Patient-Centered Outcomes for GoStrong: A Self-Management Diabetes Program in Savannah, GA

Background: To advance the goal of health improvement for diverse populations with diabetes, a patient-centered approach is foundational. Methods: Innovative methods were used to initiate and advance an approach to diabetes engagement and self-management. We began with a strategy to understand how patients with diabetes view and interact with the disease via the medical community and moved to program development through patient-centered design and to the development of strategic partnerships and continuous learning from patients, stakeholders, and academic research partners. Results: The mean age of the participants in the GoStrong™ program (n=106) was 51 ±9.2 (SD) years. There were significant differences in the HbA1c levels over time compared to the Control group (n=100). The mean HbA1c level from baseline to 36 months decreased from 7.49% to 6.89%, with the largest decline (to 6.28%, p\u3c0.01) at 12 months. The mean HbA1c level for the control group increased from 8.38% to 8.49% from baseline to 36 months, with the largest increase (to 8.89%, p\u3c0.01) at 18 months. There were significant differences for total medical costs at 12 months prior to and 12 months after starting the GoStrong program, a difference in total prescription drug costs at 12 months, and differences within the total group in number of emergency room (ER) visits. Claims information showed that GoStrong produced significantly lower total medical costs and ER visits. There was also an increase in total prescription drug costs that may be due to better medication adherence. Conclusions: For diabetics, the GoStrong program results in reduced HbA1c levels, reduced costs, and reduced ER visits

Impact of a Prevention Bundle on Clostridium difficile Infection Rate in a Hospital in Southeastern US

We sought to assess the impact of a multicomponent prevention program on hospital-acquired Clostridium difficile infections in a hospital in the Southeastern United States. We collected retrospective data of 140 patients from years 2009-2014 and applied the Poisson regression model for analysis. We did not find any significant associations of increased risk of Clostridium difficile infections for the preintervention group. Further studies are needed to test multifaceted bundles in hospitals with high infection rates

Silent Risk of Tick-borne Diseases in Georgia, USA

Background: Vector-borne diseases, including tick-borne diseases (TBD) are on the rise in the USA and worldwide, possibly due in part to changes in climate and meteorological conditions. There have been few studies in the state of Georgia addressing the prevalence of TBD. The purpose of this study was to assess the contemporary risk of TBD exposure in a rural population in South-Eastern Georgia. Methods: A self-assessment survey of symptoms of recent exposure and knowledge of TBD was administered to 258 healthy individuals visiting a university health center. Blood was drawn and serological testing was performed using the indirect microimmunofluorescence (IFA) test and Rickettsia rickettsii antigen (RR-AG). Results: Of the 258 responders, 244 reported their participation in regular recreational activities potentially associated with tick exposure; however, only 11 individuals (4%) experienced a self-reported tick bite during the previous summer or fall. Most participants acknowledged their ability to recognize ticks, but only 48% (n=169) were able to correctly identify them when provided with pictures of a variety of arthropods. Similarly, only 38% and 18% of participants (n=257) were knowledgeable about proper practices of tick avoidance and prevention of tick bites, respectively. Fifty-six percent of the participants tested positive for IgG antibody reacting with RR-AG (titer of \u3e128, 64 as the positive cutoff). Conclusions: The assessment survey identified a significant knowledge gap regarding TBD among adults in Georgia. The significant level of TBD exposure we detected may affect the serological diagnosis of clinical rickettsial diseases in Georgia, USA because preexisting antibody may be interpreted as false positives. Continuous education about TBD is needed to improve awareness of the risks of exposure to ticks, to promote proper methods of tick protection and removal, and to disseminate current knowledge about these commonplace arthropods. Progra

Authors’ Response: Health Benefits/Hazards Associated with Companion Animal-Exposure Might be Endpoint- and Animal-Specific

This response was in regards to comments made in Pet Ownership and the Risk of Dying (Letter to the Editor) by Gillum, R. F. in High Blood Pressure and Cardiovascular Prevention

Pet Ownership and the Risk of Dying from Cardiovascular Disease Among Adults Without Major Chronic Medical Conditions

Introduction: In a recent statement, the American Heart Association stated “There are scant data on pet ownership and survival in people without established cardiovascular disease (CVD)”. This study sought to fill this gap. Methods: We analyzed nationally representative data of 3964 adults aged ≥50 who were free from major physical illnesses. Pet ownership was assessed at baseline between 1988 and 1994. Vital status was followed through December 31st 2006. Results: With dogs being most popular pets owned by 22.0 (standard error 0.34) % of the participants, 34.6 % of the study population owned a pet. Pet ownership was associated with low rates of CVD deaths [hazard ratio (HR) = 0.69 (95 % CI 0.45–1.07)] and stroke [0.54 (0.28–1.01)] at borderline significant levels among women. These associations were adjusted for physical activity and largely attributed to having a cat rather than a dog. Among cat owners, the HR of all CVD deaths was 0.62 (0.36–1.05) and the HR of dying from stroke was 0.22 (0.07–0.68) compared with non-cat owners. The corresponding HRs among dog owners were 0.82 (0.51–1.34) and 0.76 (0.34–1.71) respectively. No similar associations were observed among men. The hazard of dying from hypertension was not associated with pet ownership for both men and women. Conclusions: Owning a cat rather than a dog was significantly associated with a reduced hazard of dying from CVD events, in particular, stroke. The protection pets confer may not be from physical activities, but possibly due to personality of the pet owners or stress-relieving effects of animal companionship

Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

BackgroundWe aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.MethodsIn this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.FindingsBetween Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74-1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67-1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74-1·58]; BRII-196 plus BRII-198 1·00 [0·68-1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91-1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88-1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.InterpretationNeither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.FundingUS National Institutes of Health and Operation Warp Speed

Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19. In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978. Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50–72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74–1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67–1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74–1·58]; BRII-196 plus BRII-198 1·00 [0·68–1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91–1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88–1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90. Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19. US National Institutes of Health and Operation Warp Spee