Evidence map›Paper›PMID 32546180›Full record

Trial reportTrials2020

Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial.

Lucy E Bradshaw, Alan A Montgomery, Hywel C Williams, Joanne R Chalmers, Rachel H Haines

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04680520 (A Randomised Controlled Trial to Determine Whether Application of Emollient From Birth Can Prevent Eczema in High Risk Children.), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 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.

NCT04680520 nacompletednot on this map

A Randomised Controlled Trial to Determine Whether Application of Emollient From Birth Can Prevent Eczema in High Risk Children.

TypeinterventionalSponsorUniversity of NottinghamRan2014 to 2022Enrolled1,394ConditionsEczemaArmsExperimental (Doublebase Gel® or Diprobase Cream®), Best practice skin care advice booklet
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Methods to increase response to postal and electronic questionnaires.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Strategies to improve retention in randomised trials.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT.Health technology assessment (Winchester, England) · 2024
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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

5 authors.

Lucy E BradshawNottingham Clinical Trials Unit, University of Nottingham, Nottingham, NG7 2RD, UK. lucy.bradshaw@nottingham.ac.uk.ORCID http://orcid.org/0000-0001-8382-6040
Alan A MontgomeryNottingham Clinical Trials Unit, University of Nottingham, Nottingham, NG7 2RD, UK.
Hywel C WilliamsCentre of Evidence Based Dermatology, University of Nottingham, Nottingham, NG7 2NR, UK.
Joanne R ChalmersCentre of Evidence Based Dermatology, University of Nottingham, Nottingham, NG7 2NR, UK.
Rachel H HainesNottingham Clinical Trials Unit, University of Nottingham, Nottingham, NG7 2RD, UK.

Funding

Department of Health 12/67/12Health Technology Assessment Programme 12/67/12
6 · The paper itself

Abstract

backgroundFailure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two strategies for retention in a randomised prevention trial using a two-by-two factorial randomised study within a trial (SWAT).

methodsParents of babies included in the host trial were randomised to (1) short message service (SMS) notification prior to sending questionnaires at 3, 6, 12 and 18 months versus no SMS notification and (2) a £10 voucher sent with the invitation letter for the primary follow-up visit at 24 months or given at the visit. The two co-primary outcomes were collection of host trial (1) questionnaire data at interim follow-up times and (2) primary outcome at 24 months during a home/clinic visit with a research nurse.

resultsBetween November 2014 and November 2016, 1394 participants were randomised: 350 to no SMS + voucher at visit, 345 to SMS + voucher at visit, 352 to no SMS + voucher before visit and 347 to SMS + voucher before visit. Overall questionnaire data was collected at interim follow-up times for 75% in both the group allocated to the prior SMS notification and the group allocated to no SMS notification (odds ratio (OR) SMS versus none 1.02, 95% CI 0.83 to 1.25). Host trial primary outcome data was collected at a visit for 557 (80%) allocated to the voucher before the visit in the invitation letter and for 566 (81%) whose parents were allocated to receive the voucher at the visit (OR before versus at visit 0.89, 95% CI 0.69 to 1.17).

conclusionThere was no evidence of a difference in retention according to SMS notification or voucher timing. Future synthesis of SWAT results is required to be able to detect small but important incremental effects of retention strategies.

trial registrationISRCTN registry, ID: ISRCTN21528841. Registered on 25 July 2014. SWAT Repository Store ID 25.

Indexed as

Follow-Up StudiesRewardAdultFemaleHumansLogistic ModelsPatient ParticipationSurveys and QuestionnairesText MessagingIncentiveRandomisedRetentionShort message serviceSWAT

Identifiers

PMID32546180
PMCPMC7296963

What OpenQuestion holds

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Registered trials

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.