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BACKGROUND: The process of informed consent in National Institutes of Health randomized, placebo-controlled trials is poorly studied. There are several issues regarding informed consent in emergency neurologic trials, including a shared decision-making process with the patient or a legally authorized representative about overall risks, benefits, and alternative treatments. METHODS: To evaluate the informed consent process, we collected best and worst informed consent practice information from a National Institutes of Health trial and used this in medical simulation videos to educate investigators at multiple sites to improve the consent process. Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) (clinicaltrials.gov, NCT00784134) studied the effect of intraventricular alteplase (n = 251) versus saline (placebo) injections (n = 249) for intraventricular hemorrhage reduction. Reasons for ineligibility (including refusing to consent) for all screen failures were analyzed. The broadcasted presentation outlined best practices for doctor-patient interactions during the consenting process, as well as anecdotal, study-specific reasons for consent refusal. Best and worst consent elements were then incorporated into a simulation video to enhance the informed consent process. This video was disseminated to trial sites as a webinar around the midpoint of the trial to improve the consent process. Pre- and post-intervention consent refusals were compared. RESULTS: During the trial, 10,538 patients were screened for eligibility, of which only three were excluded due to trial timing. Pre-intervention, 77 of 5686 (1.40%) screen eligible patients or their proxies refused consent. Post-intervention, 55 of 4849 (1.10%) refused consent, which was not significantly different from pre-intervention (P = 0.312). The incidence of screen failures was significantly lower post-intervention (P = 0.006), possibly due to several factors for patient exclusion. CONCLUSION: The informed consent process for prospective randomized trials may be enhanced by studying and refining best practices based on trial-specific plans and patient concerns particular to a study.

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This prospective cohort study aimed to improve hospital outcomes through geographic location of hospitalist patients and conducting daily multidisciplinary team rounds-Goal-directed Achievements through Geographic Location (GAGL). Patients were admitted to a geographic (GAGL) study unit where daily multidisciplinary rounds took place among nursing, case management, a hospitalist, pharmacy, physical and occupational therapy, respiratory therapy, and nutrition services. A total of 985 (56.4%) patients were admitted to the GAGL study unit and 760 patients (43.6%) were admitted to non-GAGL units. Patients admitted to the GAGL study unit had a shorter average length of stay (3.64 days vs 4.35 days, P = .0001) and a lower number of risk events (91 [9.2%] vs 93 [12.2%], P = .038). There was no significant difference in 30-day readmissions, avoidable day events, or code blue team activations. GAGL provides a framework for hospital organizations to improve provider communication, hospital efficiency, and patient safety.

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BACKGROUND AND OBJECTIVES: Pancreatic cysts are evaluated by endoscopic ultrasound and fine needle aspiration (EUS). The only accepted treatment is pancreatectomy, which is associated with morbidity and mortality. This study evaluated the optimal thermal dosimetry of a novel radiofrequency ablation device using a standard electrosurgical unit in ex vivo cyst models. METHODS: A modified EUS 22-gauge monopolar needle prototype with a tip electrode connected to a standard electrosurgical unit (Erbe USA, Marietta, GA, USA) was used to induce a subboiling point temperature. A cyst model was created using 2-cm sections of porcine small intestine ligated and filled with saline. After ablation, the cyst models were prepared for pathological evaluation. The epithelial layers were measured in at least two different sites with a micrometer and compared with the corresponding control sample. RESULTS: Thirty-two cyst models were ablated with maximum temperatures of 50°C, 60°C, 90°C, and 97°C in 8, 11, 11, and 2 cysts, respectively. Longer ablation times were required to induce higher temperatures. A trend in the reduction in thickness of the measured layers was observed after exposure to higher temperatures. A temperature over 50°C was required for the ablation of the muscularis, submucosa, and villi, and over 60°C was required to ablate the mucosal crypts. CONCLUSIONS: In a preclinical model, a novel radiofrequency EUS-capable needle connected to a standard electrosurgical unit using standard low-voltage coagulation provided ablation in a temperature-dependent fashion with a threshold of at least 60°C and a safe cyst margin below 97°C. This potentially will allow low-cost, convenient cyst ablation.

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INTRODUCTION: ProVation Medical documentation software was introduced in our Department of Gastroenterology (GI). We evaluated the use of a simulation module to improve the introduction of new documentation software into a tertiary care center GI department. MATERIALS AND METHODS: Train-the-trainer education was provided by the vendor of the new documentation module. A simulation module was developed to simulate the preparatory, intraprocedural, and postprocedure phase of active utilization of the software. A standardized patient (SP)/medical actor was used for provision of data to be entered in to the ProVation Medical preprocedure module. A procedural suite was configured to allow for staff to assume their roles during endoscopic cases. A checklist of key activities was used by observers during the training. A postscenario evaluation document was collected for perceptions of training. RESULTS: Twenty-one GI nurses and technicians spent 3 hours in groups of 7 over a 3-day period completing activities commensurate with these procedural phases. Nineteen of 21 learners felt the simulation was nonthreatening, and the same number gave the course an overall 5/5 rating. There were no specimen labeling errors, patient identification errors, or sentinel events related to the software rollout. All learners felt that physician involvement in the simulation would have been beneficial. CONCLUSIONS: Simulation can be used to improve the rollout of new software in a tertiary care center. Staff satisfaction associated with this type of learning activity was high, and a communicated level of comfort was achieved as a result of the simulation-based experiential learning.

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OBJECTIVE: To evaluate the use of 2 inexpensive laparoscopic trainers (iTrainers) constructed of easily attainable materials and portable tablets (iPads). METHODS: Two different laparoscopic trainers were constructed using a cardboard box, thumbtacks, and Velcro tape (box trainer). A separate box was constructed using the same supplies with a 3-ring binder (binder trainer). An iPad was used as the camera and monitor for both trainers. A total of 10 participants, including 4 junior surgical residents, 4 senior surgical residents, and 2 surgical staff, completed 3 Fundamentals of Laparoscopic Surgery (FLS) tasks using the 2 "iTrainers." Participants then completed the same tasks on a traditional FLS box trainer. All 10 participants were asked to complete a 13-question survey after the exercises. RESULTS: All the participants (100%) had access to an "iPad" for the visualization component. The 10 participants completed all 3 tasks on all 3 trainers. Senior residents outperformed junior residents on 6 of the 9 total tasks. Attending surgeons outperformed all residents on all tasks and trainers. Survey results revealed the cardboard box "iTrainer" to be the most practical and easiest to construct. CONCLUSION: "iTrainers" are an inexpensive and easy-to-construct alternative to traditional box trainers that might have construct validity as demonstrated in this trial. The box trainer might be easier to construct and have more similarities to the FLS trainer than the binder iTrainer.

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PURPOSE: We designed a three-phase bedside assistant training course for those involved with robot-assisted radical prostatectomy (RARP). We also examined whether an experienced RARP team (>1000 cases) would perceive benefit from this three-phase bedside assistant training course. MATERIALS AND METHODS: The 13 RARP bedside assistants were identified at our institution (three surgical technicians, two surgical assistants, four resident trainees, and four physician assistants). The course consisted of three phases that were taught at three separate morning sessions. Phase 1 focused on robot functionality. Phase 2 consisted of a step-by-step video session that focused on the assistant's role in each RARP step. Phase 3 involved three hands-on laparoscopic drills that were to be completed in a predetermined period. Pre- and postcourse questionnaires assessed learner knowledge pertaining to RARP. RESULTS: All 13 learners completed the three-phase training course. Nine of 13 learners thought this course would be beneficial, although, 9 of 13 already thought that they were good RARP assistants before the course. Ten of 13 learners were able to complete the hands-on drills in the predetermined periods. On completion of the course, every learner thought the course was beneficial and that it should be repeated annually. Twelve of 13 thought that the course made them a better assistant and that their intra-abdominal spatial orientation was greatly improved. Seven of the learners thought the hands-on drills were the most beneficial portion of the course, while the other six found the step-by-step lecture the most beneficial. CONCLUSIONS: A three-phase hands-on RARP bedside assistant training course is beneficial to and desired by an experienced RARP team at least annually.

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