Imaging could identify patients early enough for potential therapies, assist with therapeutic monitoring, and enhance trial recruitment and patient enrichment.
Our participatory evaluation provides important insights about the practice of international on-site monitoring, and the value of utilising internal and network expertise to enhance trial quality.
Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country.
Involving people with experience of the condition, intervention or service where applicable may be particularly germane in identifying research priorities and enhancing trial design.
However, it should be highlighted that a recent systematic review found equivocal evidence with regard to effectiveness of audio visual interventions to enhance trial knowledge (during informed consent) but the authors highlight the need to involve consumers in intervention development.
In particular, the components not only dissociated with respect to the task, but also to the response speed: Whereas the CNV was enhanced on trials with fast responses (as well as for the location task), the slow posterior positivity was enhanced on trials with slow responses (as well as for the shape task).
Survival curves for patients receiving DrotAA were similar between the PROWESS and ENHANCE trials.
Using EHR4CR to facilitate adverse event reporting was widely accepted as enhancing trials (see Table 5).
A small proportion (4.6%) of patients from the PROWESS and ENHANCE trials and a compassionate use programme (study EVAS) had purpura fulminans, meningitis, or meningococcal disease.
Exclusion criteria in the phase II DrotAA dosing, PROWESS, and ENHANCE trials included patients at high risk of bleeding or likely to die from non-sepsis-related causes within 28 days.
15 That is, we identified where it enhanced the trial endeavour rather than made an independent contribution to knowledge.
