Ethics and clinical research: How can the Ethics Committees (CPPs) and Committees for Research Ethics (CER) evolve?

In line with the spirit of the Giens workshops, this article reports on the recommended evolution of the Ethics Committees (CPPs) and the Committees for Research Ethics (CER) in France. These committees play a crucial role in the ethical evaluation of clinical research projects, a process that has become more complex, particularly in view of recent legislative, regulatory and methodological developments. This reflection highlights the current challenges faced by the CPPs, including the increasing workload, the complexity of the issues to be addressed and the need for better use of their resources.

Artificial intelligence integration in the drug lifecycle and in regulatory science: policy implications, challenges and opportunities.

Artificial intelligence tools promise transformative impacts in drug development. Regulatory agencies face challenges in integrating AI while ensuring reliability and safety in clinical trial approvals, drug marketing authorizations, and post-market surveillance. Incorporating these technologies into the existing regulatory framework and agency practices poses notable challenges, particularly in evaluating the data and models employed for these purposes.

[Can environmental impact be considered as a dimension of the proper use of medicines? From the 5th Forum of the Association for the Proper Use of Medicines].

Through their footprint throughout their life cycle, from production to use, medicines have a significant impact on the environment. Reducing this impact is rarely considered from the perspective of the choices that healthcare professionals might have to make when prescribing or dispensing medicines. Should we consider environmental impact, alongside effectiveness and tolerance, one of the dimensions of the proper use of medicines? To address this question, the 5th Forum of the Association for the Proper Use of Medicines highlighted the main sources of pharmaceutical pollution: the carbon footprint linked to production, greenhouse gas emissions, the impact of residues on water and waste from packaging.

Remote Delivery of Allied and Behavioral Healthcare During COVID-19 for Children With Developmental Disabilities.

Objective: Many children with autism spectrum disorder (ASD) and other developmental disabilities (DD) transitioned to telehealth services due to the COVID-19 pandemic. Our objectives were to describe reductions in allied and behavioral healthcare services and receipt of caregiver training to deliver services at home because of COVID-19 for children with ASD and other DD, and factors associated with worse response to remote delivery of services for children with ASD.

Method: Prior to the pandemic, children 2 to 5 years of age were enrolled in a multi-site case-control study and completed a developmental assessment.

Health and Education Services During the COVID-19 Pandemic Among Young Children with Autism Spectrum Disorder and Other Developmental Disabilities.

Objective: Understanding how the COVID-19 pandemic affected children with disabilities is essential for future public health emergencies. We compared children with autism spectrum disorder (ASD) with those with another developmental disability (DD) and from the general population (POP) regarding (1) missed or delayed appointments for regular health/dental services, immunizations, and specialty services; (2) reasons for difficulty accessing care; and (3) use of remote learning and school supports.

Method: Caregivers of children previously enrolled in the Study to Explore Early Development, a case-control study of children with ASD implemented during 2017 to 2020, were recontacted during January-June 2021 to learn about services during March-December 2020.

Lessons learned: COVID-19 vaccinations and people with disabilities.

This manuscript is being submitted as a Commentary; Abstract not applicable.

Breastfeeding by Disability Status in the United States: Pregnancy Risk Assessment Monitoring System, 2018-2020.

To describe breastfeeding initiation and breastfeeding at 1, 2, and 3 months, and information sources on breastfeeding among women with a recent live birth by disability status. We analyzed October 2018 to December 2020 data from the Pregnancy Risk Assessment Monitoring System for 24 sites in the United States that included the Washington Group Short Set of Questions on Disability (seeing, hearing, walking or climbing stairs, remembering or concentrating, self-care, communicating). We defined disability as reporting "a lot of difficulty" or "cannot do this at all" on any of these questions.

Alcohol Use, Screening, and Brief Intervention Among Pregnant Persons - 24 U.S. Jurisdictions, 2017 and 2019.

Alcohol use during pregnancy is a major preventable cause of adverse alcohol-related outcomes, including birth defects and developmental disabilities.* Alcohol screening and brief intervention (ASBI) is an evidence-based primary care tool that has been shown to prevent or reduce alcohol consumption during pregnancy; interventions have resulted in an increase in the proportion of pregnant women reporting abstinence (odds ratio = 2.26; 95% CI = 1.

Severity of Coronavirus Disease 2019 Hospitalization Outcomes and Patient Disposition Differ by Disability Status and Disability Type.

Background: Systemic inequities may place people with disabilities at higher risk of severe coronavirus disease 2019 (COVID-19) illness or lower likelihood to be discharged home after hospitalization. We examined whether severity of COVID-19 hospitalization outcomes and disposition differ by disability status and disability type.

Methods: In a retrospective analysis of April 2020-November 2021 hospital-based administrative data among 745 375 people hospitalized with COVID-19 from 866 US hospitals, people with disabilities (n = 120 360) were identified via ICD-10-CM codes.

COVID-19 Cases and Hospitalizations Among Medicare Beneficiaries With and Without Disabilities - United States, January 1, 2020-November 20, 2021.

Approximately 27% of adults in the United States live with a disability,* some of whom qualify for Medicare benefits. Persons with disabilities are at increased risk for severe COVID-19-associated outcomes compared with the general population (1); however, existing studies have limited generalizability or only pertain to a specific disability (e.g.

Mental Health and Substance Use Among Adults with Disabilities During the COVID-19 Pandemic - United States, February-March 2021.

Adults with disabilities, a group including >25% of U.S. adults (1), experience higher levels of mental health and substance use conditions and lower treatment rates than do adults without disabilities* (2,3).

Self-reported handwashing and surface disinfection behaviors by U.S. adults with disabilities to prevent COVID-19, Spring 2020.

Background: Handwashing and surface cleaning and disinfection are two hygiene behaviors promoted to prevent the spread of COVID-19. Persons with disabilities may be at increased risk for severe COVID-19 illness due to underlying medical conditions that have been associated with COVID-19.

Objective: This study aims to describe self-reported hygiene behaviors among U.

Delay or Avoidance of Medical Care Because of COVID-19-Related Concerns - United States, June 2020.

Temporary disruptions in routine and nonemergency medical care access and delivery have been observed during periods of considerable community transmission of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). However, medical care delay or avoidance might increase morbidity and mortality risk associated with treatable and preventable health conditions and might contribute to reported excess deaths directly or indirectly related to COVID-19 (2). To assess delay or avoidance of urgent or emergency and routine medical care because of concerns about COVID-19, a web-based survey was administered by Qualtrics, LLC, during June 24-30, 2020, to a nationwide representative sample of U.

Acceptability and perception of the herpes zoster vaccine in the 65 and over population: A French observational study.

The aim of the study was to evaluate the acceptability and to describe the perception of vaccination against herpes zoster (HZ) for outpatients and hospitalized patients in Lyon, France, aged 65 years and over. An observational study was based on a questionnaire completed from a face-to-face interview from January 2018 to March 2019. Volunteer outpatients who attended private medical laboratories or who were hospitalized in the geriatric department, or who were at the ambulatory medical clinic for a consultation were asked to participate.

[The human resource: cornerstone of the digital transformation of the healthcare plan].

The e-track, a real challenge for caregivers. We have known for more than twenty years that in order to "defragment" healthcare plan, break down the barriers between the city and the hospital and improve coordination between healthcare professionals, a better flow and sharing of information is essential. We are now talking about a digital shift in the light of accelerating technical progress with the rapid adoption of smartphones and mobile applications, and now the themes of big data and artificial intelligence, which are very present in the media.

Disability and Pregnancy: A Cross-Federal Agency Collaboration to Collect Population-Based Data About Experiences Around the Time of Pregnancy.

Many reproductive-aged women with a disability can achieve successful healthy pregnancies; however, they may face challenges accessing prenatal and postpartum care and finding providers who are knowledgeable about their specific condition. Depending on the nature of the disability, some women may also be at increased risk for adverse maternal and infant outcomes such as pre-eclampsia, infection, anemia, primary cesarean delivery, or preterm birth. Population-based data are needed to better understand the pregnancy and postpartum experiences of women living with disability.

Purification and characterization of a novel high molecular weight alkaline protease produced by an endophytic Bacillus halotolerans strain CT2.

A protease-producing strain CT2 isolated from Tunisian potatoes, exhibiting a potent protease activity (prot CT2), was identified as Bacillus halotolerans according to 16S ribosomal DNA sequence analysis. Maximum prot CT2 production was obtained in medium supplemented with bean seed proteins. Proteolytic activity was purified by ammonium sulphate precipitation, Sephacryl S-200 gel filtration and SP-sepharose cation-exchange chromatography.

The effects of joint disease, inhibitors and other complications on health-related quality of life among males with severe haemophilia A in the United States.

Introduction: Health-related quality of life (HRQoL) is reduced among persons with haemophilia. Little is known about how HRQoL varies with complications of haemophilia such as inhibitors and joint disease. Estimates of preference-based HRQoL measures are needed to model the cost-effectiveness of prevention strategies.

[Not Available].

A NON-SUSTAINABLE BREAKTHROUGH?: The arrival of new immunotherapy anticancer drugs on the market marks a turning point. Their reference prices are fixed in the US and are positioned at the same level that the anticancer targeted therapies. They benefit from an accelerated approval process and often obtain the status of orphan drugs.

Providing young women with credible health information about bleeding disorders.

Background: Approximately 1% of U.S. women may have an undiagnosed bleeding disorder, which can diminish quality of life and lead to life-threatening complications during menstruation, childbirth, and surgery.

Pertussis vaccination coverage among adults in the Lyon area.

Background: The compliance with recommendations for Pertussis vaccination was assessed in the Lyon population through vaccination coverage (VC).

Methods: A cross-sectional study was conducted in collaboration with 10 private biological analysis laboratories between October 2010 and March 2012, on 1930 adults (>19 years of age) from the Lyon area. Proof of vaccination (PV) was requested to prove the current vaccination status.

Understanding and improving health education among first-time parents of infants with sickle cell anemia in Alabama: a mixed methods approach.

With the increase in access to medical information, parents can acquire health information from multiple sources. An understanding of parents' reactions to a newborn infant's diagnosis of sickle cell anemia and how they acquire knowledge can identify parent beliefs and preferences about the process of sickle cell education. This study utilized a sequential exploratory mixed methods design.