Evidence map›Paper›PMID 36393889›Full record

ArticleBMJ surgery, interventions, & health technologies2022

Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network.

Courtney E Baird, Maryam Guiahi, Scott Chudnoff, Nilsa Loyo-Berrios, Stephanie Garcia, Mary Jung, Laura Elisabeth Gressler, Jialin Mao, Beth Hodshon, Art Sedrakyan and 6 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
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
0.8field-weighted citation impact, top 25% of its field
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, 5 citations in OpenAlex.

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

16 authors at 6 institutions in 1 country.

Courtney E BairdHealth Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island, USA.ORCID 0000-0002-2841-9183
Maryam GuiahiDepartment of Obstetrics and Gynecology, Division of Family Planning, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
Scott ChudnoffDepartment of Obstetrics and Gynecology, Stamford Hospital, Stamford, Connecticut, USA.
Nilsa Loyo-BerriosCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.
Stephanie GarciaOffice of the National Coordinator for Health Information Technology, Washington, District of Columbia, USA.
Mary JungCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.
Laura Elisabeth GresslerCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0003-2042-2174
Jialin MaoPopulation Health Sciences, Weill Cornell Medicine, New York, New York, USA.ORCID 0000-0001-6671-3474
Beth HodshonDepartment of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
Art SedrakyanPopulation Health Sciences, Weill Cornell Medicine, New York, New York, USA.ORCID 0000-0003-3882-9765
Sharon AndrewsCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.
Kelly ColdenCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.
Jason RobertsCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.
Abby AndersonCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, Maryland, USA.
Catherine SewellCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, Maryland, USA.
Danica Marinac-DabicCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.
United States Food and Drug Administration · USCornell University · USOffice of the National Coordinator for Health Information Technology · USStamford Hospital · USUniversity of Colorado Anschutz Medical Campus · USYale University · US

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: A multistakeholder expert group under the Women's Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent contraceptives. The group, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry and the patient community, was assembled to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess contraceptive medical product technologies. Design: We applied a Delphi survey method approach to achieve consensus on a core minimum data set for the future 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. After the first survey, questions for subsequent surveys were based on the analysis process and conference call discussions with group members. This process was repeated two times over a 6-month time period until consensus was achieved. Results: Twenty-three experts participated in the Delphi process. Participation rates in the first and second round of the Delphi survey were 83% and 100%, respectively. The working group reached final consensus on 121 core data elements capturing reproductive/gynecological history, surgical history, general medical history, encounter information, long-acting/permanent contraceptive index procedures and follow-up, procedures performed in conjunction with the index procedure, product removal, medications, complications related to the long-acting and/or permanent contraceptive procedure, pregnancy and evaluation of safety and effectiveness outcomes. Conclusions: The WHT-CRN expert group produced a consensus-based core set of data elements that allow the study of current and future contraceptives. These data elements influence patient and provider decisions about treatments and include important outcomes related to safety and effectiveness of these medical devices, which may benefit other women's health stakeholders.

Indexed as

contraceptive devicesdelphiobstetrics and gynecology devicesreal world evidencewomen's health

Identifiers

PMID36393889
PMCPMC9660629
OpenAlexW4308994728

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.