Evidence map›Paper›PMID 22870249›Full record

ReviewPloS one2012

Making co-enrolment feasible for randomised controlled trials in paediatric intensive care.

Katie Harron, Twin Lee, Tracy Ball, Quen Mok, Carrol Gamble, Duncan Macrae, Ruth Gilbert, CATCH team

Open access · goldAbstract readComparative StudyReview
In one paragraph

Review in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 8% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Co-enrolment to UK Critical Care Studies - A 2019 update.Journal of the Intensive Care Society · 2022
    Article
  6. Article
  7. Article
  8. Article
  9. Co-enrolment of Participants into Multiple Cancer Trials: Benefits and Challenges.Clinical oncology (Royal College of Radiologists (Great Britain)) · 2017
    Review
  10. Review
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 5 institutions in 1 country.

Katie HarronMRC Centre for Epidemiology of Child Health, Institute of Child Health, University College London, London, United Kingdom.
Twin Lee
Tracy Ball
Quen Mok
Carrol Gamble
Duncan Macrae
Ruth Gilbert
CATCH team
University College London · GBUniversity of Liverpool · GBGreat Ormond Street Hospital · GBRoyal Brompton Hospital · GBRoyal College of Paediatrics and Child Health · GB

Funding

Department of Health 08/13/47Medical Research Council G0400546Medical Research Council G0800792
6 · The paper itself

Abstract

aimsEnrolling children into several trials could increase recruitment and lead to quicker delivery of optimal care in paediatric intensive care units (PICU). We evaluated decisions taken by clinicians and parents in PICU on co-enrolment for two large pragmatic trials: the CATCH trial (CATheters in CHildren) comparing impregnated with standard central venous catheters (CVCs) for reducing bloodstream infection in PICU and the CHIP trial comparing tight versus standard control of hyperglycaemia.

methodsWe recorded the period of trial overlap for all PICUs taking part in both CATCH and CHiP and reasons why clinicians decided to co-enrol children or not into both studies. We examined parental decisions on co-enrolment by measuring recruitment rates and reasons for declining consent.

resultsFive PICUs recruited for CATCH and CHiP during the same period (an additional four opened CATCH after having closed CHiP). Of these five, three declined co-enrolment (one of which delayed recruiting elective patients for CATCH whilst CHiP was running), due to concerns about jeopardising CHiP recruitment, asking too much of parents, overwhelming amounts of information to explain to parents for two trials and a policy against co-enrolment. Two units co-enrolled in order to maximise recruitment to both trials. At the first unit, 35 parents were approached for both trials. 17/35 consented to both; 13/35 consented to one trial only; 5/35 declined both. Consent rates during co-enrolment were 29/35 (82%) and 18/35 (51%) for CATCH and CHiP respectively compared with 78% and 51% respectively for those approached for a single trial within this PICU. The second unit did not record data on approaches or refusals, but successfully co-enrolled one child.

conclusionsCo-enrolment did not appear to jeopardise recruitment or overwhelm parents. Strategies for seeking consent for multiple trials need to be developed and should include how to combine information for parents and patients.

Indexed as

Central Venous CathetersDecision MakingAdolescentChildChild, PreschoolCritical CareFemaleHumansHyperglycemiaInfantInfection ControlMaleRandomized Controlled Trials as Topic

Identifiers

PMID22870249
PMCPMC3411697
OpenAlexW2126258405

What OpenQuestion 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 OpenQuestion graph.