Adding to point 2, the challenges of remotely arranging next to kin consent for COVID patients to participate in this trial are unprecedented.
Visitors are largely or wholly excluded from hospitals. Many next of kin would be close contacts needing to self-isolate - some may be sick with COVID themselves.
So communications with next of kin would mostly be remote via phone or video call. This could really impact how many next of kin consent and how fast. Got to: - schedule those calls - try to build rapport and trust over the phone (much harder than face-to-face) - give them time to read and digest complex medical info, perhaps more calls to answer questions - wait until they consult with other family members - call again hoping to catch when not at work, in a meeting, on the phone consulting other family members, or just so stressed they don't pick up - realise you missed the returned call while talking to another patient's family member - get email addresses or street addresses to send consent forms out to be signed and returned (not all can sign electronically) - etc ...
A LOGISTIC JIGSAW, all needing to be completed in a couple of days to avoid missing the 'within 72 hours' inclusion criterion. But how much time pressure can ethically be applied to worried family members when you can't sit with them or use body language to show compassion and concern?
Never before would clinical trial investigators and administrators have faced these extra layers of complexity on such a wide scale. The impact on enrolment rates could not be anticipated. Well-reasoned enrolment estimates on these threads are really just guesses - unless they come from someone experiencing the hell of working in those COVID emergency/ICU wards.
Basically we all need patience and to cut them some slack!
MSB Price at posting:
$3.78 Sentiment: Buy Disclosure: Held
(20min delay)
