Professionally designed information materials and telephone reminders improved consent response rates: evidence from an RCT nested within a cohort study.
Bottom Line: The primary outcome was return of the consent form ("response"), with consent decision being the secondary outcome.Of 1,950 participants, 806 (41%) responded.Response rates were 2.7% higher (95% confidence interval: -0.06, 5.5%; P = 0.06) among those receiving designed packs than among those receiving standard packs and 6.4% higher (2.3, 10.6%; P = 0.002) among those receiving phone reminders (compared with postal reminders).
Affiliation: ALSPAC, School of Social and Community Medicine, University of Bristol, Oakfield House, Oakfield Grove, Bristol BS8 2BN, UK. Electronic address: firstname.lastname@example.org.Show MeSH
Mentions: The RCT evaluated three variations in how consent materials were provided. These were sent to the PEARL RCT sample, which was drawn from the full PEARL sample (Fig. 1). As differing participation histories could complicate the interpretation of our results, we restricted the PEARL RCT sample selection to young adults who had recently participated (those attending ALSPAC clinical assessments aged 15 or 17 or returning the 16-year questionnaire). To control for differing extents of individual participation history, we stratified our sample using a participation score (see Section 2.4). Where an individual selected for the trial was a twin, we allocated the nontrial twin to the same intervention groups and administered the interventions as if they were part of the trial. Nontrial twins were excluded from analysis. The RCT was conducted from April 18, 2011, until December 23, 2012.
Affiliation: ALSPAC, School of Social and Community Medicine, University of Bristol, Oakfield House, Oakfield Grove, Bristol BS8 2BN, UK. Electronic address: email@example.com.