Evaluation of the “safe multidisciplinary app-assisted remote patient-self-testing (SMART) model” for warfarin home management during the COVID-19 pandemic: study protocol of a multi-center randomized controlled trial

Background Warfarin treatment requires frequent monitoring of INR (international normalized ratio) to adjust dosage in a therapeutic range. In China, patients living in small towns usually go to tertiary hospitals to get warfarin monitoring and dosing, resulting in low frequencies of follow-ups and high incidence of complications. Influenced by the COVID-19 pandemic, patients on warfarin have further reduced their visits to healthcare institutions. While patient self-testing (PST) via using a point-of-care testing device for INR measuring at home has been widely used in developed countries and demonstrated improved clinical outcomes compared to usual care in clinics, it is rarely applied in developing countries, including China. This proposed study will develop and assess the “Safe Multidisciplinary App-assisted Remote patient-self-Testing (SMART) model” for warfarin home management in China during the COVID-19 pandemic. Methods This is a multi-center randomized controlled trial. We will carry out the study in three county hospitals, three small tertiary hospitals and three large tertiary hospitals with anticoagulation clinics in Hunan province of China. Eligible patients will be randomly assigned to the SMART model group (n = 360) or the control group (usual care clinic group, n = 360; anticoagulation clinic group, n = 120). Patients in the SMART model group do PST at home once every two to 4 weeks. Controls receive usual care in the clinics. All the patients will be followed up through outpatient clinics, phone call or online interviews at the 3rd, 6th, 9th and 12th month. The percentage of time in therapeutic range (TTR), incidence of warfarin associated major bleeding and thromboembolic events and costs will be compared between the SMART model group and control groups. Discussion Patients in the SMART model group would show improved TTR, lower incidence of complications and better quality of life compared to the control groups. Our design, implementation and usage of the SMART model will provide experience and evidence in developing a novel model for chronic disease management to solve the problem of healthcare service maldistribution, an issue particularly obvious in developing countries during the COVID-19 pandemic. Trial registration ChiCTR, ChiCTR 2000038984. Registered 11 October, 2020.

The team leader coaching programme (TLCP) – a programme to implement team coaching in rehabilitation clinics – a feasibility study

Purpose Team coaching is a promising way to advance a shift from the classical leader to a coach who leads his/her interprofessional colleagues. It is acknowledged as an effective instrument to reinforce leaders’ roles but is rarely used in the health-care sector. This paper aims to present the team leader coaching programme (TLCP), designed to strengthen team leaders by implementing coaching tools into their work routine. Design/methodology/approach The TLCP was designed based on the evaluated intervention on patient-centred team development, an expert workshop and a literature search. It addresses leadership styles, self-reflection, role clarity, attitude, moderation techniques and coaching tools with a focus on systemic questions. It was implemented as a train-the-trainer concept, in two training groups including 27 participants from 12 clinics (“multi-clinic” group) and another in-house training group (“single-clinic” group) including 15 participants from one clinic. Findings There were differences in the evaluation of the training between the group that received an inhouse training (“single-clinic” group) and the group that received a workshop in a group of professions from different clinics (“multi-clinic” group) with a tendency for a more positive evaluation by the “multi-clinic” group. Originality/value The TLCP is a promising programme to potentially improve teamwork in rehabilitation clinics, as it provides team leaders with coaching tools they can use in their work routine without being dependent on external coaches. It is characterized by a reflective stance, which seems to be highly necessary to optimally fulfil the role of a team leader.

A - 04 Sociocultural and Health Equity Barriers Influencing Time to Clinic Following Sports-Related Concussion

Objective Given the strong association between time to specialty concussion clinic and recovery, the purpose of this study was to examine sociocultural factors influencing time to clinic. Methods 1001 participants ages 8–18 (M = 14, SD = 2.2) with SRC were seen in a specialty concussion clinic. Groups were divided into early (within 7 days of injury) and delayed (8–20 days) to clinic. Sociocultural factors including race, insurance category of private vs. non-private (i.e., Medicaid and CHIP), and their intersectionality were examined to determine potential differences in access. Results There was a significant difference between insurance category X2(1) =41.37, p < 0.001 and days to clinic, 34.7% of those with non-private insurance compared to 15.7% with private insurance were in the delayed to clinic group. There was a significant difference in insurance category by race X2(6) =253.28, p < 0.001, with Hispanic (60.8%) and Black (50.3%) patients being more likely to have non-private insurance compared to just (9.4%) of White participants. There was a significant difference in days to clinic by race X2(6) =40.02, p < 0.001, with 34.8% of Hispanic and 25.9% of Black participants compared to 14.5% of White participants being in the delayed to clinic group. White males with private insurance on average got to clinic faster (M = 3.78, SD = 3.94) than minority females with non-private insurance (M = 9.04, 4.94). Conclusions Even though early access to a specialty concussion clinic is associated with faster recovery times, there are glaring disparities regarding health equity and whom is getting to clinic early. Further research is needed to help determine ways to minimize these barriers.

Fasting Plasma GLP-1 Is Associated With Overweight/Obesity and Cardiometabolic Risk Factors in Children and Adolescents

Context The importance of fasting glucagon-like peptide-1 (GLP-1) in altered metabolic outcomes has been questioned. Objective This work aimed to assess whether fasting GLP-1 differs in children and adolescents with overweight/obesity compared to a population-based reference, and whether concentrations predict cardiometabolic risk (CMR) factors. Methods Analyses were based on The Danish Childhood Obesity Data- and Biobank, a cross-sectional study including children and adolescents, aged 6 to 19 years, from an obesity clinic group (n = 1978) and from a population-based group (n = 2334). Fasting concentrations of plasma total GLP-1 and quantitative CMR factors were assessed. The effects of GLP-1 as a predictor of CMR risk outcomes were examined by multiple linear and logistic regression modeling. Results The obesity clinic group had higher fasting GLP-1 concentrations (median 3.3 pmol/L; interquartile range, 2.3-4.3 pmol/L) than the population-based group (2.8 pmol/L; interquartile range, 2.1-3.8 pmol/L; P < 2.2E-16). Body mass index SD score (SDS), waist circumference, and total body fat percentage were significant predictors of fasting GLP-1 concentrations in boys and girls. Fasting GLP-1 concentrations were positively associated with homeostasis model assessment of insulin resistance, fasting values of insulin, high-sensitivity C-reactive protein, C-peptide, triglycerides, alanine transaminase (ALT), glycated hemoglobin A1c, and SDS of diastolic and systolic blood pressure. A 1-SD increase in fasting GLP-1 was associated with an increased risk of insulin resistance (odds ratio [OR] 1.59), dyslipidemia (OR 1.16), increased ALT (OR 1.14), hyperglycemia (OR 1.12) and hypertension (OR 1.12). Conclusion Overweight/obesity in children and adolescents is associated with increased fasting plasma total GLP-1 concentrations, which was predictive of higher CMR factors.

Functional Mobility Outcomes in Telehealth and In-Person Assessments for Wheeled Mobility Devices

The purpose of this study was to compare telehealth and in-person service delivery models for wheeled mobility devices in terms of functional outcomes. We hypothesized that clinically significant improvements in functional mobility measured by the Functional Mobility Assessment (FMA) will occur in individuals receiving both telehealth and in-person clinic evaluations. A total of 27 Veterans receiving telehealth visits were compared to 27 individuals seen in clinic, selected from a database, matching for age, gender, and primary diagnosis. All mean individual item and total FMA scores in both groups increased from Time 1 to Time 2. Within the telehealth group, all changes in individual item and total FMA scores were statistically significant, with changes in 8 of 10 items meeting threshold for clinical significance (change >1.85 points). Within the clinic group, changes in 7 of 10 individual items and total FMA scores were statistically significant, and these same 7 items met threshold for clinical significance. Change scores for individual item and total FMA scores did not differ significantly between the two groups. A larger and clinically significant change in transfer score was seen in the telehealth group, suggesting telehealth visits may confer an advantage in being able to assess and address transfer issues in the home.

Factors Affecting Job Satisfaction and Its Effect on Employee Resignation in the Mulia Health and Dental Care (MHDC) Clinic Group

This study wants to find out whether compensation, job safety, career paths, communication, relationships with superiors, and work-life balance affect job satisfaction, and how they affect employee resignation. From a population of 100 employees, a total of 73 people were sampled. The results show that compensation and work-life balance have a significant effect on job satisfaction and resignation, while relations with superiors have a significant effect on job satisfaction, and communication has a significant effect on resignation through job satisfaction.

Clinical Application of Confidence Interval for Monitoring Changes in Tumor Markers to Determine the Responsiveness to Cancer Treatment

Background: Tumor markers are used to monitor disease progression and determine the responsiveness to cancer treatment. However, there are no standardized criteria for monitoring serial tumor marker measurements. Herein, we have developed our own monitoring system for interpreting changes in tumor markers using overlapping 95% confidence intervals (CIs) to determine whether the changes are significant.Methods: Two-year data, including 117,289 results for 11 tumor markers in our laboratory, were analyzed. The distributions of absolutely delta% and cut-off values for certain percentiles were calculated. CI ranges for each tumor marker were set based on biological variation, and data were analyzed for each patient assessed at health check-ups and clinics, individually and overall.Results: Most tumor markers had low indices of individuality, with between inter-individual variability. The 95th percentile cut-offs for each tumor marker were much higher in the health check-up group than in the clinic group. In decreasing order, the percentages of results with no overlap in 95% CIs were thyroglobulin antigen, 14.9%; protein induced by vitamin K absence-II (PIVKA), 11.9%; prostate-specific antigen, 9.8%; and cancer antigen 72-4, 8.7%. After correction using the reference interval, the percentages decreased to less than 5%, except for PIVKA (10.9%).Conclusions: We suggest that our own monitoring system can serve as a criterion for delta check and auto-verification of tumor markers. Further studies are required to validate and demonstrate this concept in real clinical situations using actual clinical data reflecting disease progression in cancer patients and responsiveness to cancer treatment.

Clinical Application of Confidence Interval for Monitoring Changes in Tumor Markers to Determine the Responsiveness to Cancer Treatment

Background: Tumor markers are used to monitor disease progression and determine the responsiveness to cancer treatment. However, there are no standardized criteria for monitoring serial tumor marker measurements. Herein, we have developed our own monitoring system for interpreting changes in tumor markers using overlapping 95% confidence intervals (CIs) to determine whether the changes are significant.Methods: Two-year data, including 117,289 results for 11 tumor markers in our laboratory, were analyzed. The distributions of absolutely delta% and cut-off values for certain percentiles were calculated. CI ranges for each tumor marker were set based on biological variation, and data were analyzed for each patient assessed at health check-ups and clinics, individually and overall.Results: Most tumor markers had low indices of individuality, with between inter-individual variability. The 95th percentile cut-offs for each tumor marker were much higher in the health check-up group than in the clinic group. In decreasing order, the percentages of results with no overlap in 95% CIs were thyroglobulin antigen, 14.9%; protein induced by vitamin K absence-II (PIVKA), 11.9%; prostate-specific antigen, 9.8%; and cancer antigen 72-4, 8.7%. After correction using the reference interval, the percentages decreased to less than 5%, except for PIVKA (10.9%).Conclusions: We suggest that our own monitoring system can serve as a criterion for delta check and auto-verification of tumor markers. Further studies are required to validate and demonstrate this concept in real clinical situations using actual clinical data reflecting disease progression in cancer patients and responsiveness to cancer treatment.

Renal Volume in ADPKD Patient Evaluation

The clinical manifestations of ADPKD are related to the growth of renal cysts. Renal volume has been recognised as the biomarker that is able to identify those patients at risk of complications (hypertension and haematuria) and at risk of progression to End Stage Renal Disease (ESRD). Recently, several scores have been introduced to predict the evolution of ADPKD. The Mayo Clinic Group developed a classification based on renal volume as measured by CT or MRI and corrected for age and height (Ht-TKV); this allowed predicting the evolution of the disease, but it has not been fully validated so far. In addition, it is used to identify patients labelled as “fast progressors” and eligible for Tolvaptan therapy according to the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) recommendations. We studied 80 patients who underwent MRI and had been classified as ADPKD typical form (class 1A-1E). A significant correlation between renal volume, hypertension, and low GFR was found (p<0.005). A progressive increase in disease severity has been found across the different Mayo classes; 41.2% were eligible for Tolvaptan therapy. The results demonstrate that the Mayo method is easy to perform and provides valid information in order to identify with rapidly progressing disease.

Complex Wound Healing Outcomes for Outpatients Receiving Care via Telemedicine, Home Health, or Wound Clinic: A Randomized Controlled Trial

Use of telemedicine has expanded rapidly in recent years, yet there are few comparative studies to determine its effectiveness in wound care. To provide experimental data in the field of telemedicine with regard to wound care, a pilot project named “Domoplaies” was publicly funded in France in 2011. A randomized, controlled trial was performed to measure the outcomes of patients with complex wounds who received home wound care from a local clinician guided by an off-site wound care expert via telemedicine, versus patients who received in-home or wound clinic visits with wound care professionals. The publicly funded network of nurses and physicians highly experienced in wound healing was used to provide wound care recommendations via telemedicine for the study. The healing rate at 6 months was slightly better for patients who received wound care via telemedicine (61/89; 68.5%) versus wound care professional at home (38/59; 64.4%) versus wound care clinic (22/35; 62.9%), but the difference was not significant ( P = .860833). The average time to healing for the 121/183 wounds that healed within 6 months was 66.8 ± 32.8 days for the telemedicine group, 69.3 ± 26.7 for the wound care professional at home group, and 55.8 ± 25.0 days for the wound care clinic group. Transportation costs for the telemedicine and home health care groups were significantly lower than the wound clinic group, and death rate was similar between all the 3 groups ( P < .01). Telemedicine performed by wound healing clinicians working in a network setting offered a safe option to remotely manage comorbid, complex wound care patients with reduced mobility.