Change in Pediatric Health Care Spending and Drug Utilization during the COVID-19 Pandemic

Objective: To evaluate how the restrictive measures implemented during the SARS-CoV-2 pandemic have influenced the incidence of the most common children’s diseases and the consumption of medications in 2020 compared to 2019. Methods: We involved all family pediatricians of the local health authority of Latina, from which we requested data of monthly visits in 2019 and 2020 for six common diseases disseminated through droplets and contact, and the territorial and integrative pharmaceutical unit of the area, from which we requested data of the net expenditure regarding the most commonly used drugs at pediatric age. Results: There was significant reduction in the incidence of the evaluated diseases and in the consumption of investigated drugs between 2019 and 2020 in the months when the restrictive measures were in place, with an attenuation of this effect during the months of the gradual loosening of those measures. Conclusion: Nonpharmaceutical intervention measures have caused changes in the diffusion of common pediatric diseases. We believe that the implementation of a reasonable containment strategy, even outside of the pandemic, could positively influence the epidemiology of infectious and allergic diseases in children, and healthcare system spending.

SARS-CoV-2 Infection in Patients on Dialysis: Incidence and Outcomes in the Lazio Region, Italy

Patients with end-stage kidney disease represent a frail population and might be at higher risk of SARS-CoV-2 infection. The Lazio Regional Dialysis and Transplant Registry collected information on dialysis patients with a positive swab. The study investigated incidence of SARS-CoV-2 infection, mortality and their potential associated factors in patients undergoing maintenance hemodialysis (MHD) in the Lazio region. Method: The occurrence of infection was assessed among MHD patients included in the RRDTL from 1 March to 30 November 2020. The adjusted cumulative incidence of infection and mortality risk within 30 days of infection onset were estimated. Logistic and Cox regression models were applied to identify factors associated with infection and mortality, respectively. Results: The MHD cohort counted 4942 patients; 256 (5.2%) had COVID-19. The adjusted cumulative incidence was 5.1%. Factors associated with infection included: being born abroad, educational level, cystic renal disease/familial nephropathy, vascular disease and being treated in a dialysis center located in Local Health Authority (LHA) Rome 2. Among infected patients, 59 (23.0%) died within 30 days; the adjusted mortality risk was 21.0%. Factors associated with 30-day mortality included: age, malnutrition and fever at the time of swab. Conclusions: Factors associated with infection seem to reflect socioeconomic conditions. Factors associated with mortality, in addition to age, are related to clinical characteristics and symptoms at the time of swab.

Efficacy Trial for a Smartphone Game to Prevent HIV among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19 (Preprint)

BACKGROUND Adolescent girls contribute about a quarter of all new HIV infections in sub-Saharan Africa. There is a need for more effective intervention approaches to help young adolescents safely navigate through adolescence and into adulthood. We are assessing the efficacy of Tumaini, a smartphone game designed to prevent HIV among young Africans. Against the background of COVID-19, meaningful alteration of the research protocol was necessary to ensure successful implementation, and retention of the study participants in ongoing research. OBJECTIVE The objective of our protocol is to: (1) determine if Tumaini delays sexual debut and increases condom use at first sex, and (2) determine whether it influences behavioral mediators of early and unprotected sex. METHODS Participants were recruited from Kisumu County, in Western Kenya. This study is a two-arm, individual-randomized controlled trial that enrolled 1,004 adolescents aged between 12 and 15 years. The intervention arm participants are playing Tumaini, while the control arm are provided with Brainilis, a commercially available control game. The study period will last 45 months. At baseline, participants in both arms completed a baseline survey and biological testing for HIV and HSV-2; participants will have annual gameplay sessions in years 1-3. They will also complete a total of 12 follow-up surveys. At endline, repeat biological testing will be conducted. Protocol adaptations were necessitated by the COVID-19 pandemic and implemented in accordance with local public health guidelines. RESULTS Participants were enrolled between October 2020 and November 2020. We plan to complete study procedures in September 2024. Enrolled participant sample was 50.1% female (n=499) and had a mean age of 14.0 years (SD=0.6 years). CONCLUSIONS This ongoing research demonstrates that with appropriate revisions to planned protocol activities guided by the need to maintain study integrity, protect both study participants and staff, and adherence to IRB and local health authority guidelines, human subject research is possible in the context of a global pandemic. If the trial demonstrates efficacy, Tumaini would provide an alternative, remote means of delivering age-appropriate education to pre-adolescents on safer sex, HIV prevention and effective life skills on a highly scalable, low cost and culturally adaptable platform. CLINICALTRIAL ClinicalTrials.gov (NCT04437667).

Organizational Change in Public Service

This study aims to investigate institutional logics underlying the initiation of change management process in public sector organisations. Organisational Institutionalism is used to frame the analysis. The study took place in three different public organisations in the Province of East Java, including one-stop-service for licencing as well as that of vehicle registration, taxing and insurance and also from local health authority. Qualitative method was employed to analyse information gathered through semi-structured interviews with 35 respondents. The study unveiled various institutional logics underlying the adoption of changes and innovation in the organisations. It ranged from the most common reason of improving performance gaps up to the needs to clean the organisation’s name and build a better image. The study contributes to the idea that organisation’s previous experiences as well as perceived institutional character affect the needs to conduct changes.

SARS-CoV-2 Infection in Fully Vaccinated Individuals of Old Age Strongly Boosts the Humoral Immune Response

Prophylactic vaccination against SARS-CoV-2 is one of the most important measures to contain the COVID-19 pandemic. Recently, break-through infections following vaccination against this virus have been reported. Here, we describe the humoral immune response of break-through infections in fully vaccinated individuals of old age from an outbreak in a nursing home. In cooperation with the local health authority, blood samples from fully vaccinated and infected as well as fully vaccinated and uninfected residents of the nursing home were collected 4 weeks after the onset of the outbreak. The humoral immune response was determined in a neutralisation assay with replication-competent virus isolates and by a quantitative ELISA. In this outbreak a total of 23 residents and four health care workers were tested positive for SARS-CoV-2. Four residents were unvaccinated, including one with a severe course of disease who later severe disease course who later succumbed to infection. Despite their old age, all vaccinated residents showed no or only mild disease. Comparison of the humoral immune response revealed significantly higher antibody levels in fully vaccinated infected individuals compared to fully vaccinated uninfected individuals (p < 0.001). Notably, although only a minority of the vaccinated uninfected group showed neutralisation capacity against SARS-CoV-2, all vaccinated and infected individuals showed high-titre neutralisation of SARS-CoV-2 including the alpha and beta variant. Large SARS-CoV-2 outbreaks can occur in fully vaccinated populations, but seem to associate with mild disease. SARS-CoV-2 infection in fully vaccinated individuals is a strong booster of the humoral immune response providing enhanced neutralisation capacity against immune evasion variants.

Development of a web platform for COVID-19 integrated care: an experience from an Italian Region

Issue After the announcement of Public Health Emergency of International Concern about COVID19 by WHO, health authorities need to implement strategies to face the emergency. These responses included early diagnosis, patient isolation, quarantine and symptomatic monitoring of contacts. In this context, integrated care and telemedicine are the best instruments for COVID management. Description of the problem The COVID19 epidemic needs a real time integration of epidemiological, clinical and laboratoristic data, in order to better manage patients and to improve public health surveillance. Based on a tool previosly used by GPs for flu vaccination and diabetes integrated care, the Local Health Authority of Pescara, Abruzzo Region, Italy, developed a web-based platform (QuickwebConnect), accessible to public health practitioners (PHP), GPs, infectious diseases physicians and laboratories, in order to integrate information about COVID19 patients. This platform contain individual-level information on patients with laboratory-confirmed COVID19, symptoms, reported onset dates, and basic demographics. Information are in real time accessible to all actors involved in the process. In addition, GPs can use this tool to directly book diagnostic tests for symptomatic or suspected patients. Results With the use of this platform, the management of pandemic emergency was improved, allowing direct management of epidemic data both at person and population level. The real time evaluation of clinical and epidemiological data improved patients care, clinical survellance of COVID19 contacts and development of tailored preventive measure in areas with high incidence. Lessons COVID19 patients care need to be quick, needing the integrate support of different actors. In addition, public health actions have to be supported by strong data. The use of a cost-effective web platform allow physician and PHP to better manage patiens and develope focused interventions. Key messages Integrated care and telemedicine are best instruments for COVID management. The real time evaluation of data aimed to develop tailored preventive measure.

THE “UNIT DISEASE”: AN ORGANIZATIONAL MODEL TO PROMOTE AND ENHANCE THE RESEARCH ACTIVITY AT THE PUBLIC HOSPITAL AND THE LOCAL HEALTH AUTHORITY IN ALESSANDRIA

Objective: to promote and enhance the research activity at the Public Hospital and the Local Health Authority in Alessandria, the translation of results into clinical practice, excellence and constant growth in the medical, health and administrative area, through the creation of research-oriented project groups.Methodology: the system development methodology refers to the Lean Thinking, and in particular to the X-Matrix, a framework in management studies to support the strategy definition and management process.Results: 14 project groups named “disease unit” were created, with own referents and components, planned and timed actions related to specific thematic areas. Members cooperated to increase scientific productivity, to promote the activation of clinical studies, the participation in funding national and European calls, the integration into international and European research networks and collaboration with universities, hospitals and IRCCS.Conclusions: the institution and coordination of the unit disease increased scientific production, supporting the collaboration and integration between the Public Hospital and the Local Health Authority with the University of Eastern Piedmont on the themes of research, innovation, experimentation and training, in relation to the way towards the IRCCS recognition.

SARS-CoV-2 infection in fully vaccinated individuals of old age strongly boosters the humoral immune response

Introduction: Prophylactic vaccination against SARS-CoV-2 is one of the most important measures to contain the COVID-19 pandemic. Recently, break-through infections following vaccination against this virus have been reported. Here, we describe the humoral immune response of break-through infections in fully vaccinated individuals of old age from an outbreak in a nursery home. Methods: In cooperation with the local health authority, blood samples from fully vaccinated and infected as well as fully vaccinated and uninfected residents of the nursery home were collected four weeks after the onset of the outbreak. The humoral immune response was determined in a neutralisation assay with replication-competent virus isolates and by a quantitative ELISA. Results: In this outbreak a total of 23 residents and four health care workers were tested positive for SARS-CoV-2. Four residents were unvaccinated, including one with a severe course of disease who later deceased. Despite their old age, all vaccinated residents showed no or only mild disease. Comparison of the humoral immune response revealed significantly higher antibody levels in fully vaccinated infected individuals compared to fully vaccinated uninfected individuals (p<0.001). Notably, although only a minority of the vaccinated uninfected group showed neutralisation capacity against SARS-CoV-2, all vaccinated and infected individuals showed high-titer neutralisation of SARS-CoV-2 including the alpha and beta variant. Discussion: Large SARS-CoV-2 outbreaks can occur in fully vaccinated populations, but seem to associate with mild disease. SARS-CoV-2 infection in fully vaccinated individuals is a strong booster of the humoral immune response providing enhanced neutralisation capacity against immune evasion variants.