Objectives:Traditional resident assessment of orthopaedic surgical technical proficiency relies exclusively on subjective parameters. More standardized objective measures are needed to ensure training consistency and surgical competency. The purpose of this study was to determine if orthopaedic surgery residents who train with a virtual reality simulator can lead to improved arthroscopy performance and to determine if a standardized arthroscopic shoulder and knee test were appropriate means for evaluating a resident's arthroscopic skill after completing a training course. Methods: Study participants were first and second year orthopaedic surgery residents at a single institution who were randomized to either train on the virtual reality surgical simulator (Insight Arthro VR) for a total of 2.5 hours (n=8) or receive 2 hours of didactic lectures with models (non-simulator) (n=6). Both groups were then evaluated in both knee and shoulder arthroscopy using a cadaver. Performance was measured by time to completion of a standardized protocol checklist and cartilage grading index (CGI) (scale 0-10). Results: All subjects had no previous arthroscopy experience prior to the study. The simulator group had a shorter time to completion in both knee (simulator: 5.1 ± 1.8 min, non-simulator: 8.0 ± 4.4 min; p=0.09) and shoulder (simulator: 6.1 ± 1.5 min, non-simulator: 9.9 ± 3.2 min; p=0.02) arthroscopy. Similarly, the simulator group had improved CGI scores in both the knee (simulator: 4.0 ± 1.1, non-simulator: 5.3 ± 1.5; p=0.07) and shoulder (simulator: 3.4 ± 0.8, non-simulator: 5.5 ± 1.6; p=0.008) arthroscopy. Conclusion: This study suggests that surgical simulators are beneficial in arthroscopy skills development for orthopaedic surgery residents. An arthroscopic testing model was able to measure a statistical improvement for a resident's arthroscopic skill. Instituting standardized cadaveric testing based on common orthopaedic surgical procedures such as knee and shoulder arthroscopy will not only ensure graduating residents possess the necessary skills to be technically proficient surgeons but it will also allow objective identification of residents in need of remediation.
Background: Informed consent (IC) is critical to performing ethical research. Unfortunately, the IC process and supporting IC forms are frequently burdensome and do not necessarily meet the informational needs of participants. The intersecting legal and ethical challenges of obtaining IC from individuals with memory or cognitive deficits further exacerbate existing IC shortcomings. For this reason, study coordinators play a critical role in facilitating the IC process in Alzheimer's disease (AD) research. To identify opportunities to improve how IC is obtained in AD research, we examined the IC process from the perspectives of study coordinators at two Alzheimer's Disease Research Centers (ADRC). Methods: We performed semi-structured interviews with 15 study coordinators from two ADRC sites detailing their experience obtaining IC. Interviews were conducted in private, recorded, transcribed, and independently coded using the constant comparative method of grounded theory. Key themes were explored as they emerged. Results: Coordinators reported overall satisfaction with the IC process. However, many reported difficulties maintaining participant attention, explaining complex procedures, and addressing medical misinformation. Although the centers use site-specific consent forms, coordinators at both centers stressed that their IC is too long and the supporting IC forms are too complicated. Coordinators indicated modifying the IC process to the perceived needs of individual participants. Adaptations reported include altering the cadence and vocabulary they employ, using supplemental materials, varying the order of IC topics, and limiting the depth of information presented. Conclusion: A qualitative analysis of interviews with study coordinators reveals opportunities to improve how we obtain IC in AD research. These insights will be used to create an electronic informed consent (eConsent) designed to boost engagement, enhance trust, and improve understanding by supporting participants' direct agency in the IC process.
Background The informed consent process educates potential participants about a research study and guides them to make a decision about participation. Most important, the consent document should meet the needs of the participant so they can make an educated decision. Studies have shown consent documents can be lengthy, redundant and ineffective at enhancing comprehension. We examined the traditional consent process from the perspective of research participants, including people commonly underrepresented in research, and from study partners from the University of Wisconsin‐Madison and Emory University Alzheimer’s Disease Research Centers. Method Private interviews were conducted with 15 participants and 8 participant/study partner dyads. The interviews were voluntary and the interviewer was not the same person who consented the participants to avoid any bias or influence over the participant’s response. Each person was asked a series of questions about their overall experience with the informed consent process. In order to evoke prior observations, respondents were encouraged to review the consent form throughout the interview. Responses were recorded, transcribed and coded. Result Analysis of the interviews revealed participants were overall satisfied with the consent process. Well‐trained study coordinators made a notable difference in the consent experience. Reported shortcomings highlighted by study partners include the length of the consent form and complex language. Some people felt that both the length and complexity were excessive based on the risks and benefits of participation. Others felt a better explanation was needed to explain more complex procedures and concepts, with one pointing out, “The DNA might pose a little problem for people…depending on how far along the person is with their understanding of medical stuff.” Some recommended using videos or online chats to make it easier for people to understand. Conclusion When designing an update for a process as vital as the consent it is imperative to capture the perspective and needs of those it directly affects. Participants and study partners offered recommendations, providing a starting point in the development of an eConsent version. In exploring an electronic approach, we hope to improve comprehension by allowing participants to have control over the order and level of detail of information presented to them.
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