The informed consent form navigator: a tool for producing readable and compliant consent documents.

Background/Objective: Informed consent forms (ICFs) and practices vary widely across institutions. This project expands on previous work at the University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy to develop a plain language ICF template. Our interdisciplinary team of researchers, comprised of biomedical informaticists, health literacy experts, and stakeholders in the Institutional Review Board (IRB) process, has developed the ICF Navigator, a novel tool to facilitate the creation of plain language ICFs that comply with all relevant regulatory requirements. Methods: Our team first developed requirements for the ICF Navigator tool. The tool was then implemented by a technical team of informaticists and software developers, in consultation with an informed consent legal expert. We developed and formalized a detailed knowledge map modeling regulatory requirements for ICFs, which drives workflows within the tool. Results: The ICF Navigator is a web-based tool that guides researchers through creating an ICF as they answer questions about their project. The navigator uses those responses to produce a clear and compliant ICF, displaying a real-time preview of the final form as content is added. Versioning and edits can be tracked to facilitate collaborative revisions by the research team and communication with the IRB. The navigator helps guide the creation of study-specific language, ensures compliance with regulatory requirements, and ensures that the resulting ICF is easy to read and understand. Conclusion: The ICF Navigator is an innovative, customizable, open-source software tool that helps researchers produce custom readable and compliant ICFs for research studies involving human subjects.

Analysis of Caregiver Burden Expressed in Social Media Discussions.

Almost 40% of US adults provide informal caregiving, yet research gaps remain around what burdens affect informal caregivers. This study uses a novel social media site, Reddit, to mine and better understand what online communities focus on as their caregiving burdens. These forums were accessed using an application programming interface, a machine learning classifier was developed to remove low information posts, and topic modeling was applied to the corpus. An expert panel summarized the forums' themes into ten categories. The largest theme extracted from Reddit's forums discussed the personal emotional toll of being a caregiver. This was followed by logistic issues while caregiving and caring for parents who have cancer. Smaller themes included approaches to end-of-life care, physical equipment needs when caregiving, and the use of wearables or technology to help monitor care recipients. The platform often discusses caregiving for parents which may reflect the age of Reddit's users. This study confirms that Reddit forums are used for caregivers to discuss the burdens associated with their role and the types of stress that can result from informal caregiving.

Institutional improvements in readability of written informed consent forms sustained post-revised Common Rule.

Obtaining informed consent is a fundamental and ethical practice within human subjects' research. Informed consent forms (ICFs) include a large amount of information, much of which may be unfamiliar to research subjects, and the revised Common Rule resulted in several required additions to that language. As limited health literacy impacts many potential subjects, efforts should be made to optimize subjects' ability to read and understand ICFs. In this brief report, we describe an assessment of ICFs at an academic medical center to evaluate longitudinal changes in readability with the introduction and update of a plain language ICF template.

Barriers and solutions to implementing a pragmatic diabetes education trial in rural primary care clinics.

INTRODUCTION: The purpose of this report is to describe barriers and solutions to the implementation and optimization of a pragmatic trial that tests an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care in rural primary care clinics. METHODS: The two-arm pragmatic trial has been implemented in six rural family medicine clinics in Arkansas. It tests a self-management education and counseling intervention for patients with type 2 diabetes compared to enhanced usual care. Barriers and solutions were identified as issues arose and through interviews with clinic directors and clinic administrators and a focus group, interviews, and tracking reports with clinic health coaches who delivered the intervention. RESULTS: Barriers to optimizing enrollment, intervention delivery, and data collection were addressed through targeted education of and relationship building with leadership, changing enrollment oversight, and ongoing training of health coaches. CONCLUSIONS: Successful implementation and optimization of this pragmatic clinical trial in rural primary care clinics was achieved through establishing common goals with clinic leadership, minimizing demands on clinic staff and administration, frequent contact and ongoing support of health coaches, and collaborative troubleshooting of issues with delivering the intervention.

Implementation of a health-literate patient decision aid for chest pain in the emergency department.

OBJECTIVE: The aim of this study was to investigate the implementation of a new health-literacy-tested patient decision aid for chest pain in Emergency Department (ED) patients. Outcomes included disposition, knowledge, decisional conflict and satisfaction prior to discharge. Patient health literacy was explored as a factor that may explain disparities in sub-group analysis of all outcomes. METHODS: A health-literacy adapted tool was deployed using a pre/post intervention design. Patients enrolled during the intervention period were given the adapted chest pain decision aid that was used in conversation with their emergency medicine physician to decide on their course of action prior to being discharged. RESULTS: A total of 169 participants were surveyed and used in the final analysis. Patients in the usual care group were 2.6 times more likely to be admitted for chest pain than patients in the intervention group. Knowledge scores were higher in the intervention group, while no significant differences were observed in decisional conflict and patient satisfaction, or by patient health literacy level. CONCLUSION AND PRACTICE IMPLICATIONS: Using the adapted chest pain decision tool in emergency medicine may improve knowledge and reduce admissions, while addressing known barriers to understanding related to patient health literacy.

Rationale and development of a randomized pragmatic trial to improve diabetes outcomes in patient-centered medical homes serving rural patients.

Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that can be readily implemented and sustained in rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on our team developed an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care that includes: 1) the American College of Physicians (ACP) Diabetes Guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change; 2) a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans'); and 3) a training module for health coaches that prepares them to assume educator/counselor roles with the Diabetes Guide as a teaching tool. While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, its optimal implementation is not known. This project took advantage of a unique opportunity to modify and disseminate the ACP health literacy intervention among patients with type 2 diabetes cared for at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices all had health coaches that could be leveraged to provide chronic disease self-management mostly via phone, but also at the point-of-care. Hence we conducted a patient-randomized, pragmatic clinical trial in 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.

Impact of a laparoscopic renal surgery mini-fellowship program on postgraduate urologist practice patterns at 3-year followup.

PURPOSE: To assist practicing urologists incorporate laparoscopic renal surgery into their practice we established a 5-day mini-fellowship program with a mentor, preceptor and a potential proctor at our institution. We report the impact of our mini-fellowship program at 3-year followup. MATERIALS AND METHODS: A total of 106 urologists underwent laparoscopic ablative (44) or laparoscopic reconstructive (62) renal surgery training. The 1:2 teacher-to-attendee experience included tutorial sessions, hands-on inanimate and animate skills training, and clinical case observations. Participants were asked to complete a detailed questionnaire on laparoscopic practice patterns 1, 2 and 3 years after the mini-fellowship. RESULTS: The questionnaire response rate at 1 to 3 years was 77%, 65% and 68%, respectively. Of responders 72%, 71% and 71% performed laparoscopic renal surgery at 1 to 3 years, respectively. Of the 106 participants 32 (39%) had previous laparoscopic experience, including 78% who responded to the questionnaire at 3 years. Of those surgeons there was an increase in the practice of laparoscopic radical nephrectomy (88% vs 72%), nephroureterectomy (56% vs 13%), pyeloplasty (40% vs 6%) and partial nephrectomy (32% vs 6%) at 3 years. Of the 106 participants 74 (70%) were laparoscopy naïve, including 48 (65%) who responded to the questionnaire at 3 years. The take rate in this group was 76%, 52%, 34% and 23% for laparoscopic radical nephrectomy, nephroureterectomy, pyeloplasty and partial nephrectomy, respectively. Of the participants 90% indicated that they would recommend this training to a colleague. CONCLUSIONS: An intensive 5-day laparoscopic ablative and reconstructive renal surgery course enabled postgraduate urologists to effectively introduce and expand the volume and breadth of their laparoscopic renal surgery practice.

Preliminary study of virtual reality and model simulation for learning laparoscopic suturing skills.

PURPOSE: Repetitive practice of laparoscopic suturing and knot tying can facilitate surgeon proficiency in performing this reconstructive technique. We compared a silicone model and pelvic trainer to a virtual reality simulator in the learning of laparoscopic suturing and knot tying by laparoscopically naïve medical students, and evaluated the subsequent performance of porcine laparoscopic cystorrhaphy. MATERIALS AND METHODS: A total of 20 medical students underwent a 1-hour didactic session with video demonstration of laparoscopic suturing and knot tying by an expert laparoscopic surgeon. The students were randomized to a pelvic trainer (10) or virtual reality simulator (10) for a minimum of 2 hours of laparoscopic suturing and knot tying training. Within 1 week of the training session the medical students performed laparoscopic closure of a 2 cm cystotomy in a porcine model. Objective structured assessment of technical skills for laparoscopic cystorrhaphy was performed at the procedure by laparoscopic surgeons blinded to the medical student training format. A video of the procedure was evaluated with an objective structured assessment of technical skills by an expert laparoscopic surgeon blinded to medical student identity and training format. The medical students completed an evaluation questionnaire regarding the training format after the laparoscopic cystorrhaphy. RESULTS: All students were able to complete the laparoscopic cystorrhaphy. There was no difference between the pelvic trainer and virtual reality groups in mean +/- SD time to perform the porcine cystorrhaphy at 40 +/- 15 vs 41 +/- 10 minutes (p = 0.87) or the objective structured assessment of technical skills score of 8.8 +/- 2.3 vs 8.2 +/- 2.2 (p = 0.24), respectively. Bladder leak occurred in 3 (30%) of the pelvic trainer trained and 6 (60%) of the virtual reality trained medical student laparoscopic cystorrhaphy procedures (Fisher exact test p = 0.37). The only significant difference between the 2 groups was that 4 virtual reality trained medical students considered the training session too short compared to none of those trained on the pelvic trainer (p = 0.04). CONCLUSIONS: There is no significant difference between the pelvic trainer and virtual reality trained medical students in proficiency to perform laparoscopic cystorrhaphy in a pig model, although both groups require considerably more training before performing this procedure clinically. The pelvic trainer training may be more user-friendly for the novice surgeon to begin learning these challenging laparoscopic skills.

Preliminary evaluation of a genitourinary skills training curriculum for medical students.

PURPOSE: Basic urology training in medical school is considered important for many medical and surgical disciplines. We developed a 2-day intensive genitourinary skills training curriculum for medical students beginning their clinical clerkship training years and evaluated the initial experience with this program. MATERIALS AND METHODS: All 94 third-year medical students at the University of California, Irvine were required to participate in a 5.5-hour genitourinary examination skills training program. The teaching course included 1.5 hours of didactic lecture and video presentation with questions and answers, followed by 5, 45-minute hands-on stations including male Foley catheter placement, female Foley catheter placement, testicular examination and digital rectal examination training with a standardized patient, virtual reality cystourethroscopy and, lastly, a urologist led tutorial of abnormal genitourinary findings. The students completed questionnaires before and after the course concerning their experience. At the end of the course the students rated the usefulness of each part of the curriculum and evaluated the faculty. In addition, they were required to complete a multiple choice examination that included 4 genitourinary specific questions. RESULTS: All 94 medical students completed the genitourinary skills training course. Before the course less than 10% of students reported comfort with genitourinary skills, including testicular examination (5%), digital rectal examination (10%), male Foley catheter placement and female Foley catheter placement (2%). Following the course the comfort level improved in all parameters of digital rectal examination (100%) and testicular examination, male Foley catheter placement and female Foley catheter placement (98%). The students rated in the order of most to least useful training 1) standardized patient for testicular examination and digital rectal examination teaching, 2) male Foley catheter placement and female Foley catheter placement training, 3) didactic lecture, 4) tutorial of abnormal genitourinary examination findings and 5) virtual reality cystourethroscopy. On the examination questions following the course 80% to 98% of the class answered each urology content question correctly. CONCLUSIONS: An intensive skills training curriculum significantly improved medical student comfort and knowledge with regard to basic genitourinary skills including testicular examination, rectal examination, and Foley catheter placement in the male and female patient. Further followup will be performed to determine the application of these skills during clinical clerkship rotations.