July 20, 2022
Note: For context and clarity, speaker credentials will be included upon first mention in each meeting’s summary. Subsequently, individuals will be referenced by their first names to equalize expertise across the many diverse disciplines represented in this document. All perspectives and expertise, including patient-lived experience, is valued equally. Speaking on a first-name basis helps the Tick-Borne Disease Working Group ensure that all voices are heard and valued based on merit and without the bias of titles, eminence, or prestige.
Welcome and Roll Call: Day 2
James (Jim) Berger, MS, MT (ASCP), SBB, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (HHS); Designated Federal Officer for the Tick-Borne Disease Working Group,welcomed participants and called the meeting to order. Jim conducted roll call (see Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting began with a quorum.
Recap of Day 1 and Day 2 Agenda
Holiday Goodreau, Executive Director, LivLyme Foundation; Co-creator, TickTracker; Working Group Co-Chair, greeted attendees and summarized proceedings from the previous day’s Tick-Borne Disease Working Group meeting. These included a Federal Inventory update, opening remarks by Assistant Secretary for Health ADM Rachel Levine, public comments, votes to reopen revisions to recommendations in two chapters (Changing Dynamics of Tick Ecology, Personal Protection, and Control and Access to Care and Education chapters), discussion of member comments for three of five chapters (Clinical Presentation and Pathogenesis, Diagnostics, and Changing Dynamics of Tick Ecology, Personal Protection, and Control), and a discussion and vote on terminology used in the report.
Holiday introduced the agenda for Day 2, which featured the following items:
- Review and Discussion of Report Chapters
- Access to Care
- Disease Prevention and Treatment
- Introduction
- Graphic Design Update
- Discussion/Unresolved Issues
- Review of Meeting 22, Next Steps, and Next Meeting
Access to Care Chapter Review
Holiday opened the discussion of individual chapters and member feedback by explaining that each member would explain their comment, as well as any recommended revisions. Chapter authors would then have an opportunity to respond. Subsequently, Working Group members would be able to discuss each comment. Cat Thomson, Contractor, Rose Li Associates, was present to record Working Group decisions made to address each comment.
Discussion of Recommendation 1
Elizabeth (Betty) Maloney, MD, President, Partnership for Tick-borne Diseases Education, informed Working Group members that Recommendation 1 had been moved back to this chapter from the introductory chapter. This recommendation stipulates a mechanism for stakeholder groups to provide input to HHS involving communications about the state of the science for tick-borne illnesses. Monica E. Embers, PhD, Associate Professor and Director of Vector-borne Disease, recommended revisions to reduce the amount of text, because this recommendation was significantly more robust than the others. She also suggested moving some language to the rationale for the recommendation. Betty agreed and will revise the recommendation.
Comment 1 from Holiday Goodreau
Holiday noted that the opening chapter should reference other tick-borne diseases, not solely Lyme disease. Betty agreed and will utilize references from Jennifer Platt, DrPH, Co-founder, Tick-borne Conditions, in other parts of the chapter to ensure representation of illnesses other than Lyme disease.
Comment 2-3 from Kristen Honey
Kristen Honey, PhD, PMP Executive Director of InnovationX, U.S. Department of Health and Human Services, explained that her comments pertaining to the recommendations were similar to Monica’s comments, insofar that they be as succinct as possible for maximal impact. Betty agreed and noted that recommendations and their corresponding rationales (which will provide more detail) will be located at the beginning of each chapter.
Comment 4 from Kristen Honey
Kristen noted that her comment was intended to make the chapter as easy to digest as possible. She referenced the White House Roadmap to Transforming the Federal Customer Experience and Service Delivery to Rebuild trust in Government as a resource to borrow language to rebuild trust in patient populations. CAPT Rebecca Bunnell, MPAS, PA-C, Senior Advisor, Division of Model Learning Systems, Learning and Diffusion Group, The Center for Medicare and Medicaid Innovation, Centers for Medicare and Medicaid Services (CMS), agreed that chapter authors (herself included) should add some of the human-centered design language used in the White House Roadmap and by CMS.
Comment 5 from Kristen Honey
Kristen underscored the importance of the sections involving health equity in the chapter and advised they be highlighted with a text box or other visual cue. Rebecca responded that some of the tables and infographics planned for this chapter help highlight health equity conceptually in the chapter. Betty explained that the Access to Care chapter was located much further within the report, far removed from the introduction where health equity is first discussed; thus, she and authors spent more time providing details on structural barriers to care—this may be the reason for why it appeared disjointed from the rest of the chapter.
Members considered restructuring the report to focus more on health equity. Jennifer recommended a section on health equity in each chapter. Rebecca suggested that the chapters be reordered so that health equity, as a concept, is more consistent throughout the report. Kristen agreed with the idea of moving the Access to Care chapter to the beginning of the report following the introduction.
Comment 6 from Kristen Honey
Kristen noted that tick-borne diseases other than Lyme disease should be referenced in the passage. Betty responded that the passage was specific to Persistent Lyme disease/Chronic Lyme disease (PLD/CLD).
Comment 7 from Kristen Honey
This comment relates to terminology, which was discussed on Day 1 and finalized later in the meeting.
Comment 8 from Kristen Honey
Kristen explained that her broad comments for the chapter’s introduction suggest that the authors more clearly define their requests to Congress. Betty noted that the chapter authors have a short passage that lays out these goals clearly that can be added to the section. Kristen endorsed the addition.
Comment 9 from Jennifer Platt
Jennifer noted her comments were similar to Kristen’s regarding the addition of health equity language, which was addressed earlier. Betty noted that the chapter authors were not prepared to discuss all inequities from different subgroups with overlapping challenges, such as the unhoused or those with disabilities. Rebecca noted that she has some sources and Jennifer offered to help with additional references. Betty, Rebecca, and Jennifer agreed to collaborate on writing the section in question to ensure the material is complimentary, not duplicative.
Comment 10 from Jennifer Platt
Jennifer inquired whether there had been any tick-borne disease research that took gender into account. Betty noted that gender differences did appear in some studies. Studies of persistent symptoms of Lyme disease tended to enroll more women; studies of borreliosis and other tick-borne diseases tended to recruit more men. Jennifer offered to provide resources on gender differences in the study of Alpha-Gal Syndrome (AGS). Kristen and Monica offered additional resources, which the chapter authors will incorporate.
Comment 11 from Jennifer Platt
Jennifer offered to add references and data for other tick-borne diseases to the passage in question. Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, referenced the Day 1 discussion on terminology to provide a broader term to capture tick-borne illnesses beyond Lyme disease.
Comment 12 from Linden Hu
Linden Hu, MD, Tufts University School of Medicine, Professor Microbiology and Medicine; Vice Dean for Research; Working Group Co-Chair, recommended slight change in language involving researchers. Betty agreed with the change.
Comment 13 from Linden Hu
In a passage about research conducted by the Department of Defense (DoD), Linden inquired if there was evidence of changes in funding, investigators, or research priorities. Betty agreed to investigate and reach out to Angel Davey at DoD, who presented to the Access to Care subcommittee. Jennifer referenced research that deemphasized the burden of tick-borne illnesses in the southern United States, underscoring the remaining challenges to spread awareness about disease risk.
Comment 14 from Linden Hu
Linden noted that the section referenced an unpublished study and inquired about referencing published material to strengthen claims. Betty highlighted the importance of the study, which surveys providers treating tick-borne diseases, including their experience with professional stigma—which she stated is the first of its kind. Linden agreed that if there was no other way to describe this material, he approved of the choice and noted it would likely be published before the Working Group’s report.
Comment 14 from Jennifer Platt
Jennifer suggested broadening language in the indicated passage to include all tick-borne illnesses. Betty responded that the passage was specific to PLD/CLD. Gabriella (Gaby) Zollner (Romero), PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense, recommended adding language about gaps in surveys for providers of other tick-borne diseases. Betty agreed.
Comment 15 from Jennifer Platt
Jennifer recommended a change in language that favored Lyme disease over other tick-borne illnesses. Betty agreed.
Comment 16 from Jennifer Platt
Jennifer noted that other tick-borne illnesses besides Lyme disease can also cause erythema migrans (EM) rash. She specifically noted that Amblyomma tick bites can cause EM rash despite not carrying Lyme disease. The presence of this rash in this context can lead to misdiagnosis of Lyme disease, and she contended that clinicians should be assessing for all tick-borne diseases. Betty explained that the paragraph already states that Amblyomma can cause EM rash, but Jennifer noted that the only other example in the passage was Southern Tick-Associated Rash Illness (STARI) rashes. Sunil K. Sood, MD, Chair of Pediatrics, South Shore University Hospital, Attending Physician, Infectious Diseases, Cohen Children’s Medical Center, Professor of Pediatrics at Hofstra/Northwell, recommended a slight change in the language to add STARI as one example among many, rather than the only example of a rash that should be investigated, and Ben agreed.
Comment 17-18 from Jennifer Platt
Jennifer recommended adding details about AGS to the indicated passages. Betty agreed, and she suggested adding references to the chapter that describe AGS in detail. Betty also recommended referencing the 2020 Tick-Borne Disease Working Group Report’s sections relevant to AGS.
Comment 19 from Jennifer Platt
Jennifer explained that her comment related to economic models of patient care that are not working for chronically ill patients. Betty responded that another section in the chapter addresses this topic in the context of patient barriers to care, which could be explored in more detail. Rebecca noted that an infographic planned for the chapter on patient costs should also address Jennifer’s point.
Comment 20 from Linden Hu
Linden noted that the passage refers to informal data that could weaken the claims being made. Betty responded that revisions to the passage could frame these claims more carefully.
Comment 21 from Jennifer Platt
Jennifer inquired whether a section referred to government-led efforts to help educate physicians. Betty confirmed this and added that the section was meant to refer to public education efforts, as well. She suggested to a revision to make the section more inclusive and more explicitly include public education.
Comment 22 from Jennifer Platt
Jennifer referred to a section about CDC and NIAID websites, noting that she agreed with the claim that they contained inaccurate information and should better reflect the changing nature of the science of tick-borne illnesses. Ben disagreed, stating that the report should reflect broadly-held views and did not share the opinion as stated. He suggested making a change that reflected a more objective tone. Dennis agreed and recommended restating the passage to recognizing that the science is unsettled without making a judgement.
Betty agreed with the idea of describing multiple opinions and recognizing the controversy. She recognized that nuance was needed and suggested pulling information on post-treatment Lyme disease syndrome (PTLDS) from the CDC website for language the Working Group could agree with. Monica reviewed the passage on the CDC website, noting that the research on persistent Lyme disease is absent. Betty responded that the site should reflect that the science is unsettled and implored the group to find a way to express this sentiment. Sunil opined that the summary of the facets of disease on the CDC website was fairly broad, but agreed with Monica that more references to ongoing research would be helpful.
Betty pointed to case reports that demonstrate ongoing infectious activity in Lyme disease patients, and she noted that the CDC website does not acknowledge persistent infection. Ben responded that case reports often lack controls that would normally help solidify the science—he acknowledged that the science is currently unsettled and should be highlighted in the report. Monica noted that CDC’s PTLDS website passage ignores a whole host of studies, including those with antibiotics. Gaby pointed to Recommendations 1 and 2 at the beginning of the chapter, which direct HHS to update federal websites—she suggested including this language in the passage since it was already adopted by the Working Group. Betty noted that she would agree to softening the language while still reflecting the sentiment of the recommendations. Ben reiterated that his contention was with the word “inaccurate.” He suggested emphasizing the incompleteness of the description of an emerging, dynamic field. Betty closed the discussion by inviting Ben and Monica to work with chapter authors to revise the section. Dennis offered to help, as well.
Comment 23-24 from Jennifer Platt
Jennifer noted that, similar to her other comments, the passages could be broadened to include tick-borne illnesses other than Lyme disease.
Comment 25 from Linden Hu
Linden noted that the passage could benefit from a few paragraphs on community-based participatory research. Betty responded that the chapter authors have planned a revision to address this comment.
Comment 26 from Kristen Honey
Kristen explained that the focus of the concluding passage for the chapter could be broadened and present a more forceful call for increased collaborative research initiatives. Kristen offered to help revise the section. Betty agreed and welcomed the assistance. Rebecca noted that if the chapters are reordered, the concluding passage could also be revised to better preview the next chapter.
Discussion on Recommendations 1 and 2
Holiday opened the discussion on the language of the first two recommendations in the Access to Care chapter (which was previously reopened by a vote on Day 1). The current draft of Recommendation 1 read:
Direct HHS to review federal websites and training under its purview that include Tick-Borne Disease content, beginning with Lyme disease, to determine whether they best reflect the current state of the science, independently analyze clinical trial evidence in detail, and appropriately delineate areas of scientific uncertainty.
The draft language of Recommendation 2 is as follows:
Fund and support continued and ongoing modification of the federal government websites, starting with the CDC and NIH websites, as well as educational materials and seminars for clinicians, the public, and public health departments to reflect the current state of the science related to persistent symptoms associated with Lyme disease, which is limited, emerging, and unsettled, and to acknowledge that there are divergent views on diagnosis and treatment of patients with persistent symptoms of Lyme disease.
Recommendation 1
Betty suggested broadening the language to cover all tick-borne illnesses, beginning with Lyme disease—which is explained in the rationale. A deleted passage about other tick-borne diseases was added back in the rationale. Members discussed the purview of authority over reviewing and updating HHS websites, but ultimately settled on the current language.
Kristen suggested combining Recommendation 1 and 2, stating that they are similar; however, Betty disagreed with this proposal, stating that CDC and NIH were already taking concrete action to modify their websites to reflect the current science. Kristen commented that she believed it was unclear how the recommendation would be implemented. Rebecca reminded members that the recommendation was added back (giving impetus for this vote) after previously being moved to the section on proposing a renewal of the Tick-Borne Disease Working Group under the Federal Advisory Committee Act (FACA). She implored the Working Group not to eliminate this recommendation, since regardless of a renewal the chapter authors believe this recommendation is still needed. Kristen offered to help revise the recommendations, explaining that they were too important to rush a vote. Betty expressed concern that adding more detail to the recommendation was contradictory to the idea of streamlining them for clarity and impact. She recommended making changes to the rationale, which would not require a vote, and Dennis agreed. Under the advisement of Holiday and Linden, chapter authors will take extra time to revise the recommendation, and members will hold a vote at the next meeting.
Recommendation 2
Betty noted that second recommendation had already been voted on and approved; the language was simply adjusted. Holiday and Kristen agreed the language could be tightened for clarity and impact. Ben suggested moving the passage about the science being unsettled to the rationale, but Betty rejected this change underscoring the importance of that idea in the recommendation. Under the advisement of Holiday and Linden, chapter authors will revise the recommendation, and members will vote on this recommendation at the next meeting.
Disease Prevention and Treatment Chapter Review
Linden opened the discussion of the Disease Prevention and Treatment chapter to review member comments. Cat was present to record Working Group decisions made to address each comment.
Comment 1 from Gaby Zollner
Gaby explained that her comment on the background section involved adding additional content about various pathogen types to underscore the importance of treatment and prevention of tick-borne diseases. Dennis and Suni agreed and will add a sentence making this point.
Comment 2-4 from Gaby Zollner and Holiday Goodreau
Gaby expressed confusion about the order in which the diseases were presented in the indicated section. Her second, related comment involved grouping the diseases by type of pathogen. Holiday’s response comment also suggested the diseases be reordered with Lyme first followed rickettsial diseases. Monica and Betty agreed, noting that diseases should be listed from highest to lowest prevalence, and Sunil agreed to the suggested revisions.
Comment 5 from Betty Maloney
Betty explained that her comment was similar to the preceding ones about the order of pathogen descriptions. In this case, she noted that discussion of Bartonella should be added to the end of the section on Rickettsia. Dennis and Sunil agreed, and Cat implemented the revision.
Comment 6 from Holiday Goodreau
Holiday inquired if a citation could be added to a passage about doxycycline. Sunil agreed and will add a reference. Dennis noted that a relevant reference could likely be repurposed from the previous report.
Comment 7 from Gaby Zollner
Gaby requested that when studies are referenced, authors add dates for when the studies were conducted. She noted that clarifying study dates will be important because the report will likely be referenced for several years in the future. Linden agreed and copyeditors should keep track of referencing the dates of studies in the text. Dennis added that there was value in explaining that doxycycline, which has been administered to patients for decades, still demonstrated effectiveness in recent studies. Members agreed to permit chapter writers to exercise discretion when adding dates in the passage.
Comment 8 from Betty Maloney
Betty encouraged adding detail on the types of frontline workers who require education on tick-borne diseases. Linden suggested to instead describe the whole group generally as healthcare practitioners, and Betty agreed with this approach. Sunil suggested removing “frontline” as well; however, Betty disagreed, stating that this was the group that most needed education. Linden agreed. Sunil was persuaded to make the change.
Comment 9 from Betty Maloney
Betty made a comment about routes of transmission, but chapter authors noted that the details are provided in the following sentence. No changes were required.
Comment 10 from Gaby Zollner
Gaby explained that her comment suggested the use of “prophylactic” when referring to agents to prevent Babesia infections, rather than therapeutics, and Sunil agreed.
Comment 11 from Gaby Zollner
Gaby suggested adding a sentence to clearly demonstrate what market considerations meant in the passage regarding preventative agents for Babesia. Dennis further suggested a revision to expand the definition of market considerations, and Cat implemented the change.
Comment 12 from Betty Maloney
Betty commented that the sentence was redundant in this passage because the same was point was made in the previous sentence. Members agreed, and Cat implemented this change.
Comment 13 from Linden Hu
Linden suggested expanding on the significance of missed diagnosis of Borrelia miyamotoi. Because this topic had not been explained in more detail in the Diagnostics chapter, Linden and Sunil agreed that more detail was needed to explain that physicians should consider the possibility of a B. miyamotoi diagnosis in various circumstances. Dennis suggested making a general statement about the antiquated means of diagnosis for this class of diseases. Betty and Sunil agreed that a sentence could be added to provide more detail. Monica added that next generation diagnostics would be useful in this context.
General Comment from Jennifer
Jennifer inquired if STARI rashes had been discussed in any of the previous reports to Congress. Dennis replied that it was referenced in a table and in text, but there was not a major focus on the topic in previous reports. Jennifer referenced a recent study that could be cited. Ben recalled that a subcommittee report from 2020 may have referenced STARI and would investigate. Members briefly reviewed the 2018 and 2020 reports and noted that the 2018 report had three references, while the 2020 report provided slightly more detail. Dennis agreed to review the reports and add detail about STARI rashes to the chapter section, if possible.
Comment 14 from Linden Hu
Linden explained that his comment was a semantic issue related to the fatality rate of Powassan virus. Ben responded that the statistic is from the CDC website that could be qualified as reported cases rather than all cases, and Sunil and Dennis agreed.
Comment 15 from Betty Maloney
Betty questioned why the descriptor of “competent” was used to describe a vector in the passage in question, because term is typically used when discussing more than one vector. Ben agreed with Betty’s description of the term and observed that it was redundant in this particular passage, so Cat removed the term.
Comment 16 from Betty Maloney
Betty noted that the section on AGS was well written, but observed that there was another section on AGS in the Pathogenesis chapter. She suggested combining both sections. Ben indicated that AGS is discussed in relation to pathogenesis and separately in relation to prevention in the respective chapters; therefore, Betty withdrew her comment.
Comment 17 from Jennifer Platt
Jennifer’s comment suggested adding case studies on various treatments (but not randomized controlled trials [RCTs]) for AGS. Dennis agreed with this suggestion, and Cat added the references and the text.
Comment 18 from Holiday Goodreau
Holiday’s comment involved reordering sections, which was previously addressed.
Comment 19 from Betty Maloney
Betty noted that the language in the passage regarding clinical trials for vaccines was vague and could be removed without affecting the overall point of the passage. Sunil and Dennis agreed with this suggestion. Per Monica’s suggestion, chapter authors will revise the passage to include descriptions of recent efforts to develop vaccines.
Comment 20 from Linden Hu
Per Linden’s comment, chapter authors will remove references to specific products, which is consistent with decisions made in previously reviewed chapters.
Comment 21 from Betty Maloney
Betty commented that the passage referring to vaccines for attenuated and/or mutant strains of Borellia may be difficult to sell to the public, but she did not have specific revisions to offer. Monica suggested adding text referring to alternative subunits. Dennis disagreed, contending that the goal was to capture what prevention efforts are currently underway; however, Dennis agreed to remove the passage. Kirby suggested adding language referring generally to other vaccine platforms without delving into specifics. Chapter authors will institute Kirby’s suggested revisions.
Comment 22 from Gaby Zollner
Gaby’s comment suggested attributing the increasing vaccine hesitancy to the COVID-19 pandemic. However, noted that vaccine hesitancy has been increasing for the last two decades
General Comment by Dennis Dixon
Dennis lauded the group for the care and collegiality in the current iteration of the Working Group even when there were fundamental disagreements. He observed that one disagreement involved approaches to treatment, which he framed as those who agree and disagree with the Infectious Diseases Society of America (IDSA) approach in the chapter text. Dennis stated that attempting to harmonize divergent views sometimes resulted in omitting controversies that should be discussed, particularly those related to treatment approaches. He proposed a clear articulation of these divergent views without favoring any particular one.
Holiday responded that explaining divergent views may be detract from persuading Congress to aid the Working Group’s efforts. Betty agreed with Dennis’s approach and implored the group to explain why there are divergent views: the science is unsettled, and more research is needed. Dennis agreed with Betty’s addition and supported the addition of discussing the importance of understanding the pathogenesis of tick-borne diseases to reach consensus on appropriate treatments. Betty added that care should be taken in describing the divergent views at a high level to reduce confusion and controversy. Holiday noted that emphasizing areas where agreement already exists (need for better testing, drugs, more funding) would be useful, and Sunil agreed.
Linden implored the group to revise the section offline. Members agreed with Dennis’s proposed points of revision in describing various diverging views without separating them into opposing camps and highlighting areas of agreement. Betty and Monica volunteered to help the chapter authors with these revisions.
Comment 23 from Gaby Zollner
Gaby explained that her comment involved highlighting health equity—which was irrelevant based on the reordering of the chapters.
Comment 24 from Gaby Zollner
Gaby noted that rationales for the recommendations were not included in the chapters. Chapter authors will produce these rationales for the next draft.
Introduction Chapter Review
Linden suggested that the Working Group examine the chapter for overall structure, noting that many details need not be discussed due to the significant revisions that have been made to the report. Holiday added that the section regarding the FACA renewal has increased in significance for the Working Group over the last few meetings and invited members not already involved in writing the Introduction chapter to volunteer if they wished. She added that a meeting will be held in August to draft the FACA section.
Linden surveyed the sections of the draft Introduction, which include:
- Executive Summary
- Current State of Tick-Borne Diseases in the United States
- Federal Response to Prior Working Group Recommendations
- New Challenges and Opportunities
Linden noted that Members suggested adding a list of accomplishments to the Federal Response section to show the positive changes implemented as a result of Working Group recommendations. Ben inquired how many recommendations had been addressed out of the total of 55 recommendations that are referenced in the Federal Response section. Linden noted that this information had been moved into the appendix, but he reconsidered this choice in order to highlight the group’s accomplishments. Betty reminded the group that Members considered putting this content in the FACA section of the Introduction.
Dennis commented that the Executive Summary did not contain content from the report, but instead provided recommendations not listed in the individual chapters. Linden noted that he wrote this section, which he stated clearly needed to be reworked.
Jennifer observed that in previous iterations of the report, the Public Comments section was located at the end. She recommended the Working Group consider moving the Public Comments section to front of the report to highlight the experience of advocates and help build trust with patient communities. Jennifer described a summary of public comments that highlight prominent themes. She noted that typically the section following the Introduction is a Methodology section, and she proposed replacing that section with the Public Comment section and moving Methodology to the back of the report. Betty underscored the importance of patient advocacy, which helped provide impetus for the Working Group in the first place, and Kristen agreed. Ben questioned how the Public Comment section would be organized. Linden responded that Lauren Overman, MPH, CPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services, put together a summary of comment themes along with some analysis, which was presented at the last meeting—confirming that this would be the primary content for the Public Comment section.
Graphic Design Update
Cheryl Fox-Gnagey, Graphic Designer, Rose Li & Associates (RLA), presented an update on the graphics created for the Tick-Borne Disease Working Group 2022 Report. Cheryl also noted that a secondary goal of this presentation was to obtain guidance from Members on further additions of design elements.
Cheryl highlighted five design elements that will be included in the 2022 report:
- Imagery
- Charts & Graphs
- Infographics
- Tables
- Illustrations
Imagery
Cheryl will provide two image options for each chapter to convey its theme. Members should freely provide Cheryl with additional ideas. Within the chapter itself, images with captions can be used to highlight various ideas.
Charts & Graphs
Authors can include charts and graphs from other sources. Alternatively, RLA can create charts and graphs requested by authors. Cheryl explained that RLA may request changes in content to meet readability standards.
Infographics
RLA has also been working on data infographics for the 2022 Report. Based on member input, RLA can create additional data infographics or include infographics from other sources. Cheryl noted that typically an infographic will go through more than one iteration before it is finalized to ensure it delivers the desired message. Cheryl also noted that a new graphic can be adapted from source material for better readability and fit within the overall text.
Tables
Working Group members can submit preformatted tables or source data to create formatted tables within the report. Large tables can be reformatted to fit within the report parameters to ensure they convey the desired information.
Additionally, Working Group Members can highlight sections of text using a textbox or sidebar. Cheryl noted that textboxes add more variety and making the Report more inviting and accessible.
Illustrations
RLA can also create illustrations to convey messaging. Through discussion or written communications, RLA can create original illustrations that visually represent ideas. Cheryl noted that these take time to complete, but also add character and nuance to the report.
Discussion of Unresolved Issues
Holiday invited Working Group members to raise any unresolved issues and concerns as the group prepared to conclude their 22nd meeting. Betty inquired about the role of alternate Working Group members, particularly in regard to rewriting sections of the report they may not have helped develop. Jim explained that the purpose of the alternate member is not to replace a primary member, but to stand in during meetings. Jim noted that Kristen is the alternate for Leith Jason States, MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, and Leith should be involved in the rewriting of the report. Jim clarified that Kristen can inform Leith on the proceedings of the meeting to help assist in the rewriting process.
Terminology Discussion
Rebecca suggested that the term physician be replaced with clinician or provider throughout the report to make the language more inclusive and accurate in terms of who actually provides care to patients. She noted that this change was instituted in the 2020 iteration of the report.
Linden observed that the Day 1 discussion on terminology used to describe tick-borne illnesses was unresolved. He moved to hold a vote to reopen the discussion to help resolve these issues and come to consensus.
Vote
Ten members voted yes (with three abstentions) to reopen the discussion on terminology used throughout the report.
Cat brought up the working hierarchal list of terms the Working Group formulated on the previous day. The list is as follows:
- Infection-associated chronic Illnesses
- Long COVID
- Tick-bite associated chronic illness
- Persistent symptoms [illness] associated with Lyme disease
- Post-treatment Lyme disease syndrome (PTLDS) – when citing literature or speaking about specific populations.
- Persistent Lyme disease/Chronic Lyme disease (PLD/CLD)
- Persistent symptoms associated with other tick-borne diseases
- Persistent manifestations associated with Lyme disease
- Current and persistent coinfections
- Persistent symptoms [illness] associated with Lyme disease
Cat noted that the two separated bottom terms were still under consideration but had not been incorporated into the main list. She also noted that two terms, “persistent illness associated with Lyme disease” and “Persistent Lyme disease/Chronic Lyme disease (PLD/CLD)”were highlighted to alert the Working Group that they were currently debating using one term or the other (but not both).
Betty contended that the Working Group use terms to engage the public; thus, she implored the group to accept terms the public uses. Betty noted that “chronic Lyme disease” was such a commonly used term that even the CDC was using it in some surveys. Ben commented that the terms the Working Group uses should fundamentally communicate pathogenesis. He also noted that he disagreed with the idea that popularity of terms should dictate how they are used in the report. Monica asserted that context is important for the use of the terms and recommended that chapter authors use the terms most useful for their sections. Kristen agreed that the terms should be used in context and noted that the audience will have terms it prefers. Linden reminded the group that Congress is the primary audience of the report. Ben noted that the terms are likely most important in how they appear in the recommendations, rather than throughout the text.
Kirby pointed out the hierarchy he originally recommended on Day 1 was meant to make “persistent illness associated with Lyme disease” and “PLD/CLD” their own categories, rather than set up a situation where one replaces the other. Cat suggested that terms be incorporated into a style sheet rather than a debate over replacing terms. Thus, each term would have a described context in which they were used. Cat also encouraged the Working Group to simply eliminate remaining terms they were not planning on using. Linden proposed creating a style sheet that the Working Group can approve with a vote.
Kristen contended that persistent Lyme disease be separated from CLD. Betty responded that the term was the product of extensive discussion in the Access to Care subcommittee, which married a term that patients were familiar with (chronic) and a term that explained the mechanism. Ben commented that from his perspective, the terms “chronic” and “persistent” were synonymous; however, neither explained mechanisms agnostically. He preferred persistent symptoms as a term that captures pathogenesis more accurately.
Gaby noted that a glossary could also be a tool for contextualizing the terms used throughout the report. Ben proposed that he could compromise with Betty on terminology by explaining each term with context in the glossary. Linden recommended that terms are defined the first time they are used in the text. He also suggested the group define PLD/CLD to ensure consensus on the use of that term, specifically.
The group produced a new hierarchy of terms, which is as follows:
- Infection-associated chronic Illnesses
- Long COVID
- Tick-bite associated chronic illness
- Lyme disease-associated chronic illness – these are illnesses that have been previously described as PLD/CLD
- Persistent Lyme disease/Chronic Lyme disease (PLD/CLD) – for use in the Access to Care and Education chapter
- Post-treatment Lyme disease syndrome (PTLDS) – when citing literature or speaking about specific patient populations
- Persistent symptoms [illness] associated with other tick-borne diseases
The group also formulated a definition for PLD/CLD, which is as follows:
- Patients who have been treated for Lyme disease and remain ill [symptomatic] for six months or more following treatment. Etiology of their ongoing symptoms is unclear
- Continual and/or relapsing disease resulting form/associated with Borrelia burgdorferi susu lato infection.
- Agnostic of etiology
Vote
Twelve members voted (with two absent) on the motion to use “Lyme disease-associated chronic illness” as the preferred term throughout the report when referencing persistent manifestations associated with Lyme disease following antibiotic therapy. The motion was carried.
Review of Meeting 22 (July)
Holiday provided Working Group members with a brief review of topics covered and accomplishments from the July meeting including:
- Discussed feedback and revisions of draft chapters
- Designated writers for unassigned chapters (still to be completed)
- Reviewed report graphics
Discussion of Next Steps and What is Expected for the September Meeting
Holiday outlined the next steps for the Working Group. Writers need to be assigned to the Introduction/FACA, Methodology, and Conclusion/Looking Forward chapters. Working Group members were invited to contact the co-chairs to volunteer. Chapter leads will implement revisions and generate a second draft of each chapter in consultation with writing group members. RLA will continue generating and finalizing graphics.
Holiday also reviewed the calendar of upcoming deadlines and meetings. The next Tick-Borne Disease Working Group meeting will take place on October 4-5, 2022, during which time the committee will review and edit chapters and incorporate finalized chapters into a report template as a second draft. The public may attend virtually.
Adjournment
The meeting was adjourned at 3:05 pm EST.
Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff
Tick-borne Disease Working Group
In alphabetical order:
Co-Chair
Holiday Goodreau, Executive Director, LivLyme Foundation, Co-creator, TickTracker (Present)
Co-Chair
Linden Hu, MD, Professor of Microbiology and Medicine, Vice Dean for Research, Tufts University School of Medicine (Present)
Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-borne Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services (Present)
CAPT Rebecca Bunnell, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Center for Medicare & Medicaid Innovation, Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services (Present)
Dennis Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services (Present)
Monica E. Embers, PhD, Associate Professor and Director of Vector-borne Disease Research, Tulane National Primate Research Center (Present)
Elizabeth Maloney, MD, President, Partnership for Tick-borne Diseases Education (Present)
Robert J. Miller, PhD, National Program Leader, Agricultural Research Service, U.S. Department of Agriculture (Present)
CDR Todd Myers, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, U.S. Department of Health and Human Services (Present)
Jennifer Platt, DrPH, Co-founder, Tick-borne Conditions United (Present)
Sunil K. Sood, MD, Chair of Pediatrics, South Shore University Hospital, Attending Physician, Infectious Diseases, Cohen Children’s Medical Center, Professor of Pediatrics at Hofstra/Northwell (Present)
Kirby C. Stafford III, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station (Present)
Leith Jason States, MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Present)
Gabriella Zollner (Romero), PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense (Present)
Alternative Federal Representatives
In alphabetical order:
Kristen Honey, PhD, PMP Executive Director of InnovationX, U.S. Department of Health and Human Services
RADM Estella Jones, DVM, U.S. Public Health Service, Deputy Director, OCTET U.S. Food and Drug Administration
Andrew Y. Li, PhD, Research Entomologist, Invasive Insect Biocontrol & Behavior Laboratory, U.S. Department of Agriculture
Samuel S. Perdue, PhD, Chief, Basic Sciences, Bacteriology and Mycology Branch at National Institutes of Health
CDR Monica Reed-Asante, PharmD, USPHS, Pharmacist, Senior Health Insurance Specialist for Centers for Medicare and Medicaid Services
LTC Michelle Colacicco-Mayhugh, PhD, PMP, Deputy Medical Entomology Consultant to the U.S. Army Surgeon General
HHS Support Staff
In alphabetical order:
James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group, Senior Blood and Tissue Policy Advisory, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services
B. Kaye Hayes, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Deputy Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Chinedu Okeke, MD, MPH-TM, MPA, Senior Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services
Lauren Overman, MPH, CPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services
Allison Petkoff, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services
Appendix 2: Writing Groups for the 2022 Report to Congress and the HHS Secretary
(Chapter leads are bold.)
Executive Summary—Linden Hu, To be determined (TBD)
Chapter 1: Introduction—Holiday Goodreau, Linden Hu, Ben Beard, Rebecca Bunnell, Monica Embers, Betty Maloney, Jennifer Platt, Leith States
Chapter 2: Methods—RLA
Chapter 3: Changing Dynamics of Tick Ecology, Personal Protection, and Control—Robert Miller, Kirby Stafford, Michelle Colacicco-Mayhugh, Jennifer Platt, Gabriella Zollner (Romero)
Chapter 4: Clinical Presentation and Pathogenesis—Ben Beard, Jennifer Platt, Leith States, Rebecca Bunnell, Monica Embers, Betty Maloney (resigned), Sunil Sood
Chapter 5: Diagnostics—Monica Embers, Todd Myers, Michelle Colacicco-Mayhugh
Chapter 6: Disease Prevention and Treatment—Dennis Dixon, Sunil Sood, Monica Embers, Sam Perdue, Jennifer Platt
Chapter 7: Access to Care and Education—Rebecca Bunnell, Betty Maloney, Leith States, Gabriella Zollner (Romero)
Chapter 8: Public Comment— Holiday Goodreau, Linden Hu, Lauren Overman, Jenifer Platt, Gabriella Zollner (Romero)
Chapter 9: Looking to the Future—TBD
Chapter 10: Conclusions—TBD
