Abstract
Background
An unprecedented volume of interventional procedures has entered the pain medicine market, including many “advanced” interventional pain procedures. Given the rapid influx, there is concern that there is discordance between what is taught in pain medicine fellowship programs and done in post-graduate practice.
Objective
The goal of the study was to compare sales volumes of advanced procedure devices in academic versus non-academic practice settings to better understand the status quo of procedural practice patterns. This information will be critical to establish a baseline understanding of where advanced pain procedures are happening for future comparison.
Methods
This cross-sectional observational study examines relative percentages of industry-reported device sales to academic versus non-academic practices from January 1, 2023 to December 31, 2023 in predefined regions of the United States. The data were tabulated and reported as means with corresponding ranges.
Results
Six companies, representing nine distinct interventional pain procedures, certified the requested data. The region with the lowest relative mean device sales at academic institutions was the West (10 %) and the highest was the Northeast (22 %). The procedure with the lowest relative mean sales at academic institutions was dorsal root ganglion stimulation (4 %) and the highest was vertebral body cooled radiofrequency for bone tumors (30 %).
Conclusion
This study highlights the difference between the relative percentage sales of advanced procedure devices in non-academic versus academic institutions, favoring non-academic sites of service. Yet, for each reported pain procedure, there were device sales in academic settings for almost all regions. It will be essential to continue to monitor how academic procedural training compares to post-graduate practice realities to tailor future educational offerings.
1. Introduction
The Accreditation Council for Graduate Medical Education (ACGME) Program Requirements for Graduate Medical Education in Pain Medicine lists a core requirement (IV.B.1.b.2) as “fellows must be able to perform all medical, diagnostic, and surgical procedures considered essential for the area of practice.”[1] Yet, as an unprecedented volume of interventional procedures has entered the pain medicine market, there is concern that comprehensive fellowship education regarding these therapies may be lagging behind [2].
Several survey studies have examined volumes of advanced procedures performed in pain medicine fellowship. One study by Mahmoud, with a 17 % response rate, surveyed pain medicine fellows and 68.5 % reported less than five targeted drug delivery surgical implants during their fellowship [3].
Another survey of 2016-17 academic year pain medicine fellows with an overall response rate of 14 %, showed that 7.5 % of respondents did not perform any spinal cord stimulator implants during fellowship [4]. Pak et al. concluded that current fellows were more likely to have received any spinal cord stimulator trial and/or implant training during fellowship compared with past fellows (100 % versus 84 %), yet there was significant institutional variability in volumes of procedure performed [4].
Lastly, a study by Woodrow et al. with a response rate of 30 % of pain medicine fellows during the 2021-22 academic year showed a median number of 10 spinal cord stimulator implantations, 2 peripheral nerve stimulator implantations, 2 vertebral augmentations, 1.5 targeted drug delivery implantations and 0 vertebral body radiofrequency ablations for bone tumors, performed by survey responders during the fellowship [5].
The goal of this study was to compare relative differences in academic versus non-academic advanced procedure device sales obtained directly from the companies to establish a baseline understanding of where advanced pain procedures are happening. This field of study may ultimately inform changes in the pain medicine fellowship curriculum.
We hypothesized that non-academic practices would have higher relative device sales compared to academic practices for all the selected procedures.
2. Methods
We conducted this cross-sectional observational study examining relative percentage sales of the procedures of interest performed in academic versus non-academic hospitals from January 1, 2023 to December 31, 2023 divided into predefined regions of the United States. The Oregon Health & Sciences University Institutional Review Board (IRB) waived oversight of this study (STUDY00027228) as it was determined not to be human subjects research.
First, the study team defined the advanced procedures of interest and their corresponding companies, including dorsal root ganglion stimulation (Abbott), peripheral nerve stimulation (SPR therapeutics, Curonix, Stimwave, Bioventus, Nalu), restorative multifidus stimulation (Mainstay Medical), basivertebral nerve ablation (Relievant), targeted drug delivery (Medtronic), minimally invasive sacroiliac joint fusion (Painteq, Aurora, Cornerloc, SI Bone), vertebral augmentation – kyphoplasty and vertebroplasty (Medtronic, Joline GmbH, Carefusion, GS Medical, Stryker, Heraeus), vertebral body radiofrequency ablation (Medtronic, Stryker), minimally invasive lumbar spine decompression (Vertos), and interspinous fusion devices (Spinal Simplicity, Aurora).
Next, the study team contacted company leadership requesting sales data organized by academic and non-academic sales as well as subdivided by pre-defined regions. Academic versus non-academic hospitals were defined by the Accreditation Council for Graduate Medical Education (ACGME) public list of Pain Medicine (Multidisciplinary) Programs. The regions were designated as follows: West (CA, OR, WA, NV, ID, MT, WY, UT, CO, AK, HI), Southwest (AZ, NM, OK, TX), Midwest (ND, SD, NE, KS, MN, IA, MO, WI, IL, IN, MI, OH), Northeast (ME, NH, VT, MA, CT, RI, NY, PA, NJ, DE, MD), and Southeast (DC, WV, VA, KY, TN, NC, SC, AR, LA, MS, AL, GA, FL).
If the company confirmed the relative sales data percentages were exact and not estimates, the data was included. Companies that declined to provide and/or certify their relative sales data were excluded.
Lastly, the data was tabulated and reported as means with corresponding ranges. Because the data were population data, estimation of confidence intervals or other measures of uncertainty were not necessary.
3. Results
Eight companies, representing eleven devices and ten distinct interventional pain procedures, agreed to provide data. The data from two of these companies were excluded. The data from the first company was excluded because the numbers provided were estimates. The data from the second company was excluded as the original company had since been acquired by a new company, who would not certify the data. All remaining companies signed a Data Certification and Use Agreement.
For all advanced procedures in all regions, there were more relative device sales at non-academic sites of service compared to academic sites. The largest regional discrepancies for percentage sales were 100 % non-academic and 0 % academic for multifidus stimulation, dorsal root ganglion stimulation and peripheral nerve stimulation (Curonix) in the Southwest region (Table 1).
Table 1.
Relative percentages of advance procedure device sales in academic versus non-academic practice by region.
| Region | Institution type | SI (Aurora) | ISP (Aurora) | Multifidus (Mainstay) | DRG (Abbott) | PNS (SPR) | PNS (Curonix) | BKP (Medtronic) | V-RFA (Medtronic) | TDD (Medtronic) | VP (Medtronic) | Row Mean (Range) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall | Non-academic | 80 % | 89 % | 81 % | 96 % | 85 % | 97 % | 88 % | 70 % | 72 % | 84 % | 84 % (70 %–96 %) |
| Academic | 20 % | 11 % | 19 % | 4 % | 15 % | 3 % | 12 % | 30 % | 28 % | 16 % | 16 % (3 %–30 %) | |
| West | Non-academic | 94 % | 97 % | 93 % | 96 % | 87 % | 99 % | 90 % | 77 % | 81 % | 86 % | 90 % (77 %–99 %) |
| Academic | 6 % | 3 % | 7 % | 4 % | 13 % | 1 % | 10 % | 23 % | 19 % | 14 % | 10 % (1 %–23 %) | |
| Southwest | Non-academic | 69 % | 76 % | 100 % | 100 % | 89 % | 100 % | 94 % | 69 % | 76 % | 86 % | 86 % (69 %–100 %) |
| Academic | 31 % | 24 % | 0 % | 0 % | 11 % | 0 % | 7 % | 31 % | 24 % | 14 % | 14 % (0 %–31 %) | |
| Midwest | Non-academic | 81 % | 59 % | 77 % | 96 % | 88 % | 92 % | 91 % | 69 % | 73 % | 84 % | 81 % (59 %–96 %) |
| Academic | 19 % | 41 % | 23 % | 4 % | 12 % | 8 % | 9 % | 31 % | 27 % | 17 % | 19 % (4 %–41 %) | |
| Southeast | Non-academic | 61 % | 77 % | 79 % | 94 % | 80 % | 97 % | 91 % | 77 % | 77 % | 89 % | 82 % (61 %–97 %) |
| Academic | 39 % | 23 % | 21 % | 6 % | 20 % | 3 % | 9 % | 23 % | 23 % | 11 % | 18 % (3 %–39 %) | |
|
Northeast |
Non-academic | 92 % | 98 % | 79 % | 92 % | 83 % | 87 % | 72 % | 57 % | 48 % | 68 % | 78 % (48 %–98 %) |
|
Academic |
8 % |
2 % |
21 % |
8 % |
17 % |
13 % |
28 % |
43 % |
52 % |
33 % |
22 % (2 %–52 %) |
|
| Column Mean (Range) | Non-academic | 79 % (61 %–94 %) | 81 % (59 %–98 %) | 86 % (77 %–100 %) | 96 % (92 %–100 %) | 85 % (80 %–89 %) | 95 % (87 %–100 %) | 88 % (72 %–94 %) | 70 % (57 %–77 %) | 71 % (48 %–81 %) | 82 % (68 %–89 %) | |
| Academic | 21 % (6 %–39 %) | 19 % (2 %–41 %) | 14 % (0 %–23 %) | 4 % (0 %–8 %) | 15 % (11 %–20 %) | 5 % (0 %–13 %) | 12 % (7 %–28 %) | 30 % (23 %–43 %) | 29 % (19 %–52 %) | 18 % (11 %–33 %) |
Abbreviations: SI, sacroiliac joint fusion; ISP, interspinous fusion device; DRG, dorsal root ganglion stimulation; PNS, peripheral nerve stimulation; BKP, vertebral augmentation – balloon kyphoplasty; V-RFA, vertebral body radiofrequency ablation for spine tumors; TDD, targeted drug delivery; VP, vertebral augmentation – vertebroplasty.
The procedures with the lowest overall relative mean sales at academic institutions were dorsal root ganglion stimulation (4 %), peripheral nerve stimulation (Curonix) (5 %), and minimally invasive lumbar decompression (7 %). The procedures with the highest overall relative mean sales at academic institutions were interspinous fusion (19 %), sacroiliac joint fusion (21 %), targeted drug delivery (29 %), and vertebral body cooled radiofrequency for bone tumors (30 %) (Table 1).
The region with the lowest overall relative mean sales at academic institutions was the West (10 %) and the highest was the Northeast (22 %) (Table 1).
4. Discussion
4.1. Sales data interpretation
This study highlights relatively higher sales of advanced procedure devices in non-academic sites of service compared to academic institutions for all included devices. Yet, for each advanced procedure, there were device sales in academic settings for almost all regions. The only exceptions were in the Southwest there were no device sales for multifidus stimulation and dorsal root ganglion stimulation in academic settings.
There are several possible explanations why academic practices have lower relative sales to non-academic sites of service. First, it is likely that relatively fewer patients are seen at academic practices, which would account for proportionally lower device sales. Unfortunately, the actual volume of patients seen for their pain at academic versus non-academic sites of service is unknown and the data not available. Without this information, we are unable to definitively conclude that the low relative percentages of advanced procedure device sales are proportionally low compared to populations served at these sites of service.
Second, academic practices may be institutionally restricted in adopting new procedures until there is sufficient high-quality evidence to support the therapy; while non-academic practices may have less red tape to become “early adopters.” Furthermore, in certain regions of the country, insurance coverage for these therapies may be “investigational” or “non-covered,” which also limits implementation. Other barriers to new device utilization include lengthy administrative approval processes, unappealing purchase agreements, and institutional politics with other specialties.
Third, some academic physicians may argue that these advanced procedure technologies do not represent the standard of care, and thus it is not essential to include them in the pain medicine curriculum. Others may purport that learning the necessary anatomy, procedural skills, and critical thinking through “bread-and-butter” pain procedures translates to being able to perform the advanced procedures later.
However, if ongoing research in this field ultimately shows an increasing difference between the procedures taught in academic practices and those done in post-graduate practices, one must question whether this is at odds with the ACGME core requirement (IV.B.1.b.2) of being able to perform all essential procedures for the area of practice.
4.2. Study limitations
There are limitations inherent to our study. First, not all contacted companies provided the requested information thus some regions may have exposure to these procedural types but use a company that did not participate in the study; for example, there are several peripheral nerve stimulation companies and only two of them provided sales data.
Second, while the data depicts the relative number of devices sold, it is unknown how this translates into number of advanced procedure cases per fellow.
Similarly, as the companies only agreed to publish relative sales data, the absolute volume of procedures performed in both academic and non-academic sites of service is not shared in this publication.
4.3. Future considerations
It will be essential to continue to monitor trends in how academic practice compares to post-academic practice realities to tailor future educational offerings. Continued collaboration with industry will be crucial.
Our expectation is that through this report, industry will continue to recognize the mutual benefit of collaboration; as a result, for future research studies we anticipate more companies will agree to participate and will also provide absolute sales data volumes, which will strengthen the utility of these reports.
5. Conclusion
Despite the limitations, we propose that our novel data source - industry sales data - is superior to data acquired by surveying practices, which is prone to response bias, non-response bias, recall bias, and missing data.
For almost all the advanced pain procedures, there were device sales in academic settings indicating that some pain medicine fellows are exposed to these therapies. This is particularly important because from the results of the study by Woodrow et al., [5] we learned that performing an interventional pain procedure once or more was strongly associated (p ≤ 0.002) with comfort performing it in post-graduate practice. Thus, by deduction, a non-zero exposure to an interventional pain therapy in academic practice is important [5].
Lastly, while the scope of this study was to compare relative sales volumes of advanced procedure devices to better understand the status quo of procedural practice patterns, we acknowledge that performing procedures is only one facet of overall pain medicine training. Specifically, we recognize that comprehensive pain medicine fellowship training includes more than procedural skills, and exposure to procedures does not necessarily equate to competence performing them.
Disclosures
Dr. Christiansen, Dr. Garcia, Dr. Jimenez and Dr. Rakshe do not have any conflicts of interest to disclose.
Author contributions
Sandy Christiansen, MD: This author designed the study, collected the data, wrote the manuscript, and prepared the manuscript for submission.
Rosa Garcia, MD: This author designed the study, wrote the manuscript, and prepared the manuscript for submission.
Daniel A. Jimenez DO, MPH: This author designed the study, wrote the manuscript, and prepared the manuscript for submission.
Shauna Rakshe, PhD: This author analyzed the data, wrote the manuscript, and prepared the manuscript for submission.
Funding
None.
Declaration of competing interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
References
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