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Record W4317868489 · doi:10.2217/pmt-2022-0091

Long-term Safety of Spinal Cord Stimulation Systems in A Prospective, Global Registry of Patients With Chronic Pain

2023· article· en· W4317868489 on OpenAlex
Richard Rauck, Eric Loudermilk, Simon Thomson, J. Paz, Louis Bojrab, John Noles, Jan Vesper, Joseph Atallah, Daniel Roth, Joseph Hegarty, Michel Prudhomme, Gregory M Phillips, Stephen G. Smith, Mohab Ibrahim, Channing D Willoughby, Jon B. Obray, Mayank Gupta, Julio Paez, Anthony Berg, Nathan J. Harrison, Paolo Maino, Praveen Mambalam, Matthew McCarty, Glyn Towlerton, Sarah Love‐Jones, Shakil Ahmed, Albert Lee, Binit Shah, Itay Goor‐Aryeh, Marc Russo, Nicolás Díaz Varela, Jeffrey B Phelps, J. Cid, Tacson Fernandez, Concepción Pérez, Douglas Keehn, Joshua M. Rosenow, Nameer Haider, Andrew G. Parrent, Melinda M. Lawrence, Peter Georgius, Laura Demartini, Agustin Mendiola, Vivek Mehta, R. Thoma, Atef F. Israel, Giuliano De Carolis, Sanjay Bhatia, Matthew Green, Armando Villarreal, Matthew T Crooks, Ryder P. Gwinn, Julie G. Pilitsis, Hitoaki Sato, Sergio Maldonado Vega, M. Gabriel Hillegass, Paul Carnes, Christian Scherer, Silviu Brill, James Yu, James Brennan, Kliment Gatzinsky, Annu Navani, Lee T Snook, Borja Mugabure Bujedo, Javier De Andrés Ares, Abel Murillo, Andrew Trobridge, Kamyar Assil, Jawad Ali Shah, Carroll McLeod, Joseph Buwembo, Olivier De Coster, Nathan Miller, Mehendra Sanapati, Medhat Mikhael, Rene Przkora, Norihiko Sukenaga, Louis J. Raso, Aaron Calodney, Luz Elena Cáceres Jerez, Takuya Uchiyama, Jan Willem Kallewaard, Brett Chandler, Fabián Piedimonte, Kenneth D. Candido, Tristan Weaver, Takashi Agari, David Holthouse, Rex Woon, Nileshkumar Patel, Kristen Lechleiter, Roshini Jain

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

affAt least one author lists a Canadian institution in the pinned OpenAlex snapshot.

Bibliographic record

VenuePain Management · 2023
Typearticle
Languageen
FieldMedicine
TopicPain Management and Treatment
Canadian institutionsUniversity of SaskatchewanLondon Health Sciences CentreWestern UniversityUniversité Laval
FundersBoston Scientific Corporation
KeywordsMedicineChronic painSpinal cord stimulationTerm (time)Physical medicine and rehabilitationStimulationProspective cohort studySpinal cordPhysical therapyInternal medicinePsychiatry

Abstract

fetched live from OpenAlex

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov)

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.037
Threshold uncertainty score0.604

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.012
GPT teacher head0.273
Teacher spread0.260 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it