Evidence map›Paper›PMID 31842960›Full record

SynthesisTrials2019

A systematic review identifying common data items in neonatal trials and assessing their completeness in routinely recorded United Kingdom national neonatal data.

Sena Jawad, Neena Modi, A Toby Prevost, Chris Gale

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. 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

4 authors.

Sena JawadNeonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital Campus, London, SW10 9NH, UK.
Neena ModiNeonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital Campus, London, SW10 9NH, UK.
A Toby PrevostImperial Clinical Trials Unit, School of Public Health, Imperial College London, London, W12 7RH, UK.
Chris GaleNeonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital Campus, London, SW10 9NH, UK. christopher.gale@imperial.ac.uk.ORCID http://orcid.org/0000-0003-0707-876X

Funding

Medical Research Council MR/N008405/1Westminster Medical School Research Trust PMS/MMS-17/18-1726
6 · The paper itself

Abstract

backgroundWe aimed to test whether a common set of key data items reported across high-impact neonatal clinical trials could be identified, and to quantify their completeness in routinely recorded United Kingdom neonatal data held in the National Neonatal Research Database (NNRD).

methodsWe systematically reviewed neonatal clinical trials published in four high-impact medical journals over 10 years (2006-2015) and extracted baseline characteristics, stratification items and potential confounders used to adjust primary outcomes. Completeness was examined using data held in the NNRD for identified data items, for infants admitted to neonatal units in 2015. The NNRD is a repository of routinely recorded data extracted from neonatal Electronic Patient Records (EPR) of all admissions to National Health Service (NHS) Neonatal Units in England, Wales and Scotland. We defined missing data as an empty field or an implausible value. We reported common data items as frequencies and percentages alongside percentages of completeness.

resultsWe identified 44 studies involving 32,095 infants and 126 data items. Fourteen data items were reported by more than 20% of studies. Gestational age (95%), sex (93%) and birth weight (91%) were the most common baseline data items. The completeness of data in the NNRD was high for these data with greater than 90% completeness found for 9 of the 14 most common items.

conclusionHigh-impact neonatal clinical trials share common data items. In the United Kingdom, these items can be obtained at a high level of completeness from routinely recorded data held in the NNRD. The feasibility and efficiency using routinely recorded EPR data, such as that held in the NNRD, for clinical trials, rather than collecting these items anew, should be examined.

trial registrationPROSPERO registration number CRD42016046138. Registered prospectively on 17 August 2016.

Indexed as

Data AccuracyPatient SelectionResearch SubjectsAge FactorsBirth WeightClinical Trials as TopicCommon Data ElementsDatabases, FactualElectronic Health RecordsFemaleGestational AgeHumansInfant, NewbornMaleSex FactorsUnited KingdomCommon data itemsData qualityEfficient trialsElectronic health recordsElectronic patient recordsNeonatal clinical trialsNNRD

Identifiers

PMID31842960
PMCPMC6915866

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Registered trials

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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.