Evidence map›Paper›PMID 25523380›Full record

ArticleThe spine journal : official journal of the North American Spine Society2015

Use of bone morphogenetic protein among patients undergoing fusion for degenerative diagnoses in the United States, 2002 to 2012.

Brook I Martin, Jon D Lurie, Anna N A Tosteson, Richard A Deyo, Farrokh R Farrokhi, Sohail K Mirza

Abstract read
In one paragraph

Article in The spine journal : official journal of the North American Spine Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Current and Future Concepts for the Treatment of Impaired Fracture Healing.International journal of molecular sciences · 2019
    Review
  5. Article
  6. The Biological Enhancement of Spinal Fusion for Spinal Degenerative Disease.International journal of molecular sciences · 2018
    Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
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

6 authors.

Brook I MartinThe Dartmouth Institute for Health Policy and Clinical Practice, 35 Centerra Parkway, Lebanon, NH 03766, USA; Department of Orthopaedic Surgery Dartmouth-Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH 03756, USA. Electronic address: Brook.I.Martin@Dartmouth.edu.
Jon D LurieThe Dartmouth Institute for Health Policy and Clinical Practice, 35 Centerra Parkway, Lebanon, NH 03766, USA; Department of Orthopaedic Surgery Dartmouth-Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH 03756, USA; Department of Medicine, Dartmouth-Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH 03756, USA.
Anna N A TostesonThe Dartmouth Institute for Health Policy and Clinical Practice, 35 Centerra Parkway, Lebanon, NH 03766, USA; Department of Community and Family Medicine. Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03756, USA.
Richard A DeyoDepartment of Family Medicine, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239, USA; Department of Medicine, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239, USA; Department of Public Health & Preventive Medicine, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239, USA.
Farrokh R FarrokhiDepartment of Neurosurgery, Virginia Mason Medical Center, 1100 9th Ave., Mail Stop X7-NS, Seattle, WA 98111, USA.
Sohail K MirzaDepartment of Medicine, Dartmouth-Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH 03756, USA.

Funding

Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Steven D Leach · 1985 to 2026
$91.3M
Outcomes Calculators for Informed Decision Making in Back SurgeryP60AR062799 · NIAMS · DARTMOUTH COLLEGE · PI TOSTESON, ANNA N. A. · 2012 to 2016
$6.1M
Early Career Development Program for Patient-Centered Outcomes ResearchK12HS021695 · AHRQ · DARTMOUTH COLLEGE · PI BARTELS, STEPHEN J · 2012 to 2013
$890k
AHRQ HHS K12 HS021695NCI NIH HHS P30 CA023108NIAMS NIH HHS P60 AR062799
6 · The paper itself

Abstract

background contextUse of bone morphogenetic protein (BMP) as an adjunct to spinal fusion surgery proliferated after Food and Drug Administration (FDA) approval in 2002. Major safety concerns emerged in 2008. PURPOSE: The purpose of this study was to examine whether published concerns about the safety of BMP altered clinical practice. STUDY DESIGN/

settingThe study design involved the analysis of the National Inpatient Sample from 2002 through 2012. PATIENT SAMPLE: Adults (older than 20 years) undergoing an elective fusion operation for common degenerative diagnoses were identified using codes from the International Classification of Diseases, ninth revision, Clinical Modification. OUTCOME MEASURES: Outcome measures were proportion of cervical and lumbar fusion operations, over time, that involved BMP.

methodsWe aggregated the data into a monthly time series and reported the proportion of cervical and lumbar fusion operations, over time, that involved BMP. Autoregressive Integrated Moving Average, a regression model for time series data, was used to test whether there was a statistically significant change in the overall rate of BMP use after an FDA Public Health Notification in 2008.

resultsUse of BMP in spinal fusion procedures increased rapidly until 2008, involving up to 45.2% of lumbar and 13.5% of cervical fusions. Bone morphogenetic protein use significantly decreased after the 2008 FDA Public Health Notification and revelations of financial payments to surgeons involved in the pivotal FDA-approved trials. For lumbar fusion, the average annual increase was 7.9 percentage points per year from 2002 to 2008, followed by an average annual decrease of 11.7 percentage points thereafter (p≤.001). Use of BMP in cervical fusion increased 2.0% per year until the FDA Public Health Notification, followed by a 2.8% per year decrease (p=.035).

conclusionsUse of BMP in spinal fusion surgery declined subsequent to published safety concerns and revelations of financial conflicts of interest for investigators involved in the pivotal clinical trials.

Indexed as

Bone Morphogenetic ProteinsCervical VertebraeHumansLumbar VertebraeSpinal DiseasesSpinal FusionTreatment OutcomeUnited StatesBone Morphogenetic ProteinsBone morphogenetic proteinsEpidemiologyNationwide inpatient samplerhBMP-2Spinal fusionSurgical safety

Identifiers

PMID25523380
PMCPMC4375057

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.