Armitage, Jane

Chen, Fang

Haynes, R

Murray, C

Naessens, K

Rahimi, K

Taylor-Clarke, M

English

PubMed

Fang Chen

K Rahimi

R Haynes

K Naessens

M Taylor-Clarke

C Murray

Jane Armitage

Springer - Publisher Connector

Investigating strategies to improve attendance at screening visits in a randomized trial

Chen, F

Rahimi, Kazem

Haynes, Richard

Armitage, J

Oxford University Research Archive

Investigating strategies to improve attendance at screening visits in a randomized trial.

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Oxford University Research Archive (ORA)

Trials

Chen Fang

Rahimi K

Haynes R

Naessens K

Taylor-Clarke M

Murray C

Armitage Jane

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ORAL PRESENTATION Open Access
Investigating strategies to improve attendance at
screening visits in a randomized trial
Fang Chen, K Rahimi, R Haynes, K Naessens, M Taylor-Clarke, C Murray, Jane Armitage*
From Clinical Trials Methodology Conference 2011
Bristol, UK. 4-5 October 2011
Background
A common method of recruiting for randomized trials is
to send letters to potentially eligible patients inviting
them to a screening appointment. In 3 consecutive UK
studies the proportion attending from those invited fell
from 49% [1] in 1994-1997 and 42%[2] in 1998-2001 to
13% at the beginning of an ongoing study in 2007. Pro-
cedures were similar in the 3 trials except that in 2007
the Patient Information Leaflet (PIL) was enclosed with
the invitation letter. In order to understand whether the
contents and/or style of invitation would explain the
declining trend, 2 separate randomized comparisons
were undertaken during the recruitment for the ongoing
study.
Methods
Potentially eligible patients identified from hospital
records were randomized to receive either an invitation
letter enclosing the PIL (a 12-page A5 MREC approved
booklet giving detailed information about the trial) or
just a one page summary. A second comparison was
made between a PIL modified after Focus Group discus-
sions and the original PIL. Modifications included more
colours, pictures and simplified language. The pre-speci-
fied endpoints for these assessments were the propor-
tions of patients attending the screening visit, and
entering the pre-randomization run-in period.
Results
Between July and October 2008, 20,759 personalized
invitation letters were randomized to have the PIL or
brief summary enclosed. There were no significant dif-
ferences in either the proportions attending: PIL
enclosed 1122/10,566 (10.6%) versus not 1181/10,590
(11.2%) [OR 1.06; 95%CI 0.97-1.16]; or in the proportion
entering the pre-randomization run-in: 720/1181 (6.8%
of those invited) versus 690/1122 (6.5%) [OR 1.05; (0.94-
1.17)].
From November 2009 to January 2010, 12,164 patient
invitations were randomized to enclose either the modi-
fied or the original PIL. A 17% higher attendance was
detected for the modified PIL: 580/6104 (9.5%) versus
499/6060 (8.2%) for the original PIL [OR=1.17; (1.03-
1.33): p=0.01). However there was no significant differ-
ence in the proportion entering the pre-randomization
run-in: 373 (6.1% of those invited) vs 339 (5.6%) for
modified versus original (OR 1.10; 0.94-1.28).
Conclusion
Whether the full PIL or brief summary was enclosed
with the invitation did not affect the likelihood of
attending or entering the run-in. Enclosing a more
patient friendly PIL modestly improved the chance of
attending, but not whether patients agreed to enter the
study.
Published: 13 December 2011
References
1. MRC/BHF Heart Protection Study Collaborative Group: MRC/BHF Heart
Protection Study of cholesterol-lowering therapy and of antioxidant
vitamin supplementation in a wide range of patients at increased risk of
coronary heart disease death: early safety and efficacy experience. Eur
Heart J 1999, 20:725-741.
2. SEARCH Study Collaborative Group: Study of the effectiveness of
additional reductions in cholesterol and homocysteine (SEARCH):
characteristics of a randomized trial among 12064 myocardial infarction
survivors. Am Heart J 2007, 154:815-823, e6.
doi:10.1186/1745-6215-12-S1-A111
Cite this article as: Chen et al.: Investigating strategies to improve
attendance at screening visits in a randomized trial. Trials 2011 12(Suppl
1):A111.
Clinical Trial Service Unit & Epidemiological Studies Unit, University of
Oxford, OX3 7LF, UK
Chen et al. Trials 2011, 12(Suppl 1):A111
http://www.trialsjournal.com/content/12/S1/A111 TRIALS
© 2011 Chen et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.


Collaborative Group: Study of the effectiveness of additional reductions in cholesterol and homocysteine (SEARCH): characteristics of a randomized trial among 12064 myocardial infarction survivors. Am Heart J

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3287684

Investigating strategies to improve attendance at screening visits in a randomized trial

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