Objective The Pfizer BNT162b2 vaccine showed a reassuring safety profile in clinical trials, but real-world data are scarce. Bell’s palsy, herpes-zoster, Guillain-Barré syndrome (GBS) and other neurological complaints in proximity to vaccination have received special public attention. We compared their rates among vaccinated and unvaccinated individuals. Methods Individuals ≥16 years vaccinated with at least one dose of BNT162b2 were eligible for this historical-cohort study in a health maintenance organization insuring 1.2 million citizens. Each vaccinee was matched to a non-vaccinated control by sex, age, population sector (general Jewish, Arab, ultra-orthodox Jewish) and comorbidities. Diagnosis of Covid-19 before or after vaccination was an exclusion criterion. The outcome was a diagnosis of: Bell’s palsy, GBS, herpes-zoster, or symptoms of numbness or tingling, coded in the visit diagnosis field using ICD-9 codes. Diagnoses of Bell’s palsy and GBS were verified by individual file review. Results Of 406,148 individuals vaccinated during the study period, 394,609 (97.2%) were eligible (11,539 excluded). 233,159 (59.1%) were matched with unvaccinated controls. Mean follow was 43±15.14 days. In vaccinated and unvaccinated individuals there were 23 versus 24 cases of Bell’s palsy (RR 0.96, CI 0.54-1.70), 1 versus 0 cases of GBS, 151 versus 141 cases of herpes-zoster (RR 1.07, CI 0.85-1.35), and 605 versus 497 cases of numbness or tingling (RR 1.22, CI 1.08-1.37), respectively. Conclusions No association was found between vaccination, Bell’s palsy, herpes-zoster or GBS. Symptoms of numbness or tingling were more common among vaccinees. This study adds reassuring data regarding the safety of the BNT162b2 vaccine.
Background The Hybrid Patient Care system integrates telehealth and in-clinic consultation. While COVID-19 increased telehealth use, healthcare providers are still seeking the best combination of virtual and in-clinic consultation. Understanding patients’ tele-consultation-related preferences is vital for achieving optimal implementation. The discrete choice experiment (DCE) is the stated preference technique for eliciting individual preferences and is increasingly being used in health-related applications. The study purpose was to evaluate attributes and levels of the DCE regarding patients’ preferences for telemedicine versus traditional, in-clinic consultation in primary care during the COVID-19 pandemic, in order to facilitate successful implementation. Methods A three-phase structure was used in the qualitative stage of the DCE: (1) a literature review and preparation of interview guides; (2) Eight focus group interviews comprised of 26 patients and 33 physicians; and (3) Attribute selection: a ranking exercise among 48 patients. The Think Aloud technique, in which respondents are asked to verbalize their thoughts, was used in the focus groups. Interview data were analyzed by thematic analysis. Results Eight attributes were proposed by the patients in the focus groups. The four most important attributes were then selected in pre-testing, and are described in this study: Availability, time until the appointment, severity of the medical problem, patient-physician relationship, and flexible reception hours. Conclusions This study has a theoretical contribution in post-COVID-19 patients’ preferences in Hybrid Medicine patient care. This provides a foundation to assess the rigors of this stage and provide additional evidence to the limited existing literature on attributes development for DCE patient preferences.
Background There is strong evidence regarding the efficacy and effectiveness of BNT162b2 vaccine in preventing symptomatic infection with SARS-CoV-2 virus. There is a relative paucity of data regarding effectiveness in prevention of asymptomatic infection. Methods In this real-world observational study, we identified a sub-population of individuals in a large health maintenance organization who were repeatedly tested for SARS-CoV-2 infection by PCR. We included these individuals in the study cohort, and compared those who were vaccinated with BNT162b2 mRNA vaccine to the unvaccinated ones. A positive SARS-CoV-2 PCR test result was used as the outcome. Follow-up period was from January 1,2021 until February 11, 2021. Findings 6,286 individuals were included in the cohort. Seven days following the second vaccine dose, a rate of six positive PCR tests per 10,000 person-days was recorded, compared with a rate of 53 positive tests per 10,000 person-days for the unvaccinated group. The estimated vaccine effectiveness against infection with SARS-CoV-2 virus after two vaccine doses was 89% (95% confidence interval 82%-94%). The estimated effectiveness two weeks following the first vaccine dose was 61% (95% confidence interval 49%-71%). Interpretation In this study, vaccination with BNT162b2 reduced infection rates among individuals who underwent screening by frequent SARS-CoV-2 PCR testing. Using a cohort of frequently tested individuals reduced the indication bias for the PCR testing, which enabled estimation of infection rates. Funding This study received no funding.
Prosthetic valve endocarditis is still a very serious complication, carrying an incidence of death between 30 and 70% in some series. Therefore early and accurate diagnosis is crucial. Early (less than 60 days post surgery) endocarditis is usually a fulminant disease, where staphylococcal infection is most common. Late prosthetic endocarditis resembles more closely other forms of the disease. Conventional echocardiography is useful in the evaluation of prosthetic valve function, but it is very limited in the demonstration of infective lesions, primarily because of acoustic shadowing. Transoesophageal echocardiography (TE) enables high resolution imaging of the heart without chest wall interference, and viewing of the heart from the posterior (atrial, low pressure) side, where most of the vegetations are expected to be found in both mitral and tricuspid positions. It also enables better visualization of the left ventricular outflow tract, where aortic prosthetic vegetations tend to be present. Furthermore, transoesophageal echocardiography allows accurate diagnosis of some of the common complications of endocarditis: abscess/cavity formation; mycotic aneurysm; prosthetic valve dehiscence and regurgitation. In spite of these advantages, limitations should be recognized. Struts are commonly seen on transoesophageal echocardiography following surgery and should not be confused with vegetations. Similarly, normal prosthetic regurgitation should not be confused with paravalvar leakage. Nevertheless, transoesophageal echocardiography, when expertly used, changes the possibility for early and more accurate diagnosis of prosthetic valve endocarditis dramatically. Transoesophageal echocardiography should be included among the major criteria in the diagnosis and follow-up of prosthetic valve endocarditis.
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