If you didn’t make it to the E-GAAPS conference, you missed a great opportunity for networking, sharing ideas, and improving your knowledge of guideline development, the importance of shared decision making, and many more topics. Below are a few highlights from this conference from our guideline committee chair, methodologist, and staff.

From our Guideline Committee Chair: I was in awe!

“This was the first guideline conference I attended and I was in awe of the talent and progression of societies in guideline development. I particularly was intrigued by the medical informatics and technology talks and will be discussing how to make our guidelines more compatible with clinical decision support. The energy and thoughtfulness of guideline developers within private health care systems was an inspiration along these lines. I see this as a logical approach to track adherence to our guideline recommendations.” 

From our Methodologist: Continual improvements to the GRADE tools and methodology.

“We’ve updated our process manual to be consistent with the IOM standards for guidelines and systematic reviews and modified the GRADE methodology for our evidence synthesis process. I was pleased to see that working groups are developing easy-to-use tools to make the process of GRADE more transparent. We also got some great ideas regarding performing pragmatic systematic reviews.”

From our Staff: Networking!

It’s great to see so many familiar faces at this conference and to make new acquaintances. I enjoyed conversations about AAN’s grant work in process, projects that are just about to publish, changes to development and dissemination methodologies, and new technologies on the horizon to aid in guideline development.” 

Finally, congratulations to the conference organizers and the planning committee. This first conference was a success and something I hope that will continue in future years. And thanks very much to New York Academy of Medicine for making their facility available; it was a spectacular venue. 

If you attended the conference, please share your key takeaways with our readers. And plan now to attend the 10^th Annual Guidelines International Conference in San Francisco in August. Bring your staff, your committee members, and your methodologists. We look forward to seeing you in there, if not sooner. 

We invite you to share your thoughts on a Medscape article¹ that asserts that a majority of guidelines fails to meet the Institute of Medicine (IOM) standards for development of systematic reviews (SRs)² and clinical practice guidelines (CPGs).³ Did any of you think your respective organizations would be further along in this transition than you are?

Here are some examples of the AAN’s progress to date on meeting the standards.

1. We updated our process manual in November 2011 to be consistent with the standards both for SRs and CPGs.

2. We established a grandfather period for all projects in process, allowing project teams 18 months to produce a guideline draft for review by the AAN Guideline Development Subcommittee (GDS). Now that the period has ended, the GDS will review the drafts from those project teams that produced a draft by the deadline, and will focus on developing IOM-compliant SRs and CPGs.

3. We drastically reduced the number of projects we have in process. At one time we had 70 guidelines in process; now we will be focused on developing four SRs and four CPGs, each of which will be IOM compliant.

What have you and your organizations done to attempt to meet the standards within your processes? Please share your thoughts within the comments.

¹Barclay L., Clinical Practice Guidelines Fail to Meet IOM Standards. Medscape. www.medscape.com/viewarticle/773099?src=nldne. Published October 22, 2012. Accessed October 22, 2012.

²Institute of Medicine of the National Academies. Finding What Works in Health Care: Standards for Systematic Reviews. www.iom.edu/Reports/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx. Released March 23, 2011. Accessed March 23, 2011.

³Institute of Medicine of the National Academies. Clinical Practice Guidelines We Can Trust: Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs). www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx. Released March 23, 2011. Accessed March 23, 2011.

It has been a year and a half since the Institute of Medicine (IOM) published its standards for development of systematic reviews (SRs)¹ and clinical practice guidelines (CPGs).² In that time, the American Academy of Neurology (AAN) has updated its process for developing SRs and CPGs in accordance with the IOM standards. To test this new process, we chose two guideline projects as pilot efforts: immunizations in multiple sclerosis (MS) and disorders of consciousness.

To enable public comment, we worked with our marketing team to put together a strategy to reach AAN members and the public. Here are some ideas we implemented:

·         Email to all AAN members

·         Email to the Neurology Now® group for patients with MS

·         Pitch to public relations teams of major patient advocacy organizations

·         Posting of information on the Facebook page of Neurology Now, the AAN’s publication for patients

·         Posting of information on the largest Facebook groups for patients with MS

·         Posting of links on the AAN Twitter channel (@AANPublic)

·         Posting of links on the Neurology Now Twitter channel (@NeurologyNow)

·         Posting on AAN Google+ pages

The AAN’s first public comment was for the immunization in MS protocol, the project plan draft for the guideline development effort. We posted the protocol on the AAN website in August for 30 days. We had 63 individuals review the protocol and provide comment. Of those reviewers, 10 were AAN members, and 53 were nonmembers. A total of 79 comments were made.

The disorders of consciousness protocol underwent public comment from September to October. We had 18 individuals review the protocol and comment. Of those reviewers, 8 were AAN members, and 10 were nonmembers. A total of 41 comments were made.

After completing two public comment periods, we have found that this process is more complicated than we originally envisioned. It is difficult to coordinate communications with all of the parties we would like to invite for document review. In spite of this challenge, we have found that most of the reviewers have provided valuable comments.

We are excited to be able to incorporate feedback from these stakeholders in our development process. We still have some kinks to work out, but we believe this process will make for a much better product.

¹Institute of Medicine of the National Academies. Finding What Works in Health Care: Standards for Systematic Reviews. www.iom.edu/Reports/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx. Released March 23, 2011. Accessed March 23, 2011.

²Institute of Medicine of the National Academies. Clinical Practice Guidelines We Can Trust: Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs). www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx. Released March 23, 2011. Accessed March 23, 2011.

G-I-N (Guidelines International Network) North America invites asks you to mark your calendar for Tuesday, June 26, 2012, for the next presentation in the G-I-N North America webinar series.  Thomas Getchius and Gary Gronseth, MD, FAAN, from the American Academy of Neurology, and Wiley Chan, MD, from Kaiser Permanente will be demonstrating examples of how technology can be used to facilitate the development of systematic reviews and clinical practice guidelines following 2011 Institute of Medicine (IOM) standards.

Please see below for more detailed information regarding this webinar. We hope you will attend!

Presenters:
Thomas Getchius, BA
Associate Director, Clinical Practice
American Academy of Neurology
Minneapolis, MN

Gary Gronseth, MD, FAAN
Professor of Neurology, University of Kansas
Kansas City, KS
Evidence-based Medicine Methodologist,
American Academy of Neurology
Minneapolis, MN

Wiley Chan, MD
Director, Guidelines & Evidence-based Medicine
Physician, Internal Medicine
NW Permanente
Portland, OR

Moderator:
Marguerite Koster, MA, MFT
Steering Group Chair, G-I-N North America
Practice Leader, Southern California Permanente Medical Group
Technology Assessment and Guidelines Unit

Learning Objectives
At the end of the call, attendees will:
1. Receive information about the American Academy of Neurology and Kaiser Permanente processes for developing systematic reviews (SRs) and clinical practice guidelines (CPGs)
2. Understand how the American Academy of Neurology and Kaiser Permanente uses various types of technology to strive to develop IOM compliant SRs and CPGs

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Date: Tuesday, June 26, 2012
Time: 1:00 p.m., Pacific Daylight Time (San Francisco, GMT-07:00)
Meeting Number: 579 448 234
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Our friends at the Guidelines International Network (G-I-N) ask that you make sure you mark your calendar for the North American Webinar Series event on March 29. The topic this month features speakers from the Agency for Healthcare, Research, and Quality (AHRQ) and the National Guidelines Clearinghouse (NGC). These two speakers will address their organizations’ approaches to addressing the Institute of Medicine (IOM) Standards and their implications for the North American Guideline Development Community. They will discuss their phased approach to the IOM Standards for Trustworthy Guidelines. They also are interested in feedback from members of the North American guideline community on how best to meet their needs as end users of the NGC. Please see the rest of the webinar information below. We hope you will attend!

Date: Thursday, March 29, 2012
Time: 1:00 p.m. - 2:30 p.m. (Pacific); 2:00 p.m.-3:30 p.m. (Mountain); 3:00 p.m.-4:30 p.m. (Central); 4:00 p.m.-5:30 p.m. (Eastern)

Access: Information below

Presenters:
Vivian H. Coates, MBA
Project Director, National Guideline Clearinghouse/National Quality Measures Clearinghouse
Vice President, ECRI Institute
Plymouth Meeting, PA

Jean Slutsky
Director, Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
Rockville, MD

Moderator:
Richard M. Rosenfeld, MD, MPH
Steering Group Chair, G-I-N North America
Professor and Chairman of Otolaryngology, SUNY Downstate Medical Center, Brooklyn, NY

Learning Objectives
At the end of the call, the attendees will gain:

1. Understanding of the IOM's sugestions for AHRQ and NGC regarding Standards for Trustworthy Guidelines
2. Familiarity with NGC's current process for gathering guideline documentation that might meet the IOM standards
3. Insight into the challenges associated with documenting adherence to the IOM standards
4. Knowledge of the phased approach AHRQ and NGC are taking to address the IOM standards
5. Understanding of specific challenges guideline developers anticipate in adopting the IOM standards

The AAN's systematic review (SR) and guideline conflict of interest process is fairly straightforward. Once the Guideline Development Subcommittee (GDS) approves the topic, we assign a lead GDS facilitator, additional members from the GDS, and then search for individuals who can aid in the development of the SR.

All panel members must complete our conflict of interest (COI) form before any work is done on the panel. A sample COI form is found at this link and requests full disclosure in the following areas: financial disclosure (gifts, royalties, stipends, patents, honoraria), clinical procedures performed, research support (commercial, government, and academic), stock, stock options, and royalties, and legal proceedings. The forms are completed and submitted, reviewed by the lead facilitator, the AAN EBM consultant, and AAN staff. Upon approval of this group, the GDS leadership reviews the forms and ratifies the decision made by the aforementioned team or requests changes to the proposed author panel. 

As others in guideline development know, intellectual conflicts may be more difficult to identify. Below is an excerpt of a definition of intellectual conflicts from the IOM:¹

A person whose work or professional group fundamentally is jeopardized, or enhanced, by a guideline recommendation is said to have intellectual COI. Intellectual COI includes authoring a publication or acting as an investigator on a peer reviewed grant directly related to recommendations under consideration. 

The process that the AAN uses to best determine whether individuals have intellectual conflicts is to obtain their CV and review all of their professional work. Here we can see what grants they've received beyond the two year financial conflict of interest period, academic appointments they've held, book chapters authored, and publications in journals. 

Are there different questions that you ask on your disclosure forms, or non-disclosure agreements? Do you have a more thorough process for identifying intellectual conflicts?

¹ IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. Accessed March 23, 2011. pg 59.

As recommended by the Institute of Medicine (IOM),^1,2 systematic review and clinical practice guideline (CPG) documents in draft form should be made available for a public comment period. However, the IOM standards did not specify what constitutes a public posting and how long the comment period should be:

Systematic Review¹

2.7.1 Provide a public comment period for the protocol and publicly report on disposition of comments.

5.2.2 Provide a public comment period for the report and publicly report on disposition of comments.

                Clinical Practice Guidelines²

7.4 A draft of the CPG at the external review stage or immediately following it (i.e., prior to the final draft) should be made available to the general public for comment. Reasonable notice of impending publication should be provided to interested public stakeholders.

Prior to bringing the issues to the physicians on our Guideline Development Subcommittee (GDS), I informed internal staff of the standards and my intention for the GDS to incorporate both sets of standards fully into our process. A concern was raised that pertained to the public comment period:

Physicians and patients may inappropriately follow draft recommendations and attempt to hold a medical society accountable for those recommendations even if the recommendations undergo substantive changes by the time they are published in final form.

When the AAN methodologist and I presented the standards to the GDS, they shared this same concern. We received varied opinions from the GDS on whether the AAN should adopt all the standards and include them in our development process or whether to leave out the incorporation of the public comment period. In the end, the GDS unanimously voted to approve incorporation of all the standards for development of systematic reviews and guidelines into our process. The AAN Practice Committee and Board of Directors also unanimously approved, and, in November 2011, we published a major revision to our process manual.³ The approval was subject to staff’s and physician leadership’s appropriately defining “public comment” and developing a process document on how to facilitate (and regulate) the public comment period.

Has your organization decided to incorporate into its development process the public comment recommendation from the IOM? If not, why? If so, how are you defining “public comment”? Have you developed a process for facilitating (and/or regulating) the public comment period? Has your organization addressed the concern noted above?

¹Institute of Medicine of the National Academies. Finding What Works in Health Care: Standards for Systematic Reviews. www.iom.edu/Reports/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx. Released March 23, 2011. Accessed March 23, 2011.

²Institute of Medicine of the National Academies. Clinical Practice Guidelines We Can Trust: Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs). www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx. Released March 23, 2011. Accessed March 23, 2011.

³American Academy of Neurology. 2011. Clinical Practice Guideline Process Manual, 2011 Ed. St. Paul, MN: The American Academy of Neurology.

I had the opportunity to talk with Sandy this week about the American College of Chest Physicians’s (ACCP) first-ever guideline methodology workshop, titled “Aim to Reach the Institute of Medicine Standards for Trustworthy Guidelines.”

TG: It’s a pleasure to be speaking with you about this today, Sandy.

SZL: Thank you, Tom. It is my pleasure to participate with you on the new AAN Guidelines Blog. Thank you for inviting me!

TG: What prompted ACCP to host this course?

SZL: We offered a similar course, although only for one day, just before the Guidelines International Network (G-I-N) conference in Chicago in 2010. We were thrilled that 98 people attended. Many conference attendees who did not attend our course heard about it from others who did. Several asked me if we were planning to repeat the course. After the IOM [Institute of Medicine] reports were published last year, there was considerable discussion, especially at the IOM-sponsored Next Steps Workshop, about the need for educational programs to improve the quality of guideline methodology. Because of the great interest, we are offering the course again in a two-day format.

TG: I noticed there’s a good mix of faculty for this two-day course. Are these individuals past ACCP guideline authors, or are they professionals who bring additional expertise?

SZL: The course will be taught by both ACCP professional staff and individuals who have participated in writing ACCP guidelines in the past. Two of our own methodologists will be teaching how to develop comprehensive and systematic reviews, meta-analyses, and evidence tables and profiles.

We also have leadership from our Health and Science Policy Committee (our guidelines oversight committee) who have up to 8 years of experience in this field. They will be teaching the sections on conflicts of interest, panel composition, guideline reviews and appraisals, maintaining currency, dissemination, implementation, and quality improvement.

One of our faculty members is a physician methodologist with experience on our two largest guidelines (antithrombotic therapies and lung cancer), as well as having served as a resource consultant on the cost-effectiveness considerations. He will teach incorporating patient values and preferences, as well as resource considerations.

Finally, I am chairing the course and guiding the curriculum, based on over 12 years of experience in this field. I will cover the IOM standards; the PICO [population, intervention of interest, comparator, outcome] process for standardizing the research and guideline method; and the manuscript and recommendations writing, grading, and voting; as well as some challenges like dissenting voices.

TG: How do the IOM standards change the way that ACCP will develop guidelines?

SZL: This is an excellent time for all guideline developers to reassess their strengths and areas in which they can improve. Although we, like AAN, pride ourselves on our rigorous guideline development processes, there is always room for enhancements. The National Guideline Clearinghouse review in September revealed that there are no guidelines that meet all of the IOM standards.

The main areas in which the ACCP is planning for improvement is increasing inclusivity on our panels by adding [evidence-based medicine]-trained consumer representatives (note that I did not say patient advocates) and incorporating external feedback earlier in the process.

TG: What are ACCP’s measures of success for this course?

SZL: Like the previous course, we are planning a two-pronged approach for evaluation. We identified learning objectives and included them in all of the promotional materials and communications about this course. This will help potential registrants make judgments about the value of the course relative to their needs. We are providing up to 16 hours of CME [continuing medical education credit] so we have a standard online evaluation that they take to get their CME credits. In addition, we also are engaging in a Commit To Change evaluation, which prompts our attendees to revisit 6 months later what they have learned in the course and what they identified as realistic and measurable changes that they could implement in their own guideline work.

TG: What advice does ACCP have for societies embarking on guideline development?

SZL: This is not an easy environment for novice guideline developers. The IOM standards set the bar quite high, and I believe there will be some form of accounting for whether these standards are met, or not, in the near future. The details, of course, are yet to be made clear, and certainly that lack of specificity is problematic.

However, courses like this one are aimed to provide a standardized methodology with quite a bit of hands-on learning. We will also provide the framework and some tools and resources that will give developers a good start. In addition, organizations like the G-I-N and the Agency for Healthcare Research and Quality (AHRQ) are very valuable for professional education and skills development. In this part of the world, we are fortunate to be able to participate in the G-I-N North America Interest Group, which will be hosting a joint conference with the New York Academy of Medicine in December. This will be an excellent opportunity for guideline developers of all levels of experience to learn and share from each other. I have found that guideline developers love networking, and that is a great way for both novice and more-experienced developers to continue to learn and improve.

In fact, Tom, networking with other guideline developers is how you and I met. It has been a pleasure for me to learn more about how the AAN guideline process works. And thank you, again, for this opportunity to contribute to the AAN Guidelines Blog.

I hope you’ll attend ACCP’s methodology summit on March 15–16, 2012, in Chicago, IL. Check out http://www.chestnet.org/accp/events/accp-guidelines-methodology-course
for registration- and meeting-related information.