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A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial

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A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial. / Arundel, Catherine Ellen; Jefferson, Laura Anne; Bailey, Matthew; Cockayne, Elizabeth Sarah; Hicks, Kathryn Jane; Green, Lorraine Ruth-Loughrey; Rodgers, Sara Anita; Torgerson, David John; of the REFORM Study Team, On Behalf.

In: Journal of Evaluation in Clinical Practice, Vol. 23, No. 1, 20.06.2016, p. 73-78.

Research output: Contribution to journalArticle

Harvard

Arundel, CE, Jefferson, LA, Bailey, M, Cockayne, ES, Hicks, KJ, Green, LR-L, Rodgers, SA, Torgerson, DJ & of the REFORM Study Team, OB 2016, 'A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial', Journal of Evaluation in Clinical Practice, vol. 23, no. 1, pp. 73-78. https://doi.org/10.1111/jep.12576

APA

Arundel, C. E., Jefferson, L. A., Bailey, M., Cockayne, E. S., Hicks, K. J., Green, L. R-L., ... of the REFORM Study Team, O. B. (2016). A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial. Journal of Evaluation in Clinical Practice, 23(1), 73-78. https://doi.org/10.1111/jep.12576

Vancouver

Arundel CE, Jefferson LA, Bailey M, Cockayne ES, Hicks KJ, Green LR-L et al. A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial. Journal of Evaluation in Clinical Practice. 2016 Jun 20;23(1):73-78. https://doi.org/10.1111/jep.12576

Author

Arundel, Catherine Ellen ; Jefferson, Laura Anne ; Bailey, Matthew ; Cockayne, Elizabeth Sarah ; Hicks, Kathryn Jane ; Green, Lorraine Ruth-Loughrey ; Rodgers, Sara Anita ; Torgerson, David John ; of the REFORM Study Team, On Behalf. / A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial. In: Journal of Evaluation in Clinical Practice. 2016 ; Vol. 23, No. 1. pp. 73-78.

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@article{dd224abaa23b4f57b2da391ccd13a9a5,
title = "A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial",
abstract = "Objectives: To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomised controlled trial (RCT).Methods: A methodological, two arm, randomised controlled trial was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomised for the embedded trial, using a 1:2 (intervention:control) allocation ratio, prior to being randomised for the REFORM RCT. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2 to 3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox Proportional Hazards Model and Incremental Cost Effectiveness Ratios.Results: Of the 1,436 intervention group participants, 73 (5.1{\%}) were randomised into the REFORM trial compared to 126 (4.4{\%}) of the 2,878 control group participants. The associated relative risk (1.16) was not statistically significant (95{\%} CI 0.88 - 1.56). The leaflet did not significantly increase return rate (RR 1.10, 95{\%} CI 0.92 -1.28) or decrease time to return (Hazard Ratio: 1.11, 95{\%} CI 0.93 -1.33). Incremental Cost Effectiveness Ratios indicated that the intervention may be cost-effective if the true estimate of effect were close to the upper bound of the associated 95{\%} CI.Conclusion: A pre-notification leaflet to potential trial participants demonstrated a small difference in favour of the intervention with regards randomisation (0.7{\%} difference) and return rates (1.1{\%} difference).Results should however be interpreted with caution as confidence intervals for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended.",
author = "Arundel, {Catherine Ellen} and Jefferson, {Laura Anne} and Matthew Bailey and Cockayne, {Elizabeth Sarah} and Hicks, {Kathryn Jane} and Green, {Lorraine Ruth-Loughrey} and Rodgers, {Sara Anita} and Torgerson, {David John} and {of the REFORM Study Team}, {On Behalf}",
note = "{\circledC} 2016, John Wiley & Sons, Ltd. This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy. Further copying may not be permitted; contact the publisher for details.",
year = "2016",
month = "6",
day = "20",
doi = "10.1111/jep.12576",
language = "English",
volume = "23",
pages = "73--78",
journal = "Journal of Evaluation in Clinical Practice",
issn = "1356-1294",
publisher = "Wiley-Blackwell",
number = "1",

}

RIS (suitable for import to EndNote) - Download

TY - JOUR

T1 - A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial

AU - Arundel, Catherine Ellen

AU - Jefferson, Laura Anne

AU - Bailey, Matthew

AU - Cockayne, Elizabeth Sarah

AU - Hicks, Kathryn Jane

AU - Green, Lorraine Ruth-Loughrey

AU - Rodgers, Sara Anita

AU - Torgerson, David John

AU - of the REFORM Study Team, On Behalf

N1 - © 2016, John Wiley & Sons, Ltd. This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy. Further copying may not be permitted; contact the publisher for details.

PY - 2016/6/20

Y1 - 2016/6/20

N2 - Objectives: To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomised controlled trial (RCT).Methods: A methodological, two arm, randomised controlled trial was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomised for the embedded trial, using a 1:2 (intervention:control) allocation ratio, prior to being randomised for the REFORM RCT. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2 to 3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox Proportional Hazards Model and Incremental Cost Effectiveness Ratios.Results: Of the 1,436 intervention group participants, 73 (5.1%) were randomised into the REFORM trial compared to 126 (4.4%) of the 2,878 control group participants. The associated relative risk (1.16) was not statistically significant (95% CI 0.88 - 1.56). The leaflet did not significantly increase return rate (RR 1.10, 95% CI 0.92 -1.28) or decrease time to return (Hazard Ratio: 1.11, 95% CI 0.93 -1.33). Incremental Cost Effectiveness Ratios indicated that the intervention may be cost-effective if the true estimate of effect were close to the upper bound of the associated 95% CI.Conclusion: A pre-notification leaflet to potential trial participants demonstrated a small difference in favour of the intervention with regards randomisation (0.7% difference) and return rates (1.1% difference).Results should however be interpreted with caution as confidence intervals for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended.

AB - Objectives: To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomised controlled trial (RCT).Methods: A methodological, two arm, randomised controlled trial was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomised for the embedded trial, using a 1:2 (intervention:control) allocation ratio, prior to being randomised for the REFORM RCT. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2 to 3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox Proportional Hazards Model and Incremental Cost Effectiveness Ratios.Results: Of the 1,436 intervention group participants, 73 (5.1%) were randomised into the REFORM trial compared to 126 (4.4%) of the 2,878 control group participants. The associated relative risk (1.16) was not statistically significant (95% CI 0.88 - 1.56). The leaflet did not significantly increase return rate (RR 1.10, 95% CI 0.92 -1.28) or decrease time to return (Hazard Ratio: 1.11, 95% CI 0.93 -1.33). Incremental Cost Effectiveness Ratios indicated that the intervention may be cost-effective if the true estimate of effect were close to the upper bound of the associated 95% CI.Conclusion: A pre-notification leaflet to potential trial participants demonstrated a small difference in favour of the intervention with regards randomisation (0.7% difference) and return rates (1.1% difference).Results should however be interpreted with caution as confidence intervals for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended.

U2 - 10.1111/jep.12576

DO - 10.1111/jep.12576

M3 - Article

VL - 23

SP - 73

EP - 78

JO - Journal of Evaluation in Clinical Practice

JF - Journal of Evaluation in Clinical Practice

SN - 1356-1294

IS - 1

ER -