113 Simplifying consent - Use of the novel integrated consent model in paediatric clinical research

Primary Subject area Hospital Paediatrics Background Obtaining informed consent from patients to participate in clinical research has traditionally been a cumbersome process, often requiring lengthy documentation and the involvement of trained research staff. Moreover, this process can be a burden to the patient/family. As a result, progress in paediatric research and enabling continual improvement in care has been slow. In the last decade, research ethicists have proposed a new “integrated consent model” (ICM) for obtaining informed consent for pragmatic clinical trials that compare standard-of-care interventions, where there is clinical equipoise. In most cases of ICM, only a brief discussion with verbal consent is required, along with a handout on study purpose, risks, benefits, and procedures. This allows for a more condensed consent process, which maximizes clarity and minimizes information overload. ICM also allows the patient/family to maintain prospective autonomy and decision-making, as compared with deferred or waived consent. The ICM model allows staff in the circle of care to obtain consent, which minimizes the stress of meeting an additional person. To our knowledge, ICM has not yet been used in the paediatric population. Objectives The objective of this abstract is to report on the utility of ICM in a non-randomized clinical trial carried out in the inpatient setting of a tertiary children’s hospital. Design/Methods We compared two widely accepted standards of care for maintaining peripheral intravenous catheter patency in a cohort of children, namely continuous infusion (“to keep the vein open” or TKVO) versus saline lock (SL). The ICM process was reviewed and approved by REB. Nurses in the circle of care received a study package that included an REB approved “consent script” to be read to the patient/family, a single page information sheet, and instructions on documenting the obtained verbal consent in the patient’s chart (Graphic 1). Results With ICM, 79% of participants were recruited into the trial by a nurse. Patient recruitment was completed 4 months ahead of the predicted schedule (Figure 1). Nursing, research, and medical staff were satisfied with ICM and found it easy to administer. ICM occurred smoothly and quickly for patients/families, with no interference with their medical care and practically no disruption to their daily schedule. Conclusion ICM is a practical alternative to laborious traditional consent models, is associated with higher patient recruitment rates, and is less burdensome for the patient/family. Paediatricians should be aware of the utility of this novel consent model.

Novel Methodology for Comparing Standard-of-Care Interventions in Patients With Cancer

Purpose: The current clinical trials development and conduct process is cumbersome and expensive, with the majority of studies focusing on either the development of new agents or new indications for established agents. Unfortunately, research comparing standard-of-care interventions is rarely performed, leaving many important and practical patient-centered questions unanswered. Novel clinical trial methodologies and approaches are needed. Methods: We have identified simple key components that, when combined, enhance the ability to both perform and increase accrual for studies that compare standard-of-care interventions. These include selection of clinically relevant and practical questions, demonstration of clinical equipoise through surveys of knowledge users and completion of systematic reviews, appropriate study design and simply defined study end points, use of an integrated consent model incorporating oral consent, efficient research ethics board approval, Web-based randomization in the clinic, real-time electronic data capture and management, and regular formal team feedback. Results: We have demonstrated the feasibility of this model in a pragmatic trial comparing two standard-of-care interventions (growth factor support or ciprofloxacin) for the primary prophylaxis of febrile neutropenia in patients with breast cancer receiving adjuvant docetaxel with cyclophosphamide chemotherapy. Research ethics board approval took 3 months, and 110 (72%) of 153 potentially eligible patients have agreed to participate in the study. When surveyed, 81 (85%) of 95 patients were completely satisfied with the integrated consent model process. Conclusion: Our proposed model contains elements that, when used alone or in combination, may allow efficient and cost-effective comparison of standard-of-care interventions.