The use of personal protection equipment does not negatively affect paramedics’ attention and dexterity: a prospective triple-cross over randomized controlled non-inferiority trial

Background The COVID-19 pandemic led to widespread use of personal protection equipment (PPE), including filtering face piece (FFP) masks, throughout the world. PPE. Previous studies indicate that PPE impairs neurocognitive performance in healthcare workers. Concerns for personnel safety have led to special recommendations regarding basic life support (BLS) in patients with a potential SARS-CoV-2 infection, including the use of PPE. Established instruments are available to assess attention and dexterity in BLS settings, respectively. We aimed to evaluate the influence of PPE with different types of FFP masks on these two neuropsychological components of EMS personnel during BLS. Methods This was a randomized controlled non-inferiority triple-crossover study. Teams of paramedics completed three 12-min long BLS scenarios on a manikin after having climbed three flights of stairs with equipment, each in three experimental conditions: (a) without pandemic PPE, (b) with PPE including a FFP2 mask with an expiration valve and (c) with PPE including an FFP2 mask without an expiration valve. The teams and intervention sequences were randomized. We measured the shift in concentration performance using the d2 test and dexterity using the nine-hole peg test (NHPT). We compared results between the three conditions. For the primary outcome, the non-inferiority margin was set at 20 points. Results Forty-eight paramedics participated. Concentration performance was significantly better after each scenario, with no differences noted between groups: d2 shift control versus with valve − 8.3 (95% CI − 19.4 to 2.7) points; control versus without valve − 8.5 (− 19.7 to 2.7) points; with valve versus without valve 0.1 (− 11.1 to 11.3) points. Similar results were found for the NHPT: + 0.3 (− 0.7 to 1.4), − 0.4 (− 1.4 to 0.7), 0.7 (− 0.4 to 1.8) s respectively. Conclusion Attention increases when performing BLS. Attention and dexterity are not inferior when wearing PPE, including FFP2 masks. PPE should be used on a low-threshold basis.

Attempts to Purchase Misoprostol Online in Indonesia: A Mystery Client Study Design

Introduction: Abortion is highly restricted in Indonesia; self-administered misoprostol can safely induce an abortion. Pharmacies, a common place to purchase misoprostol off-label in other parts of the world, are monitored in Indonesia so that they cannot function outside the law. Misoprostol is for sale online through in-country distributors. Such procurement offers a level of safety and anonymity to the buyer and seller. So as to understand online acquisition of misoprostol, we created a protocol to capture the most visible universe and of sellers, how they engaged with clients, and what women’s experiences were likely to be attempting to buy misoprostol from them. Methods and analysis: We carried out a mystery client methodology to replicate the experiences of women procuring misoprostol online. Our study consisted of five sections: (1) identify the universe of online sellers using the most common search terms, drawn from multiple platforms to capture diversity in interactions as well as products sold (2) remove sellers advertising on more than one site as determined by their telephone numbers (3) draw a roughly probability proportional to size sample (4) contact sellers as mystery clients through text/chat, depending on the platform and engage with them using one profile (marital status, age, and number of children) and (5) purchase drugs offered by the seller. Ethics and dissemination: Ethical considerations include that by purchasing abortion medications from these online sellers, its possible that we made it harder for women seeking to buy drugs from online sellers. Our engagement with these online sellers may have resulted in some of them feeling under scrutiny and possibly pausing their sales. Dissemination plans include depositing a preprint of the paper, sharing the protocol with other study teams who are interested in replicating the methodology in other locations, and sharing our data collection tools on SurveyCTO.

Prevalence and Appropriateness of Indwelling Urinary Catheters in Japanese Hospital Wards: A Multicenter Point Prevalence Study

Background: Indwelling urinary catheters are commonly used in hospitalized patients, which can lead to the development of urinary catheter complications, including catheter-associated urinary tract infection (CAUTI). Limited reports on the appropriateness of urinary catheter use exist in Japan. This study investigated the prevalence and appropriateness of indwelling urinary catheters, and the incidence of CAUTI in non-intensive care unit (non-ICU) wards in Japanese hospitals. Methods: This prospective observational study was conducted in 7 non-ICU wards from 6 hospitals in Japan from October 2017 to June 2018. At each hospital the study teams evaluated urinary catheter prevalence through in-person bedside evaluation for at least 5 days of each week for 3 months. Catheter associated urinary tract infection (CAUTI) incidence and appropriateness of catheter use was collected via chart review.Results: We assessed 710 catheter-days over 5528 patient-days. The mean prevalence of indwelling urinary catheter use in participating wards was 13% (range: 5% to 19%), while the mean incidence of CAUTI was 9.86 per 1000 catheter-days (range: 0 to 33.90). Approximately 66% of the urinary catheter days assessed had an appropriate indication for use (range: 17% to 81%). A physician's order for catheter placement was present in only 10% of catheterized patients.Conclusion: This national prospective study provides epidemiological information about the appropriate use of urinary catheters in Japanese non-ICU wards. A multimodal intervention may help improve the appropriate use of urinary catheters.

465 Bintrafusp alfa in combination with chemotherapy in patients with stage IV NSCLC: safety and pharmacokinetic results of the INTR@PID LUNG 024 study

BackgroundBintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-βRII receptor (a TGF-β ”trap”) fused to a human IgG1 mAb blocking PD-L1. Here we report cumulative safety and pharmacokinetic (PK) results from the global, phase 1b/2 INTR@PID LUNG 024 study (NCT03840915), which evaluated bintrafusp alfa in combination with chemotherapy (CT) in patients with stage IV NSCLC.MethodsAdult patients with stage IV nonsquamous or squamous NSCLC and an ECOG PS ≤1 were included. Cohorts A, B, and C included patients with no prior systemic therapy; patients in cohort D had disease that progressed with previous anti–PD-(L)1 therapy. Cohorts received bintrafusp alfa 2400 mg every 3 weeks intravenously in combination with CT for 4 cycles (A [nonsquamous only]: cisplatin or carboplatin + pemetrexed; B: carboplatin + nab-paclitaxel or paclitaxel; C: cisplatin or carboplatin + gemcitabine; D: docetaxel) followed by bintrafusp alfa maintenance (monotherapy or in combination with pemetrexed in cohort A) for up to 31 cycles. The primary objective of this study was to evaluate the safety of bintrafusp alfa in combination with CT. Dose-limiting toxicities (DLTs) were assessed during a 3-week observation period. Serial samples were drawn to assess serum concentration and calculate PK parameters by noncompartmental analysis.ResultsAs of the May 5, 2021, data cutoff, 70 patients received bintrafusp alfa in combination with CT. Of 35 patients included in the DLT analysis, 4 experienced 1 DLT according to a safety monitoring committee (data cutoff May 5, 2021; A: n=1/8; B: n=1/8; C: n=0/8; D: n=2/11). Cumulative safety data are reported in table 1. PK data were available for 67 patients (A: n=38; B: n=9; C: n=8; D: n=12). PK profiles were similar across cohorts and between patients who did and did not experience a DLT. Observed bintrafusp alfa first-cycle exposures (Cmax, AUC, and Ctrough) were consistent with the published population PK (popPK) model.1Abstract 465 Table 1Safety results from the INTR@PID LUNG 024 studyConclusionsThe safety profile of bintrafusp alfa in combination with CT was manageable and similar to that reported for ICIs in combination with CT, with the exception of TGF-β–related skin lesions known to occur with TGF-β inhibition. No new safety signals were identified and there were no treatment-related deaths. The PK profile was consistent with the predicted monotherapy popPK model, suggesting no victim DDI potential for bintrafusp alfa with CT.AcknowledgementsThe authors thank the patients and their families, investigators, co-investigators, and the study teams at each of the participating centers, at the healthcare business of Merck KGaA, Darmstadt, Germany, and at EMD Serono, Billerica, Massachusetts, USA.Trial RegistrationNCT03840915ReferenceWilkins JJ, Vugmeyster Y, Dussault I. Population pharmacokinetic analysis of bintrafusp alfa in different cancer types. Adv Ther 2019;36:2414–2433.Ethics ApprovalThe trial was approved by each site’s independent ethics committee.

Review of Consumer-to-Consumer E-Commerce Research Collaboration

This study uses a content analysis method to systematically review 83 research papers from 2002-2018 to explore consumer-to-consumer (C2C) e-commerce research trends. The findings of this study indicate that (1) C2C e-commerce is discussed and investigated in many disciplines, but mainly published in e-commerce journals; (2) studies on C2C e-commerce increasingly focus on diverse topics, but concentrate on regions such as China and the United States; (3) the focus of academic collaboration has shifted from domestic to international collaboration, and collaboration within the same institution. However, collaboration is scarce across different study teams; (4) the data-driven approach is the main approach used in studies on C2C e-commerce; (5) while the number of recent C2C e-commerce studies adopted theories is increasing, few have developed theoretical frameworks or models. Finally, study implications and future study suggestions are also discussed.

Model for developing context-sensitive responses to vulnerability in research: managing ethical dilemmas faced by frontline research staff in Kenya

Health research in low-resource settings often involves individuals and populations defined as ‘vulnerable’. There is growing attention in the literature to the ethical dilemmas that frontline research staff face while conducting such research. However, there is little documented as to how research staff might support one another in identifying and handling these dilemmas in different contexts. Over the course of conducting empirical ethics research embedded in the Childhood Acute Illness & Nutrition Network, we developed an approach to examine and respond to the ethical issues and dilemmas faced by the study teams, particularly frontline staff. In this paper we describe the specific tools and approach we developed, which centred on regular cross-team ethics reflection sessions, and share lessons learnt. We suggest that all studies involving potentially vulnerable participants should incorporate activities and processes to support frontline staff in identifying, reflecting on and responding to ethical dilemmas, throughout studies. We outline the resources needed to do this and share piloted tools for further adaptation and evaluation. Such initiatives should complement and feed into—and certainly not in any way replace or substitute for—strong institutional ethics review, safeguarding and health and safety policies and processes, as well broader staff training and career support initiatives.

Abstract MP36: The Development Of A Centralized Recruitment Process For Covid-19 Research: Hopkins Opportunity For Participant Engagement Registry

Introduction: The COVID-19 pandemic has required urgent scientific response to investigate the disease, its prevention and treatment and interactions with cardiovascular conditions. Consequently, a centralized workflow was needed to effectively recruit, screen and connect volunteers to COVID-19 research opportunities. Objective: To create a centralized registry to match eligible and interested volunteers ≥18 years with COVID-19 outpatient research studies at an academic health system. Methods: Key stakeholders, including researchers and participant advocates, collaborated to build the Hopkins Opportunity for Participant Engagement (HOPE) Registry in English and Spanish. REDCap, a secure web-based application, served as the Registry platform. Study teams recruiting for outpatient studies were invited to present their studies through the Registry. Study volunteers were recruited using multiple methods, including patient portal messages, email, social media, and online advertisement. The Registry included COVID testing results and participant survey of demographic and COVID-19 related questions. Branching logic was used to pre-screen and present participating studies for which the person was eligible. The individual then selected which studies, if any, they were interested in. Study teams received an automatic notification and reached out directly to individuals expressing interest in their study ( Figure ). Results: The HOPE Registry includes 7 studies and has enrolled 4186 people. Over half (55%) were >55 years and the majority were female (64%). Racial/ethnic groups represented were Whites (80%), Black s (9%), Asians (4.7%), Hispanics (5%), and American Indian (0.3%). Participants were interested in: 29%, treatment study; 37%, vaccine study; and 66%, donating plasma. Within 10 weeks, 585 persons were matched with an actively recruiting study. Conclusions: The ongoing HOPE registry has shown promise in engaging individuals with COVID-19 research and improving research recruitment workflow.

SELF-REGULATED LEARNING IN ENGINEERING STUDENTS: STRATEGIES FOR PEDAGOGICAL RESOURCE

This paper presents some findings of the investigation "Self-regulated learning in engineering students of the Army Engineering Faculty (FIE)". The central theoretical contributions on the “self-regulation of learning” comes from theconceptual approaches of Zimmerman and Pintrich since they allow the understanding of the processes that takes placein the control of: thoughts, feelings, motivations and actions for the achievement of the learning objectives.It was found that to achieve this self-regulation in their learning, the students in this sample developed strategies throughwhich they manage and internalize resources from the academic environment. They are grouped into two large catego-ries: group study and the use of elements of the environment. The dynamics of conformation and functioning of work incollaborative study teams are similar among students. In addition, they describe the progressive use of elements of theinstitutional environment: study spaces, materials, technologies, institutional devices and also codes and dynamics ofsocial interaction typical of this faculty. The achievement of self-regulation implies the progressive incorporation of theresources of the academic context and this is a process that demands time and effort from the student. The acquisitionof self-regulation is evidence of the solid construction of the student ́s craft and a successful educational affiliation tothe university context.

Near-vision impairment and effective near-vision spectacle coverage in two districts in Telangana, India: a population-based cross-sectional study

ObjectivesTo investigate the prevalence of near-vision impairment (NVI) and effective spectacle coverage for near vision in those aged ≥40 years in Khammam and Warangal district in Telangana, India.DesignA population-based cross-sectional study.SettingKhammam and Warangal district in Telangana, India.ParticipantsOf 6000 people enumerated, 5357 were examined (89%). 4526 participants without distance vision impairment were included in the analysis.Main outcome measuresThe study teams visited selected households and conducted eye examinations. NVI was defined as binocular presenting near vision worse than N6. ‘Unmet need’ was deemed to be present if the unaided near vision was worse than N6 and improved to N6 with near correction among the participants who did not have spectacles for near vision. ‘Met need’ was deemed to be present when unaided near vision was worse than N6 but improving to N6 with their spectacles. The ‘undermet need’ was deemed to be present when aided near vision was worse than N6 but improved to N6 with correction. Based on these definitions, e-near-vision coverage (%) is calculated as follows: e-NVC (%)=met need/(met need+undermet need+unmet need) × 100.ResultsThe mean age was 53.5 years (SD: 10.8 years), 2534/4526 (55.8%) were women, 1819/4526 (41.8%) had at least primary school education and 2368/4526 (52.3%) were from the Khammam district. The prevalence of NVI was 55.8% (95% CI 72.5 to 75.1; n=3343). Overall, the e-NVC (%) was 31.8%. It was 40.0% in Khammam and 23.2% in Warangal.ConclusionNVI is common in Khammam and Warangal districts in Telangana with inadequate effective near-vision coverage. Effective service delivery models are needed to reach out and provide services to address NVI to achieve universal eye health coverage in the region.

Methodological Challenges and Solution Strategies During Implementation of a Midwife-led Multicentre Randomized-controlled Trial (RCT) in Maternity Hospitals

Background: RCTs with complex interventions are methodically challenging. Careful planning under everyday conditions in compliance with the relevant international quality standard (ICH-GCP guideline) is crucial. Specific challenges exist for RCTs conducted in delivery rooms due to various factors that cannot be planned beforehand, such as “peak hours” of births and a high work burden for midwives and obstetricians. Moreover, in Germany as well as in other countries, midwives and obstetricians have frequently little experience as investigators in clinical trials. Methods: The randomised controlled trial “BE-UP” tests the effectiveness of an alternative birthing room on the rate of vaginal births and woman-oriented outcomes. In the process of implementing the trial in 17 obstetrical units and in the endeavour to reach the calculated sample size of 3,800 women, the research team encountered a variety of unexpected challenges. The aim is to describe in greater detail the methodical and organisational challenges and to inform about the research team’s strategies to overcome them.Results:The results are presented in five sectors: 1) Selection of and support for cooperating hospitals: they are to be selected according to predefined criteria and strategies to offer continuous support in trial implementation must be mapped out.2) Establishing a process of requesting informed consent: a quality-assured process to inform pregnant women early on must be feasible and effective. 3) Individual, digital real time randomization: besides instructing the maternity teams appropriate measures for technical failure must be provided.4) The standardized birthing room: the complex intervention is to be implemented according to study protocol, yet adapted to the prevailing conditions in the delivery rooms.5) GCP-compliant documentation: midwives and obstetricians is to be instructed in high quality data collection, supported by external monitoring throughout the trial.Conclusion:Since not all potential challenges can be anticipated in the planning of a trial, study teams need to be flexible and react promptly to any problems that threaten recruitment or the implementation of the complex intervention. Thought should be given to the perspectives of midwives and obstetricians as recruiters and how clinic-intern processes could be adapted to correspond with the trial’s requirements.