Instructions For Use Research Articles

Usability and acceptability of oral fluid hepatitis C self-testing among people who inject drugs in Coastal Kenya: a cross-sectional pilot study

BackgroundPeople who inject drugs (PWID) are disproportionally affected by hepatitis C virus (HCV) infection and many remain undiagnosed. HCV self-testing (HCVST) may be an effective approach to increase testing uptake, but has rarely been used among PWID. We assessed the usability and acceptability of HCVST among PWID in Kenya.MethodsWe conducted a cross-sectional study nested within a cohort study between August and December 2020 on Kenya’s North Coast region. Participants were handed a prototype oral fluid HCVST kit and asked to conduct the test relying on the instructions for use. Usability was assessed by documenting errors made and difficulties faced by participants. Acceptability was assessed using an interviewer-administered semi-structured questionnaire.ResultsAmong 150 participants, 19% were female and 65.3% had primary level education or lower. 71.3% made at least one error, 56.7% experienced some difficulty during at least one step, and the majority of participants (78%) required assistance during at least one step of the procedure. Most common errors occurred when placing the tube into the stand (18%), collecting the oral fluid sample (24%) and timing of reading results (53%). There was a strong association between presence of symptoms of opiate withdrawals and observed errors (94% vs 62%; p = 0.016) in a sub-group of 74 participants assessed. Inter-reader and inter-operator concordance were 97.7% (kappa: 0.92) and 99.2% (kappa: 0.95), respectively. Acceptability assessed by asking whether participants would choose to use HCVST prior to and after conducting HCVST was 98% and 95%, respectively.ConclusionsWe found a high acceptability of oral fluid HCVST among PWID. User errors were common and were associated with the presence of withdrawal symptoms among users. Despite errors, most participants were able to obtain and interpret results correctly. These findings suggest that this group of users may benefit from greater messaging and education including options to receive direct assistance when self-testing for HCV.

Diagnostic accuracy of covid-19 rapid antigen tests with unsupervised self-sampling in people with symptoms in the omicron period: cross sectional study

ObjectiveTo assess the performance of rapid antigen tests with unsupervised nasal and combined oropharyngeal and nasal self-sampling during the omicron period.DesignProspective cross sectional diagnostic test accuracy study.SettingThree public health service...

Open-Source-Systeme zur automatisierten Insulinabgabe

New developments and technological advancements in diabetes therapies are expected not only to improve metabolic outcomes of people with diabetes, but also to reduce the complexity of diabetes management and consequently their psychosocial burden. Automated insulin delivery (AID) systems—in which continuous glucose monitoring sensors and insulin pumps are linked to control algorithms that automate numerous dose decisions, mimicking the insulin secretion of an islet cell—represent an important new therapeutic approach. Because the development and approval of new therapies is costly and time-consuming, people with diabetes and their loved ones have taken action themselves. Behind the hashtag #WeAreNotWaiting is a community developing open-source AID systems for use with currently available medical devices; the source code and instructions for use are made freely available worldwide. More than 10,000 children and adults are already using open-source AID systems, and studies have demonstrated their safety and efficacy, as well as their positive impact on the quality of life of users. Due to the unclear legal situation regarding the use of unapproved therapy methods at one’s own risk, an international consensus paper has been developed by the EU-funded OPEN project, which provides supportive information for health professionals in the therapy support of “loopers”. In addition to the current state of studies, this article discusses what can be learned from the #WeAreNotWaiting movement and how we can achieve the common goal of making healthcare innovations accessible to as many patients as possible in the future.

Procedural Outcomes of a Self-Expanding Transcatheter Heart Valve in Small Annuli.

Background: Self-expanding transcatheter valves (THV) seem superior to balloon-expanding valves in regard to the incidence of prosthesis–patient mismatch (PPM). Data on the occurrence of PPM with the ACURATE neo/neo2 system as a representative of self-expanding prostheses in very small annuli, even below the applicable instructions for use (IFU), are scarce. Methods: Data from 654 patients with severe native aortic stenosis treated with the smallest size ACURATE neo/neo2 valve (size S, 23 mm) at two German high-volume centers from 06/2012 to 12/2021 were evaluated. We compared clinical and hemodynamic outcomes among patients with implantation in adherence to the recommended sizing (on-label n = 529) and below the recommended sizing range (off-label n = 125) and identified predictors for PPM in the overall population. BMI-adjusted PPM was defined according to VARC-3 recommendations. Results: Post-procedure, the mean gradient (10.0 mmHg vs. 9.0 mmHg, p = 0.834) and the rate of paravalvular leakage (PVL) ≥ moderate (3.2% vs. 2.8%, p = 0.770) were similar between on-label and off-label implantations. The rate of moderate to severe PPM (24%) was comparably low in ACURATE neo/neo2 S, with a very low proportion of severe PPM whether implanted off- or on-label (4.9% vs. 3.8%, p = 0.552). Thirty-day all-cause mortality was higher among patients with off-label implantations (6.5% vs. 2.3%, p = 0.036). In the subgroup of these patients, no device-related deaths occurred, and cardiac causes did not differ (each 5). Besides small annulus area and high BMI, a multivariate analysis identified a greater cover index (OR 3.26), deep implantation (OR 2.25) and severe calcification (OR 2.07) as independent predictors of PPM. Conclusions: The ACURATE neo/neo2 S subgroup shows a convincing hemodynamic outcome according to low mean gradient even outside the previous IFUs without a relevant increase in the rate of PVL or PPM. In addition to known factors such as annulus area and BMI, potential predictors for PPM are severe annulus calcification and implantation depth. Nevertheless, the ACURATE neo/neo2 system seems to be a reliable option in patients with very small annuli.

Laboratory evaluation of RealStar Yellow Fever Virus RT-PCR kit 1.0 for potential use in the global yellow fever laboratory network.

BackgroundEarly detection of human yellow fever (YF) infection in YF-endemic regions is critical to timely outbreak mitigation. African National Laboratories chiefly rely on serological assays that require confirmation at Regional Reference Laboratories, thus delaying results, which themselves are not always definitive often due to antibody cross-reactivity. A positive molecular test result is confirmatory for YF; therefore, a standardized YF molecular assay would facilitate immediate confirmation at National Laboratories. The WHO-coordinated global Eliminate Yellow Fever Epidemics Laboratory Technical Working Group sought to independently evaluate the quality and performance of commercial YF molecular assays relevant to use in countries with endemic YF, in the absence of stringent premarket assessments. This report details a limited laboratory WHO-coordinated evaluation of the altona Diagnostics RealStar Yellow Fever Virus RT-PCR kit 1.0.Methodology and principal findingsSpecific objectives were to assess the assay’s ability to detect YF virus strains in human serum from YF-endemic regions, determine the potential for interference and cross-reactions, verify the performance claims as stated by the manufacturer, and assess usability. RNA extracted from normal human serum spiked with YF virus showed the assay to be precise with minimal lot-to-lot variation. The 95% limit of detection calculated was approximately 1,245 RNA copies/ml [95% confidence interval 497 to 1,640 copies/ml]. Positive results were obtained with spatially and temporally diverse YF strains. The assay was specific for YF virus, was not subject to endogenous or exogenous interferents, and was clinically sensitive and specific. A review of operational characteristics revealed that a positivity cutoff was not defined in the instructions for use, but otherwise the assay was user-friendly.Conclusions and significanceThe RealStar Yellow Fever Virus RT-PCR kit 1.0 has performance characteristics consistent with the manufacturer’s claims and is suitable for use in YF-endemic regions. Its use is expected to decrease YF outbreak detection times and be instrumental in saving lives.

Development of business mathematics learning media based on macromedia flash

Learning media is a means of supporting learning to help stimulate the mind, as well as make it easier to convey information from lecturers to students or vice versa. With the existence of interactive learning media, it can increase students' motivation and interest in learning, so that the teaching and learning process can run more effectively. The purpose of the research conducted is to develop an interactive macromedia flash-based business mathematics learning media so that later it will be able to improve student learning outcomes. The learning media developed is limited to the material of linear functions and their application in the field of the shipping business. This research is included in research and development (Research and Development), which uses a modified Borg & Gall development model. The subjects of this study were students of the first semester of the Port Management Study Program, Shipping Diploma Program-Hang Tuah University Surabaya. The developed media contains about the title layer, instructions for use, learning outcomes, material, exercises, evaluations, developer profiles. The results of the learning media that have been developed are suitable for use and are able to improve student learning outcomes. Learning media that is developed only on the subject of the application of linear functions, so it is necessary to develop learning media for courses and other subjects. It is also necessary to add video and audio, so that students can study independently.

One Step at a Time Outside Instructions For Use for Endovascular Aortic Repair

In this issue, van Basten Batenburg and co-authors present the outcomes from a prospectively collected series of 150 patients with infrarenal aneurysms “one step” outside of instructions for use (IFU), specifically those with an angulated or short neck, treated with the Endurant stent graft.[1].

Personalized external aortic root support in aneurysm disease.

To bring together and annotate publications about personalised external aortic root support reported in the 18 months preceding submission. The total number of personalised external aortic root support (PEARS) operations is now approaching 700 in 30 centres in Australia, Belgium, Brazil, Czech Republic, Great Britain, Greece, Ireland, Malaysia, Netherlands, New Zealand, Poland and Slovakia. There are continued reports of stability of aortic dimensions and aortic valve function with the only exceptions known being where the surgeon has deviated from the instructions for use of the device. The median root diameter of Marfan patients having PEARS was 47 mm suggesting that the existing criterion of 50 mm is due for reconsideration. The peri-operative mortality currently estimated to be less than 0.3%. The first recipient remains alive and well after 18 years. The use of PEARS as an adjunct to the Ross operation to support the pulmonary autograft is being explored in several centres. The operation requires proctoring and adherence to a strict operative protocol and with those precautions excellent results are attained. The evidence and opinions provided in the cited publications indicate that PEARS is a proven and successful prophylactic operation for aortic root aneurysm.

Clinical Issues-September 2022.

Providing inclusive care to patients in the lesbian, gay, bisexual, transgender, and queer or questioning community Key words: unisex restroom, patient privacy, inclusivity, "Safe Zone," LGBTQ community. Preventing trips over power cords Key words: power cords, pathway, Bluetooth, wireless technology, falls. Reducing discomfort of personnel standing for prolonged procedures Key words: prolonged standing, antifatigue mats, sit-stand stools, microbreaks, ergonomics. Using a clear adhesive dressing as a sterile drape patch Key words: adhesive dressing, patch, instructions for use (IFU), sterile drapes, contamination.

Outcome Analysis From a Multicenter Registry on Unibody Stent-Graft System for the Treatment of Spontaneous Infrarenal Acute Aortic Syndrome (MURUSSIAS Registry)

Purpose: This study reports the outcomes from a Multicenter Registry on unibody stent-graft system for the treatment of spontaneous infrarenal acute aortic syndrome (MURUSSIAS registry). Materials and methods: The retrospective MURUSSIAS registry included spontaneous infrarenal acute aortic dissection (IAAS) managed with the unibody stent-graft system (AFX endovascular AAA system; Endologix Inc., Irvine, California) outside the current instruction for use. IAAS considered aortic dissection (AD), intramural hematoma (IMH), and penetrating aortic ulcer (PAU). Indications to IAAS treatment were symptoms, associated dilated abdominal aorta (>3 cm), rapidly-growing (>0.5 cm/6 months) aorta, IAAS disease progression. Measured results were technical success, early (within 30 days) and midterm outcomes (after 30 days), including mortality, complications, symptoms recurrence, type I/III endoleak occurrence, stent-graft patency, survival, and freedom from reintervention. The mean follow-up was 22.12 ± 17 months. Results: The MURUSSIAS registry included 83 patients from 7 participating centers. IAAS indication to treatment were symptoms in 42 (51%). In 14 (17%) patients, the infrarenal aortic length was <80 mm, and in 28 (34%), the aortic bifurcation diameter was <16 mm. Technical success was 100%. Mortality occurred early in 1 (1%) and at the midterm in 3 (4%) patients. Complications occurred early in 10 (12%) patients (1 severe, 3 moderates, and 6 mild) and at midterm in 2 (2%) (2 moderate). No symptoms’ recurrence or type I/III endoleaks were registered. The 36-month estimated survival and freedom from reinterventions were 89% and 92%, respectively. Conclusions: The MURUSSIAS registry is the largest collection of spontaneous IAAS managed endovascularly using the AFX endovascular AAA system. The IAAS peculiar anatomic features were fitted with the used technique with excellent results. This treatment strategy might be considered in IAAS unless specifically-designed endovascular solutions will be available also in the emergent setting. Further studies are required to assess the longer-term performances and the stability of the reported technique. Clinical Impact The lack of specifically designed devices for infrarenal acute aortic syndrome (IAAS) disease remains an issue principally for its specific anatomic features. The MURUSSIAS registry retrospectively examined the outcomes of spontaneous IAAS treated using the unibody stent-graft system in a spontaneous national study; and reports the largest available data on this topic. The use of the unibody stent-graft system showed to fit the anatomic peculiarities of IAAS with excellent outcomes. This IAAS treatment strategy should be considered unless specifically designed endovascular solutions will be available.

Editor's Choice – Endurant Stent Graft in Patients with Challenging Neck Anatomy “One Step Outside Instructions for Use”: Early and Midterm Results from the EAGLE Registry

The aim of the Endurant for Challenging Anatomy: Global Experience (EAGLE) registry is to evaluate prospectively the technical and clinical success rate of a stentgraft used in patients with challenging neck anatomy outside the instructions for use (IFU) but within objective anatomical limits. This was a prospective, international, multicentre, observational study. From 1 February 2012 to 1 September 2017, patients with an abdominal aortic aneurysm with a challenging infrarenal neck that were deemed suitable for endovascular aneurysm repair were included prospectively at 23 European centres. Patients were distributed by anatomy into three groups: short neck (SN; infrarenal neck 5 - 10 mm in combination with suprarenal angulation [α] ≤ 45° and infrarenal angulation [β] ≤ 60°); medium neck (MN; infrarenal neck 10 - 15 mm with α ≤ 60° and β 60° - 75° or α 45°- 60° and β ≤ 75°; and long angulated neck (LN; infrarenal neck ≥ 15 mm with α ≤ 75° and β 75°- 90° or α 60°- 75° and β ≤ 90°. All computed tomography scans were reviewed by an independent core laboratory. Primary outcomes were technical and clinical success. Secondary endpoints were peri-operative major adverse events, all cause mortality, aneurysm related mortality, endoleaks, migration, and secondary intervention. One hundred and fifty patients (81.3% male) were included (SN= 55, MN= 16, LN= 79). The median follow up was 36 ± 12.6 months. In the overall cohort, the technical success rate was 93.3%. Estimated freedom from aneurysm related death was 97.3% at three years. Freedom from secondary interventions was 84.7% at three years. Estimated clinical success was 96.0%, 90.8%, and 83.2% at 30 days, one year, and three years, respectively. Estimated freedom from all cause mortality, late type IA endoleak, and migration at three years was 75.1%, 93.7%, and 99.3%, respectively. The early and midterm results of the EAGLE registry show that endovascular repair with the Endurant stentgraft in selected patients with challenging infrarenal neck anatomy yields results in line with large "real world" registries. Long term results are awaited for more definitive conclusions.

Appropriate Use and Operationalization of Adherence to Digital Cognitive Behavioral Therapy for Depression and Anxiety in Youth: Systematic Review.

Digital, self-guided cognitive behavioral therapy (CBT) interventions circumvent many barriers to in-person therapy for young people (aged 12-24 years), although adherence to these interventions is low. The absence or insufficient disclosure of recommendations or instructions for appropriate use may account for this. As such, many young people may not self-administer these interventions appropriately or receive the optimal degree of treatment. This systematic review aims to synthesize the literature on digital CBT for depression and anxiety in young people to describe how appropriate use has been defined and communicated to users as instructions for use, to describe how adherence has been measured, and to determine the associations between adherence and treatment outcomes. A systematic review was conducted with 2 reviewers (SHL and MRA) extracting data independently. Overall, 4 electronic databases (Embase, MEDLINE, PsycINFO, and Cochrane Library) were searched in April 2021 for studies that met the following inclusion criteria: participants aged between 12 and 24 years, evaluated a digital CBT intervention targeting depression or anxiety, and reported instructions or recommendations for use or measures of adherence. Studies that evaluated non-CBT interventions or cognitive- or behavioral-only interventions were excluded. Methodological quality was assessed using the Cochrane Risk of Bias Tool and the Integrated Quality Criteria for the Review of Multiple Study Designs. There were 32 manuscripts that met the inclusion criteria, of which 28 (88%) were unique studies (N=16,578 youths). Definitions of appropriate use varied among the different interventions in terms of intended recipients, duration and frequency of use, and the features used to support engagement and adherence to appropriate use definitions. Reporting of appropriate use definitions in studies was inconsistent, with no study systematically describing components of appropriate use or providing information on how recommendations for use were relayed to users. Most often, definitions of appropriate use were derived from the study protocol and descriptions of intervention features. Adherence was mostly operationalized as the degree of intervention completion; however, reporting of adherence data was heterogeneous. There was little evidence of an association between degree of use and outcomes in the 9 studies that examined this. Definitions of appropriate use are unique to each digital CBT intervention. However, statements of appropriate use are not systematically reported in the literature. Furthermore, the extent to which recommendations for use are communicated to users is not routinely reported. Despite unique definitions of appropriate use, adherence was most often generically operationalized as the degree of intervention completion and was not consistently associated with outcomes. We proposed a framework to promote systematic reporting of definitions of appropriate use for digital interventions to provide guidance to users and to assist the development of appropriate and nuanced measures of adherence. PROSPERO CRD42020208668; https://tinyurl.com/4bu2yram.

Endografts for the treatment of abdominal aortic aneurysms with a hostile neck anatomy: A systematic review.

BackgroundEndovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAAs) has emerged as a better alternative to conventional open surgery for AAAs. The purpose of the review is to define the improvement in the clinical management of the patient with hostile neck AAAs due to the introduction of new endografts while giving a thorough description of their instructions for use (IFUs), main characteristics and part sizing, reporting their outcomes from clinical studies and categorizing their usability.MethodsA MEDLINE search was conducted using keyword-specific combinations. Clinical studies were searched via the clinicaltrials.gov website. Relevant articles' references were also hand-searched.ResultsWe retrieved 640 records describing Alto, Ovation iX, Treovance, Aorfix, Anaconda, Conformable, and Endurant II/IIs endografts. Aortic necks >60° can be managed with Anaconda, Aorfix, and Conformable, which can treat up to 90° necks requiring ≥15 mm (Anaconda ≥20 mm), and Treovance, which is eligible for necks ≤75° with ≥15 mm length. Ovation's innovation of combining polymer-filled O-rings with integral anchors can treat conical necked AAAs giving Ovation iX and Alto an advantage. Short-necked AAAs can be treated with Alto, eligible for necks as short as 7 mm, and Endurant II, which can treat ≥10 mm necks or 4 mm if used in conjunction with the EndoAnchors system, respectively. Alto and Conformable report a 100% technical success rate, absence of AAA-related death, migration, ruptures, and limb occlusion during follow-up. Endurant II and Ovation iX report >99% technical success rate and are almost free from the AAA mortality rate, ruptures, migration, and limb occlusion, while Ovation iX has a high rate of sac dilation (15.5%) in a 5-year follow-up. Anaconda is slightly better than Aorfix and Treovance, which are related to the lowest technical success rates, 98.3%, 96.3%, and 96%, respectively. Aorfix has the highest AAA mortality rate, 4% in a 60 month follow-up.ConclusionMost new generation endografts described have comparable results. They broaden the eligibility of patients for EVAR due to their unique technical characteristics described. There is a lack of comparative studies for newer endografts and postmarket clinical studies with long-term results concerning the most recently approved devices described, Alto and Conformable.

Medication Adherence among Patients with Chronic Diseases in Saudi Arabia.

Introduction: The management of chronic illnesses commonly includes a long-term pharmacological approach. Although these medications effectively control disease, their full benefits are often not realized because approximately 50% of patients do not take their medications as prescribed. Medication adherence has become a big concern to clinicians and healthcare systems in Saudi Arabia and worldwide because of growing evidence associating nonadherence with adverse outcomes and higher costs of care. Despite it being a well-recognized problem, few studies have investigated medication adherence in Saudi Arabia. Therefore, this study aims to gain a better perspective on medication adherence among patients with chronic diseases in Saudi Arabia. Method: A questionnaire-based cross-sectional study was conducted among patients with chronic diseases in the Makkah region, Saudi Arabia, from 1 May to 31 July 2021. Patients aged 18 years and above who were taking prescribed or over-the-counter medications were included. Descriptive statistics were used to describe the participants’ characteristics, and categorical variables were reported as frequencies and percentages. A Chi-square test was used to test the relations between variables. Results: In total, 239 participants were included in the study. Females represented 62% of the participants. In terms of the history of chronic diseases, 44% had hypertension, 40% had diabetes mellitus, 21% had heart diseases and 9% had asthma. Nearly half (49%) of participants did not follow up regularly with a primary healthcare center and 42% said that they had forgotten to take their medications in the past. However, most of the participants (78%) stated that they took their medicine as instructed by their doctor or pharmacist, and 61% took their medications on time. The majority of participants (85%) said that the pharmacist explained the method of using the medications and the instructions for use, while 30% thought that the medications they took were too much. In regard to the reasons for medication nonadherence, having no specific reasons for medication nonadherence was the most common cause for nonadherence in our study. The relationship between patients taking medications as instructed by a healthcare provider (the doctor or pharmacist) and the healthcare provider giving clear instructions to patients about medication use was significant (p < 0.001). Conclusions: Failure to adhere is a significant problem that not only affects the patient but also the healthcare system. Additional research is needed to monitor medication adherence and identify factors contributing to this problem to provide successful strategies to improve medication adherence in Saudi Arabia.

Aspects of the Safe Use of Antibacterial Drugs in Community-Acquired Pneumonia: the Implications of Drug-Drug Interactions

Background. Drug-drug interactions can seriously affect the safety profile of a drug and are an important problem worldwide. Due to the aging of the population, the increasing frequency of polypharmacy, as well as the spread of self-medication, adverse events that are difficult to identify may occur. It is hard to establish a causal relationship between the administration of a certain drug and the occurrence of an adverse event; it may also lead to the conversion of the adverse event into an adverse drug reaction. The risk of drug-drug interactions increases with combination therapy, as a result of misuse of a drug (off-label use), as well as in the absence of full disclosure from physician and patient about potential drug-drug interactions.One of the ways to detect an adverse reaction to a drug is a method of «spontaneous messages», when notification cards issued according to the regulated form are sent from subjects of drug circulation to the national centers for pharmacovigilance, then to the global database of the World Health Organization VigiBase.The aim of the work was a comprehensive analysis of the content compliance of the information presented in the instructions for the medical use of antibacterial drugs on potential drug-drug interactions with validated signals from the WHO global VigiBase database.Material and Methods. The study used information and analytical comparative non-quantitative, graphical, logical methods of analysis, as well as regression analysis. Objects of the study: instructions for medical use for international generic drugs ampicillin, amoxicillin, azithromycin, clarithromycin.Results. The contents of the instructions for use concerning possible interactions of ampicillin, amoxicillin, azithromycin, clarithromycin upon administration with other drugs were studied. Subsequently, a comparative analysis of the obtained data on drug-drug interactions of antibiotics with other drugs was carried out with signals of drug-drug interactions were validated by VigiBase.Conclusion. The study showed that a detailed description of the risks of potential drug-drug interactions in the instructions for medical use with the aim of informing doctors, patients, and caregivers helps to prevent the use of undesirable combinations, thereby reducing the risk of adverse reactions when drugs are used together. The study found that most of the identified information on the safe use of drugs was missing in the instructions for medical use.

Usability of a Novel Enteral Feeding System: A Summative Study.

BackgroundUtilization of long-term home enteral nutrition (HEN) for nutrition therapy is increasing across the world. However, HEN can be a mobility-limiting experience affecting quality of life (QoL). Improvement of QoL for patients receiving HEN is a universal goal within the nutrition community. This study evaluated usability of Mobility+®, a novel enteral feeding system (EFS).MethodsA summative study evaluating usability of the novel EFS was conducted with novices (NV), non-novices (NN), and healthcare professionals (HCP). Subjects in NV and NN groups received familiarization training where they were introduced to the novel EFS and walked through steps to fill pouch, simulate feeding, flush (rinse), and wear the system, using the Instructions for Use (IFU) booklet, followed by a testing session where they simulated system use on their own. HCP self-trained using the IFU and instructional videos. A fill from ready-to-hang (RTH) formula bag method was also tested in HCP. Participants’ ability to loosely coil the tubing and sit, stand, and move around wearing a filled feeding pouch inside a crossbody bag was also evaluated.ResultsForty-five participants completed the study. All participants successfully and safely simulated use of the novel EFS, with 97.8% (44/45) doing so on first attempt. All participants could wear the novel EFS in crossbody bag and move around without any use errors or safety issues.ConclusionThe examined novel EFS can be safely used in intended use population, with or without previous experience with enteral nutrition, on provision of basic familiarization training and written IFU. Additionally, HCP can successfully self-train on this system with instructional videos.

Late Neck Related Adverse Events are Rare Among Patients with Wide Aortic Neck Undergoing Endovascular Aneurysm Repair with the Ovation Endograft

Patients with wide aortic necks undergoing Endovascular Aneurysm Repair (EVAR) have been shown to be at a higher risk for neck-related complications. We aim to examine outcomes of EVAR with an endograft exerting minimal outward pressure (Ovation-Endologix) in patients with a large baseline neck diameter. We performed a retrospective single center study, including consecutive patients undergoing EVAR with the Ovation system from May 2011 to April 2021. Patients were divided in Groups 1 and 2 if the 20, 23, 26, 29 mm or the 34mm proximal diameter main body was used, respectively. According to the instructions for use of the device, for neck diameters 27-30mm the 34mm main body is required. Primary endpoint was rate of neckrelated complications during follow-up, (type Ia endoleak, migration >10mm and neck-related re-interventions) and rate of aortic neck dilatation (AND). AND was determined based on multiple aortic neck diameters that were recorded and compared between the 1-month computed tomography angiography (CTA) after EVAR and the last available follow-up CTA.Secondary endpoints were peri-procedural and follow-up outcomes such as endoleaks, reinterventions and overall mortality. In total 281 patients were included, 222 in Group 1 and 59 in Group 2. Patients in Group 2 presented significantly shorter neck length, higher neck angulation and more common reversed tapered configuration. Median follow-up was 36months (Range: 6-106). Early and late type Ia endoleak was observed in 4 and 2 patients in each group, respectively (P=0.063 and P=0.195, respectively). Distal migration was observed in 2 patients in Group 2 and AND was recorded in 2 patients in each group (P=0.195). Freedom from the primary endpoint was estimated at 98%, 94%, 94% at 12-, 36-, 60-months for Group 1 and at 98%, 95%, 86% for Group 2 (P-Value 0.266). Probability of survival was 95%, 86%, 75% at 12-, 36-, 60-months for Group 1 and 83%, 77%, 72% for Group 2 (P-Value 0.226).Multivariate regression analysis identified neither Group 1 versus Group 2 nor absolute value of aortic neck diameter as significant predictors of neck-related adverse events. Neck diameters did not display significant differences over time in any of the levels evaluated. EVAR with the Ovation endograft results in low rates of late neck related complications which is also true for patients with wide baseline aortic necks.

Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion.

Background: Endovascular aneurysm repair (EVAR) has become an accepted alternative to open repair (OR) for the treatment of abdominal aortic aneurysm (AAA) despite “hostile” anatomies that may reduce its effectiveness. Guidelines suggest refraining from EVAR in such circumstances, but in clinical practice, up to 44% of EVAR procedures are performed using stent grafts outside their instruction for use (IFU), with acceptable outcomes. Starting from this “inconsistency” between clinical practice and guidelines, the aim of this contribution is to report the technical results of the use of EVAR in challenging anatomies as well as the ethical aspects to identify the criteria by which the “best interest” of the patient can be set. Materials and Methods: A literature review on currently available evidence on standard EVAR using commercially available endografts in patients with hostile aortic neck anatomies was conducted. Medline using the PubMed interface and The Cochrane Library databases were searched from 1 January 2000 to 6 May 2021, considering the following outcomes: technical success; need for additional procedures; conversion to OR; reintervention; migration; the presence of type I endoleaks; AAA-related mortality rate. Results: A total of 52 publications were selected by the investigators for a detailed review. All studies were either prospective or retrospective observational studies reporting the immediate, 30-day, and/or follow-up outcomes of standard EVAR procedures in patients with challenging neck anatomies. No randomized trials were identified. Fourteen different endo-grafts systems were used in the selected studies. A total of 45 studies reported a technical success rate ranging from 93 to 100%, and 42 the need for additional procedures (mean value of 9.04%). Results at 30 days: the incidence rate of type Ia endoleak was reported by 37 studies with a mean value of 2.65%; 31 studies reported a null migration rate and 32 a null conversion rate to OR; in 31 of the 35 studies that reported AAA-related mortality, the incidence was null. Mid-term follow-up: the incidence rate of type Ia endoleak was reported by 48 studies with a mean value of 6.65%; 30 studies reported a null migration rate, 33 a null conversion rate to OR, and 28 of the 45 studies reported that the AAA-related mortality incidence was null. Conclusions: Based on the present analysis, EVAR appears to be a safe and effective procedure—and therefore recommendable—even in the presence of hostile anatomies, in patients deemed unfit for OR. However, in order to identify and pursue the patient’s best interest, particular attention must be paid to the management of the patient’s informed consent process, which—in addition to being an essential ethical-legal requirement to legitimize the medical act—ensures that clinical data can be integrated with the patient’s personal preferences and background, beyond the therapeutic potential of the proposed procedures and what is generically stated in the guidelines.

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.

Medical Affairs Support of Medical Information Requests during COVID-19 Pandemic

Introduction: Medical Affairs teams within Medical Device Companies receive Medical Information Requests (MIR) from Healthcare Professionals (HCP) seeking answers to medical, scientific, or technical information because they cannot be answered based on the individual product’s current prescribing information, indications, Instructions for Use (IFU), as cleared or approved by the appropriate competent regulatory authority (e.g., Food and Drug Administration (FDA), Notified Body in the European Union, or other regional governmental authority). In 2018, Johnson &amp; Johnson MedTech launched a Cloud-based platform to harmonize Medical Affairs’ global management and processing of MIRs from HCPs, seeking scientific or medical information about our portfolio of products. The aim of this comparative retrospective analysis was to critically examine the 2020 MIR volumes in 2020 versus 2019 and assess the impact of COVID-19 on Medical Affairs support of patients and Health Care Providers (HCPs). Methods: The authors conducted a retrospective analysis of Johnson &amp; Johnson MedTech MIR data, across quarters from January 2019 through the December 2020, to evaluate the potential impact of the COVID-19 pandemic on MIR intake volume and key metrics. Results: The Total Global (US, EMEA, and ASPAC) year over year analysis of Total Johnson &amp; Johnson MedTech MIR volume totaled, 2018-656*, 2019-1155 and 2020-1153. When stratifying Global year over year analysis of Regional (US, EMEA, and ASPAC) MIR data: US MedTech MIR volume for quarterly periods, including initial COVID-19 pandemic, Q2 2020 resulted in a 48% decrease in MIR volume across US MedTech MIR submissions, compared to Q2 2019. Q3 2020 resulted in a 43% increase in MIR volume across US MedTech MIR submissions, compared to Q3 2019. EMEA MedTech MIR volume for the quarterly periods, including initial COVID-19 pandemic, Q2 2020 resulted in a 23% decrease in MIR volume across EMEA MedTech MIR submissions, compared to Q2 2019. Q3 2020 resulted in a 22% increase in MIR volume across EMEA MedTech MIR submissions, compared to Q3 2019. ASPAC MIR volume for the quarterly periods, including initial COVID-19 pandemic, Q2 2020 resulted in an 11% increase in MIR volume across ASPAC MedTech MIR submissions, compared to Q2 2019. Q3 2020 resulted in a 90% increase in MIR volume across ASPAC MedTech MIR submissions, compared to Q3 2019. Analysis of Quarterly MIR volume by Region (US, EMEA, and ASPAC) compared to Quarterly MIR volume from Prior Year (2019-2020): US Q1-18%, Q2 -48%, Q3+39%, and Q4+7%, EMEA Q1-29%, Q2-30%, Q3+25%, and Q4+15%, and ASPAC Q1-16%, Q2+11%, Q3+90%, and Q4+256%. Conclusion: Total MIR submissions and responses continued with only small variance from the previous year when compared to annual periods, including the impact from the COVID-19 pandemic (2019 vs. 2020). Across Johnson &amp; Johnson MedTech, Healthcare professionals and the commercial sales teams increased their use of the MIR submission website during the COVID-19 pandemic, while face to face interactions were either prohibited or restricted, due to social distancing guidelines. Despite the COVID-19 pandemic, global customers benefited from the wealth of data and information available from MedTech Medical Affairs, through utilization of our interactive MIR submission website and MIRO digital platform. MIRO allowed for the continuous, timely processing of global MIRs, related to both essential hospital activities as well as elective procedures around the world, while limited face to face interactions were enforced, around the world.