Evidence map›Paper›PMID 31776875›Full record

ArticleHernia : the journal of hernias and abdominal wall surgery2020

Use of real-world registry data: a hernia mesh example.

T-H Lee, A Choudhuri, K Ulisney, J Swiger, B Poulose, M Rosen, G Gibeily

Abstract read
PubMed Publisher
In one paragraph

Article in Hernia : the journal of hernias and abdominal wall surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Data quality validation of the Spanish Incisional Hernia Surgery Registry (EVEREG): pilot study.Hernia : the journal of hernias and abdominal wall surgery · 2023
    Article
  3. 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

7 authors.

T-H LeeCenter for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue Bldg. 66 Rm. G428, Silver Spring, MD, 20993, USA.
A ChoudhuriCenter for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue Bldg. 66 Rm. G428, Silver Spring, MD, 20993, USA.
K UlisneyCenter for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue Bldg. 66 Rm. G428, Silver Spring, MD, 20993, USA.
J SwigerCenter for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue Bldg. 66 Rm. G428, Silver Spring, MD, 20993, USA.
B PouloseCenter for Abdominal Core Health, Ohio State University Wexner Medical Center, 1800 Zollinger Road, Columbus, OH, USA.
M RosenCleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, USA.
G GibeilyCenter for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue Bldg. 66 Rm. G428, Silver Spring, MD, 20993, USA. George.Gibeily@fda.hhs.gov.ORCID 0000-0001-9808-2929

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeClinical performance of hernia mesh devices is poorly understood due to a lack of relevant clinical trial and real-world data (RWD). Registries offer a means to capture longitudinal data in real-world practice. This report highlights the need for data quality, completeness, and appropriate analysis methodology for more accurate and informed interpretation of RWE of medical devices.

methodsHernia mesh registry data were used to cross-tabulate the 30-day infection rate of patients who received one of four mesh types.

resultsInitial data review suggested lower infection rate for permanent mesh versus absorbable mesh. Additional registry RWD were factored into the analysis, providing more context in the interpretation of the results.

conclusionsHigh-quality registries can be used to generate real-world evidence (RWE) to support surveillance and other regulatory decisions.

Indexed as

Absorbable ImplantsAdultAgedFemaleHernia, VentralHerniorrhaphyHumansMaleMiddle AgedProduct Surveillance, PostmarketingProsthesis-Related InfectionsRegistriesSurgical MeshUnited StatesFood and drug administrationHerniaMedical devicesMeshReal-world dataReal-world evidenceRegistriesSurveillance

Identifiers

PMID31776875

What OpenQuestion holds

Textmetadata
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.