The AAN has published evidence-based recommendations for the treatment of infantile spasms that update a 2004 guideline. “Evidence-based Guideline Update: Medical Treatment of Infantile Spasms,” which was codeveloped with the Child Neurology Society, appears in the June 12, 2012, issue of Neurology®.

The guideline suggests that the therapy adrenocorticotropic hormone, also known as ACTH, and the antiepileptic drug vigabatrin (VGB) may be effective in the treatment of infantile spasms in children. A low-dose ACTH protocol can be as effective as higher doses and may lower the risk of adverse effects. ACTH may be more effective than VGB as short-term therapy. However, VGB has been shown to be possibly effective in patients with tuberous sclerosis complex. There is not enough evidence to know whether other therapies, alone or combined, are effective for short-term treatment.

The required evaluation includes an EEG for confirmation of the diagnosis.

“The studies point to early diagnosis and thus early intervention as possibly leading to better outcomes long-term,” said guideline lead author Cristina Go, MD, “and that, more specifically, early treatment with ACTH, prednisolone, or VGB may improve long-term cognitive outcomes. As for long-term developmental outcomes, however, hormonal therapy, either with ACTH or prednisolone, possibly outperforms VGB treatment.”

Read the guideline and access PDF summaries for clinicians and patients, a slide presentation, and a clinical example. For more information, contact Julie Cox at jcox@aan.com or (612) 928-6069.

Few People with Migraine Who Are Candidates for Preventive Treatments Use Them

The AAN has published two guidelines that show many pharmaceutical, anti-inflammatory (NSAIDs), and complementary treatments can help prevent migraine attacks in certain people. However, only a minority of people with migraine who are candidates for these preventive treatments actually use them. The guidelines, which were codeveloped by the American Headache Society, are published in the April 24, 2012, issue of Neurology®.

“The strongest evidence we found was for the pharmaceutical treatments divalproex sodium, sodium valproate, topiramate, metoprolol, propranolol, and timolol, and for frovatriptan for short-term menstrually associated migraine, as well as for the herbal preparation Petasites (butterbur),” said guideline author Stephen D. Silberstein, MD, FACP, FAHS, FAAN. “However, there were several other pharmaceutical and complementary treatments with evidence for use, and still others with evidence against use or with insufficient evidence to make a determination regarding efficacy.”

The frequency and severity of migraine attacks can be reduced with preventive treatments. Some studies show that migraine attacks can be reduced by more than half. However, epidemiologic studies suggest that migraine is a condition that is underrecognized and undertreated. “About 38 percent of people who suffer from migraine could benefit from preventive treatments, but only about less than half of these people currently use them,” said Silberstein.

Patients using pharmaceutical treatments or those using easily accessible complementary or over-the counter treatments may be unaware of the need for regular follow-up with their doctor, as migraines can worsen or improve, which may require adjusting dosages or changing to another drug.

Read the migraine guidelines and access PDF summaries for clinicians and patients, a slide presentation, and a clinical example. For more information, contact Julie Cox at jcox@aan.com or (612) 928-6069.

We are excited to inform our readers of the American Academy of Neurology’s (AAN) first-ever methodology conference, to be held on Monday, June 11, 2012. This one-day event will feature guest speakers and methodologists from the AAN Guideline Development Subcommittee, sharing their experiences, insights, tools, templates, and more. Because a number of readers have expressed a personal interest in learning more about the AAN guideline development processes, we hope that you will consider registering for this event and having the opportunity to visit the AAN’s world headquarters in Minneapolis.

Register now for this event.

We are charging a nominal $125 nonrefundable registration fee to cover the costs of administration and amenities, which include meals and refreshments to be offered throughout the day. To see the full conference program, please review the attached agenda.

We encourage our readers to consider registering for this conference and passing this information along to colleagues. We look forward to an engaging event.

A new AAN guideline provides recommendations for the use of IV immunoglobulin (IVIg) in the treatment of various neuromuscular disorders. “Evidence-based Guideline: IV Immunoglobulin in the Treatment of Neuromuscular Disorders” is published in the March 27, 2012, issue of Neurology®.

Strong evidence shows IVIg effectively treats certain neuromuscular disorders. IVIg works as well as plasma exchange to treat Guillain-Barré syndrome (GBS) in adults, and is effective in the long-term treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

IVIg also is effective in treating other neuromuscular diseases, including other forms of neuropathy.

There is moderate evidence for use of this therapy in treating moderate to severe forms of myasthenia gravis and multifocal motor neuropathy.

IVIg may help treat nonresponsive dermatomyositis and Lambert-Eaton myasthenic syndrome. There is insufficient evidence to show whether IVIg is effective in the treatment of other neuromuscular disorders such as IgM paraprotein-associated neuropathy, inclusion body myositis, polymyositis, diabetic radiculoplexoneuropathy, or Miller Fisher syndrome, or in the routine treatment of postpolio syndrome.

There is insufficient evidence to show whether IVIg is superior or inferior to plasma exchange for treatment of CIDP.

High-quality studies are not available on IVIg use in children with GBS. However, because IVIg is effective in adults with GBS, it is reasonable to assume it is also effective in children with GBS. Many people seem to tolerate IVIg therapy; however, hypercoagulability and renal failure, although rare, are of concern.

Read the guideline and access PDF summaries for clinicians and patients, a slide presentation, and a clinical example. For more information, contact Julie Cox at jcox@aan.com or (651) 332-8684.

Quality measures (also known as performance measures) take guideline recommendations to the next level with implementation in clinical practice.

What is a quality/performance measure?

• A quality/performance measure:
  • Is evidence-based
  • Serves as a means of implementing guidelines in practice
  • Is actionable, feasible and addresses a gap in care with the goal of improving patient outcomes
• Each measure statement includes the following:
  • Numerator statement
    • What does the clinician need to do to complete this measure successfully? (e.g., document in the medical record that he/she discussed falls with the patient)
  • Denominator statement
    • Who is in the eligible patient population? Consider diagnossi, time frame for measurement (yearly, every visit, other time period), age, and gender limitations
• Exclusions (reason[s} to not include a specific patient int he denominator)
  • Medical reasons (e.g., patient has a medication contraindication)
  • Patient reasons 9e.g., patient declines)
  • System reasons (e.g., patient has no insurance)

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.

Today’s post focuses more on the administrative aspects of the AAN physician volunteer guideline review process than on the content of those reviews. The criteria the AAN Guideline Development Subcommittee (GDS) follows for guideline review will be discussed in a future post.

When I started working in guidelines for the AAN in 2005, I learned the system for developing our agenda books for quarterly GDS review meetings. The manuscripts were organized one to a binder tab (the committee often reviews six or more papers during a meeting), and the documents for each manuscript needed to be presented in the order below.

1. Cover sheet presenting the project title, printed on green paper
2. Memo to the committee providing information about the manuscript status and the expectations for the committee during this review
3. Status report providing an author list; indication of whether all conflicts of itnerest were reported; listing of societies with whom the AAN would be collaborating; a timeline of previous project milestones; and a detailed, bulleted list of all comments and requested changes from the previous review, printed on yellow paper
4. The manuscript itself, with each page numbered, text double-spaced, and the header "Confidential: Not for dissemination, duplication, or citation" included
5. The evidence tablers and any additional supporting documents

John Hutchins, JD, is the associate general counsel of the AAN and general counsel of the AAN Foundation. Hutchins and colleagues published an article in Neurology® on March 6 detailing the AAN’s policies on pharmaceutical and device industry support¹. The article examines prevention and limitation of conflicts of interest related to relationships with industry, not only for continuing medical education offerings, Annual Meeting support, and serving as a volunteer on a committee within the AAN, but the AAN policies as they relate to guideline development. In addition to this comprehensive article, access the Neurology® podcast. Dr. Ted Burns, podcast editor, interviews Hutchins in more detail about the AAN’s policies as they relate to guideline development. The interview starts at 1:19 and ends at 9:50.

How does your organization manage conflicts of interest among your members and, specifically, your guideline authors? Our Monday, March 12, post will go into detail regarding the process for identifying panel members, reviewing disclosures, and appointing members to the writing groups.

Subscribe to the weekly Neurology podcast.

1 Neurology March 6, 2012vol. 78 no. 10 750-754.

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.