Evidence map›Paper›PMID 36393887›Full record

ArticleBMJ surgery, interventions, & health technologies2022

Development of a core minimum data set to advance real-world evidence generation for uterine fibroids treatment technologies.

Courtney E Baird, Evan Myers, Vanessa Jacoby, Laura Elisabeth Gressler, Sateria Venable, Allison O'Neill, Veronica Price, Angie Lee, Jason Roberts, Sharon Andrews and 2 more

Abstract read
In one paragraph

Article in BMJ surgery, interventions, & health technologies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Article
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  4. Article
  5. Article
  6. Development of a coordinated registry network for pelvic organ prolapse technologies.BMJ surgery, interventions, & health technologies · 2022
    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

12 authors.

Courtney E BairdHealth Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island, USA.ORCID 0000-0002-2841-9183
Evan MyersDepartment of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina, USA.
Vanessa JacobyDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, California, USA.
Laura Elisabeth GresslerDepartment of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences, Little Rock, AR, USA.ORCID 0000-0003-2042-2174
Sateria VenableThe Fibroid Foundation, Bethesda, Maryland, USA.
Allison O'NeillCenter for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, Maryland, USA.
Veronica PriceCenter for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, Maryland, USA.
Angie LeeCenter for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, Maryland, USA.
Jason RobertsCenter for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, Maryland, USA.
Sharon AndrewsCenter for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, Maryland, USA.
Art SedrakyanHealthcare Polcy and Research, Weill Cornell Medical College, New York, New York, USA.ORCID 0000-0003-3882-9765
Danica Marinac-DabicCenter for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, Maryland, USA.

Funding

Novel Approaches to Advance Coordinated Registry Networks (CRNs).U01FD006936 · FDA · WEILL MEDICAL COLL OF CORNELL UNIV · PI SEDRAKYAN, ART · 2020 to 2022
$2.1M
FDA HHS U01 FD006936
6 · The paper itself

Abstract

Objectives: The accumulation of data through a prospective, multicenter coordinated registry network (CRN) is a robust and cost-effective way to gather real-world evidence on the performance of uterine fibroids treatment technologies for device-based and intervention-based studies. To develop the CRN, a group of uterine fibroids experts, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess uterine fibroid treatment technologies. Design: A Delphi method approach was employed to achieve consensus on a core minimum data set for the CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated, and analyzed by a study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via a conference call. This process was repeated twice over a 3-month time period until consensus was achieved. Results: Twenty-nine experts participated in the Delphi surveys, which began with an initial list of 200 data elements. The working group reached final consensus on 97 data elements capturing patient medical history, imaging data, procedure-related data, post-procedure data, and long-term follow-up data. Conclusions: The CRN successfully convened an expert panel on uterine fibroids treatment technologies and used the Delphi method to produce a consensus-based core set of data elements. These identified data elements include important outcomes related to efficacy and safety and thus, influence patient, provider, and regulatory decision-making about treatments for uterine fibroids. Finally, the core data elements provide the foundation of the infrastructure needed for the CRN that will allow for the comparative study of uterine fibroid treatment devices and technologies.

Indexed as

DelphiDevice SurveillanceObstetrics and Gynecology DevicesReal World EvidenceWomen's Health

Identifiers

PMID36393887
PMCPMC9660574

What OpenQuestion holds

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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.