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Of the six studies in which it was appropriate to report consent rates, four did not [ 37, 38, 41, 43] and two reported consent rates of 93% [ 35] and 61% [ 40] respectively.
The parents signed a case report consent for publication.
93 (31%, 26% to 36%) trials failed to report consent.
Trials with interventions targeting participants at the individual level were more likely to report consent than were trials with interventions targeting the cluster level (87%9090) v 48% (41); P<0.001).
Trials with data collection interventions at the individual level were more likely to report consent than were those that used routine data sources only (78% (146) v 29% (11); P<0.001).
Reporting of consent was also significantly associated with types of data collection interventions (P<0.001): the empirical estimate of the propensity to report consent for trials collecting routine data only was 29% compared with 78%and40%0% for trials with data collection interventions solely at the individual level or the cluster level.
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The patients concerned in this case report consented to its publication after seeing the final version.
Among all 300 trials, 5% reported consent from gatekeepers, 11% reported consent from cluster level participants, and 59% reported consent from individual level participants.
Among the trials that reported consent, 17% reported on consent from more than one type of participant for example, gatekeeper or participant at cluster level or individual level.
To classify a trial as reporting consent, we required a clear statement of consent in the published report.
9 We found an indication that authors used more rigorous standards when reporting consent practices at the individual level than at the cluster level: 69% of trials that reported consent at the individual level reported whether the method was written or verbal, but only 53% of trials that reported consent at the cluster level provided such details.
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CEO of Professional Science Editing for Scientists @ prosciediting.com