process, the MOC will ensure when a manuscript that is multidisciplinary is commissioned, there will be the proper mix of disciplines on the writing group.  Further, when a paper is technique or technology oriented, there should be some authors on the writing group who are not involved in the technique or technology.  This will help ensure that the paper is balanced in its recommendations and conclusions. 

COIs for the preliminarily-approved writing group members will be collected and reviewed at the following MOC meeting (the next month)

MOC will give final approval to the writing group.

The AHA has several policies that have been approved by the SACC to assist writing groups developing new documents. These policies include the following:

• Pharmacology policy 

• Also refer to the Methodology Manual for ACC/AHA Guideline Writing Committees for additional information on consensus development in a writing group

As mentioned in the Introduction to this manual, any AHA scientific document that is a guideline must adhere to the classes of recommendations and levels of evidence established by the ACC/AHA Guidelines Task Force (see the Methodology Manual for ACC/AHA Guideline Writing Committees).

Additionally, the writing group agrees to literature-searching criteria and search parameters, and that methodology is described in the final document. The staff scientist works with the writing group throughout the development process. Once the writing committee signs off on a final draft of the document and the science committee, council, or IWG from which the proposal was originated reviews and approves it, the document is ready for peer review.

Writing Group Timelines

The Manuscript Oversight Committee has a process for keeping manuscripts on their timelines.  For papers adhering to the 16 month timeline:

• A completed first draft should be done by 6-8 months after the paper is commissioned. Staff will be in touch with the group to be sure they are on track.  If there is no first draft within another month -- and if there is no valid reason -- then the MOC chair will contact the chair of the writing group to discuss their progress.
• A final draft should be ready to circulate to the writing group by 12 months after the paper is commissioned. Staff will be in touch with the group to be sure they are on track. If the writing group chair does not have a final draft to circulate within another month -- and if there is no valid reason -- the MOC chair will contact the chair of the writing group to discuss their progress. The chair will be told that the paper is subject to being decommissioned if the paper is not completed and submitted for peer review within the next 3 months. This would be a total of 16 months from the time of commissioning.
• If the paper is one that needs to be completed on an accelerated pace, then these timelines could be adjusted.  Occasionally, a writing group will know from the outset that they will need additional time to write a paper (i.e. practice guidelines). This will be taken into consideration.

Peer Review
All AHA scientific statements, guidelines, and scientific/statistical advisories go through peer review.  SACC members also are invited to serve as peer reviewers. AHA depends on peer reviewers for expert, critical and unbiased scientific review delivered in a timely manner. 

On completion of peer review, the writing group receives all peer review comments. The writing group is expected to respond to all official peer reviewer comments and revise the manuscript as needed. Peer reviewers also receive the revised manuscript and author responses as needed.

The AHA also has approved a policy to collect and publish reviewer disclosure and conflict-of-interest statements. ACC/AHA guidelines currently publish reviewer disclosures and conflict of interest statements. Performance measures, clinical data standards, and clinical competency statements also go through peer review.

Conference proceedings, which are produced by invited experts, do not undergo separate peer review.  Policy recommendations also are produced by invited experts and often focus on advocacy issues. These issues are not solely scientific; therefore, policy recommendations do not undergo peer review but are approved as policy.

SACC Review and Approval
All AHA scientific statements, guidelines, advisories, recommendations, conference proceedings and other documents are sent to the AHA’s highest science body, the SACC, for final approval. Documents must be approved by this committee before being published. In the event that statements or guidelines are made in conjunction with other organizations, those organizations must also approve (through their own procedures) the joint document. 

If SACC does not approve of a document or if SACC has specific recommendations and suggestions, those concerns are brought to the writing group. The writing group is expected to address the comments and modify the document as warranted. SACC approval also is required if another organization would like AHA to endorse a scientific document that AHA did not develop.

Publication and Revision
All AHA scientific documents are published in one or more of the AHA journals, including Atherosclerosis, Thrombosis, and Vascular Biology; Circulation; Circulation Research; Hypertension; and Stroke. Organizations that are joint partners on a document with AHA also are encouraged to publish the document in the appropriate journal.

All authors must sign a copyright transfer agreement before publication. SACC has recently approved the policy of publishing all author disclosure statements as well.   All AHA statements, guidelines, advisories, policy recommendations, conference proceedings and other documents are always open access, which means that anyone can access the documents online.

AHA scientific staff works with the writing group to establish a time frame for revision of each document. Typically, scientific documents are reconsidered for revision  6 months to 1 year after publication or within whatever time frame is recommended by scientific staff and authors. Upon revision, statements can be deemed either still relevant or out of date. Out-of-date documents may be either reviewed or retired.

Conclusion
The American Heart Association continues to refine and update not only our scientific documents but our processes and policies for creating such documents.  We hope that healthcare providers, policy makers and others continue to rely on our association for the most up-to-date information.