Pragmatic trials can be designed as optimal medical care: principles and methods of care trials

Uncertainty and Agreement Regarding the Role of Flow Diversion in the Management of Difficult Aneurysms

“…If this survey shows that such a condition is met for FD, we believe that for a clinician to use FD or any surgical innovation, the correct approach is to replace the notion of clinical equipoise with the notion that in the absence of a good exemptive reason, a clinician should only use an unvalidated intervention within the context of a declared care trial. 16 The widespread discrepancies in management decisions shown in this survey should provide the evidence for collective community uncertainty needed to proceed with a trial. The choices patients and clinicians face are not care versus research.…”

“…27 Care trials such as FIAT differ from conventional trials. 16 In the presence of little agreement and scant knowledge, they provide a prudent, orderly way to introduce innovations, to assist in the care of patients in the presence of uncertainty. They prioritize the protection of patients being offered promising but unvalidated therapies because the unknown implies potential risks.…”

“…In these situations, we have proposed care trials. 16 The Flow diversion In Aneurysm Treatment (FIAT) study was conceived and designed to guide the ethical introduction of FD into daily clinical management of patients with difficult aneurysms. 17 FIAT is meant to be offered to any patient for whom the use of FD is contemplated.…”

Responses to ARUBA: a systematic review and critical analysis for the design of future arteriovenous malformation trials

“…Trials can be conceived as methods to guide the use of promising clinical interventions under uncertainty. 39 If we now grant that standard care is conservative management, the solution is another trial, to offer promising yet unproven care to patients with a condition that can significantly affect their lives. Table 3 contrasts ARUBA with what we believe should be the design for future trials.…”

“…If the longterm goal is still to provide an answer as to which treatment option is best, in the meantime care trials can provide patients with a chance to access innovative or un proven treatments, and a clinical context for clinicians to practice verifiable care in the interest of current patients. 39 We must learn to better integrate clinical research and care because optimal care must take uncertainty into account.…”