Patient Recruitment Goes High-Tech

Clinical trial patient recruitment is arguably the most difficult aspect of pharmaceutical development, because it involves a variety of factors beyond study sponsors' control. The aggregation of data across 80 hospitals and 20 systems, for the purpose of understanding patients, doing feasibility studies, or engaging in decentralized recruitment, is the trend we're seeing." Nimita Limaye, PhD, is the vice president of research for the life sciences R&D strategy and technology division at the International Data Corporation (IDC), a market research and advisory firm specializing in the technology industry and headquartered in Boston, Mass. Limaye says the rise of social media-based patient recruitment has opened the door for sponsors and investigators to mine real-world data and to give patients a more central focus in research.

A Documentary Review on Private School Human Resource Management During Disruption Era

This preliminary study aimed to identify attributes for observed and latent variables. A documentary review was employed to investigate the attributes for latent variables, namely technological integration, disruptive leadership, and organizational transformation while the observed variable was human resource management during the disruption era. The findings revealed that there are six attributes for human resource management during the disruption era, four attributes for technological integration, five attributes for disruptive leadership, and four attributes for organizational transformation. All these variables and their attributes are going to investigate using structural equation modeling in order to explore relations between observed and latent variables.

Relevance of social capital in the face of unemployment in university students generated by the COVID-19 pandemic

Based on the acknowledgment that the ability in Colombia to use and generate social capital is quite deficient at the national level according to official measurements carried out in the country, the central theme of this article focuses on analyzing whether social capital is relevant to the phenomenon of unemployment in middle and low income university students generated by the effects of the COVID-19 pandemic. The study deals with a sample of 392 students of the Universidad ECCI in Bogota, mainly middle and low income, who from the completion of a semi-structured survey designed with four dimensions at social, emotional, economic, and associativity levels, show that the use of formal and informal networks in young people has some level of impact on job placement in a discreet way, due to the low capacity of recognition of network linkage, as well as the complexity of access to networks that potentiate solidarity and support in times of juncture such as the one we are living, ignoring the potential impact of social capital on development.

Social distancing causing crises: learning from workforce adaptation by e-tailers

PurposeThis study explores workforce related adaptation by e-tailers during social distancing causing crises (SDCC) and provides a conceptual framework.Design/methodology/approachA grounded theory based approach has been used wherein about 120 news articles were analyzed to understand the real-world measures taken. 50 journal papers were also referred to. A typical qualitative methodology, including open, and axial was used.FindingsIn the early stages, panic buying emerged as the key disrupting factor which necessitated staff shortage management. In the long term, e-tailers can adapt to prevent reverse worker migration and modify their hiring and training processes.Research limitations/implicationsThis study synthesizes knowledge on workforce-related adaptation by e-tailers and offers considerable potential for future research as well as the development of case studies and consulting services for the industry. Two research propositions are offered that can guide hypothesis generation and further studies can be conducted in sectors other than retail also.Practical implicationsThis study puts forward propositions based on theoretical dimensions for managers adapting to workforce-related problems during SDCC. The pandemic has led to vast unemployment and the shutting down of a number of businesses across the globe due to economic downfall. Hence, this study has economic and social implications.Originality/valueThis study is unique as it is one of the few that delves into e-tailers' workforce- related adaptation as SDCC evolves and contributes to a body of literature which is scarce.

ASIAN BIOTECH CLINICAL TRIAL DEMAND MOVES TO THE WEST

The critical element, of course, is that there can be no compromise on trial design, execution and data collection to deliver a robust drug development package. AUM's strategy is to reverse this flow and go from Asia to the West, satisfying the need of the Asian population for innovative and affordable drug development and reducing the cost of health care in Western countries by introducing drugs at an "Asian" price point. [...]the dislocation in services from widespread lockdowns resulted in significant delays in data collection and management of research samples. Even when we could transfer them to appropriate laboratories for analysis, the staff shortages, backlog of samples, and supply chain disruption of critical reagents and parts caused troubling delays in obtaining and analyzing data.

Artificial intelligence and machine learning in clinical trial design and application

In 2020, COVID-19 changed how health care was approached both in the United States and globally. In the early phases, the vast majority of energy and attention was devoted to containing the pandemic and treating the infected. Toward the end of 2020, that attention expanded to vaccinating people across the globe. What was not being considered at the time were challenges to future health and clinical trials that power new treatments for COVID-19 and non-COVID-19 treatments. © 2023 Elsevier Inc. All rights reserved.

COVID-19 host genetic risk study conducted at community pharmacies: Implications for public health, research and pharmacists' scope of practice

Community pharmacists serve a large, diverse population of patients, resulting in the potential to utilize community pharmacies as recruitment sites for clinical research. Beyond traditional roles as one of the most accessible health care professionals in the US healthcare system, pharmacists have played a major role in the response to the COVID-19 pandemic, administering hundreds of thousands of vaccines and tests. However, less emphasis is placed on the ability to leverage community pharmacies as research-focused partners for clinical studies. In this study, we demonstrate the feasibility and workflow of recruiting study participants from community pharmacies and confirm genetic markers of COVID-19 susceptibility. Specific genetic markers include those associated with COVID-19 infection risk (ACE2, TMEM27, and RAVER1), difficulty breathing (NOTCH4), and hospitalization (OAS3). In addition, collaboration with a clinical laboratory allowed for a more seamless consenting process without substantial training needs or workflow disruption at the community pharmacy site. The COVID-19 pandemic has demonstrated that the expansion of pharmacists' scope of practice is a key factor in managing the population health crisis;this study demonstrates that pharmacies can also advance clinical research studies by serving as sites for patient recruitment from a large, diverse, and ambulatory study population.

The Rise of FSP Outsourcing in Drug Development

Simultaneously, advances in mobile technology, data aggregation and analysis tools, and risk management methodologies are changing how clinical trial data are collected and monitored, influencing how companies outsource core clinical research tasks. The established full-service model, in which biopharmaceutical companies retain a preferred contract research organization (CRO) to perform the full range of clinical trial activities, has been increasingly complemented by an functional service provider (FSP) approach, which allows companies to engage discrete expert services- such as medical writing, biostatistics, or clinical monitoring-when and where they need them. [...]it cultivates continuity because FSP relationships tend to be long-term. [...]companies that need to bolster a specific type of expertise or fill a geographic gap are using FSP to do so in a highly targeted fashion. [...]data aggregation, AI, and machine learning were steadily gaining traction pre-pandemic. Because the value of a CRA rises rapidly with experience and a solid track record-and they move up quickly-we are facing a potential shortage of Level 1 or entry-level CRAs. [...]Parexel enhanced its recruitment and training efforts in parts of the world where supply and demand for CRAs is not as tight.

Design and implementation of a digital site-less clinical study of serial rapid antigen testing to identify asymptomatic SARS-CoV-2 infection.

Background: Rapid antigen detection tests (Ag-RDT) for SARS-CoV-2 with emergency use authorization generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. We aim to describe a novel study design that was used to generate regulatory-quality data to evaluate the serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals. Methods: This prospective cohort study used a siteless, digital approach to assess longitudinal performance of Ag-RDT. Individuals over 2 years old from across the USA with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Participants throughout the mainland USA were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported. Key Results: A total of 7361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 US states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide. Conclusions: The digital site-less approach employed in the "Test Us At Home" study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19 and can be adapted across research disciplines to optimize study enrollment and accessibility.

Tidal lung hysteresis to interpret PEEP-induced changes in compliance in ARDS patients.

BACKGROUND: In ARDS, the PEEP level associated with the best respiratory system compliance is often selected; however, intra-tidal recruitment can increase compliance, falsely suggesting improvement in baseline mechanics. Tidal lung hysteresis increases with intra-tidal recruitment and can help interpreting changes in compliance. This study aims to assess tidal recruitment in ARDS patients and to test a combined approach, based on tidal hysteresis and compliance, to interpret decremental PEEP trials. METHODS: A decremental PEEP trial was performed in 38 COVID-19 moderate to severe ARDS patients. At each step, we performed a low-flow inflation-deflation manoeuvre between PEEP and a constant plateau pressure, to measure tidal hysteresis and compliance. RESULTS: According to changes of tidal hysteresis, three typical patterns were observed: 10 (26%) patients showed consistently high tidal-recruitment, 12 (32%) consistently low tidal-recruitment and 16 (42%) displayed a biphasic pattern moving from low to high tidal-recruitment below a certain PEEP. Compliance increased after 82% of PEEP step decreases and this was associated to a large increase of tidal hysteresis in 44% of cases. Agreement between best compliance and combined approaches was accordingly poor (K = 0.024). The combined approach suggested to increase PEEP in high tidal-recruiters, mainly to keep PEEP constant in biphasic pattern and to decrease PEEP in low tidal-recruiters. PEEP based on the combined approach was associated with lower tidal hysteresis (92.7 ± 20.9 vs. 204.7 ± 110.0 mL; p < 0.001) and lower dissipated energy per breath (0.1 ± 0.1 vs. 0.4 ± 0.2 J; p < 0.001) compared to the best compliance approach. Tidal hysteresis ≥ 100 mL was highly predictive of tidal recruitment at next PEEP step reduction (AUC 0.97; p < 0.001). CONCLUSIONS: Assessment of tidal hysteresis improves the interpretation of decremental PEEP trials and may help limiting tidal recruitment and energy dissipated into the respiratory system during mechanical ventilation of ARDS patients.

Best Practices in Recruitment and Outreach to Women and Diverse Veterans for Coronavirus Research at the U.S. Department of Veterans Affairs.

In September 2020, the Department of Veterans Affairs (VA) launched a novel volunteer research registry to rapidly recruit eligible study participants for research on SARS-CoV-2 and COVID-19 vaccines and treatments at VA Medical Centers selected as study sites for COVID-19 clinical trials. Targeted multimedia outreach campaigns were used to recruit diverse populations, including those historically under-represented in medical research. By November 2022, 58,561 volunteers were enrolled in the registry, 19% of whom were women, 9% Hispanic/Latino, and 8% Black. The registry's strategic approach to outreach proved successful in recruiting diverse volunteers, with geotargeted e-mails recruiting the most diversity.

Medical students as health workers during the COVID-19 pandemic.

BACKGROUND: We describe efforts at one tertiary university teaching hospital to rapidly recruit, train and deploy medical students into paid clinical support worker roles during the COVID-19 pandemic. METHODS: Recruitment was conducted by means of a single email outlining the emergent clinical situation and specifying role descriptions, terms and conditions, and temporary staff enrolment paperwork. Applicants could begin work provided they were in good standing and received departmental orientation. Student representatives liaised with teaching faculty and participating departments. Roles were modified in response to student and departmental feedback. RESULTS: Between 25 December 2020 and 9 March 2021, 189 students contributed 1335 shifts, providing 10 651 hours of clinical care in total. The median number of shifts worked per student was 6 (mean: 7; range: 1-35). Departmental leaders attested that the student workers eased the burden on hospital nursing teams. CONCLUSION: Medical students contributed usefully and safely to the provision of healthcare within well-defined and supervised clinical support worker roles. We propose a model of working which could be adapted in the event of future pandemics or major incidents. The pedagogical value to medical students of working in clinical support roles warrants closer evaluation.

Diversity Elements on Maternal Fetal Medicine (MFM) Fellowship Websites: Opportunity for Improvement in Recruitment and Representation.

Background: There has been a fundamental shift in recruitment of medical students and trainees into residency and fellowship programs during the Covid 19 pandemic.1 Historically, websites for medical trainees demonstrate a lack of explicit focus on diversity, equity, and inclusion. 2-7 Diversity has positive associations of improving healthcare team performance, patient care, and even financial goals.8 A lack of diversity may negatively impact patient care.9 Directed recruitment of underrepresented in medicine applicants has proven successful to increase diversity within training programs. Department websites have a more prominent role in virtual recruitment since the beginning of the COVID pandemic. Features on these websites may be utilized to attract underrepresented in medicine applicants and increase diversity in a field. Objective: To analyze Maternal Fetal Medicine fellowship websites for presence of diversity elements important to those people who are underrepresented in medicine. Study Design: Fellowship websites were accessed summer of 2021. They were analyzed for presence of twelve website elements that demonstrate commitment to diversity, including: 1) nondiscrimination statement; 2) diversity and inclusion message; 3) diversity specific language; 4) resources for trainees; 5) community demographics; 6-7) personalized biographies of faculty or fellows; 8-9) individual photographs of faculty or fellows; 10) photos or biographies of alumni; 11) diversity publications and; 12) department statistics. Program size, region, and location were collected. Self-reported underrepresented in medicine data on residency programs was extracted from the National Graduate Medical Education Survey from 2019. Programs were dichotomized into 6+ diversity elements. Nonparametric, chi-square and Fisher's exact were used for analysis. Results: Fellowship programs were analyzed (excluding military/fetal surgery, n = 91/94). Websites included a mean of 4.1± 2.5 diversity elements. Most featured fewer than 6 elements (n =75, 82.4%). When dichotomized to 6+ diversity elements, larger faculty size was the only significant factor (p=0.01). The majority of programs had fewer than 12 faculty members (n=54, 59.3%) and only 9.3% of those programs had 6 or more diversity elements. By contrast, among programs with more than 12 faculty, 29.7% had 6 or more diversity elements. Faculty photos, fellow photos, and diversity publications were the most commonly featured items (92.4%, 68.1%, and 49.5%, respectively). Mean rate of underrepresented in medicine was 18.8% ± 11.3% and no significant associations were noted. There was a non-significant difference in diversity elements in the West United States with a mean of 5.3±2.2 diversity elements, compared to 3.7±2 in the South. Conclusion: Fellowship websites convey information for trainees, especially in an era of virtual recruitment. This study highlights opportunities for directed improvements of websites for features which URIM medical trainees have identified as important.

Quality internships in the hospitality industry: a way to help address the labor shortage

Internships can serve as a pipeline to employers and have played an important role in hospitality education programs. The COVID-19 Pandemic has moved many internships online limiting student benefits and options. As the hospitality industry struggles to compete in the post-Coronavirus labor market, it has never been more important to ensure highly satisfying internship experiences. Findings indicate that host sites permitting student interns to be creative and feel appreciated while identifying long-term career opportunities produce more satisfied interns. While satisfaction may be enhanced when supervisors mentor their interns by building strong Leader-Member Exchange relationships, they may not be required for intern satisfaction. © 2023 Taylor & Francis Group, LLC.

Role of Point-of-Care Ultrasound in the Management of Mechanical Ventilation

Ultrasound (US) became an essential tool in the hands of the intensivist and is now recommended both for procedural guidance and diagnostic purposes. Point-of-care ultrasound (POCUS) is an immediately available and repeatable, non-irradiating bedside tool integrating the clinical examination. Recent years were characterized by a growing interest in the fields of lung ultrasound (LUS) and diaphragm ultrasound (DUS). The combination of these two ultrasound techniques with critical care echocardiography (CCE) may integrate the classical approach to mechanically ventilated patients, both for monitoring and diagnostic purposes, finally contributing to the titration of mechanical ventilation and to the management of respiratory disease. Lung, diaphragm, and cardiac US provide significant information to improve the management of the critical patient under mechanical ventilation, from the initial assessment, through the ventilation setting (like PEEP) and its complication diagnosis (like pneumothorax, atelectasis), until the weaning process. LUS is of particular help in COVID-19 patients. It is potentially able to distinguish between the two phenotypes (type H and type L) of COVID-19, based on the different signs and patterns and also the assessment of prone positioning effects and lung recruitment maneuvers in these patients. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.

Virtual onboarding and socialization, an exploration of employee discussions and experiences

PurposeDuring the coronavirus disease 2019 (COVID-19) pandemic, employers struggled to develop virtual onboarding (VO) experiences among new employees. Prior research has examined VO processes. This study, by contrast, compares online commentaries in relation to current research findings to determine a functional description of effective VO.Design/methodology/approachUsing a qualitative, inductive thematic analysis, the researchers explored new employees' online, anonymous, public commentary about the employers' VO experiences. Through analyzing 83 posted communications, the researchers sought to not only categorize themes, but to also identify meaning within the employees' commentary. From the thematic analysis, meaningful themes were established and compared to existing literature to identify comprehensive trends in effective VO.FindingsThe analysis developed nine themes of discussion question (DQ) prompts and nine themes of discussion responses. The professionals' online discussion about VO in the workplace as well as attributes of each theme was compared to contemporary VO research. In combination with a review of established literature of effective VO and an examination of organizational socialization theory, the study confirms that some virtually onboarded employees are excelling with, and some are challenged by the communication deficiencies of the remote experience. Employee experiences are highlighted to develop a description of contemporary effective VO experiences to support future workplace efficiencies.Research limitations/implicationsData were gathered via Blind and each response shared on Blind is subject to the viewpoint of the participants. For future research, face-to-face interviews might offer context regarding new hires' VO experiences. Also the generalizability is impacted because not all participants of VO participate via Blind. Participant bias is possible given the perceived dissatisfaction or negative experiences. Future research can perform a national random study of employees. Finally, the data and participants in this study were USA based. Future research should consider other international contexts such as Europe.Practical implicationsThe thematic findings of this study yield valuable practical recommendations. New hires that experience VO are seeking improved virtual communication channels between themselves and the managers and colleagues of the hires. As such, corporate managers/trainers can implement a virtual mentoring program to have senior employees prepare and guide new hires into employees' new remote working environment to reduce employees' uncertainty. To improve VO processes in a post-pandemic society, corporate managers/trainers can incorporate social media communication given that employees participate in social media to develop their careers. With social media work groups, new virtual hires can be better socialized through effective peer-to-peer informal internal communications where the hires can freely ask questions and build better work relationships.Social implicationsIn each onboarding experience and evident in each of the five themes, learning is an underlying concept. New employees are describing that it is challenging to development organizational shared values, skills, attitudes, knowledge, abilities, behaviors and relationships in a VO process. As organizational leaders continue to develop VO experiences, a focus on learning as dependent on the virtual learning process and content can be significant in terms of creating a positive employee VO learning experience. Originality/valueThe findings are unique in exploring new hires' self-reported VO experiences. This study offers insight into effective VO practices such as developing virtual trainings that are well planned, engaging and supporting of relationships, collaborations and career goals.

A Semi-supervised Sensing Rate Learning based CMAB scheme to combat COVID-19 by trustful data collection in the crowd.

The recruitment of trustworthy and high-quality workers is an important research issue for MCS. Previous studies either assume that the qualities of workers are known in advance, or assume that the platform knows the qualities of workers once it receives their collected data. In reality, to reduce costs and thus maximize revenue, many strategic workers do not perform their sensing tasks honestly and report fake data to the platform, which is called False data attacks. And it is very hard for the platform to evaluate the authenticity of the received data In this paper, an incentive mechanism named Semi-supervision based Combinatorial Multi-Armed Bandit reverse Auction (SCMABA) is proposed to solve the recruitment problem of multiple unknown and strategic workers in MCS. First, we model the worker recruitment as a multi-armed bandit reverse auction problem and design an UCB-based algorithm to separate the exploration and exploitation, regarding the Sensing Rates (SRs) of recruited workers as the gain of the bandit Next, a Semi-supervised Sensing Rate Learning (SSRL) approach is proposed to quickly and accurately obtain the workers' SRs, which consists of two phases, supervision and self-supervision. Last, SCMABA is designed organically combining the SRs acquisition mechanism with multi-armed bandit reverse auction, where supervised SR learning is used in the exploration, and the self-supervised one is used in the exploitation. We theoretically prove that our SCMABA achieves truthfulness and individual rationality and exhibits outstanding performances of the SCMABA mechanism through in-depth simulations of real-world data traces.

Targeting tumor-associated macrophages for cancer immunotherapy.

Tumor-associated macrophages (TAMs) are one of the most abundant immune components in the tumor microenvironment and play a plethora of roles in regulating tumorigenesis. Therefore, the therapeutic targeting of TAMs has emerged as a new paradigm for immunotherapy of cancer. Herein, the review summarizes the origin, polarization, and function of TAMs in the progression of malignant diseases. The understanding of such knowledge leads to several distinct therapeutic strategies to manipulate TAMs to battle cancer, which include those to reduce TAM abundance, such as depleting TAMs or inhibiting their recruitment and differentiation, and those to harness or boost the anti-tumor activities of TAMs such as blocking phagocytosis checkpoints, inducing antibody-dependent cellular phagocytosis, and reprogramming TAM polarization. In addition, modulation of TAMs may reshape the tumor microenvironment and therefore synergize with other cancer therapeutics. Therefore, the rational combination of TAM-targeting therapeutics with conventional therapies including radiotherapy, chemotherapy, and other immunotherapies is also reviewed. Overall, targeting TAMs presents itself as a promising strategy to add to the growing repertoire of treatment approaches in the fight against cancer, and it is hopeful that these approaches currently being pioneered will serve to vastly improve patient outcomes and quality of life.

Relationality and online interpersonal research: Ethical, methodological and pragmatic extensions

The availability, affordability and usability of communication technologies have created new ways to conduct interpersonal qualitative research. Access to digital communications remains uneven, but the online environment provides an alternative, and at times a potentially preferable, research space. As Covid-19 has interrupted and disrupted the dominant assumption that qualitative research must be conducted in person, this paper outlines possibilities and reservations of online interpersonal methods. Though the standard ethical considerations of qualitative research hold true, we argue that these are necessary, but often inadequate, in the contexts of conducting online synchronous interpersonal research. Through centring relational and reflexive practice, we consider the associated pragmatic, methodological and ethical domains from feminist and virtual–material positional perspectives. Unpacking the complexities and possibilities of researching digital environments, we present six guiding principles to inform ethically responsive, methodologically robust and pragmatically feasible approaches to conducting online interpersonal qualitative research.