TMJ CRN

Background

Temporomandibular disorders (TMD) are common disabling conditions and from 6% to 12% of the population is estimated to experience clinical symptoms23. The treatments include many devices that have limited evidence of safety and effectiveness and little comparative data is available. Data on long-term outcomes is particularly limited, leading to use of trial-and-error approach in treating patients. As a result, some patients develop serious conditions including worsened chronic pain, facial paralysis, disfigurement, infection, device migration within the skull, reduced jaw mobility, increased opioid use and dependence, increased suicidality, and other serious adverse events.

There is an urgent need to understand factors that lead to patients’ experiences of success or failure for all TMD treatments, especially those that are irreversible such as temporomandibular joint implants, and, to share these with health care professionals and regulators for informed decision-making. The TMJ CRN was initiated by MDEpiNet to address these issues. The project aims to ultimately inform the development of scientificallyrobust, 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.

Objectives

The main objective of the TMJ CRN is to develop a standardized data infrastructure for capturing patient-generated data, physician experience, and other healthcare ecosystem data necessary to better understand the disparate treatment pathways and outcomes that patients experience. Another goal is to change clinical trial conduct to incorporate patient preference and real-world experience into FDA-regulated and public health trials, beginning with medical devices. The CRN also aims to provide a roadmap for the development of precision medicine algorithms that predict individual outcomes from TMJ therapies, and develop evidence-based protocols, guidelines, and best practices for inclusion in professional health care curriculums.

Partnership Structure

The TMJ-CRN consists of a partnership between the FDA/CDRH, The TMJ Association, AHRQ, Device Manufacturers, FDA/CDER, FDA/OWH, TMJ Patients, Weill Cornell Medicine, and the National Institute of Dental and Craniofacial Research. The TMJ Patient-Led Round Table is supported by a number of agencies including MDEpiNet, The TMJ Association, TMJ Patients, the FDA, National Institute of Dental and Craniofacial Research, FDA/OWH, American Association of Oral and Maxillofacial Surgeons, American Society of Temporomandibular Joint Surgeons, Zimmer Biomet, TMJ Concepts, clinicians, scientists, advocacy organizations, and other experts, all under the auspices of MDEpiNet. The Steering Committee consists of the participating organization listed above.

Four Working Groups have been established focusing on:

  • TMJ Patients: Natural History and Assessment of Biomarkers Associated with Outcomes in TMJ Implant Patients<\li>
  • PRO Evaluation<\li>
  • Physician and Patient Education/Patient-Centered Treatment<\li>
  • Data Collection and Analysis<\li>

Existing agreements
MDEpiNet Coordinating Center established MOU with the CRN’s Leads, including with Terrie Cowley (TMJ Association).

Data Infrastructure

Patient population
The patient population for this CRN includes individuals diagnosed with or receiving treatment for TMJ disorders.

Data sources
The development of a TMJ specific registry is underway. Registries of common overlapping conditions are identified and will be linked and used to perform research evaluating TMJ-related procedures. Examples of common overlapping conditions and registries include the Get with the Guidelines Registry from the AHA for stroke, the Multiple Sclerosis Registry for multiple sclerosis, and the Kaiser Permanent Spine Registry Database for functional disorders of the upper cervical spine. Claims data analyses can also help address specific issues related to reoperations after implant use.

Current Projects and Plans

Current projects for TMJ CRN include the development of a minimum core dataset through the Delphi method and focus on pilot studies to test the data collection methods. The developed minimum core data set of elements will be vetted by the multi-stakeholder community via formal consensus building. The core dataset elements will include a data dictionary with permissible values sets, adherence to international standards, and capture by the NLM’s repository of common data elements. The development of the minimum core dataset is anticipated to take approximately 4 to 6 months. The Delphi process will require approximately 2 to 4 additional months. All pilots are anticipated to be completed within a 3-year timeframe. Following the completion of these projects, a report evaluating these processes will be generated and submitted for publication. The CRN is also planning exploratory claims data analyses and protocol is in development as well.