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02 North American Neuromodulation Society Educational Curriculum for Intrathecal Drug Delivery Systems Implantation and Mana…

Neuromodulation: Technology at the Neural

Interface
Volume 26, Issue 6, August 2023, Pages 1208-1217

Clinical Science

North American Neuromodulation Society Educational

Curriculum for Intrathecal Drug Delivery Systems
Implantation and Management
Gassan Chaiban MD 1, Rany T. Abdallah MD, PhD, MBA 2, Alaa Abd-Elsayed MD 3, Hemant Kalia MD 4, Mark Malinowski DO 5,
Anuj Bhatia MD 6, Adam Burkey MD, MSCE 7, Alexios Carayannopoulos DO, MPH 8, Sandy Christiansen MD 9, Jay Karri MD 10,
Eric Lee MD 11, Tariq Malik MD 12, Kate Meacham MD, PhD 13, Vwaire J.E. Orhurhu MD, MPH 14, Jeffrey S. Raskin MD, MS 15,
Eellan Sivanesan MD 16, Reda Tolba MD 17, Ahmed M. Raslan MD 18

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Abstract

Objectives
Intrathecal drug delivery systems (IDDSs) are used for the treatment of pain and spasticity. A wide range of educational
criteria exist for these devices. The North American Neuromodulation Society (NANS) Education Committee developed
a comprehensive IDDS curriculum to function as a standard for physician graduate education and assessment through
training and into practice.

Material and Methods

A multidisciplinary and diverse task force gathered by the NANS Education Committee met in person and virtually over
several sessions and developed an IDDS curriculum modeling their previous work on spinal cord stimulation and
following the Accreditation Council for Graduate Medical Education (ACGME) Milestones. There were iterative
revisions and adaptations to the curriculum, and the final version was approved by the NANS Board of Directors.

Results
The curriculum was developed with distinction between implanting physicians and managing physician and
physicians who perform both tasks. There is a lateral temporal progression from early learner to practitioner, with
advanced learner in the middle. In addition, there is a modular vertical organization that divides the curriculum into
the six educational competencies outlined by the ACGME.

Conclusion
A comprehensive, modular, graduated, and segmented educational curriculum for IDDSs was developed by NANS. We
propose the curriculum to be the standard for guidance and assessment of trainees and physicians pursuing training in
implanting or managing IDDSs.

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Introduction

Intrathecal drug delivery systems (IDDSs) are devices used for pharmacologic neuromodulation of the central nervous
system (primarily the spinal cord); implantation and use for the treatment of intractable chronic pain and spasticity
were introduced in the 1980s.1 IDDSs have gone through several iterative evolutionary phases. The most recent version
consists of a subcutaneous electronic programmable pump and medication reservoir connected to an intrathecal
catheter.2 The system delivers medication directly into the cerebrospinal fluid with the purpose of targeting neural
cellular substrates in the spinal cord.2 Although most IDDSs have been implanted and managed by neurosurgeons and
pain physicians, the field has expanded to include a variety of specialists. Physicians implanting or managing IDDSs
matriculate/graduate from multiple primary specialties including anesthesiology, emergency medicine, neurology,
neurosurgery, physical medicine and rehabilitation, and psychiatry, among others. Each specialty is founded on a
unique skill set, which leads to significant practice variability with regard to IDDS implantation and management
(practice models). Without a standardized rubric for IDDS training and assessment, multiple training pathways can
lead to different IDDS practice models. Clinical management varies from individual practitioners who comprehensively
trial, implant, and medically manage their patients to those who may only medically manage the IDDS therapy while
referring to neurosurgeons or spine surgeons for implantation. Research of IDDS clinical indications, pharmacotherapy,
and device design is constantly progressing with increasing complexity and ubiquitous use. The evolving complexity of
IDDSs underscores the need for a standardized training curriculum in the pursuit of a safe practice model of intrathecal
drug delivery.3,4

Every specialty that potentially trains physicians to eventually become implanters or managers of IDDSs has an
Accreditation Council for Graduate Medical Education (ACGME) Milestones training matrix that offers broad guidance
on ensuring quality of training,5 but a systematic IDDS-focused, milestones-based curriculum is lacking. There is a lack
of consistency across various accredited residency and fellowship programs regarding safe and comprehensive
management of IDDSs.

The creation of a curriculum is intended to provide a concrete outline based on core competencies ensuring that
graduates of different specialty training programs be able to comprehensively manage all aspects of IDDSs, including
choosing appropriate medication(s), trialing medication(s), making educated decisions based on trials, device
implantation, and safe long-term management of patients with an IDDS.3

A multidisciplinary task force was formed by the education committee of the North American Neuromodulation
Society (NANS) to promulgate a training curriculum for IDDSs that takes into consideration the primary skill set of the
practitioners and the level of involvement they have in the scope of their practice as proceduralist only, managing
physician only, or both. Although created de novo, the curriculum is modeled after and plays a similar role to the
recently published spinal cord stimulator curriculum published by NANS.6 The curriculum also is structured following
the ACGME six core competencies: medical knowledge, patient care and procedural skills, systems-based practice,
interpersonal skills and communication, practice-based learning, and professionalism. A guiding principle was that
technical and medical knowledge is necessary but not sufficient for successful outcomes in patients with an IDDS.7
Successful clinical outcomes in patients with an IDDS require a collaborative team approach in managing adverse
events such as bleeding, infection, and neurological sequelae or troubleshooting mechanical issues.10, 8, 9 This team
approach also is crucial for optimal long-term management of intrathecal medication administration, programming
interrogations and adjustments, and device medication refills. Long-term intrathecal therapy could be impacted by
physiological dependence and tolerance to medications, changing health conditions, psychologic disturbances, and
social situations.8 It also is important to consider the role a physician plays in managing or consulting patients
receiving intrathecal therapy as part of a larger health system. There is a need for high-quality coordinated medical and
surgical care for comorbidities through consultation, education, and collaboration with other physicians regarding
concerns that may not be directly “pain-related” in patients with an IDDS to optimize outcomes and experience.11,12

Section snippets

Goals and Objectives

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12/11/23, 16.02 North American Neuromodulation Society Educational Curriculum for Intrathecal Drug Delivery Systems Implantation and Mana…

The uniform management of IDDSs is affected by the variability in training within each specialty and across specialties.
This variability makes the preparation and implementation of the curriculum challenging; however, it is the impetus
behind this standardized rubric (curriculum). The rubric defines the core knowledge and skill set(s) that span
disciplinary boundaries to establish a standard in training and ultimately lead to improved patient outcomes.

This IDDS curriculum is intended to be a…

Materials and Methods

A multidisciplinary and diverse task force including neurosurgeons, anesthesiologists, physiatrists, and neurologists
was formed by the education committee of NANS with invited members of the International Neuromodulation Society
(INS) in January 2019. The task force primarily comprised volunteer members of the NANS Education Committee. In
addition, the membership was solicited from the INS Education Committee. To ensure multidisciplinary and diverse
representation, task force membership…

Results

Complete lateral (temporal) progression from early learner to advanced learner and then independent practitioner was
followed for the vast majority of line items. The advanced learner was expected to have already fulfilled all
requirements for the early learner. Furthermore, the practitioner has to fulfill requirements that do not include an
earlier line item, which was expected of the practitioner but not of the advanced or early learner. This accounts for
empty spaces in the curriculum. The…

Limitations

The curriculum was developed by the NANS Education Committee, whose members are mostly located in the United
States. Although there were two task force representatives from Canada and the United Arab Emirates, task force
membership and hence curriculum development could be biased in favor of US health care standards. However, the
task force intentionally refrained from benchmarking practices against US standards such as those of the US Food and
Drug Administration.

To maintain an operationally…

Conclusions and Recommendations

We propose the adoption of the IDDS curriculum (Table 2)5, 6, 7, 8, 9,11,12,16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28,
29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60 as a
standardized instrument for guidance and assessment of both trainers and trainees of IDDSs across multiple
specialties. It also can be used to guide the development of texts and standardized assessment and credentialing
efforts.…

Next Steps

The IDDS curriculum will be used to develop educational texts, standardized assessments, and credentialing for
trainees. Using the curriculum as an evaluation framework, a post hoc certification procedural skill in IDDS
implantation and management for trainees will be offered by the NANS. Research to evaluate the degree of IDDS
curriculum adoption and impact on trainee education is proposed.…

Acknowledgements
The authors thank Dr Shirley McCartney for their editorial support during the preparation of this article.…

Authorship Statement

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12/11/23, 16.02 North American Neuromodulation Society Educational Curriculum for Intrathecal Drug Delivery Systems Implantation and Mana…

All authors contributed to the design, development of the curriculum, and writing of the final manuscript.…

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…The Education Committee of the North American Neuromodulation Society (NANS) convened to create a training curriculum for
the specialists who will be involved with PNS therapy (Tables 1–6). This current document provides a roadmap for a competency-
based curriculum analogous to the training requirements created for SCS and intrathecal drug delivery systems (IDDS).6,7 An
international multidisciplinary diverse task force was formed by the members of education committees of NANS and the
International Neuromodulation Society (INS), which included neurosurgeons, anesthesiologists, physiatrists, neurologists, and
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Source(s) of financial support: This study was supported by the North American Neuromodulation Society.

Conflict of Interest: Alaa Abd-Elsayed reports stock options from Micron, Thermaquel, Clere, Harvard MedTech, and Neuronoff and
consulting fees from Medtronic and Avanos. Gassan Chaiban reports consulting fees from Boston Scientific. Alexios Carayannopoulos
reports serving on a data safety monitoring or advisory board for Saluda Medical. Reda Tolba reports consulting fees from Medtronic and
Abbott. Rany T. Abdallah reports consulting fees from Avanos and Medtronic and payment or honoraria from Abbott, Avanos, and
Medtronic. Vwaire J.E. Orhurhu reports consulting fees from Medtronic and Boston Scientific. Jeffrey S. Raskin reports lecture fees from
Medtronic. Anuj Bhatia reports consulting fees from Bioventus and travel support from Medtronic. Mark Malinowski reports consulting and
speaker fees from Abbott, Nalu, and SI-Bone. The remaining authors reported no conflict of interest.

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