Evidence map›Paper›PMID 36704544›Full record

ArticleBMJ surgery, interventions, & health technologies2023

Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators.

Sanket S Dhruva, Jennifer L Ridgeway, Joseph S Ross, Joseph P Drozda, Natalia A Wilson

Abstract read
In one paragraph

Article in BMJ surgery, interventions, & health technologies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
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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

5 authors.

Sanket S DhruvaSection of Cardiology, Department of Medicine, University of California San Francisco School of Medicine, San Francisco, California, USA.ORCID 0000-0003-0674-2032
Jennifer L RidgewayRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, and the Division of Health Care Delivery Research, Mayo Clinic, Rochester, Minnesota, USA.
Joseph S RossDepartment of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.ORCID 0000-0002-9218-3320
Joseph P DrozdaMercy Research, Mercy, Chesterfield, Missouri, USA.ORCID 0000-0001-9181-8534
Natalia A WilsonCenter for Healthcare Delivery and Policy, Arizona State University, Phoenix, Arizona, USA.ORCID 0000-0002-6531-7776

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NESTcc Renewal -Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC)U01FD006292 · FDA · MEDICAL DEVICE INNOVATION CONSORTIUM · PI SMITH, RICHARD · 2018 to 2025
$76.1M
FDA HHS U01 FD006292NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

Objectives: To examine the current state of unique device identifier (UDI) implementation, including barriers and facilitators, among eight health systems participating in a research network committed to real-world evidence (RWE) generation for medical devices. Design: Mixed methods, including a structured survey and semistructured interviews. Setting: Eight health systems participating in the National Evaluation System for health Technology research network within the USA. Participants: Individuals identified as being involved in or knowledgeable about UDI implementation or medical device identification from supply chain, information technology and high-volume procedural area(s) in their health system. Main outcomes measures: Interview topics were related to UDI implementation, including barriers and facilitators; UDI use; benefits of UDI adoption; and vision for UDI implementation. Data were analysed using directed content analysis, drawing on prior conceptual models of UDI implementation and the Exploration, Preparation, Implementation, Sustainment framework. A brief survey of health system characteristics and scope of UDI implementation was also conducted. Results: Thirty-five individuals completed interviews. Three of eight health systems reported having implemented UDI. Themes identified about barriers and facilitators to UDI implementation included knowledge of the UDI and its benefits among decision-makers; organisational systems, culture and networks that support technology and workflow changes; and external factors such as policy mandates and technology. A final theme focused on the availability of UDIs for RWE; lack of availability significantly hindered RWE studies on medical devices. Conclusions: UDI adoption within health systems requires knowledge of and impetus to achieve operational and clinical benefits. These are necessary to support UDI availability for medical device safety and effectiveness studies and RWE generation.

Indexed as

Device EvaluationDevicesProcess Assessment (Health Care)Real World Evidence

Identifiers

PMID36704544
PMCPMC9872505

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.