Virtual visits to optimize research trial offerings to heart failure patients.

Background: Clinical trials are crucial for development of new treatments that impact outcomes. Assessments used in heart failure trials include the 6-minute hallway walk test (6MWT) and timed up and go test (TUG). Objectives: We hypothesized that 6MWT and TUG performed virtually would be feasible and comparable to in-person functionality testing for heart failure patients. Methods: This pilot study explored the use of virtual visits to collect functional information on patients living with heart failure. Patients were enrolled in an outpatient setting. Informed consent was obtained. Baseline testing consisted of patient-reported New York Hospital Association class, quality-of-life surveys (EQ-5D-5L, Kansas City Cardiomyopathy Questionnaire [KCCQ], Frailty Index for Elders), and cognitive assessments (Mini-Cog). Patients also completed an in-person TUG and 6MWT at baseline. Patients were issued supplies to set up TUG/6MWT courses at home. Follow-up video visits occurred 7 days and 14 days (± 3 days) postbaseline. Surveys (EQ-5D-5L, KCCQ, Frailty Index), TUG, and 6MWT were completed. Study staff reviewed 6MWT/TUG course set-up for accuracy and supervised patients during testing. Results: Of the 94 patients enrolled, 74 patients completed all 6MWT assessments. One-way repeated measures ANOVA found no statistical difference between mean in-person and virtual 6MWT (P = .45). One-way repeated measures ANOVA found a statistical difference between mean TUG scores (P = .03). Patients were comfortable with the use of virtual visits (56%), would participate in research studies through telemedicine (98.7%), and found completing a virtual research visit to be not difficult (77.3%). Conclusion: Virtual administration of the 6MWT was shown to be feasible and acceptable to heart failure patients as compared to in-person functionality testing. This approach could be implemented into clinical care pathways for evaluation of heart failure patients, as well as adopted by industry-sponsored and investigator-initiated research studies in heart failure cohorts for data collection.

Effect of High-Dose Zinc and Ascorbic Acid Supplementation vs Usual Care on Symptom Length and Reduction Among Ambulatory Patients With SARS-CoV-2 Infection: The COVID A to Z Randomized Clinical Trial.

Importance: There is limited evidence regarding early treatment of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to mitigate symptom progression. Objective: To examine whether high-dose zinc and/or high-dose ascorbic acid reduce the severity or duration of symptoms compared with usual care among ambulatory patients with SARS-CoV-2 infection. Design, Setting, and Participants: This multicenter, single health system randomized clinical factorial open-label trial enrolled 214 adult patients with a diagnosis of SARS-CoV-2 infection confirmed with a polymerase chain reaction assay who received outpatient care in sites in Ohio and Florida. The trial was conducted from April 27, 2020, to October 14, 2020. Intervention: Patients were randomized in a 1:1:1:1 allocation ratio to receive either 10 days of zinc gluconate (50 mg), ascorbic acid (8000 mg), both agents, or standard of care. Outcomes: The primary end point was the number of days required to reach a 50% reduction in symptoms, including severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point scale for each symptom). Secondary end points included days required to reach a total symptom severity score of 0, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed medications, and adverse effects of the study supplements. Results: A total of 214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132 (61.7%) women. The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary end point. Patients who received usual care without supplementation achieved a 50% reduction in symptoms at a mean (SD) of 6.7 (4.4) days compared with 5.5 (3.7) days for the ascorbic acid group, 5.9 (4.9) days for the zinc gluconate group, and 5.5 (3.4) days for the group receiving both (overall P = .45). There was no significant difference in secondary outcomes among the treatment groups. Conclusions and Relevance: In this randomized clinical trial of ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms compared with standard of care. Trial Registration: ClinicalTrials.gov Identifier: NCT04342728.

Accuracy of commercially available heart rate monitors in athletes: a prospective study.

Endurance athletes, particularly competitive runners, are using wrist worn devices with the heart rate (HR) feature to guide their training. However, few studies have assessed the effectiveness of these at high levels of exertion. The purpose of this study was to measure the accuracy of the HR monitor feature in four watches at six different treadmill speeds. This prospective study recruited 50 healthy, athletic adults (68% male, mean age of 29, and mean BMI of 23 kg/m2). All subjects wore a three lead ECG and Polar H7 chest strap monitor and two different randomly assigned wrist worn HR monitors. These included the Apple Watch III, Fitbit Iconic, Garmin Vivosmart HR, and Tom Tom Spark 3. Once all devices were on, they were asked to run at the following speeds on a treadmill (in mph): 4, 5, 6, 7, 8, and 9 for two min. HR was assessed on all devices and agreement among measurements determined with Lin's concordance correlation coefficient (CCC) (rc). The Polar H7 chest strap had the greatest agreement with the ECG (rc=98). This was followed by the Apple Watch III (rc=96). The Fitbit Iconic, Garmin Vivosmart HR, and Tom Tom Spark 3 all had the same level of agreement (rc=89). The Polar H7 chest strap was the most accurate, and the Apple Watch was superior among watches. For endurance athletes and their coaches, a chest strap device or Apple Watch may be the best choice for guiding workouts and performance.

Supportive periodontal therapy for high- and low-risk patients.

AIM: The validity of the risk assessment in predicting tooth loss due to periodontitis or disease progression was explored. METHODS: Systemic factors, smoking status, bleeding on probing (BoP) percentage, number of residual pockets (probing pocket depth ≥6 mm), tooth loss, and alveolar bone loss in relation to age were the variables of the risk assessment. Based on an improving or deteriorating risk assessment in 2005 compared with 1999, 89 patients were divided into either a high- or low-risk group. Findings were compared with the 2008 outcome. RESULTS: Using BoP≤20% as the cut-off, the relationship between BoP and interleukin-1 genotype status was neither significant in 2005 nor in 2008. Neither the high- nor low-risk group was predictive for tooth loss. Patients displayed similar proportions of probing pocket depths ≥6mm in 2005 and in 2008. Linear stepwise regression analysis demonstrated that only the number of supportive periodontal therapy visits explained the number of teeth lost due to periodontitis (P<0.01). CONCLUSIONS: The categorization of patients into high- and low-risk groups, according to the periodontal risk assessment model applied within a supportive periodontal therapy period of 3 years, had limitations in predicting future tooth loss.

Effects of diabetes mellitus on periodontal and peri-implant conditions: update on associations and risks.

OBJECTIVES: To review the evidence for the association between diabetes and periodontal and peri-implant conditions and the impact of periodontal therapy in subjects with diabetes. MATERIAL AND METHODS: A search of MEDLINE-PubMed was performed up to and including December 2007. The search was limited to clinical studies published in English. Publications on animal studies were excluded. The selection criteria included all levels of available evidence. RESULTS: Evidence on the association between diabetes and periodontitis supports the concept of increased severity but not extent of periodontitis in subjects with poorly controlled diabetes. Subjects with controlled diabetes do not show an increase in extent and severity of periodontitis. Periodontitis is associated with poor glycaemic control and diabetes-related complications. It is inconclusive that periodontal therapy with or without the use of antibiotics results in improvements of glycaemic control and of markers of systemic inflammation. Evidence is lacking to indicate that implant therapy in subjects with diabetes yields long-term outcomes comparable with those of non-diabetic subjects. CONCLUSIONS: Poorly controlled diabetes may be considered a risk factor for increased severity of periodontitis. The effects of periodontal therapy on glycaemic control and systemic inflammation is not proven beyond doubt and need to be confirmed in large-scale randomized-controlled clinical trials.