Assessment of Reader Technologies for Over-the-Counter Diagnostic Testing.

Background: Over-the-counter (OTC) diagnostic testing is on the rise with many in vitro diagnostic tests being lateral flow assays (LFAs). A growing number of these are adopting reader technologies, which provides an alternative to visual readouts for results interpretation, allowing for improved accessibility of OTC diagnostics. As the reader technology market develops, there are many technologies entering the market, but no clear, single solution has yet been identified. The purpose of this research is to identify and discuss important parameters for the assessment of LFA reader technologies for consideration by manufacturers or researchers. Methods: As part of The National Institute of Biomedical Imaging and Bioengineering's Rapid Acceleration of Diagnostics (RADx) Tech program, reader manufacturers were interviewed to investigate the current state of reader technology development through several parameters identified as important industry standards. Readers were categorized by technology type and parameters including cost, detection method, multiplex capabilities, assay type, maturity, and use case were all assessed. Results: Fifteen reader manufacturers were identified and interviewed, and information on a total of 19 technologies was assessed. Reader technology type was found to be predictive of other attributes, whether the reader is smart technology only, a standalone reader, a reader with smart technology required, or a reader with smart technology optional. Conclusions: Pairing reader technology with OTC diagnostic tests is important for improving existing COVID-19 tests and can be utilized in other diagnostics as the OTC use case grows in popularity. Reader technology type, which is predictive of core reader attributes, should be considered when selecting a reader technology for a specific LFA test within the context of regulatory guidance. As diagnostics increase in complexity, readers provide solutions to accessibility challenges, facilitate public health reporting, and ease the transition to multiplex testing, therefore increasing market availability.

Information Accessibility in the Form of Braille.

Braille is often proposed by the uninformed as the optimal solution to providing an alternative to visual information to the visually impaired. The purpose of this article is to highlight the complexity of the braille user population and discuss the importance of understanding the use of braille as a solution for equal access of information. As part of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) Rapid Acceleration of Diagnostics (RADx) Tech program and its goal to make home tests accessible to people with disabilities, a series of interviews with industry experts was conducted to better understand braille technologies and the braille user space. Published literature findings provided additional context and support to these interviews. It was found that expert consensus and data from published literature vary. The braille user population is complex and lacks consistent characterization. Visually printed media should not be solely relied on to communicate information. In conclusion, braille is one solution for improving access to information. Understanding the unique needs of braille users and how they engage with information in a world that is heavily reliant on visual content, is a critical step in developing and implementing non-visual alternatives that will collectively address information access.

Mobilizing data during a crisis: Building rapid evidence pipelines using multi-institutional real world data.

The COVID-19 pandemic generated tremendous interest in using real world data (RWD). Many consortia across the public and private sectors formed in 2020 with the goal of rapidly producing high-quality evidence from RWD to guide medical decision-making, public health priorities, and more. Experiences were gathered from five large consortia on rapid multi-institutional evidence generation during the COVID-19 pandemic. Insights have been compiled across five dimensions: consortium composition, governance structure and alignment of priorities, data sharing, data analysis, and evidence dissemination. The purpose of this piece is to offer guidance on building large-scale multi-institutional RWD analysis pipelines for future public health issues. The composition of each consortium was largely influenced by existing collaborations. A central set of priorities for evidence generation guided each consortium, however different approaches to governance emerged. Challenges surrounding limited access to clinical data due to various contributors were overcome in unique ways. While all consortia used different methods to construct and analyze patient cohorts ranging from centralized to federated approaches, all proved effective for generating meaningful real-world evidence. Actionable recommendations for clinical practice and public health agencies were made from translating insights from consortium analyses. Each consortium was successful in rapidly answering questions about COVID-19 diagnosis and treatment despite all taking slightly different approaches to data sharing and analysis. Leveraging RWD, leveraged in a manner that applies scientific rigor and transparency, can complement higher-level evidence and serve as an important adjunct to clinical trials to quickly guide policy and critical care, especially for a pandemic response.

Research integrity and academic medicine: the pressure to publish and research misconduct.

CONTEXT: This narrative review article explores research integrity and the implications of scholarly work in medical education. The paper describes how the current landscape of medical education emphasizes research and scholarly activity for medical students, resident physicians, and faculty physician educators. There is a gap in the existing literature that fully explores research integrity, the challenges surrounding the significant pressure to perform scholarly activity, and the potential for ethical lapses by those involved in medical education. OBJECTIVES: The objectives of this review article are to provide a background on authorship and publication safeguards, outline common types of research misconduct, describe the implications of publication in medical education, discuss the consequences of ethical breaches, and outline possible solutions to promote research integrity in academic medicine. METHODS: To complete this narrative review, the authors explored the current literature utilizing multiple databases beginning in June of 2021, and they completed the literature review in January of 2023. To capture the wide scope of the review, numerous searches were performed. A number of Medical Subject Headings (MeSH) terms were utilized to identify relevant articles. The MeSH terms included "scientific misconduct," "research misconduct," "authorship," "plagiarism," "biomedical research/ethics," "faculty, medical," "fellowships and scholarships," and "internship and residency." Additional references were accessed to include medical school and residency accreditation standards, residency match statistics, regulatory guidelines, and standard definitions. RESULTS: Within the realm of academic medicine, research misconduct and misrepresentation continue to occur without clear solutions. There is a wide range of severity in breaches of research integrity, ranging from minor infractions to fraud. Throughout the medical education system in the United States, there is pressure to publish research and scholarly work. Higher rates of publications are associated with a successful residency match for students and academic promotion for faculty physicians. For those who participate in research misconduct, there is a multitude of potential adverse consequences. Potential solutions to ensure research integrity exist but are not without barriers to implementation. CONCLUSIONS: Pressure in the world of academic medicine to publish contributes to the potential for research misconduct and authorship misrepresentation. Lapses in research integrity can result in a wide range of potentially adverse consequences for the offender, their institution, the scientific community, and the public. If adopted, universal research integrity policies and procedures could make major strides in eliminating research misconduct in the realm of academic medicine.

Analyzing Surgical Technique in Diverse Open Surgical Videos With Multitask Machine Learning.

Objective: To overcome limitations of open surgery artificial intelligence (AI) models by curating the largest collection of annotated videos and to leverage this AI-ready data set to develop a generalizable multitask AI model capable of real-time understanding of clinically significant surgical behaviors in prospectively collected real-world surgical videos. Design, Setting, and Participants: The study team programmatically queried open surgery procedures on YouTube and manually annotated selected videos to create the AI-ready data set used to train a multitask AI model for 2 proof-of-concept studies, one generating surgical signatures that define the patterns of a given procedure and the other identifying kinematics of hand motion that correlate with surgeon skill level and experience. The Annotated Videos of Open Surgery (AVOS) data set includes 1997 videos from 23 open-surgical procedure types uploaded to YouTube from 50 countries over the last 15 years. Prospectively recorded surgical videos were collected from a single tertiary care academic medical center. Deidentified videos were recorded of surgeons performing open surgical procedures and analyzed for correlation with surgical training. Exposures: The multitask AI model was trained on the AI-ready video data set and then retrospectively applied to the prospectively collected video data set. Main Outcomes and Measures: Analysis of open surgical videos in near real-time, performance on AI-ready and prospectively collected videos, and quantification of surgeon skill. Results: Using the AI-ready data set, the study team developed a multitask AI model capable of real-time understanding of surgical behaviors-the building blocks of procedural flow and surgeon skill-across space and time. Through principal component analysis, a single compound skill feature was identified, composed of a linear combination of kinematic hand attributes. This feature was a significant discriminator between experienced surgeons and surgical trainees across 101 prospectively collected surgical videos of 14 operators. For each unit increase in the compound feature value, the odds of the operator being an experienced surgeon were 3.6 times higher (95% CI, 1.67-7.62; P = .001). Conclusions and Relevance: In this observational study, the AVOS-trained model was applied to analyze prospectively collected open surgical videos and identify kinematic descriptors of surgical skill related to efficiency of hand motion. The ability to provide AI-deduced insights into surgical structure and skill is valuable in optimizing surgical skill acquisition and ultimately improving surgical care.

Eliminating sternal wound infections: Why every cardiac surgery program needs an I hate infections team.

Objectives: The majority of studies examining deep sternal wound infection (DSWI) prevention focus on ameliorating 1 variable at a time. There is a paucity of data regarding the synergistic effects of combining clinical and environmental interventions. This article describes an interdisciplinary, multimodal approach to eliminate DSWIs at a large community hospital. Methods: We developed a robust, multidisciplinary infection prevention team to evaluate and act in all phases of perioperative care to achieve a cardiac surgery DSWI rate of 0, named: the I hate infections team. The team identified opportunities for improved care and best practices and implemented changes on an ongoing basis. Results: Patient-related interventions consisted of preoperative methicillin-resistant Staphylococcus aureus identification, individualized perioperative antibiotics, antimicrobial dosing strategies, and maintenance of normothermia. Operative-related interventions involved glycemic control, sternal adhesives, medications and hemostasis, rigid sternal fixation for high-risk patients, chlorhexidine gluconate dressings over invasive lines, and use of disposable health care equipment. Environment-related interventions included optimizing operating room ventilation and terminal cleaning, reducing airborne particle counts, and decreasing foot traffic. Together, these interventions reduced the DSWI incidence from 1.6% preintervention to 0% for 12 consecutive months after full bundle implementation. Conclusions: A multidisciplinary team focused on eliminating DSWI identified known risk factors and implemented evidence-based interventions in each phase of care to ameliorate risk. Although the influence of each individual intervention on DSWI remains unknown, use of the bundled infection prevention approach reduced the incidence to 0 for the first 12 months after implementation.

Extremity tourniquets raise blood pressure and maintain heart rate.

BACKGROUND: Tourniquets have been modified and used for centuries to occlude blood flow to control hemorrhage. More recently, the occlusion of peripheral vessels has been linked to resultant increases in blood pressure, which may provide additional therapeutic potential, particularly during states of low cardiac output. OBJECTIVE: The objective of this study was to investigate a causal relationship between tourniquet application and blood pressure in healthy adults. METHODS: Healthy adult volunteers were recruited to participate in this IRB-approved study. Each participant met inclusion criteria and demonstrated baseline normotension. Brachial cuff blood pressure and heart rate were recorded pre- and post-tourniquet application to the bilateral legs. RESULTS: Twenty-seven adults aged 22 to 35 years participated and were included in analysis. The average systolic blood pressure was 122 ± 7 mmHg, diastolic blood pressure was 72 ± 9 mmHg, and heart rate was 70 ± 13 bpm. Following bilateral tourniquet application over the femoral vasculature, we observed a statistically significant increase in systolic (7 mmHg, p < 0.001) and diastolic (4 mmHg, p = 0.05) blood pressures with no significant change in heart rate (2 bpm, p > 0.05). CONCLUSIONS: The elevations in systolic and diastolic blood pressures establish a dependent relationship between tourniquet application to the lower extremities and blood pressure elevation. These results may support new indications for tourniquet-use or extremity vessel occlusion in settings of hemodynamic instability.

Results of a postoperative telemedicine trial after cardiac surgery and incorporation into practice.

Objective: The study objective was to describe the implementation and results of a postoperative telemedicine program for adult cardiac surgery, including a clinical study and an organic postoperative telemedicine program aimed at reducing readmission rates and barriers to care. Methods: Patients undergoing coronary artery bypass grafting consented to enrollment in our Perfect Care study funded by The Duke Endowment including advanced practice provider-led postdischarge telemedicine services with data collection. There were 2 telemedicine visits at days 3 and 10 postdischarge using a live face-to-face video platform. Patients were provided with home wearables for heart rate monitoring, blood pressure cuffs, and scales. The success of the Perfect Care study led to the formation of our organic program, the Tele Heart Care, which was adapted to include a larger patient population while remaining structurally similar. Results: Fifty patients were enrolled prospectively between January and October 2021 in Perfect Care. The 30-day readmission rates for those enrolled was 4% compared with a 16% readmission rate for nonenrolled patients during this period. Furthermore, 36% of enrolled patients received medication modifications to optimize blood pressure, heart rate and rhythm, and fluid-volume status, or to treat infectious symptoms. Tele Heart Care enrolled 203 patients and was associated with a decrease in 30-day readmission rates in all cardiac surgery patients at our institution from 24% to 4% over a 6-month period. Conclusions: An advanced practice provider-led postdischarge telemedicine program after cardiac surgery can reduce hospital readmission and barriers to care, and improve patient satisfaction. With involvement of multiple stakeholders, a successful program can be launched despite the present state of national health system finances with limited human capital and constrained access to monitoring equipment.

Patient Attitudes and Perceived Barriers Toward Mental Health Treatment Options in a Rural Student-Run Clinic.

Background While the prevalence of mental health conditions is similar in rural areas and non-rural areas, access to mental health care is more limited in rural areas. Patient attitudes toward specific mental health treatment options in rural populations have been understudied. Some previous studies indicate potential positive outcomes using osteopathic manipulative treatment (OMT) as an adjunct for mental health care. Physicians using OMT are more heavily represented in rural areas. Hence, understanding the mental health treatment needs and option preferences of the rural could inform policies that increase underserved population's access to various mental health treatment modalities including OMT. This study aims to characterize patient attitudes toward, beliefs regarding, and perceived barriers to treatment options for mental health treatment, access, and care in a rural, underserved clinical setting. Methods Adult patients attending a single outpatient rural clinic over a four-month period in 2022 were screened for participation. The survey consisted of Likert scale graded questions about mental health treatment options, access, knowledge, and perceived barriers including qualitative questions about OMTs. Versions of the survey were created in English and Spanish languages. Results Out of 46 respondents, 25 were English-speaking and 21 were Spanish-speaking. The most popular mental health treatments by respondents were indicated as therapy, spiritual guidance, and modifying diet and exercise. Considering barriers to care, 61% of respondents indicated cost of treatment as a logistical barrier. Finally, 80.5% of respondents did not have a good understanding of OMT. Conclusions The knowledge and understanding of patients' perceived attitudes and barriers toward mental health care, inclusive of OMT, can provide insight to clinicians to improve patient outcomes and guide efforts in overcoming barriers to increase and expand mental health treatment availability and utilization by patients.