Minutes of the Interagency Autism Coordinating Committee (IACC) Subcommittee for Planning the Annual Strategic Plan Updating Process on November 19, 2010
The Subcommittee for Planning the Annual Strategic Plan Updating Process held a conference call on Friday, November 19, 2010, from 8:00 a.m. to 11:00 a.m.
Subcommittee Members and OARC Staff Participating in the Teleconference:
Thomas R. Insel, M.D., IACC Chair, National Institute of Mental Health (NIMH); Della Hann, Ph.D., Executive Secretary, Office of Autism Research Coordination (OARC), NIMH; Susan Daniels, Ph.D., Office of Autism Research Coordination (OARC), NIMH; Coleen Boyle, Ph.D., Centers for Disease Control and Prevention (CDC); Geraldine Dawson, Ph.D., Autism Speaks; Lee Grossman, Autism Society; Jennifer Johnson, Ed.D., (representing Ms. Sharon Lewis), Administration for Children and Families; Walter Koroshetz, M.D., National Institute of Neurological Disorders and Stroke (NINDS); Ari Ne'eman, Autistic Self Advocacy Network; Lyn Redwood, R.N., M.S.N., Coalition of SafeMinds; Cathy Rice (representing Dr. Coleen Boyle), Centers for Disease Control and Prevention (CDC); Alison Singer, M.B.A., Autism Science Foundation; Marjorie Solomon, Ph.D., M.B.A., University of California, Davis
Welcome, Introductions, and Approval of the Minutes
The IACC Subcommittee for Planning the Annual Strategic Plan Updating Process met to discuss the proposed updates for the 2011 Strategic Plan. The subcommittee members performed a roll call and then approved the minutes from their meeting on October 6, 2010.
Discussion of Proposed Updates to Question 4 of the Strategic Plan
Dr. Geri Dawson, who had led revisions for Question 4, reviewed the suggested edits and additions proposed by her group. In the section addressing advances in the field during 2010, the group cited studies demonstrating the effectiveness of the medication risperidone in combination with behavioral interventions, the efficacy of early intervention programs based on the Early Start Denver Model, and the benefits of social skills training for people with ASD. They also selected a study that supported the use of modified cognitive behavioral interventions for treating anxiety in people with Asperger's syndrome and an environmental scan conducted by the Centers for Medicare & Medicaid Services that assessed the evidence-base for 31 interventions used to treat ASD.
Dr. Dawson then reviewed existing gaps in the field of treatment and intervention. There is a need to use known genetic risk factors to develop animal models, discover targets for the development of therapeutics, and identify subgroups of people with ASD who respond well to specific medications and other interventions. She also cited the need to address conditions that co-occur with ASD and to identify subtypes of ASD to develop a more personalized treatment approach. There is also a need for research on the use of augmentative and alternative communication devices to facilitate communication for people with ASD who are non-verbal. Focus is needed to identify and address health disparities for people with ASD, she said.
Discussion of New Objectives
Dr. Dawson presented the new proposed objectives for the chapter and noted that her group had tried to consolidate objectives to reduce the total number. The first objective called for the support of at least five community-based studies that inform the dissemination and implementation of practices and interventions to the broader community. The second proposed objective called for five multi-site comparative effectiveness studies to evaluate the effectiveness of treatments for medical and psychiatric comorbidities. The third called for at least three studies investigating the use of biomarkers to stratify people with ASD to predict treatment response. The fourth called for at least five studies of interventions for nonverbal individuals with ASD and the final objective called for two studies focused on the prevention of "secondary disabilities" such as comorbid conditions, poor quality of life, unemployment, homelessness, and involvement in the justice system.
Mr. Ne'eman raised his concern that a proposed objective on addressing the ethical, legal, and social issues (ELSI) related to ASD treatment research had been removed. He was informed that it had been moved to Question 3. Ms. Blackwell noted that some of the objectives in Question 4 overlapped with those proposed in Question 5. She recommended replacing reference to "secondary disability" in the prevention objective with another term such as "behavioral health issues." She stated that homelessness was not a secondary disability but instead a negative situational circumstance. Dr. Insel noted that the first short-term objective in Question 4 already addressed co-occurring medical conditions and recommended removing references to comorbidities in the proposed objective to avoid redundancy. The subcommittee discussed the use of the term "comorbid" which implies that the condition is unrelated to the primary disorder. For example, it is unknown whether a condition like epilepsy is part of ASD itself or should be considered independently. Labeling these conditions as comorbidities may limit the ability to stratify subgroups, Dr. Insel cautioned. Mr. Ne'eman said that he would like to see the objective address access to mental health treatment. Dr. Boyle said that the objective described a health promotion opportunity to improve overall health and quality of life for people with ASD. Members of the subcommittee noted that quality of life issues should be included in Question 5. Dr. Dawson and Dr. Boyle volunteered to develop language for the objective on the prevention of secondary disability.
Dr. Koroshetz asked whether the field had advanced to the point where biomarkers had been identified that could be used to stratify groups to predict response to treatment. Dr. Insel commented that the field was far from that point and explained that the biomarker must first be shown to have sufficient power. The final step is to use the biomarker to stratify subgroups to predict response, which is an expensive undertaking, he said. In the case of breast cancer, a known biomarker has existed for 15 years but large-scale trials are only now being conducted. The subcommittee agreed to remove the proposed biomarker objective and noted that many of the existing objectives still needed to be addressed.
Dr. Insel commented that the proposed objective calling for comparative effectiveness studies was huge in scope (each study would cost about $50 million) and did not seem to answer a clear scientific question. The subcommittee discussed the need to be accountable and identify research that would elicit answers. The subcommittee discussed the first proposed objective on the dissemination and implementation of practices and interventions in the broader community. Dr. Dawson noted that several best practices models had been established but that they had not been scaled up in size and studies had not addressed the issues that would promote or hinder their adoption in the community setting. She noted that the Health Resources and Services Administration (HRSA) would be publishing an evidence-based protocol for treating gastrointestinal disorders in people with ASD. Dr. Boyle stated that dissemination differs substantially from testing effectiveness and Dr. Hann noted that the Plan already contained a long-term objective in Question 5 related to disseminating evidence-based interventions.
Mr. Ne'eman applauded the first proposed new objective in Question 4 for its mention of assessing potential harm from ASD treatments and he recommended adding the language to other objectives in the chapter. Dr. Insel recommended adding language to the introduction to capture concerns about potential harm so that it would carry through the document and not need to be stated repeatedly. Dr. Koroshetz, Dr. Dawson, and Dr. Solomon discussed how avoiding harm was ingrained in research practices and described how the safety and ethics of each clinical study was overseen by an institutional review board and a data safety monitoring board. Dr. Insel suggested that the "What do we need?" section should also address the value of research proving that an intervention is not effective.
Dr. Insel stated that the shift in the chapter's focus on efficacy to comparative effectiveness studies reflected the policy changes brought about by the Affordable Care Act. Ms. Blackwell said that she had included a list of provisions of the Act in Question 6 but wondered if health reform should be talked about in a more overarching sense elsewhere in the Plan. The subcommittee discussed whether calling for comparative effectiveness studies was premature considering that few effectiveness studies for ASD interventions existed. The group noted that there would be funding for such studies and expressed concerns about missing such an opportunity. Dr. Koroshetz commented that comparative effectiveness studies may sometimes include interventions that have never been shown to be effective but are commonly used in the community. Dr. Dawson suggested combining the first two proposed objectives but not requiring that they be comparative effectiveness studies. Dr. Koroshetz recommended developing an objective from the language in the research opportunities section about comparing interventions.
Dr. Hann reviewed the recommendations for revisions to Question 4 -- The first two objectives would be combined and reworded to focus on real-world effectiveness and comparative effectiveness. The proposed objective on biomarkers would be eliminated and Dr. Boyle and Dr. Dawson will develop language for the objective on preventing secondary disability. Dr. Dawson and Ms. Blackwell will collaborate to reduce overlap between Question 4 and 5.
Discussion of Proposed Updates to Question 7 of the Strategic Plan
The subcommittee moved to the proposed revisions to Question 7 and Dr. Dawson presented the sections on advances in data sharing and biobanking. She described the formation of the Autism Informatics Consortium, created to make information tools and resources more useful and usable for ASD researchers. She then described the efforts of Autism Treatment Network which has begun to collect biosamples at four of their 14 sites and the Autism Tissue Program which has established a neurological tissue genetic repository from brains of people with ASD donated to the program. Dr. Boyle included updates from the CDC's Autism and Developmental Disability Monitoring (ADDM) Network which recently established that about 1% of children has ASD. She cited several recent reviews of intervention quality and effectiveness as advances in the area of information dissemination. The group updating Question 7 had not cited any advances in research workforce development and Dr. Boyle asked the subcommittee for input.
Mr. Ne'eman suggested discussing the Affordable Care Act and Ms. Singer recommended citing the number of people hired with stimulus funds and the concerns about the period after this funding ends. Dr. Insel said that NIH could supply the exact number of people hired. Mr. Ne'eman recommended included mention of the NIH Director's Award, created to increase diversity in the workforce, and the need to ensure the recruitment of diverse populations including people with ASD and other disabilities.
Ms. Blackwell asked that the passage on information and communication dissemination expand its reference to state plans for ASD to include autism state task forces and blue ribbon panels. She also asked that the reference to plans for ASD and "other DD services" be removed. Dr. Insel suggested including the exact number of DNA samples collected by Simons and NIMH, and Dr. Dawson recommended including the Autism Genome Project as well. The subcommittee discussed emphasizing the magnitude of success in ASD data sharing and Dr. Insel noted that it was held up as an example for other disorders during the 2010 Society for Neuroscience conference. Dr. Dawson recommended citing the number of global unique identifiers (GUIDs) currently included in the National Database for Autism Research. She described several existing gaps in data sharing including the need to improve options for data federation, develop data dictionaries and ontologies, and standardize procedures for collecting imaging data. Gaps in biobanking included the need to establish a network of clinical research sites to collect standardized data and the need for high-throughput screening tools to quickly evaluate gene-environment interactions relevant to ASD. Dr. Boyle cited the need for more real-time autism surveillance and the need to effectively disseminate treatment about intervention quality and effectiveness. Gaps in research workforce development include the need for ongoing investment in facilitating research careers in ASD research, particularly in health services research, translational research, and international collaborative studies.
Dr. Jennifer Johnson recommended talking to Dr. Bonnie Strickland to better understand the scope of HRSA's work in research workforce development. Dr. Insel noted that two pharmaceutical companies had opened autism research divisions and suggested citing this as an advance in the workforce development section. Ms. Redwood noted that the ADDM Network has been inconsistent in the number of monitoring sites and the availability of education records. She stated that the prevalence statistics were hard to interpret without information about functional level. The subcommittee discussed the potential difficulty of defining functional level and Mr. Ne'eman said he would prefer that individuals be categorized by service needs or characteristics. Ms. Singer said that the data collected during surveillance is used to inform the future and anticipate needs of adults with ASD. Parent advocacy groups have shown a willingness to get involved and data is needed to drive these efforts, she said.
Discussion of New and Modified Objectives
Several modifications to existing objectives were proposed including the addition of a single web location for the "State of the States" report and state ASD service plans. The subcommittee suggested using www.hhs.gov/autism but was warned that the site was not carefully maintained and that posting state plans may give the appearance of HHS support. Ms. Blackwell was asked about the status of the "State of the States" and she said that the first report would be published in 2011. Dr. Insel asked if having the report electronically would be sufficient and registered his concern with adding more pieces to an objective that had been slated for completion in 2009. Dr. Dawson noted that Easter Seals maintained an ongoing assessment of ASD services by state. She then reviewed the suggested revisions to objective D on maintaining a network of biobanks. This included language about support for post-processing of tissue and the development of an international web-based digital brain atlas. Objective M had been revised to include mention of an ASD services and supports web portal.
The group revising Question 7 proposed four new objectives, the first establishing a network of clinical research sites to collect biosamples and act as a platform for comparative effectiveness research. The second objective dealt with encouraging programs to expand the research workforce and recruit early career scientists into the ASD field. The third objective called for the creation of an information resource for ASD researchers to share data and standardized methods across projects. The final objective called for resources to develop promising vertebrate and invertebrate models and support new approaches to developing high throughput screening technologies.
Dr. Insel asked if the first objective described the Autism Treatment Network and Dr. Dawson said that currently only a limited number of sites were collecting data and none were collecting fibroblasts. They discussed the practicality of collecting fibroblasts in a community setting and Dr. Dawson stated that it was within the realm of the possible. Dr. Insel talked about the importance of standardizing phenotyping, biospecimen collection, and imaging protocols to make them usable across studies. He asked whether the Plan should include an objective to hold a meeting related to data harmonization. Dr. Koroshetz said that NINDS had developed a common data elements project that established data standards for individual neurological diseases. Dr. Solomon mentioned the Biomedical Informatics Research Network (BIRN) initiative funded by NIH to provide data sharing infrastructure and strategies. She also mentioned an autism research development training grant at the M.I.N.D. Institute. Ms. Blackwell asked that the web portal idea be removed from the revised objectives because it was prohibitively expensive. Dr. Koroshetz recommended adding details about how patients can contribute to biobanks.
Discussion of Proposed Updates to the Introduction
Ms. Redwood reviewed her proposed revisions to the introduction which included the addition of the following sentences to the first paragraph. "Today autism is more common than childhood cancer, juvenile diabetes and pediatric AIDS combined and the increasing number of children being diagnosed with autism has creation a national health emergency. An estimated 1.5 million individuals in the U.S. are currently affected by autism." Dr. Cathy Rice asked for a citation for the 1.5 million figure, but no reference was identified, causing the subcommittee to opt to instead refer to documented autism prevalence estimates available from the Centers for Disease Control and Prevention (CDC). Mr. Ne'eman objected to the comparison between ASD and terminal childhood diseases. Ms. Redwood noted that the language had been taken from the Autism Speaks web site and was intended only to compare the level of public awareness and research funding between the disorders. Mr. Ne'eman said that a more apt comparison would be to Down syndrome and other developmental disorders. He noted that the real tragedy was not ASD itself but the number of people with ASD who have unmet needs. Dr. Insel said that the committee had received public feedback that the introduction lacked urgency and force and that Ms. Redwood's revisions reflected these concerns. Ms. Blackwell recommended using the President's language identifying autism as one of three national health priorities and using the childhood prevalence estimates from the CDC. Mr. Ne'eman agreed to draft language for the introduction which could then be reviewed by the full committee alongside the current proposed language. Dr. Johnson stated the need to emphasize early in the introduction that ASD is a societal issue as well as a health issue.
Ms. Redwood had recommending changing one reference to "people with ASD" to "individuals with ASD." Ms. Blackwell asked that it be changed back to people to reflect the person-centric language used throughout the Plan, which was later echoed by OARC staff noting that the term "people" rather than "individuals" had been specifically discussed and selected for usage throughout the Plan by the committee in 2009 . Ms. Redwood included language calling for research to identify "mechanisms of injury." The subcommittee asked that the new phrase be shortened to "identification of mechanisms" and exclude mention of injury. Ms. Blackwell added language to reflect the new addendums on progress and included a new paragraph on medical comorbidities as a cross-cutting theme. Dr. Insel praised the addition and offered to collaborate to further refine the information on medical comorbidities.
The subcommittee discussed language characterizing the breadth of the spectrum, from the most severely affected who "cannot live independently and require twenty-four hour care and supervision" to high-functioning individuals. Ms. Blackwell objected to the language and suggested changing it to reflect that more severely affected people with ASD need a wide array of assistance modalities to lead independent lives. She said that the passage should not refer to care or supervision but rather to services and supports. Ms. Singer stated that her daughter and brother required both care and supervision and Ms. Redwood commented that as a nurse she provided care, not services. Mr. Ne'eman said that he was concerned that the proposed language endorsed institutionalization and more restrictive service provision settings. As with the introductory paragraph, the subcommittee agreed to draft alternate language to present to the committee for final input.
Ms. Redwood had added language about the importance of including stakeholders in the research development process. Mr. Ne'eman said that he would like to include mention that adults with ASD have historically been underrepresented in study design. The subcommittee suggested that stakeholder involvement ensured that "personal experience" with the disorder was reflected, rather than ensuring "the human dimension."
Discussion of Action Items and Adjournment
Reaching the end of the scheduled meeting time, the subcommittee agreed to meet again on December 3, 2010 to review the remaining proposed revisions to the Strategic Plan. The members were instructed to email any comments about these chapters to the selected point person. All drafts were due by November 30. The aim of the December 3rd meeting would be to finalize the drafts for review by the full IACC on December 14, 2010.
Dr. Solomon raised the issue of the numerous uncoded projects in Question 2 and discussed developing coding categories to capture these projects. These categories could potentially be based on the three bulleted questions included under the chapter title. Dr. Daniels noted that these overarching questions would certainly overlap with the existing objectives and might confuse the coding process in the future. The subcommittee decided to defer discussion of possible additional coding categories to the following year and just use the currently available objective codes for the 2009 Portfolio Analysis. Ms. Redwood requested that the December 3rd meeting be held solely by teleconference. Dr. Hann noted that any members could phone into the meeting if they were unable to attend in person but stated that during past revisions, the ability to speak with others in person helped facilitate the process. The meeting was then adjourned.
These minutes of the IACC Subcommittee for Planning the Annual Strategic Plan Updating Process were approved by the subcommittee on December 3, 2010.
I hereby certify that this meeting summary is accurate and complete.
Thomas Insel /s/
Thomas Insel, M.D.
Chair, Interagency Autism Coordinating Committee