Evidence map›Paper›PMID 30117635›Full record

ArticleNeuromodulation : journal of the International Neuromodulation Society2019

Spinal Cord Stimulation Infection Rate and Risk Factors: Results From a United States Payer Database.

Steven M Falowski, David A Provenzano, Ying Xia, Alissa H Doth

Registry-linked trialAbstract read
In one paragraph

Article in Neuromodulation : journal of the International Neuromodulation Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05373654 (Observational, Prospective, Monocentric Study, Assessing the Use of Rechargeable Spinal Cord Stimulators for the Treatment of Neuropathic Pain. Quantitative and Qualitative Evaluation Protocol), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05373654 nacompletednot on this mapstarted 2023, after this paper: background citation

Observational, Prospective, Monocentric Study, Assessing the Use of Rechargeable Spinal Cord Stimulators for the Treatment of Neuropathic Pain. Quantitative and Qualitative Evaluation Protocol

TypeinterventionalSponsorElsanRan2023 to 2023Enrolled50ConditionsNeuropathic PainArmsF-SUS Questionnaire, Interview (only for dissatisfied patients)
3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Postoperative Infections Associated With Prolonged Spinal Cord Stimulation Trial Duration (PROMISE RCT).Neuromodulation : journal of the International Neuromodulation Society · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Steven M FalowskiSt. Luke's University Health Network, Bethlehem, PA, USA.
David A ProvenzanoPain Diagnostics and Interventional Care, Sewickley, PA, USA.
Ying XiaDepartment of Health Economics and Outcomes Research, Medtronic, Health Economics and Outcomes Research, Minneapolis, MN, USA.
Alissa H DothDepartment of Health Economics and Outcomes Research, Medtronic, Health Economics and Outcomes Research, Minneapolis, MN, USA.ORCID https://orcid.org/0000-0003-4176-9652

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveSurgical site infections can cause negative clinical and economic outcomes. A recent international survey on Spinal Cord Stimulation (SCS) infection control practices demonstrated low compliance with evidence-based guidelines. This study defines infection rate for SCS implants and identifies infection risk factors. MATERIALS AND

methodsA retrospective analysis of the MarketScan® Databases identified patients with SCS implant (2009-2014) and continuous health plan enrollment for ≥12-months (12 m) preimplant. For logistic regression analysis, patients were enrolled for 12 m postimplant. Kaplan-Meier and Cox Proportional Hazard survival analyses assessed time to infection, with infection rate reported at 12 m postimplant. Logistic regression characterized risk factors based on demographics, comorbidities, and clinical characteristics.

resultsIn the logistic regression (n = 6615), 12 m device-related infection rate was 3.11%. Infection risk factors included peripheral vascular disease (OR, 1.784; 95% CI: 1.011-3.149; p = 0.0457) and infection in 12 m before implant (OR, 1.518; 95% CI: 1.022-2.254; p = 0.0386). The odds of patients experiencing an infection decreased by 3.2% with each additional year of age (OR, 0.968; 95% CI: 0.952-0.984; p < 0.0001). Survival analysis (n = 13,214) identified prior infection (HR, 1.770; 95% CI: 1.342-2.336; p < 0.0001) as a risk factor. Infection was less likely in older patients (HR, 0.974; 95% CI: 0.962-0.986; p < 0.0001). Expected risk factors including obesity, diabetes, and smoking were not identified as risk factors in this analysis. There was no significant difference between infection rate for initial and replacement implants.

conclusionsThe 3.11% SCS-related infection rate within 12 m of implant emphasizes the need for improved infection control practices. Research is needed to limit SCS infections in younger patients and those with infection history.

Indexed as

AdultAgedChronic PainFemaleHumansMaleMiddle AgedRegression AnalysisRetrospective StudiesRisk FactorsSpinal Cord StimulationSurgical Wound InfectionSurvival AnalysisTime FactorsUnited StatesComplicationhealthcare utilizationinfectionspinal cord stimulation

Identifiers

PMID30117635
PMCPMC6585777

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.