Evidence map›Paper›PMID 34981851›Full record

ArticlePaediatric and perinatal epidemiology2023

Improving the external validity of Antenatal Late Preterm Steroids trial findings.

Jennifer A Hutcheon, Jessica Liauw

Open access · greenAbstract read
In one paragraph

Article in Paediatric and perinatal epidemiology, 2023. 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
1.7field-weighted citation impact, top 16% 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

5 citing papers in PubMed, 12 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors at 1 institution in 1 country.

Jennifer A HutcheonDepartment of Obstetrics and Gynaecology, University of British Columbia, Vancouver, British Columbia, Canada.ORCID 0000-0003-0502-3423
Jessica LiauwDepartment of Obstetrics and Gynaecology, University of British Columbia, Vancouver, British Columbia, Canada.ORCID 0000-0002-1573-5574
University of British Columbia · CA

Funding

Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research NetU10HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI CLIFTON, REBECCA GERSNOVIEZ · 2009 to 2021
$174.2M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
NICHD Maternal Fetal Medicine Units NetworkU10HD034116 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI CASEY, BRIAN M · 1996 to 2015
$19.3M
NICHD Maternal Fetal Medicine Units NetworkU10HD034208 · NICHD · UNIVERSITY OF UTAH · PI VARNER, MICHAEL W. · 1996 to 2015
$16.6M
NICHD Maternal Fetal Medicine Units NetworkU10HD027869 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI TITA, ALAN THEVENET N. · 1991 to 2015
$12.8M
NICHD Maternal Fetal Medicine Units NetworkU10HD040485 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI WAPNER, RONALD · 2001 to 2015
$12.5M
NICHD Maternal Fetal Medicine Units NetworkU10HD040560 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI THORP, JOHN M · 2001 to 2015
$10.3M
NICHD Maternal Fetal Medicine Units NetworkU10HD040512 · NICHD · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GROBMAN, WILLIAM ADAM · 2001 to 2015
$8.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD027917 · NICHD · WAYNE STATE UNIVERSITY · PI GONIK, BERNARD · 1991 to 2015
$8.2M
NICHD Maternal Fetal Medicine Units NetworkU10HD027915 · NICHD · OHIO STATE UNIVERSITY · PI IAMS, JAY · 1992 to 2015
$7.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD040545 · NICHD · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI CHAUHAN, SUNEET P · 2001 to 2015
$7.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD040500 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI ROUSE, DWIGHT J · 2001 to 2015
$7.5M
NCATS NIH HHS UL1 TR000040NHLBI NIH HHS U01 HL098354NHLBI NIH HHS U01 HL098554NICHD NIH HHS U10 HD021410NICHD NIH HHS U10 HD027869NICHD NIH HHS U10 HD027915NICHD NIH HHS U10 HD027917NICHD NIH HHS U10 HD034116NICHD NIH HHS U10 HD034208NICHD NIH HHS U10 HD036801NICHD NIH HHS U10 HD040485NICHD NIH HHS U10 HD040500NICHD NIH HHS U10 HD040512NICHD NIH HHS U10 HD040544NICHD NIH HHS U10 HD040545NICHD NIH HHS U10 HD040560NICHD NIH HHS U10 HD053097NICHD NIH HHS U10 HD053118NICHD NIH HHS U10 HD068258NICHD NIH HHS U10 HD068268NICHD NIH HHS U10 HD068282NICHD NIH HHS UG1 HD040485NICHD NIH HHS UG1 HD040545
6 · The paper itself

Abstract

backgroundThe external validity of randomised trials can be compromised when trial participants differ from real-world populations. In the Antenatal Late Preterm Steroids (ALPS) trial of antenatal corticosteroids at late preterm ages, participants had systematically younger gestational ages than those outside the trial setting. As risk of respiratory morbidity (the primary trial outcome) is higher at younger gestations, absolute benefits of corticosteroids calculated in the trial population may overestimate real-world treatment benefits.

objectivesTo estimate the real-world absolute risk reduction and number-needed-to-treat (NNT) for antenatal corticosteroids at late preterm ages, accounting for gestational age differences between the ALPS and real-world populations.

methodsIndividual participant data from the ALPS trial (which recruited 2831 women with imminent preterm birth at 34+0 to 36+5 weeks') was appended to population-based data for 15,741 women admitted for delivery between 34+0 and 36+5 weeks' from British Columbia, Canada, 2000-2013. We used logistic regression to calculate inverse odds of sampling weights for each trial participant and re-estimated treatment effects of corticosteroids on neonatal respiratory morbidity in ALPS participants, weighted to reflect the gestational age distribution of the population-based (real-world) sample.

resultsThe real-world absolute risk reduction was estimated to be -2.2 (95% CI -4.6, 0.0) cases of respiratory morbidity per 100, compared with -2.8 (95% CI -5.3, -0.3) in original trial data. Corresponding NNTs were 46 in the real-world setting vs 35 in the trial. Our focus on absolute measures also highlighted that the benefits of antenatal corticosteroids may be meaningfully greater at 34 weeks vs. 36 weeks (e.g., risk reductions of -3.7 vs. -1.2 per 100 respectively).

conclusionsThe absolute risk reductions and NNTs associated with antenatal corticosteroid administration at late preterm ages estimated in our study may be more appropriate for patient counselling as they better reflect the anticipated benefits of treatment when used in a real-world situation.

Indexed as

Premature BirthRespiratory Distress Syndrome, NewbornAdrenal Cortex HormonesFemaleGestational AgeHumansInfant, NewbornPregnancySteroidsAdrenal Cortex HormonesSteroidsantenatal corticosteroidsAntenatal Late Preterm Steroids trialbetamethasonegestational ageneonatal respiratory morbidity

Identifiers

PMID34981851
PMCPMC9250943
OpenAlexW4206088411

What OpenQuestion holds

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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.