The coronavirus disease 2019 (COVID-19) outbreak has had a profoundly negative impact on people all over the world, particularly those with disabilities such as autism. However, there are gaps in research understanding the impact of COVID-19 on this population and the support required.

 To explore the evidence available on the impact of the COVID-19 pandemic on caregivers of children with autism.

 A scoping review methodology using the Arksey and O'Malley framework was employed. Five electronic databases from March 2020 to December 2022 were reviewed. Two thousand two hundred and six articles were retrieved with primary search terms: caregivers (population), autism (diagnosis) and COVID-19 (context). Following the screening of titles, abstracts and articles, 36 articles were included in the final review. Thematic and content qualitative analysis was completed.

 Preferred reporting items for systematic reviews and meta-analyses extension for scoping reviews (PRISMA-ScR) guided the reporting of the findings. Three main themes were identified: (1) caregiver's mental health and wellbeing, (2) response to remote health care and support and (3) caregiver resilience.

 The pandemic affected children with autism and their families regarding changes in routine, difficulties with support and emotional states. However, little research has been conducted on the impact in upper-middle-income countries such as South Africa.Contribution: The findings from this review carry practical implications that extend beyond the pandemic, such as political instability or natural disasters that may present similar stressors for children with autism and their families.

Background: Societal changes during the COVID-19 pandemic may affect children's health behaviors and exacerbate disparities. This study aimed to describe children's health behaviors during the COVID-19 pandemic, how they vary by sociodemographic characteristics, and the extent to which parent coping strategies mitigate the impact of pandemic-related financial strain on these behaviors. Methods: This study used pooled data from 50 cohorts in the Environmental influences on Child Health Outcomes Program. Children or parent proxies reported sociodemographic characteristics, health behaviors, and parent coping strategies. Results: Of 3315 children aged 3-17 years, 49% were female and 57% were non-Hispanic white. Children of parents who reported food access as a source of stress were 35% less likely to engage in a higher level of physical activity. Children of parents who changed their work schedule to care for their children had 82 fewer min/day of screen time and 13 more min/day of sleep compared with children of parents who maintained their schedule. Parents changing their work schedule were also associated with a 31% lower odds of the child consuming sugar-sweetened beverages. Conclusions: Parents experiencing pandemic-related financial strain may need additional support to promote healthy behaviors. Understanding how changes in parent work schedules support shorter screen time and longer sleep duration can inform future interventions.

The SARS-CoV2 global pandemic impacted participants in the Alzheimer's Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) clinical trial, who faced three stressors: 1) fear of developing dementia; 2) concerns about missing treatment; and 3) risk of SARS-CoV2 infection.

To describe the frequency of psychological disorders among the participants of the API ADAD Colombia clinical study, treated by a holistic mental health team during the COVID-19 pandemic. The extent of use of mental health team services was explored considering different risk factors, and users and non-users of these services were compared.

Participants had free and optional access to psychology and psychiatry services, outside of the study protocol. Descriptive statistics was used to analyze the frequency of the mental health difficulties. A multivariable logistic regression model has been used to assess associations with using this program.

66 participants were treated by the Mental Health Team from March 1, 2020, to December 31, 2020. Before and after the start of the pandemic, the most common psychological problems were anxiety (36.4% before, 63.6% after) and depression (34.8% before, 37.9% after). 70% of users assisted by psychology and 81.6% of those assisted by psychiatry felt that the services were useful for them. Female sex, depression, and anxiety before the pandemic were positively associated with being assisted by either psychology or psychiatry, while the association with hyperlipidemia was negative.

A holistic mental health program, carried out in the context of a study, could mitigate psychopathology during pandemics such as COVID-19.

Owing to the infectious nature of COVID-19, alternative solutions, such as electronic informed consent (eIC), needed to be implemented to inform research participants about study-related information and to obtain their consent. This study aimed to investigate stakeholders' experiences with alternative consenting methods as well as their views on any regulatory or legal guidelines for eIC implementation in clinical research. Results may serve as the cornerstone to rethink the informed consent process in clinical research.

This study consisted of an online survey among three stakeholder groups across European Union (EU) Member States and the United Kingdom. The stakeholder groups included (i) investigators, (ii) data protection officers (DPOs) or legal experts working in the pharmaceutical industry, academia, and academic biobanks, and (iii) ethics committee (EC) members. Data collection occurred between April and December 2021. The data collected were analyzed using descriptive and inferential statistics.

The online survey was completed by 191 respondents, of whom 52% were investigators. Respondents were active in 24 out of the 27 EU Member States and the United Kingdom. The majority of each stakeholder group considered validated electronic methods moderately or extremely useful to re-consent previously enrolled research participants upon study amendments or to obtain consent from COVID-19 patients. Nevertheless, this exploratory survey identified that only 13% of DPOs/legal experts, 26% of investigators, and 41% of EC members had experience with eIC. In addition, results suggest that the legal acceptance of eIC across EU Member States and the United Kingdom is variable and that a definition of eIC, issued by national law or policy, is rarely available. The results also showed that the COVID-19 pandemic brought additional challenges to inform participants and to obtain their consent; for example, related to travel restrictions.

A number of alternative consenting methods were recommended, for example by the European Medicines Agency, to ensure clinical study continuation during the COVID-19 pandemic. Although stakeholders support the use of eIC in clinical research, it seems that the experience with eIC is low. To harmonize eIC practices as much as possible, further investments in multi-stakeholder, multi-national guidance are needed.

Despite gaps in knowledge, long-term sequelae of coronavirus disease 2019 (COVID-19) infections are globally acknowledged and thus require special attention by public health organizations and services. Therefore, it is necessary to support and promote public health initiatives that address long-term disability due to COVID-19.

To investigate the impact of COVID-19 social distancing on medical research from the perspective of postgraduate students.

A cross-sectional study using an online survey was conducted from October 31 to November 1, 2021. A questionnaire was used to assess the impact of COVID-19 social distancing on medical research among postgraduate students. The questionnaire included basic information, medical research information, and information about social distancing measures. Participants also completed the self-made Research Work Affected Scale of Postgraduates (RWAS-P; qualitative evaluation: very mildly 0-10; mildly 11-20; moderately 21-30; severely 31-40; very severely 41-50). Logistic regression was used to identify factors related to the impact of COVID-19 social distancing.

A total of 468 participants were analyzed; 95.2% of the participants adhered to social distancing measures. The median total RWAS-P score was 22. The median RWAS-P scores for earlier research data, current research projects, future research plans, paper publication, and graduation schedule were 2, 6, 6, 6, and 4, respectively (score range 0-10). The higher grade of students, experimental research, and existence of inappetence or sleeplessness were related to negative attitude towards COVID-19 social distancing (odd ratio = 6.35, 9.80, 2.31, 2.15, 1.95, respectively).

Participants reported that social distancing had a moderate overall impact on their medical research. Social distancing had the greatest impact on current research projects, future research plans, and paper publications among postgraduate students. Higher grade level, experimental research type, inappetence, and sleeplessness were related to the impact of social distancing on their medical research.

The COVID-19 pandemic has imposed a great challenge on health research because of the pressing need to respond promptly and effectively to this crisis situation. It is important to offer a high level perspective of the main barriers and facilitators found when conducting health science studies during the COVID-19 crisis and to discuss the research initiatives suggested by global, regional or local health research authorities.

A systematic scoping review was carried out. A literature search was conducted in the Medline, Cochrane Library, Lilacs and Google Scholar databases. Original research studies, review and opinion articles and editorials available in full text published in Spanish, English or Portuguese between January 2020 and May 2021 were included. Two authors working independently selected the papers and collected the data. The barriers and facilitators identified were described and organized in four categories according to the literature: sociocultural, administrative, organizational and methodological. Official documents and communications from global, regional and local health and research authorities were also included. Results are presented in narrative and table form.

Overall, 26 documents were selected for data analysis and synthesis. The barriers most frequently mentioned in the literature include issues with access to participants, ethics committees paperwork, biological risk for the researchers, and lack of inter and intra-institutional coordination. On the other hand, the facilitators identified include the adoption of on-line solutions, cooperative work among research actors, and a more flexible informed consent process. Regarding the initiatives disseminated by health and research authorities, four strategies were identified: prioritization of research questions, cooperation and inclusion promotion, fight against infodemia, and strengthening of the methodological quality of the studies.

Continued cooperation and interoperability among institutions, countries and disciplines to facilitate future research processes is a challenge in the context of the pandemic; similarly, it is now important to maintain open science and funding of cooperative studies when other priorities emerge. Likewise, there is an evident need to develop and sustain efficient information management systems to help with decision-making. Ongoing review of the effects of the pandemic on health research practice is needed in order to gain comprehensive insights of what we need to learn as a society from this crisis.

Coronavirus disease 2019 (COVID-19) affects all components of the respiratory system, including the neuromuscular breathing apparatus, conducting and respiratory airways, pulmonary vascular endothelium, and pulmonary blood flow. In contrast to other respiratory viruses, children have less severe symptoms when infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A minority of children experience a post-infectious inflammatory syndrome, the pathology and long-term outcomes of which are poorly understood. The reason for the lower burden of symptomatic disease in children is not yet clear, but several pathophysiological characteristics are postulated. The SARS-CoV-2 pandemic has brought distinct challenges to the care of children globally. Proper recommendations have been proposed for a range of non-asthmatic respiratory disorders in children, including primary ciliary dyskinesia and cystic fibrosis. These recommendations involve the continuation of the treatment during this period and ways to maintain stability. School closures, loss of follow-up visit attendance, and loss of other protective systems for children are the indirect outcomes of measures to mitigate the COVID-19 pandemic. Moreover, COVID-19 has reshaped the delivery of respiratory care in children, with non-urgent and elective procedures being postponed, and distancing imperatives have led to rapid scaling of telemedicine. The pandemic has seen an unprecedented reorientation in clinical trial research towards COVID-19 and a disruption in other trials worldwide, which will have long-lasting effects on medical science. In this narrative review, we sought to outline the most recent findings on the direct and indirect effects of SARS-CoV-2 pandemic on pediatric respiratory chronic diseases other than asthma, by critically revising the most recent literature on the subject.

The current coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to a serious global health crisis. Increasing evidence suggests that elderly individuals with underlying chronic diseases, including Parkinson's disease (PD), are particularly vulnerable to this infection. Changes in the routine care of PD patients should be implemented carefully without affecting the quality provided. The utilization of telemedicine for clinical consultation, assessment and rehabilitation has also been widely recommended. Therefore, the aim of this review is to provide recommendations in the management of PD during the pandemic as well as in the early phase of vaccination programs to highlight the potential sequelae and future perspectives of vaccination and further research in PD. Even though a year has passed since COVID- 19 emerged, most of us are still facing great challenges in providing a continuum of care to patients with chronic neurological disorders. However, we should regard this health crisis as an opportunity to change our routine approach in managing PD patients and learn more about the impact of SARS-CoV-2. Hopefully, PD patients can be vaccinated promptly, and more detailed research related to PD in COVID-19 can still be carried out.

SARS-CoV-2 entry into host cells relies on the spike (S) protein binding to the human ACE2 receptor. In this study, we investigated the structural dynamics of the viral S protein at the fusion peptide (FP) domain and small molecule binding for therapeutics development. Following comparative modeling analysis and docking studies of our previously identified fusion inhibitor chlorcyclizine, we performed a pharmacophore-based virtual screen and identified two novel chemotypes of entry inhibitors targeting the FP. The compounds were evaluated in the pseudoparticle viral entry assay and SARS-CoV-2 cytopathic effect assay and showed single-digital micromole inhibition against SARS-CoV-2 as well as SARS-CoV-1 and MERS. The characterization of the FP binding site of SARS-CoV-2 S protein provides a promising target for the structure-based development of small molecule entry inhibitors as drug candidates for the treatment of COVID-19.

The coronavirus disease-2019 (COVID-19) pandemic has changed the conduct of clinical trials. For studies with physical function and physical activity outcomes that require in-person participation, thoughtful approaches in transitioning to the remote research environment are critical. Here, we share our experiences in transitioning from in-person to remote assessments of physical function and activity during the pandemic and highlight key considerations for success. Details on the development of the remote assessment protocol, integration of a two-way video platform, and implementation of remote assessments are addressed. In particular, procedural challenges and considerations in transitioning and conducting remote assessments will be discussed in terms of efforts to maintain participant safety, maximize study efficiency, and sustain trial integrity. Plans for triangulation and analysis are also discussed. Although the role of telehealth platforms and research activities in remote settings are still growing, our experiences suggest that adopting remote assessment strategies are useful and convenient in assessing study outcomes during, and possibly even beyond, the current pandemic. Trial register and number: ClinicalTrials.gov [NCT03728257].

The coronavirus disease 2019 pandemic has caused a breakdown in the healthcare system worldwide. The need to rapidly update guidelines in order to control the transmission in the population and for evidenced-based healthcare care has led to the need for timely, voluminous and valid research. Amid the quest for a vaccine and better therapies, researchers clamouring for information has led to a wide variety of ethical issues due to the unique situation. This paper aims to examine the positive and negative aspects of recent changes in the process of obtaining informed consent. The article outlines the various aspects, from history, previously described exemptions to consenting as well as those implemented during the pandemic and the current impact of virtual methods. Further, the authors make recommendations based on the outcome of suggested adjustments described in the literature. This article looks into increasing the awareness of physicians and researchers about ethical issues that need to be addressed to provide optimal care for patients while assuring their integrity and confidentiality.

The development and production of novel vaccine to prevent COVID-19 is an international imperative to human lives. For that purpose, clinical trials have to be carried out as per international ethical standards. The current study was undertaken to examine the willingness to participate in COVID-19 vaccine clinical trials and to determine factors that might affect their decision to participate.

A cross-sectional survey study was carried out among the public in Jordan. During the study period, a convenience sample of adults (aged 18 years or above) were asked to participate via an online self-administered survey that was designed to evaluate the willingness to participate in COVID-19 vaccine clinical trials and to determine factors affecting their decision to participate.

Results showed that, among participants (n=1,287), 36.1% reported to be willing to participate in clinical trials of the vaccine. Additionally, a lower percentage (18.1%) were willing to allow their children to participate. Motivators that encourage participation were the desire to return to normal life (73.2%), followed by the desire to help in finding a treatment for COVID-19 infection (68.1%). Barriers towards the participation were not wanting to be challenged by the virus (54.7%), fear (40.7%), lack of time (40.4%), and mistrust in pharmaceutical companies (38.9%). Finally, results showed that higher educational level was associated with lower willingness to participate (P=0.001), whereas having a previous participation in clinical studies is associated with a significantly higher willingness to participate in COVID-19 vaccine clinical trials (P<0.001).

A good portion of Jordanians are positive regarding participation in clinical studies of COVID-19 vaccine. Educational level and previous participation in clinical studies were among the determinants of such willingness. In addition, fear and lack of time were among the barriers of participation.