Stimulating development of innovative medicines in the European Union: does a new definition for unmet medical need add value?

The European Commission (EC) has proposed to redefine 'unmet medical need' to steer pharmaceutical innovation and link the definition to incentives and regulatory tools and procedures. A multistakeholder meeting of the Regulatory Science Network Netherlands (RSNN) discussed the impact of this proposal. Four principles were highlighted (flexibility, feasibility, fairness, and sensitivity to risk) that were not considered sufficiently addressed.

[A national network of molecular tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae: a pilot implementation experience in Brazil].

This study aimed to know the opinion of professionals participating in an experiment to implement a pilot for molecular tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae at the Brazilian Unified National Health System (SUS). The detection rate of C. trachomatis and/or N.

HIV in pregnant woman and children: Mother-to-child transmission of HIV in the Brazilian land border from 2010 to 2021.

Objective: The aim of the present study was to analyze the profile and trends of HIV mother-to-child transmission (MTCT) in the Brazilian land border strip (LBS).

Methods: This was a quantitative, ecological, and cross-sectional study using secondary data available in the information systems of the Brazilian Ministry of Health. All cases reported in the Notifiable Diseases Information System between 2010 and 2021 were studied.

Prioritizing a research agenda on built environments and physical activity: a twin panel Delphi consensus process with researchers and knowledge users.

Background: The growth of urban dwelling populations globally has led to rapid increases of research and policy initiatives addressing associations between the built environment and physical activity (PA). Given this rapid proliferation, it is important to identify priority areas and research questions for moving the field forward. The objective of this study was to identify and compare research priorities on the built environment and PA among researchers and knowledge users (e.

Subnational certification of elimination of mother-to-child transmission of HIV and/or syphilis: a Brazilian experience report.

Objective: to describe the subnational implementation process of the certification for elimination of mother-to-child transmission of HIV and/or syphilis, its main barriers, challenges and opportunities.

Methods: in 2022, indicators from the last full year for impact targets and the last two full years for process targets, available in national information systems, were evaluated; descriptive reports were analyzed and actions were acknowledged within four thematic axes, according to PAHO/WHO recommendations.

Results: 43 municipalities ≥ 100,000 inhabitants were certified, covering 24.

Perspectives and challenges for mother-to-child transmission of HIV, hepatitis B, and syphilis in Brazil.

Background: Eliminating mother-to-child transmission (MTCT) of HIV, hepatitis B, and syphilis is a challenge in Brazil. Many policies have been implemented since 1986, but important gaps remain. This study aimed to describe the trends of MTCT in Brazil and evaluate the gaps and perspectives in this scenario.

Scoping review of adult-oriented outdoor play publications in Canada.

Introduction: Since 2015, there has been growing interest in Canada and beyond on the benefits of outdoor play for physical, emotional, social and environmental health, wellbeing and development, for adults as well as children and youth.

Methods: This scoping review aims to answer the question, "How, and in what context, is adult-oriented outdoor play being studied in Canada?" We conducted an electronic search for peer-reviewed articles on outdoor play published in English or French after September 2015 by authors from Canadian institutions or about Canadian adults. The 224 retrieved articles were organized according to eight priorities: health, well-being and development; outdoor play environments; safety and outdoor play; cross-sectoral connections; equity, diversity and inclusion; professional development; Indigenous Peoples and land-based outdoor play; and COVID-19.

Scoping review of children's and youth's outdoor play publications in Canada.

Introduction: Since 2015, interest in the benefits of outdoor play for physical, emotional, social and environmental health, well-being and development has been growing in Canada and elsewhere.

Methods: This scoping review aims to answer the question, "How, and in what context, is children's and youth's outdoor play being studied in Canada?" Included were studies of any type on outdoor play published after September 2015 in English or French by authors from Canadian institutions or assessing Canadian children and/or youth. Articles retrieved from MEDLINE, CINAHL and Scopus by March 2021 were organized according to eight priority areas: health, well-being and development; outdoor play environments; safety and outdoor play; cross-sectoral connections; equity, diversity and inclusion; professional development; Indigenous Peoples and land-based outdoor play; and COVID-19.

Gestational and congenital syphilis across the international border in Brazil.

Background: Brazil lacks data from syphilis in its border areas. We aimed to describe the spatial and temporal distribution of acquired syphilis (AS), in pregnancy (SP) and congenital syphilis (CS) in Brazilian municipalities in the arches border contexts.

Methods: An ecological, cross-sectional study was conducted from 2010 to 2020.

Play, Learn, and Teach Outdoors-Network (PLaTO-Net): terminology, taxonomy, and ontology.

Background: A recent dialogue in the field of play, learn, and teach outdoors (referred to as "PLaTO" hereafter) demonstrated the need for developing harmonized and consensus-based terminology, taxonomy, and ontology for PLaTO. This is important as the field evolves and diversifies in its approaches, contents, and contexts over time and in different countries, cultures, and settings. Within this paper, we report the systematic and iterative processes undertaken to achieve this objective, which has built on the creation of the global PLaTO-Network (PLaTO-Net).

Regional differences in movement behaviours of children and youth during the second wave of the COVID-19 pandemic in Canada: follow-up from a national study.

Objectives: Public health restrictions varied by region during the COVID-19 pandemic and reduced opportunities for children to be physically active. The purpose of this study was to assess regional differences in movement behaviours of Canadian children and youth during the second wave of the COVID-19 pandemic.

Methods: A national sample of Canadian parents (n=1568; 58% women) of children and youth (5-17 years of age) completed an online survey.

Physical activity, diet, and weight loss in patients recruited from primary care settings: An update on obesity management interventions.

Background: Obesity and related comorbidities are the most common chronic conditions in North America where behavior modification including the adoption of physical activity (PA) and a healthful diet are primary treatment strategies. Patients are more likely to engage in behavior modification if encouraged by their physician; however, behavioral counseling in primary care rarely occurs due to lack of training and resources. A more effective method may be to refer patients from clinical settings to other health professionals.

Brazilian Protocol for Sexually Transmitted Infections, 2020: infections that cause genital ulcers.

Infections that cause genital ulcers are one of the themes comprising the Clinical Protocol and Therapeutic Guidelines for Comprehensive Care for People with Sexually Transmitted Infections, published by the Brazilian Ministry of Health in 2020. The Protocol and Guidelines have been developed based on scientific evidence and validated in discussions with specialists. This article addresses clinical genital ulcer syndrome caused by sexually transmitted infections and its most common etiological agents: Treponema pallidum (syphilis), herpes simplex virus-2 (genital herpes) and herpes simplex virus-1 (perioral herpes), Haemophilus ducreyi (chancroid), Chlamydia trachomatis serotypes L1, L2 and L3 (lymphogranuloma venereum), and Klebsiella granulomatis (donovanosis).

Brazilian Protocol for Sexually Transmitted Infections, 2020: infections that cause urethral discharge.

This article approaches infections that cause urethral discharge. This theme is part of the Clinical Protocol and Therapeutic Guidelines for Comprehensive Care for People with Sexually Transmitted Infections, published by the Ministry of Health of Brazil in 2020. These guidelines were prepared based on scientific evidence and validated in discussions with experts.

Brazilian Protocol for Sexually Transmitted Infections 2020: epidemiological surveillance.

This article summarizes the chapter on epidemiological surveillance of sexually transmitted infections (STI) that comprises the 2020 Clinical Protocol and Therapeutic Guidelines (PCDT) for Comprehensive Care for People with STI, published by the Health Surveillance Department of the Brazilian Ministry of Health. It presents some reflections on the new case definitions for surveillance of acquired syphilis, syphilis in pregnant women, and congenital syphilis. The 2020 PCDT-IST was elaborated grounded on scientific evidence and validated in discussions with specialists.

[Brazilian Protocol for Sexually Transmitted Infections 2020: infections that cause genital ulcers].

Infections that cause genital ulcers are one of the themes comprising the Clinical Protocol and Therapeutic Guidelines for Comprehensive Care for People with Sexually Transmitted Infections, published by the Brazilian Ministry of Health in 2020. The Protocol and Guidelines have been developed based on scientific evidence and validated in discussions with specialists. This article addresses clinical genital ulcer syndrome caused by sexually transmitted infections, and its most common etiological agents: Treponema pallidum (syphilis), herpes simplex virus-2 (genital herpes) and herpes simplex virus-1 (perioral herpes), Haemophilus ducreyi (chancroid), Chlamydia trachomatis serotypes L1, L2 and L3 (venereal lymphogranuloma), and Klebsiella granulomatis (donovanosis).

[Brazilian Protocol for Sexually Transmitted Infections 2020: infections that cause urethral discharge].

This article approach infections that cause urethral discharge, theme which is part of the Clinical Protocol and Therapeutic Guidelines for Comprehensive Care for People with Sexually Transmitted Infections, published by the Ministry of Health of Brazil in 2020. These guidelines were prepared based on scientific evidence and validated in discussions with experts. When urethritis is not treated correctly, or when the microorganism develops antimicrobial resistance, it can cause serious and even irreversible health damage.

[Brazilian Protocol for Sexually Transmitted Infections 2020: epidemiological surveillance].

This article summarizes the chapter on epidemiological surveillance of sexually transmitted infections (STI) that forms part of the Clinical Protocol and Treatment Guidelines (PDCT) for Comprehensive Care for People with STI 2020), published by the Health Surveillance Secretariat of the Ministry of Health of Brazil. It presents some reflections on the new case definitions for surveillance of acquired syphilis, syphilis in pregnant women and congenital syphilis. The PCDT-IST 2020 was developed based on scientific evidence and validated in discussions with specialists.

Regional differences in access to the outdoors and outdoor play of Canadian children and youth during the COVID-19 outbreak.

To reduce the spread of COVID-19, public health authorities across the country have recommended that Canadians keep their distance, wash their hands, and stay home. To enforce these measures, restrictions on outdoor behaviour have been implemented, limiting access to parks and recreational outdoor spaces. New evidence shows that COVID-19 restrictions are associated with an overall lower amount of time spent in outdoor play among Canadian children and youth.

Nonexercise Equations for Determining Change in Cardiorespiratory Fitness.

Purpose: This study aimed to determine whether change in estimated cardiorespiratory fitness (eCRF) is associated with change in measured cardiorespiratory fitness (mCRF) independent of exercise amount and intensity over 24 wk.

Methods: Participants were 163 sedentary adults with abdominal obesity (mean ± SD waist circumference, 109.9 ± 11.

Change in Submaximal Cardiorespiratory Fitness and All-Cause Mortality.

Objective: To evaluate the relationship between change in submaximal cardiorespiratory fitness (sCRF) and all-cause mortality risk in adult men and women.

Patients And Methods: A prospective study with at least 2 clinical visits (mean follow-up time, 4.2±3.

High-risk papillomavirus infection among women living with human Immunodeficiency virus: Brazilian multicentric study.

Cervical cancer is an important health issue in Latin America. Although HPV infections can have spontaneous clearance, persistence of high-risk (HR) HPV is a risk factor for cervical cancer among women and it is even higher in HIV-infected women. To determine the prevalence of HR-HPV and risk factors among HIV-infected women attending reference services for HIV/AIDS in different regions of Brazil.