The YODA Project: Developing Methods for Sharing Clinical Trial Data

Abstract Data sharing and data transparency are becoming the new standard in clinical research to ensure that patients and clinicians possess all necessary information about a drug or device when making treatment decisions. The Yale University Open Data Access (YODA) Project developed a model to facilitate access to participant-level clinical research data to promote independent analysis by external investigators. The YODA Project is currently collaborating with Medtronic, Inc. and Janssen, the pharmaceutical companies of Johnson & Johnson, to facilitate access to their clinical trial program data by external investigators in a manner that is aligned with the following principles: advance science and public health, conduct responsible research, ensure good stewardship of data, and promote transparency. As interest in the release of participant-level data grows, it is critical to carefully consider the approach to releasing data to ensure that the release is executed in a manner that preserves patient confidentiality, facilitates scientific productivity, and respects the values and rights of the participating parties. The YODA Project has identified several key decisions that should be addressed throughout the planning and implementation of the data release process, such as patient confidentiality, data storage, and data use. As varying methods emerge for sharing data, the YODA Project strives to be an innovative leader and to set standards for the field. Keywords Data sharing, data release, clinical trial data, participant-level, data storage, data transparenc

A taxonomy and cultural analysis of intra‐hospital patient transfers

Existing research on intra‐hospital patient transitions focuses chiefly on handoffs, or exchanges of information, between clinicians. Less is known about patient transfers within hospitals, which include but extend beyond the exchange of information. Using participant observations and interviews at a 1,541‐bed, academic, tertiary medical center, we explored the ways in which staff define and understand patient transfers between units. We conducted observations of staff (n = 16) working in four hospital departments and interviewed staff (n = 29) involved in transfers to general medicine floors from either the Emergency Department or the Medical Intensive Care Unit between February and September 2015. The collected data allowed us to understand transfers in the context of several hospital cultural microsystems. Decisions were made through the lens of the specific unit identity to which staff felt they belonged; staff actively strategized to manage workload; and empty beds were treated as a scarce commodity. Staff concepts informed the development of a taxonomy of intra‐hospital transfers that includes five categories of activity: disposition, or determining the right floor and bed for the patient; notification to sending and receiving staff of patient assignment, departure and arrival; preparation to send and receive the patient; communication between sending and receiving units; and coordination to ensure that transfer components occur in a timely and seamless manner. This taxonomy widens the study of intra‐hospital patient transfers from a communication activity to a complex cultural phenomenon with several categories of activity and views them as part of multidimensional hospital culture, as constructed and understood by staff.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/145512/1/nur21875.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/145512/2/nur21875_am.pd

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillanc

Surgical Treatment of a Chronic Brain Abscess and Growing Skull Fracture in a Dog

A 2-year-old female spayed Miniature Dachshund was presented for seizures and right prosencephalic signs. A multiloculated, ring-enhancing mass in the right cerebrum associated with dilation of the right lateral ventricle and brain herniation was seen on magnetic resonance imaging. An irregular calvarial defect with smoothly scalloped edges was seen overlying the mass on computed tomography. The mass was removed via craniectomy and was diagnosed as a chronic brain abscess caused by Peptostreptococcus anaerobius. The patient was maintained on antibiotics for 12 weeks. Follow-up MRI performed 14 weeks after surgery confirmed complete removal of the abscess as well as a contrast-enhancing collection of extra-axial material consistent with a chronic subdural hematoma. The neurologic abnormalities, including seizures, have improved in the 44 months since surgery. Brain abscesses in dogs can have an insidious clinical course prior to causing serious neurologic deterioration. Ventricular entrapment by an intracranial mass can contribute to acute neurologic decline. If surgically accessible, outcome following removal of a brain abscess can be excellent; aerobic and anaerobic bacterial culture should be performed in these cases. Subdural hematoma can occur following removal of a large intracranial mass. Growing skull fractures can occur in dogs but may not require specific surgical considerations