ArticleContemporary clinical trials communications2018
Impact of informed consent content and length on recruitment of older adults into a community based primary prevention trial.
Article in Contemporary clinical trials communications, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed, 15 citations in OpenAlex.
- Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment.Substance abuse · 2022Trial
- Widening participation in cognitive neuroscience: a mixed-methods study of age-related motivators, barriers and attitudes towards imaging methods.BMC medical research methodology · 2026Article
- Barriers and facilitators to recruiting older adult care home residents into clinical trials of medicines and vaccines: a scoping review.Age and ageing · 2026Article
- Evaluating the impact of a SIMPlified LaYered consent process on recruitment of potential participants to theBMJ open · 2024Article
- Article
- Anticipating adaptation: tracking the impact of planned and unplanned adaptations during the implementation of a complex population-based genomic screening program.Translational behavioral medicine · 2023Article
- Article
- Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study.Frontiers in psychiatry · 2021Article
- Opportunities for eConsent to enhance consumer engagement in clinical trials.The Medical journal of Australia · 2020Article
- Readability of informed consent documents and its impact on consent refusal rate.Perspectives in clinical researchArticle
Corrections and comments
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo compare recruitment, refusal and randomisation rates of older adults into a general practice-based clinical trial with two versions (varied format, content and language) of the Participant Information and Consent Form (PICF).
methodsThis prospective PICF study was conducted within the STAREE (STAtins in Reducing Events in the Elderly) clinical trial. Participants phone screened between October 2015 to February 2016 formed Group 1 and were mailed the extended PICF version and participants phone screened between October 2016 to February 2017 formed Group 2 and were mailed the shortened PICF version. Participants who attended a subsequent baseline screening visit were guided through a comprehensive informed consent process.
resultsDuring the screening phase of the trial, the likelihood of refusing trial participation was lower in Group 2 compared to Group 1 equating to an overall 23% reduction in risk (RR 0.77, P = 0.005, 95% CI 0.62-0.95). Group 2 had a 6.4% higher randomisation rate compared with Group 1 (65.3% versus 58.9% respectively) but this difference was not statistically significant. Factors associated with trial participation were male gender, age between 70 and 75 years and living alone (all p < .0.05).
conclusionsWhilst avoiding lengthy and complex PICF documents may assist with initial trial engagement, it needs to be supplemented with other strategies to support ongoing trial interest to randomisation and beyond. Participants refused trial participation throughout the screening phase indicating that the PICF was only one factor among several affecting an individual's decision to participate in this clinical trial.
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