Consent Form Reporting on ClinicalTrials.Gov, 2013-2023.

This cross-sectional study examines the availability of consent forms for National Institutes of Health­funded trials on ClinicalTrials.gov.

Paths Forward for Clinicians Amidst the Rise of Unregulated Clinical Decision Support Software: Our Perspective on NarxCare.

Amidst the US overdose epidemic, policymakers, law enforcement agencies, and healthcare institutions have contributed to a decrease in opioid prescribing, assuming reduced mortality would result-an assumption we now understand was oversimplified. At this intersection between public health and public safety domains as they relate to opioid prescribing, unregulated and proprietary clinical decision support tools have emerged without rigorous external validation or public data sharing. In the following piece, we discuss challenges facing clinicians practicing medicine amidst unregulated clinical decision support tools, using the case of Bamboo Health's NarxCare-a prescription drug monitoring program-based analytics platform marketed as a clinical decision support tool-that is already positioned to impact over 1 billion patient encounters annually. We argue that sufficient evidence does not yet exist to support NarxCare's wide implementation, and that clinical decision support tools like NarxCare have flourished in recent years due to a lack of federal regulatory oversight and shielding by their proprietary formulas, which have facilitated their unchecked and outsized influence on patient care. Finally, we suggest specific actions by federal regulatory agencies, healthcare institutions, individual clinicians, and researchers, as well as academic journals, to mitigate potential harms associated with unregulated clinical decision support tools.

Opioid-involved overdose trainings delivered using remote learning modalities.

AIM: This education-focused study examined changes in nursing students' knowledge and attitudes towards responding to opioid-involved overdoses following participation in trainings delivered using remote learning modalities. DESIGN: This pre-post study examined learning outcomes among 17 nursing students. METHODS: Participants completed the Opioid Overdose Attitude Scale and Opioid Overdose Knowledge Scale to assess attitudes and knowledge, respectively. Trainings were delivered to two separate groups, one via virtual reality immersive video and another over video conferencing. RESULTS: Attitude scores increased by an average of 12.2 points and knowledge scores increased by 1.65 points. Within the virtual reality group, attitude scores increased by an average of 10 points, while no significant changes were observed in knowledge scores. The video conferencing group improved in both attitude and knowledge scores, by an average of 16.2 points and 2.1 points, respectively. CONCLUSIONS: These hypothesis generating results illustrate the utility of remote learning approaches to deliver trainings, while maintaining social distance during the ongoing COVID-19 pandemic.

Drug repurposing: a systematic review on root causes, barriers and facilitators.

BACKGROUND: Repurposing is a drug development strategy receiving heightened attention after the Food and Drug Administration granted emergency use authorization of several repurposed drugs to treat Covid-19. There remain knowledge gaps on the root causes, facilitators and barriers for repurposing. METHOD: This systematic review used controlled vocabulary and free text terms to search ABI/Informa, Academic Search Premier, Business Source Complete, Cochrane Library, EconLit, Google Scholar, Ovid Embase, Ovid Medline, Pubmed, Scopus, and Web of Science Core Collection databases for the characteristics, reasons and example of companies deprioritizing development of promising drugs and barriers, facilitators and examples of successful re-purposing. RESULTS: We identified 11,814 articles, screened 5,976 for relevance, found 437 eligible for full text review, 115 of which were included in full analysis. Most articles (66%, 76/115) discussed why promising drugs are abandoned, with lack of efficacy or superiority to other therapies (n = 59), strategic business reasons (n = 35), safety problems (n = 28), research design decisions (n = 12), the complex nature of a studied disease or drug (n = 7) and regulatory bodies requiring more information (n = 2) among top reasons. Key barriers to repurposing include inadequate resources (n = 42), trial data access and transparency around abandoned compounds (n = 20) and expertise (n = 11). Additional barriers include uncertainty about the value of repurposing (n = 13), liability risks (n = 5) and intellectual property (IP) challenges (n = 26). Facilitators include the ability to form multi-partner collaborations (n = 38), access to compound databases and database screening tools (n = 32), regulatory modifications (n = 5) and tax incentives (n = 2). CONCLUSION: Promising drugs are commonly shelved due to insufficient efficacy or superiority to alternate therapies, poor market prospects, and industry consolidation. Inadequate resources and data access and challenges negotiating IP are key barriers to repurposing reaching its full potential as a core approach in drug development. Multi-partner collaborations and the availability and use of compound databases and tax incentives are key facilitators for repurposing. More research is needed on the current value of repurposing in drug development and how to better facilitate resources to support it, where valuable, especially financial, staffing for out-licensing shelved products, and legal expertise to negotiate IP agreements in multi-partner collaborations. TRIAL REGISTRATION: The protocol was registered on Open Science Framework ( https://osf.io/f634k/ ) as it was not eligible for registration on PROSPERO as the review did not focus on a health-related outcome.

Characterizing opioid prescribing to adolescents at time of discharge from a pediatric hospital over a five-year period.

PURPOSE: To characterize opioid prescribing over a 5-year period to adolescents upon discharge from one urban pediatric medical center. DESIGN AND METHODS: A retrospective cross-sectional analysis of 4354 adolescents discharged with a pain medication after an admission of ≤5 days between January 2015 and December 2019 was performed. Two outcome groups, based on the analgesics prescribed at discharge, were compared: those discharged with a prescription for a non-opioid only and those discharged with an opioid prescription. The association between year of discharge and receipt of opioid, while adjusting for relevant demographic and clinical characteristics, was also explored. RESULTS: Approximately 64% of the sample was discharged with an opioid prescription. Of those, the median daily dosage was 45.0 morphine milligram equivalents (MME) [IQR: 32.4, 45.0]. Year of discharge was associated with decreased odds of receiving an opioid when adjusting for age, race, sex, insurance, pain scores, opioid exposure during hospitalization, length of stay, and undergoing surgery. The odds of being discharged with an opioid decreased each year by 29% (Adjusted Odds Ratio [AOR] = 0.71, CI:0.68-0.73). Concurrently, the proportion of patients discharged with nonopioid pain medication increased from 25% of adolescent patients in 2015 to 50% in 2019. CONCLUSIONS: Overall, opioid prescribing to adolescents at time of discharge decreased over time in our sample. PRACTICE IMPLICATIONS: While prescribing has decreased opioid analgesics are dispensed to young patients. Risk of opioid use disorder and overdose is rare in this population, but adolescence is good opportunity for nursing to promote safe prescribing and analgesic use.

A pilot study to compare virtual reality to hybrid simulation for opioid-related overdose and naloxone training.

BACKGROUND: In the midst of the international opioid-related overdose (OOD) crisis, appropriate naloxone training is needed by both healthcare professionals and community members to better leverage its life-saving potential. OBJECTIVE: Pilot the use of a virtual reality simulation for training student nurses to identify signs and symptoms of an OOD, properly administer intranasal naloxone, and provide immediate recovery care after revival. DESIGN: This quasi-experimental pretest-posttest study evaluated knowledge and attitudes towards intervening during an opioid-related overdose among student nurses before and after participating in a traditional hybrid simulation or virtual reality simulation. SETTING: A medium sized urban university's school of nursing in the Northeastern United States. PARTICIPANTS: Fifty (N = 50) senior Bachelor of Nursing Science (BSN) students. METHODS: Knowledge and attitudes were assessed using the Opioid Overdose Knowledge Scale (OOKS) and Opioid Overdose Attitudes Scale (OOAS). Students completed measures 3 weeks prior to training and 3 weeks after. Appropriate t-tests evaluated changes in OOAS and OOKS scores both within and between training groups (e.g. hybrid simulation compared to virtual reality). RESULTS: Sample characteristics were well balanced in both the hybrid simulation group (n = 31) and virtual reality group (n = 19). There were no statistically significant differences in average OOKS and OOAS scores at baseline or at follow up between those receiving hybrid simulation or the virtual reality training. All participants' attitudes scores decreased from baseline to follow up by <2 points. However, there was no difference in the change in knowledge scores between the training groups. CONCLUSIONS: Individuals participating in the virtual reality simulation had similar knowledge retention and attitudes towards responding during an opioid-related overdose and administering intranasal naloxone when compared to individuals participating in hybrid simulation. The lack of significant findings between training groups indicates that the mobile virtual reality training is comparable to the in-person hybrid simulation for training nursing students to appropriately administer naloxone to reverse OOD and provide immediate recovery care after revival.

Evaluating nurse understanding and participation in the informed consent process.

BACKGROUND: Informed consent is fundamental to the autonomous decision-making of patients, yet much is still unknown about the process in the clinical setting. In an evolving healthcare landscape, nurses must be prepared to address patient understanding and participate in the informed consent process to better fulfill their well-established role as patient advocates. RESEARCH OBJECTIVE: This study examines hospital-based nurses' experiences and understandings of the informed consent process. RESEARCH DESIGN: This qualitative descriptive study utilized a semi-structured interview approach identifying thematic concerns, experiences, and knowledge of informed consent across a selected population of clinically practicing nurses. PARTICIPANTS AND RESEARCH CONTEXT: In all, 20 baccalaureate prepared registered nurses practicing in various clinical settings (i.e. critical care, oncology, medical/surgical) at a large northeastern academic medical center in the United States completed semi-structured interviews and a demographic survey. The mean age of participants was 36.6 years old, with a mean of 12.2 years of clinical experience. ETHICAL CONSIDERATIONS: Participation in this study involved minimal risk and no invasive measures. This study received Institutional Review Board approval from the University of Pennsylvania. All participants voluntarily consented. FINDINGS: The majority of participants (N = 19) believe patient safety is directly linked to patient comprehension of the informed consent process. However, when asked if nurses have a defined role in the informed consent process, nearly half did not agree (N = 9). Through this qualitative approach, three major nursing roles emerged: the nurse as a communicator, the nurse as an advocate, and the clerical role of the nurse. DISCUSSION AND CONCLUSION: This investigation contributes to the foundation of ethical research that will better prepare nurses for patient engagement, advance current understanding of informed consent, and allow for future development of solutions. Nurses are at the forefront of patient-provider interactions and they are often presented opportunities to learn about and engage in the informed consent process.