Evidence map›Paper›PMID 33308263›Full record

ArticleTrials2020

Developing a core outcome set for the treatment of pregnant women with pregestational diabetes-a study protocol.

Oratile Kgosidialwa, Delia Bogdanet, Aoife Egan, Paula M O'Shea, Linda Biesty, Declan Devane, Fidelma Dunne, INSPIRED group

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 6% 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

2 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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 at 2 institutions in 2 countries.

Oratile KgosidialwaSchool of Medicine, National University of Ireland Galway, Galway, Ireland. oratile.kgosidialwa2@hse.ie.ORCID http://orcid.org/0000-0002-4249-6302
Delia BogdanetSchool of Medicine, National University of Ireland Galway, Galway, Ireland.
Aoife EganDepartment of Endocrinology, Mayo Clinic Rochester, Rochester, MN, USA.
Paula M O'SheaSchool of Medicine, National University of Ireland Galway, Galway, Ireland.
Linda BiestySchool of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.
Declan DevaneSchool of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.
Fidelma DunneSchool of Medicine, National University of Ireland Galway, Galway, Ireland.
INSPIRED group
Ollscoil na Gaillimhe – University of Galway · IEMayo Clinic · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes including increased rates of caesarean section birth, macrosomia, congenital malformation, prematurity, admission to the neonatal intensive care unit and stillbirth. As a result, there has been an increase in interventions to improve outcomes in both mother and infant. To date, meaningful comparisons between these studies are limited due to heterogeneity in outcome selection and reporting. The aim of this study is to develop a core outcome set (COS) for randomised controlled trials evaluating the effectiveness of interventions for the treatment of pregnant women with PGDM.

methodsThe study consists of three steps. The first step is a systematic review of the literature to assess outcomes reported in randomised controlled trials assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. The second step is a three round, online Delphi survey to prioritise these outcomes. In this step, stakeholders (including women with PGDM, healthcare workers, researchers and policymakers) will be asked to rank the importance of outcomes for inclusion in the COS using a 9-point Likert type scale. Outcomes that meet the inclusion criteria after completion of the Delphi surveys will be brought to the consensus meeting. The consensus meeting will be the third and final step, where the COS will be finalised. The consensus meeting will include members from each stakeholder group. DISCUSSION: This paper describes the process used to develop a COS for the reporting of studies evaluating the effectiveness of interventions in pregnant women with PGDM. The COS will enable greater comparison between and information synthesis across RCTs in the treatment of PGDM. In addition, this COS will also help improve trial reporting and minimise research waste by prioritising the collection and reporting of outcomes that matter to all relevant stakeholder groups.

trial registrationThis COS has been registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative ( http://www.comet-initiative.org/studies/details/1425 ) on the 4th of November 2019. The systematic review component of this study has also been registered with the International Prospective Register of Systematic Reviews (PROSPERO) ( https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020173549 ).

Indexed as

Diabetes MellitusPregnant PeopleCesarean SectionDelphi TechniqueFemaleHumansInfant, NewbornOutcome Assessment, Health CarePregnancyRandomized Controlled Trials as TopicResearch DesignSystematic Reviews as TopicTreatment OutcomeCore outcome setInterventionPregestational diabetes mellitusPregnancyRandomised controlled trialsType 1 diabetes mellitusType 2 diabetes mellitus

Identifiers

PMID33308263
PMCPMC7730783
OpenAlexW3110815015

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.