NPRC RARE registry reports on Maternal Congenital Heart Disease at SMFM

Posted on January 13, 2015 by astuebe

NPRC’s RARE registry presented three abstracts at the 2015 Pregnancy Meeting on outcomes among women with congenital heart disease.

Rubeo-SMFM

Zach Rubeo presents data on maternal congenital heart disease at The Pregnancy Meeting in San Diego.

 

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Review of multicenter studies by multiple institutional review boards: characteristics and outcomes for perinatal studies implemented by a multicenter network

Posted on December 2, 2014 by astuebe

Abramovici A, Salazar A, Edvalson T, Gallagher N, Dorman K, Tita A; National Perinatal Research Collaborative.
Am J Obstet Gynecol. 2014 Aug 1. pii: S0002-9378(14)00807-2. doi: 10.1016/j.ajog.2014.07.058.
Abstract
OBJECTIVE:
The objective of the study was to describe characteristics and outcomes of a review of multisite perinatal studies by individual institutional review boards (IRBs) and identify barriers and opportunities for streamlined IRB review.
STUDY DESIGN:
We compared the review of 5 collaborative protocols by individual IRBs at National Perinatal Research Consortium centers from 2007 through 2012. Three randomized trials, 1 observational study, and 1 follow-up study of a trial were selected. IRB logs and communications were reviewed and abstracted by trained team members.
RESULTS:
Seven or 8 IRBs reviewed each protocol. Monthly IRB meeting frequency varied from 1 to 6. Full board review was required by all IRBs for the primary trials but not by all for the observational protocols. The overall duration from submission to approval (P = .024) and number of stipulations (P = .007) differed across protocols but not across IRBs. However, times from submission-to-IRB review (P = .011) and IRB review-to-initial letter (P < .007) differed across sites. Both overall submission-to-approval and initial review-to-approval times increased with the increasing number of IRB review stipulations (both values P < .001). Significant delays (>60 days) were few and not consistent across IRBs or protocols. Most stipulations were stylistic or editorial modifications rather than regulatory requests. All protocols were approved without changes, and no more than 1 IRB meeting was needed at each site.
CONCLUSION:
Findings confirm unnecessary duplication and variability and some similarities in IRB review processes and outcomes for multisite perinatal studies. This may help guide initiatives to streamline IRB review and reduce research delays and burdens.

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RARE abstract presented at Translational Sciences

Posted on April 9, 2014 by astuebe

translational-sciences

CREATION OF A MULTI-INSTITUTIONAL CTSA-SPONSORED OBSTETRICS REGISTRY FOR ADVERSE RARE EVENTS (RARE)

Alison Stuebe3, Karen Dorman3, Ron Wapner1, Michelle DiVito1, Alan Tita2, Joseph Biggio2, Rachel LeDuke2, Victoria Chapman2, George Saade4, Ashley Salazar4, Michael Varner5, Tracy Manuck5, Laurie Lesher5

Presented as a poster at Translational Sciences 2014, Washington, DC

OBJECTIVES/SPECIFIC AIMS: Childbirth is the most common reason for hospitalization in the US, yet limited evidence informs treatment for many serious, but uncommon, pregnancy complications. We sought to assess the feasibility of developing a multi-institutional database among CTSA centers to evaluate treatments and outcomes for four rare obstetrical events: placenta accreta, monochorionic twins, maternal congenital heart disease, and mechanical ventilation during pregnancy.

METHODS/STUDY POPULATION: Members of the National Perinatal Research Consortium (NPRC) were awarded pilot funds by our respective CTSAs for a multisite project. We piloted use of CTSA IRBshare for a federated IRB and developed and implemented a multi-institutional REDCap database for abstraction of cases identified by querying administrative and clinical data at our institutions.

RESULTS/ANTICIPATED RESULTS: We encountered opportunities and challenges for multi-institutional collaboration. We easily implemented our database using REDCap’s secure, web-based application. However, we could not use IRBshare as planned, because exempt IRB applications are excluded. We also encountered challenges creating multi-site data use agreements for our shared database. Institutional variation in ICD9 and CPT codes also affected the sensitivity and specificity of case-finding queries.

DISCUSSION/SIGNIFICANCE OF IMPACT: This project demonstrates that CTSA-supported multi- institutional collaboration is feasible, but roadblocks exist. Addressing these barriers may advance opportunities for collaborative clinical and translational research, as recommended by the IOM report.

INSTITUTIONS (ALL):

Columbia University, New York, NY, United States.
University of Alabama at Birmingham, Birmingham, AL, United States.
University of North Carolina, Chapel Hill, NC, United States.
University of Texas – Medical Branch, Galveston, TX, United States.
University of Utah, Salt Lake City, UT, United States.

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Funded CTSA Multisite Pilot Project

Childbirth is the most common reason for hospitalization in this country, yet data are limited regarding the effectiveness of treatment strategies for many serious, but uncommon, pregnancy complications. To address this gap, NIH-funded multidisciplinary researchers at five institutions have formed the National Perinatal Research Consortium (NPRC). The Consortium’s overarching goal is to conduct multicenter clinical trials and comparative effectiveness studies that will determine optimal management strategies for serious pregnancy complications.

The objective of this proposal is to develop a shared multidisciplinary research infrastructure among our five institutions and to demonstrate our capacity to collaborate in a pilot comparative effectiveness study of several rare obstetric events and their associated treatments.  We will collect data on cases of placenta accreta, monochorionic twins, maternal congenital heart disease, and mechanical ventilation during pregnancy, including both maternal and infant outcomes. Studying these rare conditions requires multidisciplinary collaboration among maternal-fetal medicine, OB/GYN, cardiology, critical care and neonatology specialists.

To achieve our objective, we will pursue three specific aims:

1)    Pilot a federated IRB model for clinical studies across our institutions;

2)    Develop and implement a shared multi-institutional RedCap database;

3)    Collect data on maternal and neonatal outcomes for these rare events, comparing outcomes among various management strategies used at our centers.

This project will result in important new evidence for optimal management of these morbid pregnancy complications, position our consortium to secure funding for future multisite clinical trials and comparative effectiveness studies, provide career development opportunities, and confirm our ability to collaborate through our respective CTSA centers.

Posted on August 30, 2013 by astuebe | Leave a comment