Evidence map›Paper›PMID 32420511›Full record

ArticleContemporary clinical trials communications2020

Study within a trial (SWAT) protocol. Investigating the effect of personalised versus non-personalised study invitations on recruitment: An embedded randomised controlled recruitment trial.

Joanne Woodford, Kajsa Norbäck, Josefin Hagström, Helena Grönqvist, Adwoa Parker, Catherine Arundel, Louise von Essen

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2020. 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.

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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

7 authors.

Joanne WoodfordDepartment of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.
Kajsa NorbäckDepartment of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.
Josefin HagströmDepartment of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.
Helena GrönqvistDepartment of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.
Adwoa ParkerDepartment of Health Sciences, Faculty of Sciences, York Trials Unit, University of York, United Kingdom.
Catherine ArundelDepartment of Health Sciences, Faculty of Sciences, York Trials Unit, University of York, United Kingdom.
Louise von EssenDepartment of Women's and Children's Health, Uppsala University Psychosocial Care Programme (U-CARE), Uppsala University, Sweden.

Funding

Medical Research Council MR/R013748/1
6 · The paper itself

Abstract

introductionRecruitment into clinical trials is a common challenge experienced by healthcare researchers. Currently, there is little evidence regarding strategies to improve recruitment into clinical trials. However, preliminary research suggests the personalisation of study invitation letters may increase recruitment rates. As such, there is a need to investigate the effectiveness of personalisation strategies on trial recruitment rates. This study within a trial (SWAT) will investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host trial ENGAGE, a feasibility study of an internet-administered, guided, Cognitive-Behavioural Therapy (CBT) based self-help intervention for parents of children previously treated for cancer.

methodsAn embedded randomised controlled trial (RCT) will investigate the effectiveness of a personalised study invitation letter including the potential participant's name and address compared with a standard, non-personalised letter without name or address, on participant recruitment rates into the ENGAGE study. The primary outcome is differences in the proportion of participants recruited, examined using logistic regression. Results will be reported as adjusted odds ratios with 95% confidence intervals. DISCUSSION: Even moderate effects of the personalisation of study invitation letters on recruitment rates could be of significant value by shortening study length, saving resources, and providing a faster answer to the clinical question posed by the study. This protocol can be used as a template for other researchers who wish to contribute to the evidence base for trial decision-making, by embedding a similar SWAT into their trial.

trial registrationISRCTN 57233429; ISRCTN 18404129; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231).

Indexed as

CBT, Cognitive-Behavioural TherapyCONSORT, Consolidated Standards of Reporting TrialsEmbedded randomised controlled trialISRCTN, International Standard Randomised Controlled Trials NumberRCT, Randomised controlled trialRecruitmentStudy within a trialSWATSWAT, Study within a trial

Identifiers

PMID32420511
PMCPMC7214762

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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.