Checklist to select contract Research Organization for early phase Bioavailability/Bioequivalence Clinical Studies in Healthy Adult Human Volunteers

Nowadays health agencies of regulated markets are becoming stringent regarding the bio-studies. So clinical/contract research organization (CRO) need to be selected carefully after their detailed assessment. As per requirement of bio-study CRO should be assessed with the study specific checklist of questions before awarding the bio-study. Questions related to various services of study like: Clinic phase, analytical phase, Pharmacokinetic and statistical phase, ethics approval, QA/QC, record handing etc. and related to CRO capabilities are discussed here with their relevance to conclude the abilities of CRO for successful execution of bio-study. Hence, this paper focuses all possible questions which need to be assessed before selection of CRO mainly for Bioavailability/Bioequivalence (BABE) study in healthy adult volunteers. Properly selected CRO will help for smooth execution of study and quality report and subsequently, hassle-free approval of dossier submitted to regulatory agency.

Physiological benefits of a honeydew-based functional food fortified with selected bioactive agents justified by trials

Honey is a consumer-preferred, highly esteemed natural product with a broad variety of distinct bioactive components. In recent days, the consumption of high-added-value, honey-based products are increasingly coming to the forefront of interest, and thus huge efforts are being made by researchers/developers to elaborate honey variants with fortified biological value. Relevant human clinical trials have scarcely been accomplished; thus, the biological impact of honey and its derivatives has not been thoroughly revealed. In this work, we present our experiments on the development of a novel honey-based prototype and its plausible physiological impacts certified via human clinical trials. The investigated product was a newly elaborated honeydew-based prototype fortified with pumpkin, sea buckthorn, and inulin, which was subjected to a 13-week-long, double-blind, placebo-controlled human clinical trial. The prototypes were applied to 20 adult volunteers to establish the complex impact of the newly developed product. Conclusions drawn at the end of the trial were based on results of blood tests taken at diverse phases of the study. The positive physiological effects of consumption of the investigated products are underpinned by the fact that no significant elevations have been measured in terms of the blood glucose level and parameters featuring long-term blood sugar levels. Slight decrease of both LDL and HDL cholesterol levels were also experienced.

Factors That Motivate Older Adults to Participate in Research: Typologies and Implications

A key challenge for scholars who study aging is identifying a pool of research volunteers willing to participate. Toolkits and strategies acknowledge the differences in recruitment needed for older adults relative to younger adults, but there is little information about variations among older adult research volunteers. Based on a community sample of older adults age 60+, this study evaluates differences across seven specific motivators across three broad categories: values/altruism, personal growth/improvement, and immediate gratification. We then identify and evaluate four typologies of older adult volunteers based on the combinations of motivations the older adults in our sample identify as important to participation in research studies. Based on these analyses, we describe how our results might inform recruitment and retention practices in aging studies. Further, we will discuss how these results will help shape our technology-based reminder system with a greater understanding of motivations.

The impact of the Caring Callers Program on Senior Companion Volunteers and Clients During the COVID-19 Pandemic

Purpose of the Study The purpose of this study was to examine the impact of the Caring Callers Program on older adults and volunteers. Our research team piloted this telephone reassurance program during the COVID-19 pandemic. In the Caring Callers Program, socially isolated older adults were paired with older adult volunteers from the Senior Companion Program (20 pairs). Methods In the Caring Callers Program, Senior Companion volunteers provided the clients with emotional support through a weekly phone call over the 12 weeks period (May through July 2020). Prior to the intervention implementation, the volunteers received a two-hour group-based training through a teleconference platform. Program outcomes were measured through quantitative and qualitative approaches. Results The clients (mean age=73.5) showed significantly increased overall self-rated health at post-test, compared to pre-test and they discussed social and emotional benefits. The clients were very satisfied with the program and indicated that the program met their expectations. Our individual, in-depth interviews with the volunteers (mean age=73.2) also revealed that the volunteers were able to develop their skills that are helpful for their Senior Companion volunteer activities and experience mutual benefits by spending their time more purposefully. Overall, our participants shared that they wanted to continue participating in the Caring Callers Program. Discussion We learned the importance of training not only for the volunteers but also for the clients, prior information on their pair, making sure of the volunteer-client fit, and benefits of using telephone particularly in this group of vulnerable older adults.

Who Volunteers? Results from a Regular Cognitive Monitoring Study

Previous research indicates volunteering promotes well-being of individuals and communities. Volunteering in later-life may buffer some of the negative health effects experienced during retirement, facilitating opportunities for older adults to engage in meaningful activities and stay active. The current study examined characteristics of older adults who volunteered outside of participation in a regular cognitive monitoring study. All 124 members (M= 76.87, SD= 7.47; 80 volunteers, 44 non-volunteers) of a regular cognitive monitoring study, requiring completion of a 15-minute cognitive online test once a month, with complete data on personal characteristics, volunteer activities, as well as study adherence and dropout rates were included. ANCOVA and logistic regression analyses adjusted for sociodemographic characteristics were used to assess differences between volunteers and non-volunteers. Results indicated that volunteers were less educated (p<.05), and slightly more likely to be younger and women compared to non-volunteers. There were no differences in cognitive performance (ps>.05). Volunteers had lower scores for neuroticism (p=.02) and were marginally higher agreeable and extraverted (ps<.09). Volunteers needed more reminders to complete the monthly test (ps<.01) but had lower dropout rates (p=.001). The most frequent type of volunteer activity reported was religious. Volunteers were motivated mainly by altruism, although most reported multiple reasons such as building social relationships and feeling important. Findings provide information about characteristics that can help identify older adults who are likely to volunteer. Results regarding study adherence may have implications for promoting recruitment and retention among older adult volunteers.

Motivations and Experiences of Older Adult Volunteers in a Telehealth Nursing Simulation Activity

The COVID-19 pandemic has posed challenges to safely engaging older adults in volunteer activities. This research explored a unique partnership between a Retired Senior and Volunteer Program (RSVP) and a school of nursing to administer a telehealth virtual simulation training for nurse practitioner students. Semi-structured interviews were carried out with nursing simulation coordinators and volunteers after the telehealth simulation exercise. The purpose of this research was to identify principles of successful virtual volunteer engagement for telehealth simulations. This initial pilot study encompassed debriefing interviews with volunteers (N = 3) and interviews with simulation coordinators (N = 2). Three major themes emerged within the response coding: 1) the benefits of virtual simulation volunteering, 2) technology as a facilitating factor and challenge, and 3) unique volunteer management considerations. Both volunteers and coordinators noted that volunteers derived positive emotional benefits and new insights from their participation. Coordinators discussed the “authenticity” factor that older adults brought to the simulation experience as a benefit to engaging older adult volunteers. Technology sub-themes included accessibility considerations, experience with the online format, and other logistical considerations in conducting telehealth simulation. Volunteer management sub-themes encompassed volunteer skills and motivations, the perceived successful aspects of training, and improvements for future simulations. Volunteers discussed an interest and connection to healthcare and education as a motivating factor for their participation in the telehealth simulation. This small scale pilot research will be expanded through future simulation activities to continue to identify principles of practice for engaging older adults in virtual volunteerism.

Challenges and benefits: Volunteerism among older adults during Covid-19

Social distancing restrictions and regulations, put in place to reduce the spread of COVID-19, disrupted the daily lives of active older adult volunteers. One year into the pandemic, we used a mixed-methods approach to explore how these regulations had impacted the quality of life, loneliness, and volunteer behavior of 26 older adults who were active volunteers (i.e., at least an hour a week) prior to the start of the pandemic. All the participants were white and non-Hispanic, and the majority were female (65.4%). The average age was 71, with a range from 53 to 87 years old. On average, participant scores on the UCLA loneliness scale (4.23 ±1.39) indicated a low amount of loneliness and high scores on the Brunnsviken Brief Quality of Life (BBQ) scale (83.54 ±10.97) indicated a high quality of life. Thematic findings from the interviews conveyed that, despite the challenges and risks associated with volunteering during a pandemic, participants valued volunteer work enough to make adjustments or seek out new volunteer activities. The research team identified two overarching themes related to participants' discussions of volunteering during the pandemic: Challenges and changes and Benefits of volunteering during a pandemic. Participants' discussions of how volunteer work changed and why they continued to or sought out new volunteer activities during a pandemic can guide organizations seeking to support or recruit older volunteers, particularly as the pandemic continues. These findings also provide further evidence of the important role that volunteerism can play in the well-being of older adults.

Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France

Due to their ease-of-use, lateral flow assay SARS-CoV-2 antigen-detecting rapid diagnostic tests could be suitable candidates for antigen-detecting rapid diagnostic self-test (Ag-RDST). We evaluated the practicability of the Ag-RDST BIOSYNEX Antigen Self-Test COVID-19 Ag+ (Biosynex Swiss SA, Freiburg, Switzerland), using self-collected nasal secretions from the turbinate medium (NMT), in 106 prospectively included adult volunteers living in Paris, France. The majority of the participants correctly understood the instructions for use (94.4%; 95% confidence interval (CI): 88.3–97.4), showing a great ability to perform the entire self-test procedure to obtain a valid and interpretable result (100%; 95% CI: 96.5–100), and demonstrated the ability to correctly interpret test results (96.2%; 95% CI: 94.2–97.5) with a high level of general satisfaction. About one in eight participants (# 15%) needed verbal help to perform or interpret the test, and only 3.8% of test results were misinterpreted. By reference to multiplex real-time RT-PCR, the Ag-RDST showed 90.9% and 100% sensitivity and specificity, respectively, and high agreement (98.1%), reliability (0.94), and accuracy (90.9%) to detect SARS-CoV-2 antigen. Taken together, our study demonstrates the high usability and accuracy of BIOSYNEX Antigen Self-Test COVID-19 Ag+ for supervised self-collected NMT sampling in an unselected adult population living in France.

Detection of Mental Stress through EEG Signal in Virtual Reality Environment

This paper investigates the use of an electroencephalogram (EEG) signal to classify a subject’s stress level while using virtual reality (VR). For this purpose, we designed an acquisition protocol based on alternating relaxing and stressful scenes in the form of a VR interactive simulation, accompanied by an EEG headset to monitor the subject’s psycho-physical condition. Relaxation scenes were developed based on scenarios created for psychotherapy treatment utilizing bilateral stimulation, while the Stroop test worked as a stressor. The experiment was conducted on a group of 28 healthy adult volunteers (office workers), participating in a VR session. Subjects’ EEG signal was continuously monitored using the EMOTIV EPOC Flex wireless EEG head cap system. After the session, volunteers were asked to re-fill questionnaires regarding the current stress level and mood. Then, we classified the stress level using a convolutional neural network (CNN) and compared the classification performance with conventional machine learning algorithms. The best results were obtained considering all brain waves (96.42%) with a multilayer perceptron (MLP) and Support Vector Machine (SVM) classifiers.