SWAT 76 evaluation: randomised evaluation of sending pre-notification cards to trial participants before a face-to-face primary outcome measurement to increase attendance

Shaun Treweek; Stephanie Gallant; Annie S Anderson

doi:10.12688/f1000research.50890.1

SWAT 76 evaluation: randomised evaluation of sending pre-notification cards to trial participants before a face-to-face primary outcome measurement to increase attendance

Shaun Treweek^* (Corresponding Author), Stephanie Gallant, Annie S Anderson

^*Corresponding author for this work

University of Dundee

Research output: Book/Report › Other Report

1 Citation (Scopus)

3 Downloads (Pure)

Abstract

Retention is considered the second highest trial methods priority in the UK after recruitment. This Study Within A Trial (SWAT) evaluated whether sending a pre-notification card around one month before a face-to-face primary outcome measurement visit compared to not sending the card increased trial retention. The SWAT was a two-arm, parallel randomised (1:1 allocation ratio), stratified by centre, study. It was embedded within the ActWELL host trial, which evaluated whether women receiving lifestyle change counselling from volunteer coaches improved outcomes including weight and physical activity. The text on the card was not developed using formal behavioural change theory but did target factors thought to influence attendance. The SWAT primary outcome was the difference in the proportion of participants attending the host trial primary outcome measurement visit. The secondary outcome was the direct cost of sending cards. Host trial participants and research staff at the primary outcome visit were blind to the SWAT. Analysis was intention-to-treat. GRADE was used the assess the certainty of evidence. 558 host trial participants took part in the SWAT and were included in the analysis. Sending a pre-notification card may result in a slight increase in attendance at a face-to-face primary outcome measurement visit: risk difference = 3.3% (95% confidence interval = -3.0% to 9.6%). This is GRADE low certainty evidence. A recording error meant it was unclear whether 17 participants allocated to the card were actually sent one but a sensitivity analysis did not change the overall result or conclusion. The direct cost of producing and sending the cards was £192 GBP (€213 EUR; $260 USD). Trialists could consider using pre-notification as they may gain a slight increase in retention to face-to-face trial measurement visits but further evaluations are needed.

Original language	English
Publisher	F1000 Research Ltd.
Number of pages	14
Volume	10
DOIs	https://doi.org/10.12688/f1000research.50890.1
Publication status	Published - 2021

Publication series

Name	F1000Research
ISSN (Print)	2046-1402

Bibliographical note

Grant information: The SWAT evaluation and the ActWELL trial were funded by the Scottish Government (BC/Screening/17/01).
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Keywords

SWAT
pre-notification cards
randomised trial
retention

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Treweek_etal_SWAT_76_evaluation_VOR
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. https://creativecommons.org/licenses/by/4.0/
Final published version, 13.8 MBLicence: CC BY

Cite this

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title = "SWAT 76 evaluation: randomised evaluation of sending pre-notification cards to trial participants before a face-to-face primary outcome measurement to increase attendance",

abstract = "Retention is considered the second highest trial methods priority in the UK after recruitment. This Study Within A Trial (SWAT) evaluated whether sending a pre-notification card around one month before a face-to-face primary outcome measurement visit compared to not sending the card increased trial retention. The SWAT was a two-arm, parallel randomised (1:1 allocation ratio), stratified by centre, study. It was embedded within the ActWELL host trial, which evaluated whether women receiving lifestyle change counselling from volunteer coaches improved outcomes including weight and physical activity. The text on the card was not developed using formal behavioural change theory but did target factors thought to influence attendance. The SWAT primary outcome was the difference in the proportion of participants attending the host trial primary outcome measurement visit. The secondary outcome was the direct cost of sending cards. Host trial participants and research staff at the primary outcome visit were blind to the SWAT. Analysis was intention-to-treat. GRADE was used the assess the certainty of evidence. 558 host trial participants took part in the SWAT and were included in the analysis. Sending a pre-notification card may result in a slight increase in attendance at a face-to-face primary outcome measurement visit: risk difference = 3.3% (95% confidence interval = -3.0% to 9.6%). This is GRADE low certainty evidence. A recording error meant it was unclear whether 17 participants allocated to the card were actually sent one but a sensitivity analysis did not change the overall result or conclusion. The direct cost of producing and sending the cards was £192 GBP (€213 EUR; $260 USD). Trialists could consider using pre-notification as they may gain a slight increase in retention to face-to-face trial measurement visits but further evaluations are needed. ",

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note = "Grant information: The SWAT evaluation and the ActWELL trial were funded by the Scottish Government (BC/Screening/17/01). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).",

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N1 - Grant information: The SWAT evaluation and the ActWELL trial were funded by the Scottish Government (BC/Screening/17/01). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

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N2 - Retention is considered the second highest trial methods priority in the UK after recruitment. This Study Within A Trial (SWAT) evaluated whether sending a pre-notification card around one month before a face-to-face primary outcome measurement visit compared to not sending the card increased trial retention. The SWAT was a two-arm, parallel randomised (1:1 allocation ratio), stratified by centre, study. It was embedded within the ActWELL host trial, which evaluated whether women receiving lifestyle change counselling from volunteer coaches improved outcomes including weight and physical activity. The text on the card was not developed using formal behavioural change theory but did target factors thought to influence attendance. The SWAT primary outcome was the difference in the proportion of participants attending the host trial primary outcome measurement visit. The secondary outcome was the direct cost of sending cards. Host trial participants and research staff at the primary outcome visit were blind to the SWAT. Analysis was intention-to-treat. GRADE was used the assess the certainty of evidence. 558 host trial participants took part in the SWAT and were included in the analysis. Sending a pre-notification card may result in a slight increase in attendance at a face-to-face primary outcome measurement visit: risk difference = 3.3% (95% confidence interval = -3.0% to 9.6%). This is GRADE low certainty evidence. A recording error meant it was unclear whether 17 participants allocated to the card were actually sent one but a sensitivity analysis did not change the overall result or conclusion. The direct cost of producing and sending the cards was £192 GBP (€213 EUR; $260 USD). Trialists could consider using pre-notification as they may gain a slight increase in retention to face-to-face trial measurement visits but further evaluations are needed.

AB - Retention is considered the second highest trial methods priority in the UK after recruitment. This Study Within A Trial (SWAT) evaluated whether sending a pre-notification card around one month before a face-to-face primary outcome measurement visit compared to not sending the card increased trial retention. The SWAT was a two-arm, parallel randomised (1:1 allocation ratio), stratified by centre, study. It was embedded within the ActWELL host trial, which evaluated whether women receiving lifestyle change counselling from volunteer coaches improved outcomes including weight and physical activity. The text on the card was not developed using formal behavioural change theory but did target factors thought to influence attendance. The SWAT primary outcome was the difference in the proportion of participants attending the host trial primary outcome measurement visit. The secondary outcome was the direct cost of sending cards. Host trial participants and research staff at the primary outcome visit were blind to the SWAT. Analysis was intention-to-treat. GRADE was used the assess the certainty of evidence. 558 host trial participants took part in the SWAT and were included in the analysis. Sending a pre-notification card may result in a slight increase in attendance at a face-to-face primary outcome measurement visit: risk difference = 3.3% (95% confidence interval = -3.0% to 9.6%). This is GRADE low certainty evidence. A recording error meant it was unclear whether 17 participants allocated to the card were actually sent one but a sensitivity analysis did not change the overall result or conclusion. The direct cost of producing and sending the cards was £192 GBP (€213 EUR; $260 USD). Trialists could consider using pre-notification as they may gain a slight increase in retention to face-to-face trial measurement visits but further evaluations are needed.

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DO - 10.12688/f1000research.50890.1

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VL - 10

T3 - F1000Research

BT - SWAT 76 evaluation

PB - F1000 Research Ltd.

ER -

SWAT 76 evaluation: randomised evaluation of sending pre-notification cards to trial participants before a face-to-face primary outcome measurement to increase attendance

Abstract

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Bibliographical note

Keywords

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