Browsing by Subject "INFORMED-CONSENT"

Sort by: Order: Results:

Now showing items 1-2 of 2
  • Stassen, Willem; Wallis, Lee; Castren, Maaret; Vincent-Lambert, Craig; Kurland, Lisa (2019)
    The incidence of cardiovascular disease and STEMI is on the rise in sub-Saharan Africa. Timely treatment is essential to reduce mortality. Internationally, prehospital 12 lead ECG telemetry has been proposed to reduce time to reperfusion. Its value in South Africa has not been established. The aim of this study was to determine the effect of prehospital 12 lead ECG telemetry on the PCI-times of STEMI patients in South Africa. A multicentre randomised controlled trial was attempted among adult patients with prehospital 12 lead ECG evidence of STEMI. Due to poor enrolment and small sample sizes, meaningful analyses could not be made. The challenges and lessons learnt from this attempt at Africa's first prehospital RCT are discussed. Challenges associated with conducting this RCT related to the healthcare landscape, resources, training of paramedics, rollout and rando-misation, technology, consent and research culture. High quality evidence to guide prehospital emergency care practice is lacking both in Africa and the rest of the world. This is likely due to the difficulties with performing prehospital clinical trials. Every trial will be unique to the test intervention and setting of each study, but by considering some of the challenges and lessons learnt in the attempt at this trial, future studies might experience less difficulty. This may lead to a stronger evidence-base for prehospital emergency
  • Closed Open Laparotomy COOL Sou; Doig, Christopher J.; Page, Stacey A.; McKee, Jessica L.; Tolonen, Matti; Kirkpatrick, Andrew W. (2019)
    Background Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study () will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS. Main body Research in critically ill incapacitated patients is important to advance care. Conducting research among SCIAS is complicated due to the severity of illness including delirium, need for emergent interventions, diagnostic criteria confirmed only at laparotomy, and obtundation from anaesthesia. In other circumstances involving critically ill patients, clinical experts have worked closely with ethicists to apply principles that balance the rights of patients whilst simultaneously permitting inclusion in research. In Canada, the Tri-Council Policy Statement-2 (TCPS-2) describes six criteria that permit study enrollment and randomization in such situations: (a) serious threat to the prospective participant requires immediate intervention; (b) either no standard efficacious care exists or the research offers realistic possibility of direct benefit; (c) risks are not greater than that involved in standard care or are clearly justified by prospect for direct benefits; (d) prospective participant is unconscious or lacks capacity to understand the complexities of the research; (e) third-party authorization cannot be secured in sufficient time; and (f) no relevant prior directives are known to exist that preclude participation. TCPS-2 criteria are in principle not dissimilar to other (inter)national criteria. The COOL study will use waiver of consent to initiate enrollment and randomization, followed by surrogate or proxy consent, and finally delayed informed consent in subjects that survive and regain capacity. Conclusions A delayed consent mechanism is a practical and ethical solution to challenges in research in SCIAS. The ultimate goal of consent is to balance respect for patient participants and to permit participation in new trials with a reasonable opportunity for improved outcome and minimal risk of harm.