ArticleContemporary clinical trials communications2019
The impact of central IRB's on informed consent readability and trial adherence in SPRINT.
Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed, 1 citations in OpenAlex.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundFederal agencies have encouraged the use of central institutional review boards (CIRBs) for multi-site clinical trials. There is limited evidence supporting the use of CIRBs. Our aim is to evaluate how SPRINT sites regulated by CIRBs performed regarding informed consent readability and participant trial adherence compared to those regulated by local IRBs.
methodsWe conducted a cohort study using the SPRINT clinical trial. We collected the IRB of record from the stamped and approved 2012 informed consents from each of the sites. We defined CIRB as an IRB for more than one SPRINT site. Our outcomes were informed consent readability measured using the Flesch-Kincaid readability scale and trial adherence defined as a loss to follow-up, consent withdrawal, and missed last 3-month visit.
resultsSixty-one percent of all SPRINT sites used a CIRB as their IRB of record. The adjusted mean grade reading level for CIRB consents was 13.4 (95% CI 12.6-13.8) compared to 12.3 (95% CI 12.1-13.1) for non CIRB consents (p = 0.07). CIRB sites had similar rates of withdrawal of consent and loss to follow-up as non-CIRB sites; subjects missing the last appointment of the study were more likely to come from sites regulated by a CIRB. The Veterans Affairs CIRB had the lowest rate of withdrawal of consent (1.9%) and the lowest rate of missed appointments (1.9%) among CIRBs.
conclusionsNiether CIRB-regulated sites nor IRB regulated sites enforce the recommended readability level of the informed consent documents. Sites regulated by both IRBs had similar participant trial adherence.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.