Evidence map›Paper›PMID 36393893›Full record

ArticleBMJ surgery, interventions, & health technologies2022

Development of a coordinated registry network for pelvic organ prolapse technologies.

Courtney E Baird, Bilal Chughtai, Catherine S Bradley, Kathleen Kobashi, Mary Jung, Art Sedrakyan, Sharon Andrews, Ann Ferriter, Terri Cornelison, Danica Marinac-Dabic

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 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

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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

10 authors.

Courtney E BairdHealth Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island, USA.ORCID 0000-0002-2841-9183
Bilal ChughtaiDepartment of Urology, Weill Cornell Medicine, New York, New York, USA.
Catherine S BradleyDepartment of Obstetrics and Gynecology, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA.
Kathleen KobashiDepartment of Urology, Houston Methodist Hospital, Houston, Texas, USA.
Mary JungCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, 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.
Ann FerriterCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA.
Terri CornelisonCenter for Devices and Radiological Health (CDRH), 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.

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) could be a robust and cost-effective way to gather real-world evidence on the performance of pelvic organ prolapse (POP) technologies for device-based and intervention-based studies. To develop the CRN, a group of POP experts consisting of representatives from professional societies, the 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 important to assess POP technologies. Design: A Delphi method approach was employed to achieve consensus on a core minimum dataset 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 the study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via conference call. This process was repeated twice over a 6-month time period during which consensus was achieved. Results: Twenty-one experts participated in the effort and proposed 120 data elements. Participation rates in the first and second round of the Delphi survey were 95.2% and 71.4%, respectively. The working group reached final consensus among responders on 90 data elements capturing relevant general medical and surgical history, procedure and discharge, short-term and long-term follow-up, device factors, and surgery and surgeon factors. Conclusions: The CRN successfully developed a set of core data elements to support the study of POP technologies through convening an expert panel on POP technologies and using the Delphi method. These standardized data elements have the potential to influence patient and provider decisions about treatments and include important outcomes related to efficacy and safety.

Indexed as

Delphidevice evaluationreal world evidenceurology deviceswomen's health

Identifiers

PMID36393893
PMCPMC9660621

What OpenQuestion holds

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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.