Implementation Challenges for a Multisite Advance Care Planning Pragmatic Trial: Lessons Learned.

BACKGROUND/PROBLEM: Advance care planning (ACP) pragmatic trials are needed. PROPOSED SOLUTION: We determined key system-level activities to implement ACP interventions for a cluster-randomized pragmatic trial. We identified patients with serious illness from 50 primary care clinics across three University of California health systems using a validated algorithm. If patients lacked documented ACP within the last 3 years, they were eligible for an intervention: (Arm 1) an advance directive (AD); (Arm 2) AD + PREPAREforYourCare.org; (Arm 3) AD + PREPARE + lay health navigator outreach. Triggered by an appointment, we mailed and sent interventions through automated electronic health record (EHR) messaging. We collaborated with patients/caregivers, clinicians, payors, and national/health system leader advisors. We are currently finalizing 24 months follow-up data. OUTCOMES/METHODS: We used the Consolidated Framework for Implementation Research (CFIR) and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) frameworks to track secular trends and implementation efforts. KEY MESSAGE/RESULTS: Required multisite, system-level activities: 1) obtaining leadership, legal/privacy, and EHR approvals; 2) standardizing ACP documentation; 3) providing clinician education; 3) validating an automated serious illness identification algorithm; 4) standardizing ACP messaging with input from over 100 key advisors; 5) monitoring secular trends (e.g., COVID); and 6) standardizing ACP workflows (e.g., scanned ADs). Of 8707 patients with serious illness, 6883 were eligible for an intervention. Across all arms, 99% received the mailed intervention, 78.3% had an active patient portal (64.2% opened intervention), and 90.5% of arm three patients (n = 2243) received navigator outreach. LESSONS LEARNED: Implementing a multisite health system-wide ACP program and pragmatic trial, with automated EHR-based cohort identification and intervention delivery, requires a high level of multidisciplinary key advisor engagement, standardization, and monitoring. These activities provide guidance for the implementation of other large-scale, population-based ACP efforts.

Effectiveness of BBIBP-CorV vaccine in preventing SARS-CoV2 infection and severe outcomes in people living with multiple sclerosis: A population-based study.

BACKGROUND: The objective of the present study was to estimate the effectiveness of the BBIBP-CorV vaccine (VE) in preventing SARS-CoV-2 infection, related hospitalization, and death among people living with multiple sclerosis (PLWMS). METHODS: In this population-based retrospective observational study, data on all PLWMS, vaccination, SARS-CoV-2 tests, hospitalization, and deaths were collected in Isfahan, Iran between February 9, 2021, and November 4, 2021. We estimated the hazard ratio between vaccinated (partially and fully) and unvaccinated groups using the Andersen-Gill extension of the Cox proportional hazards model. We also performed Cox proportional hazards analysis to identify risk factors for breakthrough infection and COVID-19-related hospitalization in fully-immunized group. RESULTS: Of the 9869 PLWMS, 1368 were in partially-vaccinated group, 4107 were in the fully-vaccinated group, and 3794 were in the unvaccinated group. In the partially-vaccinated group, the estimated VE against COVID-19 infection was 39.3% (16%, 56.1%), hospitalization was 64.9% (1.3%, 87.5%), and mortality was 92.7% (88.8%, 100%). The respective results for the fully-vaccinated group were 63.9% (56%, 70.3%), 75.7% (57.5%, 86.1%), and 100%. Progressive MS was independently associated with a greater risk of breakthrough infection (HR=1.952, 95%CI: 1.174-3.246, p = 0.010). Older adults (≥50 years vs. 18-49 years, HR=3.115, 95%CI: 1.145-8.470, p = 0.026) and those on rituximab (HR=7.584; 95% CI: 1.864-30.854; p = 0.005) were at an increased risk of COVID-19-related hospitalization. CONCLUSION: This study showed that two doses of the BBIBP-CorV vaccine can effectively prevent COVID-19 infection and hospitalization among PLWMS. Old PLWMS and those who treating with rituximab are at increased risk of hospitalization after receiving two doses of the vaccine.

Effectiveness of BBIBP-CorV vaccine in preventing SARS-CoV2 infection and severe outcomes in people living with multiple sclerosis: A population-based study

Background The objective of the present study was to estimate the effectiveness of the BBIBP-CorV vaccine (VE) in preventing SARS-CoV-2 infection, related hospitalization, and death among people living with multiple sclerosis (PLWMS). Methods In this population-based retrospective observational study, data on all PLWMS, vaccination, SARS-CoV-2 tests, hospitalization, and deaths were collected in Isfahan, Iran between February 9, 2021, and November 4, 2021. We estimated the hazard ratio between vaccinated (partially and fully) and unvaccinated groups using the Andersen-Gill extension of the Cox proportional hazards model. We also performed Cox proportional hazards analysis to identify risk factors for breakthrough infection and COVID-19-related hospitalization in fully-immunized group. Results Of the 9869 PLWMS, 1368 were in partially-vaccinated group, 4107 were in the fully-vaccinated group, and 3794 were in the unvaccinated group. In the partially-vaccinated group, the estimated VE against COVID-19 infection was 39.3% (16%, 56.1%), hospitalization was 64.9% (1.3%, 87.5%), and mortality was 92.7% (88.8%, 100%). The respective results for the fully-vaccinated group were 63.9% (56%, 70.3%), 75.7% (57.5%, 86.1%), and 100%. Progressive MS was independently associated with a greater risk of breakthrough infection (HR=1.952, 95%CI: 1.174-3.246, p=0.010). Older adults (≥50 years vs. 18-49 years, HR=3.115, 95%CI: 1.145-8.470, p=0.026) and those on rituximab (HR=7.584;95% CI: 1.864-30.854;p=0.005) were at an increased risk of COVID-19-related hospitalization. Conclusion This study showed that two doses of the BBIBP-CorV vaccine can effectively prevent COVID-19 infection and hospitalization among PLWMS. Old PLWMS and those who treating with rituximab are at increased risk of hospitalization after receiving two doses of the vaccine.

RT-LAMP in SARS-CoV-2 detection: point to improve primer designing and decrease molecular diagnosis pitfalls.

BACKGROUND: Due to the high transmission rate of SARS-CoV-2, diagnostic tests have become tools for identifying patients. The key points were the virus genomes survey to design RT-LAMP primers; comparing the sensitivity and specificity of RT-LAMP and RT-qPCR; and determining the relationship among clinical symptoms, CT scan, RT-qPCR, and RT-LAMP results. METHODS: This cohort study included 444 symptomatic patients. The specificity and sensitivity of RT-LAMP were assayed. The five statistical models, simultaneously, by RapidMiner to find the best method for detecting the virus were done through the correlation between the clinical symptoms, RT-LAMP, RT-qPCR, and CT scan results. The chi-square test by SPSS 26.0 was used to calculate kappa agreement. RESULTS: The virus genome was detected in all the positive samples (198) by RT-qPCR and RT-LAMP. In addition, 246 samples were negative by RT-qPCR, while 88 were positive by RT-LAMP. Data mining analysis indicated that there were most associations between the RT-LAMP and CT scan data compared to RT-qPCR and CT scan data. CONCLUSIONS: RT-LAMP could detect SARS-CoV-2 with great simplicity, speed, and cheapness. Therefore, it is logical to screen, a large number of patients by RT-LAMP, and then RT-qPCR can be used on the limited samples.

Safety of Sinopharm vaccine for people with Multiple Sclerosis: Study of adverse reactions and disease activity.

BACKGROUND: The aim of this study was to evaluate the safety of Sinofarm vaccine (BBIBP-CorV) in patients with multiple sclerosis (pwMS). METHODS: This study was conducted on pwMS patients in Isfahan, Iran. All participants received two doses of BBIBP-CorV (Sinopharm vaccine). Demographic information and data on vaccine side effects were collected after each dose using questionnaires. All patients that recorded worsening of MS symptoms were evaluated and those with true relapse were treated with IV methyl prednisolone. RESULTS: Of the 1538 patients, 1151 (74.8%) were female and the mean age was 40.45 ± 9.74. The average disease duration was 10.38±6.81 years and 76.1% of participants had RRMS. 92.8% of the participants were using DMTs and mean EDSS was 2.06 ± 3.16. 54.2% (833 patient) reported at least one adverse event after the first dose of vaccine and 46.8% (720 patient) after the second dose; in both cases going away in a few days. Most prevalent adverse events after both doses were injection site pain, headache, myalgia, fever and fatigue. Adverse events were more prevalent in younger and less prevalent in mildly disabled patients. There were seven cases of Covid-19 infection between the first and second vaccination dose, and eight cases during one-month follow -up after the second dose, none of whom needed mechanical ventilation. Ten patients after first dose and thirteen patients after the second dose experienced acute relapse. A patient had two relapses, one after each vaccine dose that were clinically and radiologically confirmed. The first relapse occurred seven days after the first vaccination with hemiparesis and other relapse, 14 days after the second dose with diplopia, hemiparesis and ataxia. CONCLUSION: Adverse events in pwMS following vaccination with Sinopharm vaccine was similar to the general population, which were more common in younger patients and less common in those with mild disability. As no increase in relapse rate after vaccination was detected, Sinopharm vaccine was safe in MS patients.

COVID-19 infection and hospitalization rate in Iranian multiple sclerosis patients: What we know by May 2021.

BACKGROUND: Despite investigations on the effect of disease modifying therapies (DMTs) used in multiple sclerosis (MS) on coronavirus disease 2019 (COVID-19); there are still controversies. OBJECTIVE: We designed this study to evaluate the epidemiological features of covid-19 in a large sample of people with MS (pwMS) in Isfahan, Iran, as well as the association between DMTs, risk of COVID-19 infection and hospitalization. METHODS: In an observational pwMS, we interviewed subjects on their MS and COVID-19 history. RESULTS: 3050 subjects were included (74% female) with a mean age of 41.36. 423 (13.8%) had confirmed COVID-19 which shows that pwMS are at a higher risk of infection compared to the general population, No significant relationship was observed in COVID-19 infection when individual drugs. Dimethyl fumarate and rituximab had the lowest and the highest relative risks for hospitalization rate compared to other drugs, respectively. CONCLUSION: We found no evidence supporting a higher prevalence of COVID-19 in pwMS compared to the general population. However, our results show pwMS to be more prone to hospitalization compared to the general population, Therefore, it is advised to use safer treatment if possible until complete vaccination, and to postpone the use of rituximab.