一年后：中风试验中预先同意的进展报告.pptx

1、One Year Later:Progress Report on Advance Consent in Stroke Trials,Michel Shamy MD MA FRCPC CTO Conference November 2024,Disclosures,I am a stroke neurologist,researcher,former REB memberFunding for this project from CIHR&New Frontiers in ResearchLeadership roles with multicentre RCTs:ACT-GLOBAL,iCA

2、TCHERNo connections to industryI am presenting on behalf of a teamUbong Udoh,Emma Cummings,Rena Seeger&Brian DewarCo-PI Dar Dowlatshahi MD PhD,Lets bring you up to speed,Acute stroke:sudden neurological event causing disabling symptomsUntil 30 years ago,felt to be untreatableMajor RCT successes have

3、 led to reorganization of careKey element:“Time is Brain”Treatment within 30 minutes of arrival in ERLatest RCTs based on even faster timelinesIt is standard of care to provide emergency treatment for acute stroke without first gaining consent,Consent for Acute Stroke RCTs,Because.Potential particip

4、ants are often incapacitated(and always under stress)SDMs are rarely available(and always under stress)Experimental&standard treatments must be administered very quicklyStandard of care is not to wait for consent.Acute stroke RCTs use deferral of consentInform patient/SDM but do not seek consent unt

5、il after acute treatmentDeferral of consent saves 20 mins&is broadly acceptable(97%)Could we improve upon this system with advance consent?,What is advance consent?,Inviting people with known cerebrovascular disease.Hence who are at risk of stroke.to give or decline consent in stroke prevention clin

6、ic.Ahead of an acute stroke and eligibility for trial participationWould supplement standard consent proceduresWould only apply if they are incapacitated at the timeConsent documented in EMRAnalogous to principles of advance care planning,Why offer Advance Consent?,Respects autonomy of individuals t