​“Everyday activities, including eating and talking, are often difficult for people with temporomandibular disorders (TMDs), and many of them suffer severe chronic pain due to this condition. Common social activities that most people take for granted, such as smiling, laughing, and kissing, can become unbearable. This dysfunction and pain, and its associated suffering, take a terrible toll on affected individuals, their families, and their friends.

Individuals with TMDs often feel stigmatized and invalidated in their experiences by their family, friends, and, particularly, a health care community that frequently relies on “seeing” a condition in order to treat it. Misjudgments and a failure to understand the nature and depths of TMDs can have severe consequences—more pain and more suffering—for individuals, their families, and our society. People with TMDs, desperate for solutions, often seek out multiple clinicians, turning to dubious treatments in search of a cure, which can potentially lead to iatrogenic injury and costly, yet ineffective, treatments.” ​(2020 National Academies of Sciences, Engineering, and Medicine Consensus Study Report, Temporomandibular Disorders: Priorities for Research and Care, Preface xiii)

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​Temporomandibular disorders (TMDs) are common disabling conditions, with an estimated 6% to 12% of the population experiencing clinical symptoms. The treatments include many devices that have limited evidence of safety and effectiveness, and little comparative data exists. Long-term outcomes data are especially sparse, leading to a trial-and-error approach that can result in worsening conditions. Some patients experience serious complications, including:

• Increased chronic pain

• Facial paralysis

• Disfigurement

• Infection

• Metal sensitivity

• Device migration within the skull

• Device breakage

• Reduced jaw mobility

• Increased opioid use and dependence

• Heightened suicidality

• Serious adverse events

​

In 1991, the estimated annual economic impact of TMDs in the U.S. was $32 billion. The 2020 NASEM report notes that “studies assessing the direct and indirect costs specific to a TMD diagnosis are rare.” Research into these costs is urgently needed, particularly as health care delivery continues to evolve.

​

​The Need for Action

There is an urgent need to understand what contributes to success or failure in TMD treatments, especially irreversible ones, such as TMJ implants, and to share this information with healthcare providers and regulators to support informed, patient-centered decision-making. 

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​TMJ Patient Led Roundtable

​

Key Stakeholders

 

​The TMJ Patient-Led RoundTable, operates under the auspices of Medical Devices Epidemiology Network (MDEpiNet), comprises key stakeholders as partners including TMJ Patients and Patient Advocacy Groups (specifically The TMJ Association), the FDA/Center for Devices and Radiological Health (CDRH), FDA/Center for Biologics Evaluation and Research (CBER), FDA/Office of Women’s Health (OWH), National Institute of Dental and Craniofacial Research (NIDCR), the Agency for Health Care Research and Quality (AHRQ), the Centers for Medicare and Medicaid Services (CMS), National Academies of Sciences, Engineering and Medicine TMD Forum representatives, Weill Cornell Medicine, TMJ implant manufacturers, American Association of Oral and Maxillofacial Surgeons (AAMOS), American Society of TMJ Surgeons (ASTMJS), clinicians, scientists, advocacy organizations, and other experts. Most importantly, the RoundTable is a vehicle in which patients play critical roles throughout all related activities.  

 

Monthly meetings with all stakeholders have been held since the 2016 inception of the TMJ Patient-led RoundTable.

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​Accomplishments

The first TMJ Patient-led RoundTable was held on June 16, 2016, at the FDA headquarters in Silver Spring, Maryland. The meeting led to the formation of a Steering Committee and four working groups, focused on (1) TMJ Patients: Natural History and Assessment of Biomarkers Associated with Outcomes in TMJ Implant Patients, (2) Patient Reported Outcomes Evaluation, (3) Physician and Patient Education/Patient-Centered Treatment, and (4) Data Collection and Analysis.

​

​The RoundTable reconvened on May 11, 2018, at the FDA Headquarters to update participants on the results of the working group projects, establish a roadmap to address highlighted gaps in knowledge regarding TMD, and identify data collection needs for the development of high-quality, real-world evidence (RWE). A key outcome was the recognition of the need for a Coordinated Registry Network (CRN) to collect accessible, relevant, and reliable TMD data.

​

Development of TMJ – CRN 

​These challenges were addressed in a multi-stakeholder environment, the Food and Drug Administration (FDA), TMJ Association, and Medical Device Epidemiology Network (MDEpiNet), in collaboration with many private and public sector thought leaders, launched the TMJ-CRN (as detailed in the TMJ Patient Roundtable Briefing Report). These collaborations included the FDA partnering with the HHS Office of Assistant Secretary for Planning and Evaluation (ASPE) Patient-Centered Outcomes Research Trust Fund (PCORTF). Specific objectives were to bridge the patient-centered outcomes research and innovation through the Community of Practice of Coordinated Registry Networks (CRNs) in 12 strategic clinical areas (as reported in the 2021 Annual ASPE Report),  including TMDs. With the support of FDA/ASPE/PCORTF grant, the development of the TMJ Coordinated Registry Network (TMJ-CRN) was launched in 2019. 

​The TMJ-CRN aims to develop the foundation for a national infrastructure for capturing real-world evidence in the TMD clinical space. This will ultimately help inform the development of scientifically robust, comprehensive treatment guidelines to enhance outcomes of TMD treatments based upon knowledge of a patient’s overall phenotype, disease progression, and treatment trajectory, while also improving the lives of patients suffering from TMD.

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​Goals of the TMJ-CRN

​The TMJ-CRN is currently building the national infrastructure needed to capture real-world evidence in TMD clinical care. It seeks to:

• Establish a standardized data infrastructure for capturing patient-generated data, physician experience, and related healthcare data

• Incorporate real-world evidence into regulatory and clinical decision-making, with a strong emphasis on patient-generated data

• Develop precision medicine algorithms that predict individual outcomes

• Support evidence-based clinical guidelines and inform professional health care curricula

 

With the accomplishment of these goals, real-world data will begin to fill in gaps in our knowledge of treatment outcomes and help establish scientifically based clinical treatment guidelines. In the future, this information will lead to new medical research that establishes precision treatments for the heterogeneous range of TMDs.

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​​​Identification of Core Minimum Dataset

​The minimum core data elements (mCDE) for the TMJ-CRN was developed using the Delphi method, with patients playing a substantial role in leading the initial identification and extraction of data elements. Their lived experience and perspective were essential to ensuring the dataset reflects what truly matters to those affected by TMDs.

The process began with the extraction of data elements from existing sources that identified conditions overlapping with TMD. These elements were reviewed and organized by both the informatics and clinical working groups, with strong input and oversight from patient leaders, to align each element with its context in the clinical workflow. This collaborative and patient-partnered approach helped ensure that the dataset would support research and care that are both scientifically valid and deeply patient-centered.

​

Publication: Gressler LE, Cowley T, Velezis M, Aryal S, Clare D, Kusiak JW, Cowley AW, Sedrakyan A, Marinac-Dabic D, Reardon M, Schmidt L, Feldman JG, DiFabio V, Bergman S, Simonyan V, Yesha Y, Vasiliu-Feltes I, Durham J, Steen AI, Woods P, Kapos FP, Loyo-Berrios N. Building the foundation for a modern patient-partnered infrastructure to study temporomandibular disorders. Front Digit Health. 2023 May 15;5:1132446. doi: 10.3389/fdgth.2023.1132446. PMID: 37255961; PMCID: PMC10226081.

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​Technological Platform TMJ-CRN

To ensure secure and accurate data collection, the TMJ-CRN leveraged the High-performance Integrated Virtual Environment (HIVE) platform. The identified core minimum data elements were defined in the context of technical implementation within HIVE web-application framework.

​Key features include:

• Permissioned blockchain technology to enhance data authenticity and security

• Immutable records of all data operations

• Consent tracking and validation through smart contracts

• Data cataloging and flexible data access

 

​The HIVE infrastructure was demonstrated in January 2021, successfully showcasing secure data collection, patient consent tracking, and system transparency.

The HIVE infrastructure was later used to conduct a patient module technical pilot utilizing the mCDEs.  The technical pilot was run in September/October 2024 with 38 patient participants. 

User Feedback Summary: Registry Form Usability Testing

Our recent usability testing revealed several key insights that will guide improvements to the registry forms:

 

Data Entry Challenges

• Medical history complexity: Participants found it challenging to enter comprehensive medical histories within the current form structure, suggesting a need for more intuitive data collection methods.

• Provider information recall: Gathering detailed provider information proved difficult for participants, particularly when multiple healthcare providers were involved in their care history.

 

Content and Instruction Improvements

• Treatment timeline clarity: Additional guidance is needed to help participants distinguish between past and current treatments when completing their entries.

• Disease-specific questioning: Form questions require better tailoring to accommodate complex disease progression patterns, as current wording doesn't adequately capture varied patient experiences.

 

Positive Findings

• Appropriate form length: Participants generally found the forms to be of reasonable length and not overly burdensome to complete.

 

Recommended Enhancements

• Expanded diagnostic scope: Consider incorporating additional diagnoses beyond TMJ that could contribute valuable data to the registry.

• Mental health integration: Include comprehensive mental health-related questions to capture the full scope of patient experiences and comorbidities.

 

These findings will inform our next iteration of form design to create a more user-friendly and comprehensive data collection experience.

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Special Meeting Series

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​The TMJ Patient-Led RoundTable Meeting Series: “TMJ Patients at Critical Crossroads”

Temporomandibular Disorders (TMD) affect millions of people worldwide, yet progress in developing effective treatments and comprehensive care has been limited. Following the 2023 "TMD at a Crossroads" meeting, experts identified critical barriers including insufficient funding, poor collaboration between healthcare disciplines, and limited access to specialized care.  The seven areas for improvement includes:

• Reframe TMD as a Complex Musculoskeletal Condition: Support translational research that better reflects the disorder's complexity

• Expand Treatment Options: Move beyond reliance on medical devices to include broader therapeutic approaches

• Strengthen Professional Education: Integrate interprofessional TMD curricula into medical and dental training programs

• Define Patient Engagement Roles: Establish clear frameworks for involving patients in their own care management

• Bridge Research and Treatment Gaps: Leverage sustainable opportunities to connect scientific findings with clinical practice

• Build Infrastructure: Establish Centers of Excellence and create a national TMJ Registry for better coordination

• Foster Interprofessional Care: Promote collaboration across healthcare disciplines (i.e., medical and dental)

 

These coordinated efforts aim to create a robust framework that addresses TMD's complexities, improves collaboration between healthcare professionals, and translates research into evidence-based care. Implementation of these recommendations could significantly improve patient quality of life and advance the entire field of TMD research and treatment.

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Meeting Series Information:

• September 12, 2023

• September 19, 2023

 

Publication Pending: TBD

​

Additional Resources

• TMJ Patient Roundtable Briefing Report

• A Priority Listing of Research Recommendations & Agency Assignments

• Diagnostics

• Dental Education Update

• Stigma

• Summary of TMJ Components and Repair

• TMD and Nutrition Summary

• TMD Treatment Meta-Analysis and Systematic Reviews

 

Relevant Publications

• 2020 National Academy of Sciences, Engineering, and Medicine report, Temporomandibular Disorders: Priorities for Research and Care

• Building the Foundation for a Modern Patient-partnered Infrastructure to Study Temporomandibular Disorders

• Focus Groups to Inform the Development of a Patient-Reported Outcome Measure (PROM) for Temporomandibular Joint Disorders (TMDs)

• How Dental Teams Can Help Patients with Temporomandibular Disorders Receive General Dental Care: An International Delphi Process

• Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks 

Coordinators
 

Deanne Clare (Logistics)

Martha Velezis, MPH, MS (Informatics)