Using social media for patient care, research, and professional development: A North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition position paper.

The advent of social media has changed numerous aspects of modern life, with users developing and maintaining personal and professional relationships, following and sharing breaking news and importantly, searching for and disseminating health information and medical research. In the present paper, we reviewed available literature to outline the potential uses, pitfalls and impacts of social media for providers, scientists and institutions involved in digestive health in the domains of patient care, research and professional development. We recommend that these groups become more active participants on social media platforms to combat misinformation, advocate for patients, and curate and disseminate valuable research and educational materials. We also recommend that societies such as NASPGHAN assist its members in accessing training on effective social media use and the creation and maintenance of public-facing profiles and that academic institutions incorporate substantive social media contributions into academic promotion processes.

Synthesis of research on ENFit gastrostomy tubes with potential implications for US patients using these devices.

Misconnections between enteral devices and other medical devices have been associated with patient death and serious injuries. To minimize such misconnections, the design of connectors on enteral devices has been standardized. The most common adaptation of the standardized enteral connector is called ENFit. Gastrostomy tubes (G-tubes), which may or may not possess the ENFit connector, are increasingly used to deliver commercial and blenderized diets in home settings to enteral device users. To investigate and compare the performance of G-tubes with and without ENFit connectors, research investigations have recently been performed. However, synthesis of such investigations and quantitative discussion of the consequences of transitioning to ENFit-based G-tube devices has not yet occurred. Here we review the research findings from these studies, with data on patient practices from a Mayo Clinic survey, to estimate the impact on tube feeders in home settings of transitioning to ENFit-based G-tube devices. Extrapolating the findings from these studies to US enteral G-tube patients, 1.5%-8.6% of adult patients and 0.2%-1.9% of pediatric patients may experience perceptible slowing in their gravity feeds if using ENFit-based G-tube devices. About 2.5%-8.6% of adult patients and 0.5%-5.5% of pediatric patients (or their caregivers) may need to push with perceptibly more force for syringe push-based feeding using ENFit-based G-tube devices. Lastly, the article offers suggestions for patients and device manufacturers. [Correction added on 2 May 2022, after first online publication: In the preceding sentence, the percentage of adult patients was revised from 2.5%-8.6% to 1.5%-8.6%.].

Assessing dosing errors in legacy and low dose tip ENFit® syringes.

WHAT IS KNOWN AND OBJECTIVE: To avoid misconnections between different medical devices, a unique standardized design of connectors (ENFit® ) for enteral medical devices has been developed. It was expected that the syringes with these connectors will replace the pre-existing syringes, henceforth referred to as legacy syringes. However, the changes in the connector's design led to concerns regarding dosing errors for low volume syringes (≤2 ml). Therefore, novel low dose tip (LDT) syringes were designed to address these concerns. These LDT syringes can connect with the standardized ENFit® male connectors. Only a few studies have investigated dosing errors, and findings have largely been mixed. The objective of this report was to calculate the contributions of unavoidable dosing errors for LDT syringes, compare with legacy syringes and to suggest strategies to optimize dose accuracy for enteral applications. METHODS: Studies performed with a limited number of syringes to date may not reflect the actual diversity of dosing error that can occur across syringe orientations, batches, manufacturers, medications, etc. A computer-aided design software SolidWorks® was used to calculate the dosing errors in 0.5 and 1.0 ml legacy syringe connectors and were compared with dosing errors in LDT syringe connectors with the same nominal volume. Influence of orientation during delivery, spillage and flushing on dosing error was also investigated. RESULTS AND DISCUSSION: For 0.5 and 1.0 ml LDT syringes, in absence of medication in the moat area, the maximum dosing error will be ±5% when delivering 100% of nominal volume, which is also equal to the dosing error in 0.5 and 1.0 ml slip tip legacy syringes. However, with medication present in moat area, and with syringe reused during flushing, the LDT dosing error can range from 1% to 18% and 28% to 35% for 1.0 and 0.5 ml syringes, respectively. The corresponding dosing error for legacy syringes would be when the same syringe is used for flushing or when syringe disengages pointing vertically up. The corresponding dosing errors for legacy syringes could range from -7 to 12% and -9% to 19% for 1.0 and 0.5 ml syringes, respectively. Dosing errors for legacy and LDT syringes increase as the nominal capacity of syringe reduces, or when the dose delivered is lower than the nominal capacity of the syringe. WHAT IS NEW AND CONCLUSION: For LDT syringes, dosing errors can be reduced by clearing the moat area of the syringe and by using a new syringe for flushing post-delivery of medication. For legacy syringes, dosing errors can be minimized by ensuring the female connector points up during disengagement from the syringe post-medication administration, and by using a new syringe for flushing.

Food and Drug Administration insights on clinical study of weight-loss devices intended for adolescent patients.

BACKGROUND: Medical devices intended for weight loss may provide clinically meaningful benefit to children who are overweight and have obesity; however, no device has been approved by the U.S. Food and Drug Administration (FDA) for use in patients below 18 years of age. Encouragingly, FDA regularly sees new device designs because the field of weight-loss devices is advancing rapidly. As more devices for weight loss are in development, their use in adolescent populations is expected to follow, but supporting data are needed. OBJECTIVES: This report describes efforts that FDA has taken to understand the unmet clinical need, understand how pediatric patients might benefit from a weight-loss device, and provide considerations for how to best design weight-loss device clinical studies considering device-specific patient risk for adolescents. METHODS: We review the recommendations provided to the FDA in 2005 via a Pediatric Advisory Committee meeting and discuss feedback received in 2018 through our Network of Experts programme. RESULTS: FDA encourages weight-loss device manufacturers and academic researchers to collect data through properly controlled trials so that more treatment options can be accessible to pediatric patients. CONCLUSIONS: FDA remains open to considering risk-based clinical study designs incorporating pediatric patients and will continue to take into account the risk to adolescent study participants when determining whether the benefit-risk evidence supports initiation of an adolescent weight-loss device study.

The Regulatory Perspectives on Endoscopic Devices for Obesity.

The recent increase in US Food and Drug Administration-approved weight-loss devices has diversified obesity treatment options. The regulatory pathways for endoscopically placed weight-loss devices and considerations for clinical trials are discussed, including the benefit-risk paradigm intended to aid in weight-loss-device trial development. Also discussed is the benefit-risk analysis of recently approved endoscopic devices. A strategic priority of the FDA Center for Devices and Radiological Health is to increase the use of patient input in decision making. Thus, we consider how endoscopic weight-loss devices with profiles similar to those that have been approved may be viewed in a patient preference study.