ArticlePloS one2017
A randomized trial comparing concise and standard consent forms in the START trial.
Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00867048 (Strategic Timing of AntiRetroviral Treatment), which is not on this map. Cited by 24 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Strategic Timing of AntiRetroviral Treatment
Who cites it
24 citing papers in PubMed.
- A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension.Clinical trials (London, England) · 2026Trial
- Trial
- Trial
- Randomized comparison of two interventions to enhance understanding during the informed consent process for research.Clinical trials (London, England) · 2021Trial
- A randomized controlled study of a consent intervention for participating in an NIH genome sequencing study.European journal of human genetics : EJHG · 2018Trial
- Assessing informed consent in an opioid relapse prevention study with adults under current or recent criminal justice supervision.Journal of substance abuse treatment · 2017Trial
- Article
- What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials.BMC medical ethics · 2022Article
- Examining the language demands of informed consent documents in patient recruitment to cancer trials using tools from corpus and computational linguistics.Health (London, England : 1997) · 2022Article
- Factors Influencing Successful Recruitment of Racial and Ethnic Minority Patients for an Observational HIV Cohort Study in Washington, DC.Journal of racial and ethnic health disparities · 2022Observational
- Foundations for Meaningful Consent in Canada's Digital Health Ecosystem: Retrospective Study.JMIR medical informatics · 2022Article
- Experimenting with modifications to consent forms in comparative effectiveness research: understanding the impact of language about financial implications and key information.BMC medical ethics · 2022Article
- Article
- Assessing Parent Decisions About Child Participation in a Behavioral Health Intervention Study and Utility of Informed Consent Forms.JAMA network open · 2020Article
- Bridging the Researcher-Participant Gap: A Research Agenda to Build Effective Research Relationships.The American journal of bioethics : AJOB · 2020Article
- Readability of consent forms in veterinary clinical research.Journal of veterinary internal medicine · 2019Article
- Article
- Developing informed consent materials for non-English-speaking participants: An analysis of four professional firm translations from English to Spanish.Clinical trials (London, England) · 2018Article
- Assessment of a shortened informed consent form for pediatric research: a pilot study.Pediatric research · 2018Article
- What information and the extent of information research participants need in informed consent forms: a multi-country survey.BMC medical ethics · 2018Article
Corrections and comments
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Authors and funding
17 authors.
Funding
Abstract
backgroundImproving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed.
methodsWe conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin).
results77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups.
conclusionsAn easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient.
trial registrationInformed consent substudy was registered as part of START study in clinicaltrials.gov #NCT00867048, and EudraCT # 2008-006439-12.
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