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A randomised controlled trial comparing opt-in and opt-out home visits for tracing lost participants in a prospective birth cohort study

Bray, Isabelle; Noble, Sian; Boyd, Andy; Brown, Lindsey; Hayes, Pei; Malcolm, Joanne; Robinson, Ross; Williams, Rachel; Burston, Kirsty; Macleod, John; Molloy, Lynn; Tilling, Kate


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Issy Bray
Associate Professor in Public Health (Epidemiology)

Sian Noble

Andy Boyd

Lindsey Brown

Pei Hayes

Joanne Malcolm

Ross Robinson

Rachel Williams

Kirsty Burston

John Macleod

Lynn Molloy

Kate Tilling


© 2015 Bray et al. Background: Attrition is an important problem in cohort studies. Tracing cohort members who have moved or otherwise lost contact with the study is vital. There is some debate about the acceptability and relative effectiveness of opt-in versus opt-out methods of contacting cohort members to re-engage them in this context. We conducted a randomised controlled trial to compare the two approaches in terms of effectiveness (tracing to confirm address and consenting to continue in the study), cost-effectiveness and acceptability. Methods: Participants in this trial were individuals (young people and mothers) recruited to the Avon Longitudinal Study of Parents and Children (ALSPAC), who had not engaged with the study in the previous 5 years and for whom mail had been returned from their last known address. The sampling frame was restricted to those for whom database searching led to a potential new address being found in the Bristol area. 300 participants were randomly selected and assigned using stratified randomisation to the opt-in or opt-out arm. A tailored letter was sent to the potential new address, either asking participants to opt in to a home visit, or giving them the option to opt out of a home visit. Fieldworkers from Ipsos MORI conducted home visits to confirm address details. Results: The proportion who were traced was higher in the opt-out arm (77/150∈=∈51 %) than the opt-in arm (6/150∈=∈4 %), as was the proportion who consented to continue in ALSPAC (46/150∈=∈31 % v 4/150∈=∈3 %). The mean cost per participant was £8.14 in the opt-in arm and £71.93 in the opt-out arm. There was no evidence of a difference in acceptability between the opt-in and opt-out approaches. Conclusion: Since the opt-in approach yielded very low response rates, and there were no differences in terms of acceptability, we conclude that the opt-out approach is the most effective method of tracing disengaged study members. The gains made in contacting participants must be weighed against the increase in cost using this methodology.


Bray, I., Noble, S., Boyd, A., Brown, L., Hayes, P., Malcolm, J., …Tilling, K. (2015). A randomised controlled trial comparing opt-in and opt-out home visits for tracing lost participants in a prospective birth cohort study. BMC Medical Research Methodology, 15(1),

Journal Article Type Article
Publication Date Jul 24, 2015
Journal BMC Medical Research Methodology
Electronic ISSN 1471-2288
Publisher BMC
Peer Reviewed Peer Reviewed
Volume 15
Issue 1
Keywords opt-in, opt-out, consent, tracing, tracking, participation, cohort study, acceptability, cost-effectiveness
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