Evidence map›Paper›PMID 35249543›Full record

Trial reportBMC medical research methodology2022

The effect of personalised versus non-personalised study invitations on recruitment within the ENGAGE feasibility trial: an embedded randomised controlled recruitment trial.

Ella Thiblin, Joanne Woodford, Mattias Öhman, Louise von Essen

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medical research methodology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Trial
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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

4 authors.

Ella ThiblinHealthcare Sciences and e-Health, Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds väg 14B, 751 05, Uppsala, Sweden.
Joanne WoodfordHealthcare Sciences and e-Health, Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds väg 14B, 751 05, Uppsala, Sweden.
Mattias ÖhmanInstitute for Housing and Urban Research, Uppsala University, Uppsala, Sweden.
Louise von EssenHealthcare Sciences and e-Health, Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds väg 14B, 751 05, Uppsala, Sweden. louise-von.essen@kbh.uu.se.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecruitment into clinical trials is challenging and there is a lack of evidence on effective recruitment strategies. Personalisation of invitation letters is a potentially pragmatic and feasible way of increasing recruitment rates at a low-cost. However, there is a lack of evidence concerning the effect of personalising of study invitation letters on recruitment rates.

methodsWe undertook a Study Within A Trial (SWAT) to investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host feasibility trial ENGAGE, a feasibility study of an internet-administered, guided, Low Intensity Cognitive-Behavioural Therapy based self-help intervention for parents of children previously treated for cancer. An intervention group (n = 254) received a personalised study invitation letter and the control group (n = 255) received a non-personalised study invitation letter. The primary outcome was the proportion of participants in the intervention group and the control group enrolled into the ENGAGE host feasibility trial. Secondary outcomes relating to the recruitment and screening process, and retention were examined. Differences in proportions between groups for the primary and secondary outcomes were estimated using logistic regression.

resultsOf the 509 potential participants, 56 (11.0%) were enrolled into the ENGAGE host feasibility trial: personalised: 30/254 (11.8%) and non-personalised: 26/255 (10.2%). No statistically significant effect on personalisation of enrolment was found (OR 1.18, 95% CI 0.68-2.06). No statistically significant differences were found for any secondary outcome.

conclusionsPersonalisation of study invitations had no effect on recruitment. However, given the small study sample size in the present SWAT, and lack of similar embedded recruitment RCTs to enable a meta-analysis, additional SWATs to examine the personalisation of study invitation letters are warranted.

trial registrationISRCTN57233429 ; ISRCTN18404129 ; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231) ( https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,939618,en.pdf ).

Indexed as

Health BehaviorResearch DesignChildFeasibility StudiesHumansLogistic ModelsSample SizeRandomised controlled trialRecruitmentRetentionStudy invitationStudy within a trialTrial methodology

Identifiers

PMID35249543
PMCPMC8898447

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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.