Evidence map›Paper›PMID 27344192›Full record

ArticleSeminars in perinatology2016

Methodological issues in the design and analyses of neonatal research studies: Experience of the NICHD Neonatal Research Network.

Abhik Das, Jon Tyson, Claudia Pedroza, Barbara Schmidt, Marie Gantz, Dennis Wallace, William E Truog, Rosemary D Higgins

Abstract read
In one paragraph

Article in Seminars in perinatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. In-hospital mortality and morbidity among extremely preterm infants in relation to maternal body mass index.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
  8. 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

8 authors.

Abhik DasBiostatistics and Epidemiology Division, RTI International, 6110 Executive Blvd, Suite 902, Rockville, MD 20852. Electronic address: adas@rti.org.
Jon TysonCenter for Clinical Research and Evidence-Based Medicine, University of Texas Health Science Center at Houston, Houston, TX.
Claudia PedrozaCenter for Clinical Research and Evidence-Based Medicine, University of Texas Health Science Center at Houston, Houston, TX.
Barbara SchmidtDepartment of Pediatrics, University of Pennsylvania, Philadelphia, PA.
Marie GantzBiostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.
Dennis WallaceBiostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.
William E TruogChildren's Mercy Hospitals and Clinics, University of Missouri-Kansas City School of Medicine, Kansas City, MO.
Rosemary D HigginsPregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Health & Human Development, National Institutes of Health, Bethesda, MD.

Funding

Neonatal Research Network Data Coordinating Center (DCC)U10HD036790 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 2008 to 2017
$62.3M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD021373 · NICHD · UNIVERSITY OF TEXAS SW MED CTR/DALLAS · PI KENNEDY, KATHLEEN A · 1991 to 2015
$6.1M
NICHD Neonatal Research Network -- Cincinnati Clinical CenterUG1HD027853 · NICHD · CINCINNATI CHILDRENS HOSP MED CTR · PI STEPHANIE L MERHAR · 2016 to 2026
$3.7M
Clinical Center for NICHD/Neonatal Research NetworkUG1HD068244 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI Sara Bonamo DeMauro, Eric C Eichenwald · 2016 to 2026
$3.6M
Multicenter Network of Neonatal Intensive Care Units-University of Texas at Houston (UT Houston) Clinical CenterUG1HD087229 · NICHD · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI TYSON, JON E. · 2016 to 2022
$2.0M
One Center, Two StatesUG1HD068284 · NICHD · CHILDREN'S MERCY HOSP (KANSAS CITY, MO) · PI TRUOG, WILLIAM E · 2016 to 2017
$15k
NICHD NIH HHS U10 HD021373NICHD NIH HHS U10 HD036790NICHD NIH HHS UG1 HD027853NICHD NIH HHS UG1 HD068244NICHD NIH HHS UG1 HD068284NICHD NIH HHS UG1 HD087229
6 · The paper itself

Abstract

Impressive advances in neonatology have occurred over the 30 years of life of The Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network (NRN). However, substantial room for improvement remains in investigating and further developing the evidence base for improving outcomes among the extremely premature. We discuss some of the specific methodological challenges in the statistical design and analysis of randomized trials and observational studies in this population. Challenges faced by the NRN include designing trials for unusual or rare outcomes, accounting for and explaining center variations, identifying other subgroup differences, and balancing safety and efficacy concerns between short-term hospital outcomes and longer-term neurodevelopmental outcomes. In conclusion, the constellation of unique patient characteristics in neonates calls for broad understanding and careful consideration of the issues identified in this article for conducting rigorous studies in this population.

Indexed as

Biomedical ResearchHumansInfant, NewbornInfant, Premature, DiseasesLongitudinal StudiesNational Institute of Child Health and Human Development (U.S.)NeonatologyObservational Studies as TopicPropensity ScoreRandomized Controlled Trials as TopicSurvival RateUnited StatesCausal inferenceCompeting outcomesRandomization of multiplesStatistical methodologyTrial design

Identifiers

PMID27344192
PMCPMC5065743

What OpenQuestion holds

Textmetadata
LicenceTDM
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.