Can a Checklist Improve the Informed Consent Process?

Abstract

Informed consent often fails to provide patients and families with a full understanding of the proposed procedure. We developed an informed consent checklist for identifying specific aspects of the surgical consent that were not fully understood by families. The purpose of this study was to measure the effect of using this checklist on families’ knowledge, satisfaction, experience, and decisional conflict during the consent process. The families of pediatric patients scheduled for an orthopaedic preoperative visit were prospectively randomized into one of two groups: checklist or traditional appointment. Families in the checklist group completed the informed consent checklist which was then used by the surgeon to further discuss aspects of the surgery that needed clarification. Those in the traditional group had similar discussions about surgery without the aid of a checklist. Sixty-one families participated in the study; 27 in the checklist group and 34 in the traditional group without a checklist. The checklist group reported no difference in mean scores for all satisfaction (P = 0.37), decisional conflict (P = 0.51), and knowledge items (P = 0.31). For patient experience, the traditional group reported the visits were significantly more relaxed (mean 4.9, 95% confidence interval (CI) 4.8-5.0) than the checklist group (mean 4.5, 95% CI 4.3-4.7). Our results suggest that having a family member complete the informed consent checklist prior to meeting with the surgeon did not improve, and may worsen, the consent experience for some families. Other methods need to be evaluated to determine the optimal consent process from the family’s perspective.

Patient-completed safety checklists as an empowerment tool for patient involvement in patient safety: concepts, considerations and recommendations

“…27 Shirley et al developed a checklist for parents to use prior to providing informed consent for their child's surgery with the aim of increasing understanding of important information, including potential risks and alternative treatment options. 28 Russ et al developed a patient-completed surgical safety checklist delivered via an animated smartphone app for patients undergoing surgery in the UK's NHS. The 'MySurgery' app is centred around key areas of evidence-based risk involved in having any surgical procedure and is designed to be used by patients and their carers prior to, during and following their surgical admission.…”

“…Likewise, individuals with more passive personality types may find it difficult to use checklists, particularly where they involve challenging clinicians or becoming more involved in care conversations. 5,28,29,35 This underlines the importance of involving diverse groups of patients in the concept testing and design phases of checklist development, which will enable a broader understanding of potential barriers to accessing these tools and an exploration of alternative engagement strategies.…”

Feasibility of implementing a surgical patient safety checklist: prospective cross-sectional evaluation

“…Hardiman and colleagues developed a patient checklist for postsurgical care for patients who had undergone ileostomy surgery [6]. Other patient checklists have been developed to aid discharge from hospital following medical admissions and one preoperative visit checklist aiming to increase parents' understanding of the surgical consent process for paediatric orthopaedic patients [7,8]. These studies suggest that patient checklists and similar interventions are feasible to use [6][7][8].…”

“…Other patient checklists have been developed to aid discharge from hospital following medical admissions and one preoperative visit checklist aiming to increase parents' understanding of the surgical consent process for paediatric orthopaedic patients [7,8]. These studies suggest that patient checklists and similar interventions are feasible to use [6][7][8]. To our knowledge, only two studies to date have investigated patient-completed checklists' feasibility and effectiveness.…”