How much did it cost to develop and implement an eHealth intervention for a minority children population that overlapped with the COVID-19 pandemic?

BACKGROUND: eHealth interventions using active video games (AVGs) offer an alternative method to help children exercise, especially during a pandemic where options are limited. There is limited data on costs associated with developing and implementing such interventions. OBJECTIVES: We quantified the costs of delivering an eHealth RCT intervention among minority children during COVID-19. METHODS: We categorized the total trial cost into five subcategories: intervention material development, advertising and recruitment, intervention delivery, personnel salaries, and COVID-19-related equipment costs. RESULTS: The total RCT cost was $1,927,807 (Direct: $1,227,903; Indirect: $699,904) with three visits required for each participant. The average cost per participant completing the RCT (79 participants/237 visits) was $24,403 (Direct: $15,543; Indirect: $8860). Due to no-shows and cancellations (198 visits) and dropouts before study completion (61 visits; 56 participants), 496 visits had to be scheduled to ensure complete data collection on 79 participants. If all 496 visits were from participants completing the three-visit protocol, that would correspond to 165 participants, bringing the average cost per participant down to $11,684 (Direct: $7442; Indirect: $4242). Of the subcategories, intervention material development accounted for the largest portion, followed by personnel salaries. While the direct COVID-19-specific cost constituted <1% of the entire budget, the indirect effects were much larger and significantly impacted the trial. CONCLUSION: RCTs typically involve significant resources, even more so during a pandemic. Future eHealth intervention investigators should budget and plan accordingly to prepare for unexpected costs such as recruitment challenges to increase flexibility while maximizing the intervention efficacy.

The impact of narratives and active video games on long-term moderate-to-vigorous physical activity: A randomized controlled trial protocol.

BACKGROUND: Although physical activity (PA) has been shown in helping prevent and treat obesity, current PA interventions are still not effective in ameliorating the obesity epidemic. Additional forms of PA need to be investigated to improve PA engagement and outcomes. We hypothesize that pairing a narrative (i.e., story) with an active video game (AVG), a less traditional form of PA, will increase participant engagement in PA. This paper presents the rationale, implementation, and pilot results of a study assessing the effect of narrative's impact on PA and a series of other health outcomes. OBJECTIVE: This paper presents the rationale, implementation, and pilot results of a study assessing the effect of narrative's impact on PA and a series of other health outcomes. METHODS/DESIGN: The Active Video Game Study is a six-month randomized controlled single-blind trial projected to include 210 participants. The intervention strategy will pair a narrative to an active video game (AVG). Participants will be randomized into 3 groups: condition A [Narrative + AVG], condition B [AVG Only], and condition C [Control]. Participants will undergo three in-person data collection visits over the course of six months. Inclusion criteria are that children are between the ages of 8-12 and have a BMI ≥ 85%. The primary outcome is change in moderate to vigorous physical activity (MVPA). Secondary outcome measures include change in BMI percentile, fasting insulin and glucose, lipid panel, C-reactive protein, and cognitive function. A pilot trial of n = 6 was conducted to help develop procedures and address problems that could arise in the main trial. DISCUSSION: Successful completion of this study will provide the empirical basis for novel intervention and design strategies to enhance the impact of AVGs on long-term MVPA.

Propuesta para la creación de la unidad de farmacovigilancia de la empresa socialista para la producción de medicamentos biológicos (ESPROMED BIO) CA / Proposal for the creation of the pharmacovigilance unit of the socialist company for the production of biological medicines (ESPOMED BIO) CA

En Venezuela la producción de vacunas contra el tétanos y contra la difteria, tétanos y tosferina (DPT) se realizaba en el área de producción del Instituto Nacional de Higiene "Rafael Rangel" (INHRR), y con la construcción de la Empresa Socialista Para la Producción de Medicamentos Biológicos - ESPROMED BIO, C.A, se formularán las mismas vacunas antes mencionadas con nueva tecnología y adicionalmente las vacuna pentavalente y la vacuna antirrábica humana serán acondicionadas, por lo tanto se plantea la necesidad de crear una Unidad de Farmacovigilancia, que recolecte, registre y reporte los ESAVIS, para cumplir con las normativas nacionales y las recomendaciones internacionales, es por ello que esta investigación tiene como objetivo general, diseñar una propuesta para la creación de una Unidad de Farmacovigilancia, según la Norma Venezolana de Buenas Prácticas de Farmacovigilancia (2010). Se trata de una investigación enmarcada en la línea de Propuesta Basada en la Aplicación de Normas Regulatorias en la Industria Farmacéutica, con un diseño transversal, descriptiva, documental en modalidad tipo Proyecto Factible. Los resultados y conclusiones obtenidos en la investigación para la Propuesta de Creación de la Unidad de Farmacovigilancia presentada en esta investigación, pretende solucionar de manera práctica el problema planteado, cumplir con las normativas legales nacionales como las Buenas Prácticas de Farmacovigilancia, y adicionalmente los lineamientos establecidos por la Organización Mundial de la Salud (OMS), ya que en un futuro se plantea certificar la ESPROMED BIO, C.A, por la OMS como laboratorio productor nacional de vacunas.

In Venezuela the production of vaccines against tetanus and diphtheria, tetanus and pertussis (DPT) was carried out in the production area of the National Hygiene Institute "Rafael Rangel" (INHRR), and the construction of Socialist Company for the Production of Biological Drugs - ESPROMED BIO, CA, the same vaccines mentioned above with new technology, the pentavalent vaccine and human rabies vaccine will be formulated, therefore it requires a Pharmacovigilance Unit, to collect, record AEFI and report to comply with national regulations and international recommendations, which is why this research has the general objective to design a proposal for the creation of a Pharmacovigilance Unit, according to the Venezuelan Standard Good Pharmacovigilance Practices (2010 ). It is a research under the line of pharmacovigilance, transversal, descriptive documentary mode type Feasible Project. The results and conclusions obtained from the research and the proposed creation of the Pharmacovigilance Unit presented in this research aims to solve the problem posed practical, comply with national legal requirements as Good Pharmacovigilance Practices and additionally with the guidelines established by the World Health Organization (WHO), and that in the future arises certify ESPROMED BIO, CA, by WHO as producer national laboratory