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| 데이터등록일 | 데이터 수정일 | 데이터 이용기한 | 판매제공처 |
|---|---|---|---|
| 2022-12-01 | 2023-07-06 | 무기한 | 비네아 |
| 데이터 제공포맷 | 데이터 제공방식 | 데이터 파일용량 | 데이터 상품구분 |
| json/zip | 다운로드 | 1.04 MB | dataset |
● 데이터 상품명 임상 데이터셋 ● 데이터 상품 부제 COVID-19의 임상 관련 의학논문 데이터셋 ● 데이터 상품 요약 인용지수 상위 의학저널에 게재된 COVID-19의 임상에 관련된 의학 학술논문 데이터 ● 키워드 데이터셋 상품 정보 ■ 상품 설명 및 특징 - 의학논문의 저자 키워드, 초록, 제목 등에서 추출한 키워드에 키워드 속성, 대역어, 키워드 출처, 논문 DOI, 저자, 발행연월, 논문URL, 저널명, 저널 ISSN, 발행기관, Impact Factor의 정보를 매핑한 데이터 ■ 컬럼(속성) 정보 - 키워드명: 키워드 - 키워드속성: 키워드 성격 - 키워드출처: 키워드 출현 위치 - 키워드대역어: 자체 보유 의학사전 및 구글번역기에 의한 대역어 - 논문DOI명: 키워드 출현 논문의 DOI - 논문제목: 키워드 출현 논문의 제목 - 논문저자: 키워드 출현 논문의 저자 - 논문발행연월: 키워드 출현 논문의 발행연월 - 논문초록: 키워드 출현 논문의 초록 - 논문URL: 키워드 출현 논문의 URL - 저널ISSN명: 키워드 출현 논문의 저널 ISSN - 저널제목: 키워드 출현 논문의 저널명 - 저널발행기관명: 키워드 출현 논문의 발행기관명 ● 연관 데이터셋 상품 정보 ■ 상품 설명 및 특징 - 특정 키워드의 연관 키워드를 co-occurrence기법과 Latent Semantic Algorithm에 의해 추출한 데이터셋 ■ 컬럼(속성) 정보 - 키워드명: 키워드 - 키워드속성: 키워드의 성격 - 연관키워드명: 키워드와 연관된 키워드 - 연관키워드 속성: 연관키워드의 속성 - 연관중요도: 동의여 여부와 동시출현수를 지표로 하는 중요도 ● 기간 및 범위 - 2014년 5월 ~ 2022년 12월 ● 활용 예제 - 특정 주제에 해당되는 키워드의 속성별, 저널별, 연도별, 저자별 추이 - 키워드의 연관어를 속성별, 저널별, 연도별, 저자별 분석
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| 217024 | 8 | 임상 | Seizure | Term | seizure | abstract | 압수 | 30879 | 10.1016/j.ijid.2020.09.1475 | Clinical characteristics of 30 COVID-19 patients with epilepsy: A retrospective study in Wuhan | Minxian Sun@@@Xiaoyun Ruan@@@Yuanyuan Li@@@Pei Wang@@@Shasha Zheng@@@Guiying Shui@@@Li Li@@@Yan Huang@@@Hongmei Zhang | 202102 | Observational Study | PMC | {{{ Abstract }}} !!{{ Objective: }} This study aims to present the clinical characteristics of 30 hospitalized cases with epileptic seizures and coronavirus disease 2019(COVID-19). !!{{ Methods: }} This is a retrospective observational research study. Clinical data were extracted from electronic medical records in 1550 patients with a laboratory-confirmed diagnosis of COVID-19, who were hospitalized in Wuhan Central Hospital, China, from 1 January to 31 April 2020. 30 COVID-19 patients with the diagnosis of epilepsy were enrolled. The clinical characteristics, complications, treatments, and clinical outcomes of 30 cases were collected and analyzed. !!{{ Result: }} Of 30 patients with a diagnosis of epilepsy and COVID-19, 13 patients (43.4%) had new-onset epileptic seizures without an epilepsy history(new-onset seizure group, NS group), ten patients(33.3%) had an epilepsy history with a recurrent epileptic seizure (recurrent seizure group, RS group) and seven patients(23.3%) had an epilepsy history but no seizure during the course of COVID-19 (epilepsy history group, EH group). Patients in the RS group had a larger number of other-neurological-disease histories than those in the NS and EH groups (7/10[70%] VS 1/13 [7.7%] VS 1/7[14.3%]); the difference between the RS group and NS group is significant (P < 0.05). Patients in the NE and RS groups suffered more severe/critical COVID-19 infection than patients in the EH group (10/13[76.9%] VS 6/10[60%] VS 1/7[14.3%]); the difference between the NS group and EH group is significant (P < 0.05). 36.7% of patients had one to five neurological complications, and 46.4% of patients had 6-10 neurological complications. The complications in patients with seizures (in the RS and NS groups) seem to be more than those without seizures (in the EH group), but it did not reach statistical significance. The proportion of antiepileptic drugs (AEDs) treatment before admission was higher in the EH group than in the RE group(7/7 [100%] VS 2/10 [20%], P < 0.05). The mortality of 30 patients with epilepsy and COVID-19 was 36.67%. The mortality of the NS group(38.5%) and the RS group(50%) were a little higher than in the EH group(14.3%). None of the convalescent patients had a recurrent seizure, and there were no more deaths in the 3-month follow-up after discharge. !!{{ Conclusions: }} COVID-19 patients with recurrent epileptic seizures had more underlying neurological diseases than patients who had an epilepsy history but without a seizure. Patients with new-onset and recurrent epileptic seizures suffered more severe/critical COVID-19, which may lead to a worse prognosis. If patients with epilepsy history continue using AEDs during COVID-19 pandemics, the risk of recurrent seizure may be reduced, and a good prognosis for patients with epilepsy history could be expected. !!{{ Keywords: }} COVID-19; Clinical outcomes; Complication; Epilepsy; New-Onset; Recurrent; Seizure. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7531277/ | 65 | 1201-9712 | International Journal of Infectious Diseases | Hamilton, ON : Elsevier. | |
| 216160 | 8 | 임상 | healthcare | Term | healthcare | abstract | 보건 의료 | 30861 | 10.1111/inr.12724 | Evaluating Polish nurses' working conditions and patient safety during the COVID-19 pandemic | Iwona Malinowska-Lipie?@@@Tadeusz Wadas@@@Teresa Gabry?@@@Maria K?zka@@@Agnieszka Gniadek@@@Tomasz Brzostek@@@Allison Squires | 202206 | Observational Study | PMC | {{{ Abstract }}} !!{{ Aim: }} To study the relationship between Polish nurses' working conditions and their attitudes towards patient safety during the COVID-19 pandemic. !!{{ Background: }} Facing the COVID-19 pandemic, caused by the SARS-CoV-2 virus, healthcare worldwide has been reorganised. How these changes affected patient safety for hospitalised persons is not well understood. !!{{ Introduction: }} Difficult working conditions related to the outbreak of the COVID-19 pandemic may affect the provision of safe and effective care by healthcare staff. !!{{ Methods: }} This observational research was performed on the group of 577 nurses working during the COVID-19 pandemic in isolation infection wards (n = 201) and non-infectious diseases wards (n = 376) in Polish hospitals. The evaluation of working conditions was performed with an author's questionnaire, while the evaluation of factors influencing attitudes towards safety of the hospitalised patients was performed using Safety Attitudes Questionnaire. The STROBE checklist was used to report this study. !!{{ Results: }} The procedures developed by management in advance for COVID-19 patient treatment had a statistically significant influence on nurses' 'evaluation of teamwork climate, safety climate, job satisfaction, perception of management and work conditions'. Providing management with the ability to perform a swab polymerase chain reaction SARS-CoV-2 test for hospital staff in the workplace, and psychological support from professionals and employers were statistically significant for higher ratings of 'teamwork climate, safety climate, job satisfaction, stress recognition, perception of management and work conditions' by the Polish nurses. Hospital workload during the COVID-19 pandemic was significantly correlated with lower evaluation of work conditions. !!{{ Discussion: }} Our study reinforces the existing literature on many fronts and demonstrates how even when operating under the COVID-19 pandemic conditions, some factors remain critical for fostering a culture of patient safety. Reinforcing patient safety practices is a imperative under these conditions. !!{{ Conclusions and implications for nursing: }} Working conditions influence nurses' attitudes towards safety of the hospitalised patients. These are largely modifiable factors related to the workplace and include prior preparation of procedures, restrictions to extending daily work hours and psychological counselling for the staff. !!{{ Keywords: }} COVID-19; attitudes to safety; nurses; patient safety; work conditions. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8653238/ | 1784 | 0020-8132 | International nursing review | Oxford, UK : Blackwell Science Ltd. | |
| 230978 | 8 | 임상 | convenience | Term | convenience | abstract | None | 31208 | 10.1136/bmjopen-2021-049872 | Implementation of a complex intervention to improve hospital discharge: process evaluation of a cluster randomised controlled trial | Yael Rachamin@@@Thomas Grischott@@@Stefan Neuner-Jehle | 202105 | Article | PMC | {{{ Abstract }}} !!{{ Objectives: }} To study the implementation of a cluster randomised controlled effectiveness-implementation hybrid trial testing the effectiveness of a medication review at hospital discharge combined with a communication stimulus between hospital physicians (HPs) and general practitioners (GPs) on rehospitalisation of multimorbid older patients. !!{{ Design: }} Extension of Grant's mixed method process evaluation framework to trials with multilevel clustering. !!{{ Setting: }} General internal medicine wards in Swiss hospitals. !!{{ Participants: }} Convenience samples of 15 chief physicians (of 21 hospitals participating in the effectiveness trial), 60 (74) senior HPs, 65 (164) junior HPs and 187 (411) GPs. !!{{ Implementation strategy: }} Two-hour teaching sessions for senior HPs on a patient-centred, checklist-guided discharge routine. !!{{ Process evaluation components: }} Data collection on recruitment, delivery and response from chief physicians (semistructured interviews), senior HPs, junior HPs, GPs (surveys) and patients (via HPs). Quantitative data were summarised using descriptive statistics, and interviews analysed using thematic analysis. !!{{ Outcome measures: }} Intervention dose (quantitative), implementation fidelity (qualitative), feasibility and acceptability, facilitators and barriers, implementation support strategies. !!{{ Results: }} Recruitment of hospitals was laborious but successful, with 21 hospitals recruited. Minimal workload and a perceived benefit for the clinic were crucial factors for participation. Intervention dose was high (95% of checklist activities carried out), but intervention fidelity was limited (discharge letters) or unknown (medication review). Recruitment and retention of patients was challenging, partly due to patient characteristics (old, frail) and the COVID-19 pandemic: Only 612 of the anticipated 2100 patients were recruited, and 31% were lost to follow-up within the first month after discharge. The intervention was deemed feasible and helpful by HPs, and the relevance of the topic appreciated by both HPs and GPs. !!{{ Conclusions: }} The results from this evaluation will support interpretation of the findings of the effectiveness study and may inform researchers and policy makers who aim at improving hospital discharge. !!{{ Trial registration number: }} ISRCTN18427377. !!{{ Keywords: }} general medicine (see internal medicine); public health; qualitative research; quality in health care. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162085/ | 8 | 2044-6055 | BMJ Open | [London] : BMJ Publishing Group Ltd | |
| 221136 | 8 | 임상 | the SARS-CoV-2 | Virus | the sars-cov-2 | title,abstract | None | 30976 | 10.1093/sleep/zsab041 | Sleep quality deterioration in middle-aged and older adults living in a rural Ecuadorian village severely struck by the SARS-CoV-2 pandemic. A population-based longitudinal prospective study | Oscar H Del Brutto@@@Robertino M Mera@@@Aldo F Costa@@@Bettsy Y Recalde@@@Pablo R Castillo | 202108 | Clinical Trial | PMC | {{{ Abstract }}} !!{{ Study objectives: }} This study assessed changes in sleep quality before and after the peak of the SARS-CoV-2 pandemic in community dwellers enrolled in the Atahualpa Project. !!{{ Methods: }} Atahualpa residents aged ≥40 years were eligible if they had a Pittsburgh Sleep Quality Index (PSQI) 9 months before the pandemic and a lateral flow-based test for identification of SARS-CoV-2 antibodies during the peak of the pandemic. Six months later, individuals completed a follow-up PSQI. The independent relationship between SARS-CoV-2 infection and deterioration in sleep quality was assessed by fitting logistic mixed models for longitudinal data. !!{{ Results: }} Of 639 participants (mean age at baseline: 59 ± 12.8 years), 325 (51%) had SARS-CoV-2 antibodies. A total of 185 (29%) individuals at baseline and 311 (49%) at follow-up were poor sleepers (p < 0.001). Mixed logistic regression models demonstrated a significant increase in poor sleepers at follow-up (odds ratio [OR]: 2.85; 95% CI: 2.16 to 3.75), which was more marked among SARS-CoV-2 seropositive subjects (OR: 3.8; 95% CI: 2.48 to 5.81). The adjusted proportion of poor sleepers increased from 29% to 56.2% (95% CI: 50.9% to 61.6%) among SARS-CoV-2 seropositive individuals, but only to 40.7% (95% CI: 35.3% to 46.1%) in their seronegative counterparts (p < 0.001). Likewise, progression from a good to a poor sleeper status was higher among seropositive individuals than in their seronegative counterparts (38.1% vs 22.3%; p < 0.001), after adjusting for relevant covariates. !!{{ Conclusions: }} This study shows a deleterious effect of SARS-CoV-2 in sleep quality. An effect of SARS-CoV-2 in disrupting sleep-related pathways cannot be ruled out. !!{{ Trial registration: }} The Atahualpa Project has been registered at ClinicalTrials.gov; the identifier number is NCT01627600 , and the date was: 10/02/2012 (https://clinicaltrials.gov/ct2/show/NCT01627600?cond=Atahualpa&draw=2&rank=1). The Sleep Disorders substudy has been registered at ClinicalTrials.gov; the identifier number is NCT01877616 , and the date was: 06/13/2013 (https://clinicaltrials.gov/ct2/show/NCT01877616?cond=Atahualpa&draw=2&rank=4). !!{{ Keywords: }} COVID-19; Coronavirus-19; Pittsburgh Sleep Quality Index; SARS-CoV-2; sleep quality. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7928566/ | 2242 | 0161-8105 | Sleep | New York : Oxford University Press. | |
| 231786 | 8 | 임상 | Nurse | Term | nurse | abstract | 간호사 | 31225 | 10.1016/j.nepr.2021.103170 | Responding to a simulated disaster in the virtual or live classroom: Is there a difference in BSN student learning? | Lisa Kirk Wiese@@@Tamara Love@@@Rhonda Goodman | 202108 | Article | PMC | {{{ Abstract }}} !!{{ Aim: }} This study aim was to investigate if prelicensure baccalaureate nursing students gained more knowledge from a live or virtual disaster simulation. The study goal was to inform the use of e-learning or traditional textbooks in undergraduate nursing population health courses. !!{{ Background: }} Weather-related disasters have increased in frequency and severity in the past ten years, with 2020 being the most active storm season ever seen (National Oceanographic and Atmospheric Administration, 2021.) Even with advances in early warning systems and mitigation efforts, educating student nurses in disaster response remains a priority. Due to the impact of Covid-19 quarantine policies, many in-person student learning labs and clinical experiences were cancelled. However, virtual simulation offers an alternative to developing nursing student skills and clinical reasoning ability (Aebersold, 2018; Fogg et al., 2020). !!{{ Design: }} A randomized quasi-experimental, repeated measures 2 × 2 crossover design (Kim, 2018) was applied, which allowed students to participate in both the live and virtual simulations. !!{{ Methods: }} Analysis was conducted using paired samples t-test to evaluate knowledge gains. To measure students' self-assessment of knowledge, Unver et al. (2018) 12-item survey was administered. To explore students' own perceptions about the disaster simulations, semi-structured interview questions were offered through private Wiki postings. The responses were analyzed using Salda?a's in vivo coding (2015) and thematic analysis. !!{{ Results: }} Students retained more empirical knowledge following the virtual assignment as compared to the disaster simulation, except in two items addressing triage. Neither age, years of education, or GPA impacted test results. However, students' own assessment of learning did not differ between live and virtual simulations. In all but three items, students perceived a significant increase (p < .05) in their learning following the simulation, regardless whether it was live or virtual. In narrative responses, students overwhelmingly cited the benefit of an in-person simulation. However, they did not believe that they were prepared adequately for the live simulation. They also expressed that they would be more prepared if the simulation was repeated. Students expressed discomfort, even distress, regarding not being able to care adequately for everyone, even though it was a simulation (See Table 5). This highlighted that live simulations can affect students emotionally, and follow-up debriefing is essential to help in both acknowledging and processing student feelings. !!{{ Conclusion: }} These findings, which support the use of virtual disaster training in nursing education, are especially important in the light of Covid-19 and increasing threat of storm disasters. !!{{ Keywords: }} Disaster training; Live simulation; Quarantine restrictions; Virtual simulation. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8513508/ | 2412 | 1471-5953 | Nurse education in practice | [Edinburgh] : Elsevier Ltd. | |
| 231787 | 8 | 임상 | offer | Action | offer | abstract | None | 31225 | 10.1016/j.nepr.2021.103170 | Responding to a simulated disaster in the virtual or live classroom: Is there a difference in BSN student learning? | Lisa Kirk Wiese@@@Tamara Love@@@Rhonda Goodman | 202108 | Article | PMC | {{{ Abstract }}} !!{{ Aim: }} This study aim was to investigate if prelicensure baccalaureate nursing students gained more knowledge from a live or virtual disaster simulation. The study goal was to inform the use of e-learning or traditional textbooks in undergraduate nursing population health courses. !!{{ Background: }} Weather-related disasters have increased in frequency and severity in the past ten years, with 2020 being the most active storm season ever seen (National Oceanographic and Atmospheric Administration, 2021.) Even with advances in early warning systems and mitigation efforts, educating student nurses in disaster response remains a priority. Due to the impact of Covid-19 quarantine policies, many in-person student learning labs and clinical experiences were cancelled. However, virtual simulation offers an alternative to developing nursing student skills and clinical reasoning ability (Aebersold, 2018; Fogg et al., 2020). !!{{ Design: }} A randomized quasi-experimental, repeated measures 2 × 2 crossover design (Kim, 2018) was applied, which allowed students to participate in both the live and virtual simulations. !!{{ Methods: }} Analysis was conducted using paired samples t-test to evaluate knowledge gains. To measure students' self-assessment of knowledge, Unver et al. (2018) 12-item survey was administered. To explore students' own perceptions about the disaster simulations, semi-structured interview questions were offered through private Wiki postings. The responses were analyzed using Salda?a's in vivo coding (2015) and thematic analysis. !!{{ Results: }} Students retained more empirical knowledge following the virtual assignment as compared to the disaster simulation, except in two items addressing triage. Neither age, years of education, or GPA impacted test results. However, students' own assessment of learning did not differ between live and virtual simulations. In all but three items, students perceived a significant increase (p < .05) in their learning following the simulation, regardless whether it was live or virtual. In narrative responses, students overwhelmingly cited the benefit of an in-person simulation. However, they did not believe that they were prepared adequately for the live simulation. They also expressed that they would be more prepared if the simulation was repeated. Students expressed discomfort, even distress, regarding not being able to care adequately for everyone, even though it was a simulation (See Table 5). This highlighted that live simulations can affect students emotionally, and follow-up debriefing is essential to help in both acknowledging and processing student feelings. !!{{ Conclusion: }} These findings, which support the use of virtual disaster training in nursing education, are especially important in the light of Covid-19 and increasing threat of storm disasters. !!{{ Keywords: }} Disaster training; Live simulation; Quarantine restrictions; Virtual simulation. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8513508/ | 2412 | 1471-5953 | Nurse education in practice | [Edinburgh] : Elsevier Ltd. | |
| 231982 | 8 | 임상 | emotional | Term | emotional | abstract | None | 31231 | 10.1016/j.rxeng.2021.09.009 | Prevalence of burnout syndrome during the COVID-19 pandemic and associated factors | A Oprisan@@@E Baettig-Arriagada@@@C Baeza-Delgado@@@L Mart?-Bonmat? | 202203 | Observational Study | PMC | {{{ Abstract in English, Spanish }}} !!{{ Background: }} The coronavirus 2019 (COVID-19) epidemic spread throughout the world from the beginning of 2020, increasing healthcare professionals' workloads and levels of physical and emotional stress. !!{{ Aims: }} To determine the prevalence of burnout syndrome in Spanish radiologists during the COVID-19 pandemic and the factors associated with the development of this syndrome, and to compare these findings with those obtained before the pandemic. !!{{ Methods: }} This observation study took place between April 2020 and August 2020 (during the pandemic) through an online survey. A total of 150 responses were obtained. Demographic and work-related information was compiled. Burnout syndrome was measured with the Maslach Burnout Inventory Human Services Survey (MBI-HSS). The prevalence and characteristics of burnout syndrome obtained in this survey were compared with those of the same survey done in 2019. We performed a statistical analysis to identify possible risk factors and protective factors associated with this syndrome and to determine the homogeneity of the two samples. !!{{ Results: }} The prevalence of burnout syndrome increased during the COVID-19 pandemic (49.3% vs. 33.6%, p = 0.002). No risk factors or protective factors that were valid both before and after the pandemic were identified. No correlations were identified between sociodemographic or work-related characteristics and burnout syndrome. !!{{ Conclusion: }} This study demonstrates that burnout syndrome increased significantly in radiologists during the COVID-19 pandemic, affecting nearly half of all those who responded to the survey. These results underline the need to assess support for professional wellbeing of radiologists in Spain. No correlations were identified between burnout and gender, age, number of calls, years in the job, annual income, teaching, marital status, number of children, or type of contract. !!{{ Antecedentes: }} La epidemia por coronavirus 2019 (COVID-19) se ha extendido por todo el mundo desde principios de 2020, sometiendo a los profesionales sanitarios a una sobrecarga laboral y a un mayor nivel de estr?s f?sico y emocional. !!{{ Objetivos: }} El objetivo de este estudio es determinar la prevalencia de desgaste profesional y sus posibles factores asociados en los radi?logos espa?oles durante la COVID-19, y su comparaci?n con la situaci?n previa a la pandemia. !!{{ M?todos: }} Estudio observacional realizado entre los meses de abril y agosto de 2020 (durante la pandemia) mediante una encuesta en l?nea. Se obtuvieron un total de 150 respuestas. Se recopil? y compar? la informaci?n demogr?fica y laboral de los encuestados. Se determin? la presencia del desgaste profesional con el cuestionario Maslach Burnout Inventory Human Services Survey (MBI-HSS) y se compar? su prevalencia y caracter?sticas con el estudio realizado de la misma manera en 2019. Se hizo un an?lisis estad?stico para identificar los posibles factores de riesgo y protectores asociados con este s?ndrome, as? como un an?lisis de homogeneidad entre las dos muestras. !!{{ Resultados: }} La prevalencia del s?ndrome aument? de forma significativa ( p = 0,002) durante la pandemia COVID-19 (49,3% frente a 33,6%). Ning?n factor de riesgo o de protecci?n se ha identificado como constante antes y despu?s de la pandemia. No se he identificado ninguna correlaci?n del desgaste con las caracter?sticas sociodemogr?ficas o laborales. !!{{ Conclusi?n: }} Este estudio demuestra un aumento importante del desgaste profesional durante la pandemia por la COVID-19 con afectaci?n de casi la mitad de los radi?logos encuestados. Estos resultados destacan la necesidad de valorar el apoyo orientado al bienestar profesional de los radi?logos en Espa?a. No se ha identificado correlaci?n entre el s?ndrome y g?nero, edad, n?mero de guardias, antig?edad, ingreso anual, docencia, estado civil, n?mero de hijos o tipo de contrato laboral. !!{{ Keywords: }} Agotamiento emocional; COVID-19; Depersonalization; Desgaste profesional; Despersonalizaci?n; Emotional exhaustion; Personal fulfillment; Professional exhaustion; Radiologists; Radi?logos; Realizaci?n personal. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9055794/ | 2325 | 2173-5107 | Radiologi?a | English ed. [Madrid] : Elsevier Espan?a. | |
| 232008 | 8 | 임상 | Radi?logos | Term | radi?logo | author | None | 31231 | 10.1016/j.rxeng.2021.09.009 | Prevalence of burnout syndrome during the COVID-19 pandemic and associated factors | A Oprisan@@@E Baettig-Arriagada@@@C Baeza-Delgado@@@L Mart?-Bonmat? | 202203 | Observational Study | PMC | {{{ Abstract in English, Spanish }}} !!{{ Background: }} The coronavirus 2019 (COVID-19) epidemic spread throughout the world from the beginning of 2020, increasing healthcare professionals' workloads and levels of physical and emotional stress. !!{{ Aims: }} To determine the prevalence of burnout syndrome in Spanish radiologists during the COVID-19 pandemic and the factors associated with the development of this syndrome, and to compare these findings with those obtained before the pandemic. !!{{ Methods: }} This observation study took place between April 2020 and August 2020 (during the pandemic) through an online survey. A total of 150 responses were obtained. Demographic and work-related information was compiled. Burnout syndrome was measured with the Maslach Burnout Inventory Human Services Survey (MBI-HSS). The prevalence and characteristics of burnout syndrome obtained in this survey were compared with those of the same survey done in 2019. We performed a statistical analysis to identify possible risk factors and protective factors associated with this syndrome and to determine the homogeneity of the two samples. !!{{ Results: }} The prevalence of burnout syndrome increased during the COVID-19 pandemic (49.3% vs. 33.6%, p = 0.002). No risk factors or protective factors that were valid both before and after the pandemic were identified. No correlations were identified between sociodemographic or work-related characteristics and burnout syndrome. !!{{ Conclusion: }} This study demonstrates that burnout syndrome increased significantly in radiologists during the COVID-19 pandemic, affecting nearly half of all those who responded to the survey. These results underline the need to assess support for professional wellbeing of radiologists in Spain. No correlations were identified between burnout and gender, age, number of calls, years in the job, annual income, teaching, marital status, number of children, or type of contract. !!{{ Antecedentes: }} La epidemia por coronavirus 2019 (COVID-19) se ha extendido por todo el mundo desde principios de 2020, sometiendo a los profesionales sanitarios a una sobrecarga laboral y a un mayor nivel de estr?s f?sico y emocional. !!{{ Objetivos: }} El objetivo de este estudio es determinar la prevalencia de desgaste profesional y sus posibles factores asociados en los radi?logos espa?oles durante la COVID-19, y su comparaci?n con la situaci?n previa a la pandemia. !!{{ M?todos: }} Estudio observacional realizado entre los meses de abril y agosto de 2020 (durante la pandemia) mediante una encuesta en l?nea. Se obtuvieron un total de 150 respuestas. Se recopil? y compar? la informaci?n demogr?fica y laboral de los encuestados. Se determin? la presencia del desgaste profesional con el cuestionario Maslach Burnout Inventory Human Services Survey (MBI-HSS) y se compar? su prevalencia y caracter?sticas con el estudio realizado de la misma manera en 2019. Se hizo un an?lisis estad?stico para identificar los posibles factores de riesgo y protectores asociados con este s?ndrome, as? como un an?lisis de homogeneidad entre las dos muestras. !!{{ Resultados: }} La prevalencia del s?ndrome aument? de forma significativa ( p = 0,002) durante la pandemia COVID-19 (49,3% frente a 33,6%). Ning?n factor de riesgo o de protecci?n se ha identificado como constante antes y despu?s de la pandemia. No se he identificado ninguna correlaci?n del desgaste con las caracter?sticas sociodemogr?ficas o laborales. !!{{ Conclusi?n: }} Este estudio demuestra un aumento importante del desgaste profesional durante la pandemia por la COVID-19 con afectaci?n de casi la mitad de los radi?logos encuestados. Estos resultados destacan la necesidad de valorar el apoyo orientado al bienestar profesional de los radi?logos en Espa?a. No se ha identificado correlaci?n entre el s?ndrome y g?nero, edad, n?mero de guardias, antig?edad, ingreso anual, docencia, estado civil, n?mero de hijos o tipo de contrato laboral. !!{{ Keywords: }} Agotamiento emocional; COVID-19; Depersonalization; Desgaste profesional; Despersonalizaci?n; Emotional exhaustion; Personal fulfillment; Professional exhaustion; Radiologists; Radi?logos; Realizaci?n personal. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9055794/ | 2325 | 2173-5107 | Radiologi?a | English ed. [Madrid] : Elsevier Espan?a. | |
| 230994 | 8 | 임상 | implementation | Term | implementation | abstract | 구현 | 31208 | 10.1136/bmjopen-2021-049872 | Implementation of a complex intervention to improve hospital discharge: process evaluation of a cluster randomised controlled trial | Yael Rachamin@@@Thomas Grischott@@@Stefan Neuner-Jehle | 202105 | Article | PMC | {{{ Abstract }}} !!{{ Objectives: }} To study the implementation of a cluster randomised controlled effectiveness-implementation hybrid trial testing the effectiveness of a medication review at hospital discharge combined with a communication stimulus between hospital physicians (HPs) and general practitioners (GPs) on rehospitalisation of multimorbid older patients. !!{{ Design: }} Extension of Grant's mixed method process evaluation framework to trials with multilevel clustering. !!{{ Setting: }} General internal medicine wards in Swiss hospitals. !!{{ Participants: }} Convenience samples of 15 chief physicians (of 21 hospitals participating in the effectiveness trial), 60 (74) senior HPs, 65 (164) junior HPs and 187 (411) GPs. !!{{ Implementation strategy: }} Two-hour teaching sessions for senior HPs on a patient-centred, checklist-guided discharge routine. !!{{ Process evaluation components: }} Data collection on recruitment, delivery and response from chief physicians (semistructured interviews), senior HPs, junior HPs, GPs (surveys) and patients (via HPs). Quantitative data were summarised using descriptive statistics, and interviews analysed using thematic analysis. !!{{ Outcome measures: }} Intervention dose (quantitative), implementation fidelity (qualitative), feasibility and acceptability, facilitators and barriers, implementation support strategies. !!{{ Results: }} Recruitment of hospitals was laborious but successful, with 21 hospitals recruited. Minimal workload and a perceived benefit for the clinic were crucial factors for participation. Intervention dose was high (95% of checklist activities carried out), but intervention fidelity was limited (discharge letters) or unknown (medication review). Recruitment and retention of patients was challenging, partly due to patient characteristics (old, frail) and the COVID-19 pandemic: Only 612 of the anticipated 2100 patients were recruited, and 31% were lost to follow-up within the first month after discharge. The intervention was deemed feasible and helpful by HPs, and the relevance of the topic appreciated by both HPs and GPs. !!{{ Conclusions: }} The results from this evaluation will support interpretation of the findings of the effectiveness study and may inform researchers and policy makers who aim at improving hospital discharge. !!{{ Trial registration number: }} ISRCTN18427377. !!{{ Keywords: }} general medicine (see internal medicine); public health; qualitative research; quality in health care. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162085/ | 8 | 2044-6055 | BMJ Open | [London] : BMJ Publishing Group Ltd | |
| 231014 | 8 | 임상 | Support | Term | support | abstract | None | 31208 | 10.1136/bmjopen-2021-049872 | Implementation of a complex intervention to improve hospital discharge: process evaluation of a cluster randomised controlled trial | Yael Rachamin@@@Thomas Grischott@@@Stefan Neuner-Jehle | 202105 | Article | PMC | {{{ Abstract }}} !!{{ Objectives: }} To study the implementation of a cluster randomised controlled effectiveness-implementation hybrid trial testing the effectiveness of a medication review at hospital discharge combined with a communication stimulus between hospital physicians (HPs) and general practitioners (GPs) on rehospitalisation of multimorbid older patients. !!{{ Design: }} Extension of Grant's mixed method process evaluation framework to trials with multilevel clustering. !!{{ Setting: }} General internal medicine wards in Swiss hospitals. !!{{ Participants: }} Convenience samples of 15 chief physicians (of 21 hospitals participating in the effectiveness trial), 60 (74) senior HPs, 65 (164) junior HPs and 187 (411) GPs. !!{{ Implementation strategy: }} Two-hour teaching sessions for senior HPs on a patient-centred, checklist-guided discharge routine. !!{{ Process evaluation components: }} Data collection on recruitment, delivery and response from chief physicians (semistructured interviews), senior HPs, junior HPs, GPs (surveys) and patients (via HPs). Quantitative data were summarised using descriptive statistics, and interviews analysed using thematic analysis. !!{{ Outcome measures: }} Intervention dose (quantitative), implementation fidelity (qualitative), feasibility and acceptability, facilitators and barriers, implementation support strategies. !!{{ Results: }} Recruitment of hospitals was laborious but successful, with 21 hospitals recruited. Minimal workload and a perceived benefit for the clinic were crucial factors for participation. Intervention dose was high (95% of checklist activities carried out), but intervention fidelity was limited (discharge letters) or unknown (medication review). Recruitment and retention of patients was challenging, partly due to patient characteristics (old, frail) and the COVID-19 pandemic: Only 612 of the anticipated 2100 patients were recruited, and 31% were lost to follow-up within the first month after discharge. The intervention was deemed feasible and helpful by HPs, and the relevance of the topic appreciated by both HPs and GPs. !!{{ Conclusions: }} The results from this evaluation will support interpretation of the findings of the effectiveness study and may inform researchers and policy makers who aim at improving hospital discharge. !!{{ Trial registration number: }} ISRCTN18427377. !!{{ Keywords: }} general medicine (see internal medicine); public health; qualitative research; quality in health care. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162085/ | 8 | 2044-6055 | BMJ Open | [London] : BMJ Publishing Group Ltd | |
| 231771 | 8 | 임상 | disaster | Term | disaster | abstract | 재해 | 31225 | 10.1016/j.nepr.2021.103170 | Responding to a simulated disaster in the virtual or live classroom: Is there a difference in BSN student learning? | Lisa Kirk Wiese@@@Tamara Love@@@Rhonda Goodman | 202108 | Article | PMC | {{{ Abstract }}} !!{{ Aim: }} This study aim was to investigate if prelicensure baccalaureate nursing students gained more knowledge from a live or virtual disaster simulation. The study goal was to inform the use of e-learning or traditional textbooks in undergraduate nursing population health courses. !!{{ Background: }} Weather-related disasters have increased in frequency and severity in the past ten years, with 2020 being the most active storm season ever seen (National Oceanographic and Atmospheric Administration, 2021.) Even with advances in early warning systems and mitigation efforts, educating student nurses in disaster response remains a priority. Due to the impact of Covid-19 quarantine policies, many in-person student learning labs and clinical experiences were cancelled. However, virtual simulation offers an alternative to developing nursing student skills and clinical reasoning ability (Aebersold, 2018; Fogg et al., 2020). !!{{ Design: }} A randomized quasi-experimental, repeated measures 2 × 2 crossover design (Kim, 2018) was applied, which allowed students to participate in both the live and virtual simulations. !!{{ Methods: }} Analysis was conducted using paired samples t-test to evaluate knowledge gains. To measure students' self-assessment of knowledge, Unver et al. (2018) 12-item survey was administered. To explore students' own perceptions about the disaster simulations, semi-structured interview questions were offered through private Wiki postings. The responses were analyzed using Salda?a's in vivo coding (2015) and thematic analysis. !!{{ Results: }} Students retained more empirical knowledge following the virtual assignment as compared to the disaster simulation, except in two items addressing triage. Neither age, years of education, or GPA impacted test results. However, students' own assessment of learning did not differ between live and virtual simulations. In all but three items, students perceived a significant increase (p < .05) in their learning following the simulation, regardless whether it was live or virtual. In narrative responses, students overwhelmingly cited the benefit of an in-person simulation. However, they did not believe that they were prepared adequately for the live simulation. They also expressed that they would be more prepared if the simulation was repeated. Students expressed discomfort, even distress, regarding not being able to care adequately for everyone, even though it was a simulation (See Table 5). This highlighted that live simulations can affect students emotionally, and follow-up debriefing is essential to help in both acknowledging and processing student feelings. !!{{ Conclusion: }} These findings, which support the use of virtual disaster training in nursing education, are especially important in the light of Covid-19 and increasing threat of storm disasters. !!{{ Keywords: }} Disaster training; Live simulation; Quarantine restrictions; Virtual simulation. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8513508/ | 2412 | 1471-5953 | Nurse education in practice | [Edinburgh] : Elsevier Ltd. | |
| 231932 | 8 | 임상 | hypothetical | Term | hypothetical | abstract | None | 31230 | 10.1186/s13584-022-00536-7 | How to boost the boosters? A survey-experiment on the effectiveness of different policies aimed at enhancing acceptance of a Seasonal vaccination against COVID-19 | Talia Goren@@@Itai Beeri@@@Dana Rachel Vashdi | 202207 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} Evidence suggests a gradual decrease in the effectiveness of the anti-COVID-19 vaccines, stressing the potential need for periodical booster shots. However, it is hard to tell whether previously applied policies for enhancing vaccine acceptance will be as effective for repeated periodical booster shots during a pandemic. Hence, this study aims to explore the effectiveness of different health policies on periodical vaccination acceptance amidst an ongoing pandemic. !!{{ Methods: }} A cross sectional online experiment was performed in a representative sample of 929 Israeli citizens. Participants were randomly allocated to 4 groups simulating different hypothetical periodical-vaccination-promoting policy scenarios: (1) Mandate (N = 229); (2) a negative monetary incentive (N = 244); (3) a positive monetary incentive (N = 228) and (4) information provision (N = 228). Compliance intentions and vaccine-acceptance-related variables were measured. Analysis included multivariate hierarchic logistic and linear regressions. !!{{ Results: }} Compliance intentions levels were medium (M = 3.13 on a 1-5 scale). Only 20.2% of the sample demonstrated strong acceptance of periodical vaccination, which is lower than the acceptance rate of the seasonal flu shot in the country in the year preceding the pandemic. Type of policy was related to the extent to which a respondent strongly agreed to be periodically vaccinated or not. Specifically, strong acceptance was more likely when positive or negative incentives were presented in comparison to the mandate or information provision conditions. However, when examining the extent of compliance among respondents who were less decisive, the type of policy did not predict the extent to which these respondents intended to comply. In addition, compliance intentions were related with the perceived benefits and barriers of the vaccine, the perceived efficacy of getting vaccinated and social norms. Hesitator's intentions were additionally associated with anti-COVID-19 vaccination history, perceived severity of the disease and trust in government. !!{{ Conclusions: }} Pandemic-containing vaccines may be perceived as less effective and beneficial than pandemic-preventing vaccines. Individuals with different levels of motivation for periodical vaccination during a pandemic may be affected by different factors. While strongly opinionated individuals are affected by the type of vaccination-promoting policy, hesitators are affected by a larger number of factors, which provide policy makers with greater opportunities to enhance their vaccination intentions. !!{{ Keywords: }} Incentives; On-going pandemic; Periodical vaccination; Vaccination acceptance; Vaccination policies. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9251947/ | 2093 | 2045-4015 | Israel Journal of Health Policy Research | London : BioMed Central. | |
| 231772 | 8 | 임상 | Disaster training | Term | disaster training | author | None | 31225 | 10.1016/j.nepr.2021.103170 | Responding to a simulated disaster in the virtual or live classroom: Is there a difference in BSN student learning? | Lisa Kirk Wiese@@@Tamara Love@@@Rhonda Goodman | 202108 | Article | PMC | {{{ Abstract }}} !!{{ Aim: }} This study aim was to investigate if prelicensure baccalaureate nursing students gained more knowledge from a live or virtual disaster simulation. The study goal was to inform the use of e-learning or traditional textbooks in undergraduate nursing population health courses. !!{{ Background: }} Weather-related disasters have increased in frequency and severity in the past ten years, with 2020 being the most active storm season ever seen (National Oceanographic and Atmospheric Administration, 2021.) Even with advances in early warning systems and mitigation efforts, educating student nurses in disaster response remains a priority. Due to the impact of Covid-19 quarantine policies, many in-person student learning labs and clinical experiences were cancelled. However, virtual simulation offers an alternative to developing nursing student skills and clinical reasoning ability (Aebersold, 2018; Fogg et al., 2020). !!{{ Design: }} A randomized quasi-experimental, repeated measures 2 × 2 crossover design (Kim, 2018) was applied, which allowed students to participate in both the live and virtual simulations. !!{{ Methods: }} Analysis was conducted using paired samples t-test to evaluate knowledge gains. To measure students' self-assessment of knowledge, Unver et al. (2018) 12-item survey was administered. To explore students' own perceptions about the disaster simulations, semi-structured interview questions were offered through private Wiki postings. The responses were analyzed using Salda?a's in vivo coding (2015) and thematic analysis. !!{{ Results: }} Students retained more empirical knowledge following the virtual assignment as compared to the disaster simulation, except in two items addressing triage. Neither age, years of education, or GPA impacted test results. However, students' own assessment of learning did not differ between live and virtual simulations. In all but three items, students perceived a significant increase (p < .05) in their learning following the simulation, regardless whether it was live or virtual. In narrative responses, students overwhelmingly cited the benefit of an in-person simulation. However, they did not believe that they were prepared adequately for the live simulation. They also expressed that they would be more prepared if the simulation was repeated. Students expressed discomfort, even distress, regarding not being able to care adequately for everyone, even though it was a simulation (See Table 5). This highlighted that live simulations can affect students emotionally, and follow-up debriefing is essential to help in both acknowledging and processing student feelings. !!{{ Conclusion: }} These findings, which support the use of virtual disaster training in nursing education, are especially important in the light of Covid-19 and increasing threat of storm disasters. !!{{ Keywords: }} Disaster training; Live simulation; Quarantine restrictions; Virtual simulation. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8513508/ | 2412 | 1471-5953 | Nurse education in practice | [Edinburgh] : Elsevier Ltd. | |
| 245546 | 8 | 임상 | secure | Term | secure | abstract | None | 31581 | 10.1186/s12877-022-03371-2 | Efficacy of care manager-led support for family caregivers of people with dementia during the COVID-19 pandemic: a randomized controlled study | Kana Kazawa@@@Tatsuhiko Kubo@@@Hiroki Ohge@@@Shinya Ishii | 202208 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} A prolonged COVID-19 pandemic could exacerbate the risk of infection and undesirable effects associated with infection control measures of older people with dementia (PWD), and the care burden of families. In this study, we examined the efficacy of care manager-led information provision and practical support for families of older PWD who need care, regarding appropriate infection prevention, prevention of deterioration of cognitive and physical functions, and preparedness in cases of infection spread or infection during the pandemic. !!{{ Methods: }} Fifty-three family members (aged ≥20 years) who were primary caregivers living with older PWD using public long-term care services were enrolled in an one-month randomized controlled trial. This duration was set based on behavior modification theory and with consideration of ethical issue that the most vulnerable people not benefiting from the intervention. The intervention group (IG) received care manager-led information provision and practical support, and the control group (CG) received usual care. Care burden (primary outcome) was measured using the Zarit Caregiver Burden Interview, and secondary outcomes were analyzed using Patient Health Questionnaire-9 (PHQ9), the Fear of COVID-19 Scale, and salivary α-amylase activity. Data were collected at baseline and after 1 month. Multiple regression analysis was conducted to examine the efficacy of the intervention. The participants evaluated the care managers' support. !!{{ Results: }} The participants were randomly divided into IG (n = 27) and CG (n = 26) groups. After the intervention, compared with the CG, there was a decrease in PHQ-9 (β = -.202, p = 0.044) and α-amylase activity in saliva (β = -.265, p = 0.050) in IG. IG also showed an increased fear of COVID-19 after the intervention (β = .261, p = 0.003). With the care managers' support, 57.2% of the participants felt secure in their daily lives and 53.1% agreed that they were able to practice infection prevention suitable for older PWD. !!{{ Conclusions: }} Our findings suggest that the care manager-led intervention may be useful for families of older PWD to enhance behavioral changes in preventing COVID-19 infection and improve their psychological outcomes in the COVID-19 era. !!{{ Trial registration: }} This study was registered on April 2, 2021 (No. UMIN000043820). !!{{ Keywords: }} COVID-19; Care burden; Dementia; Family; Infection control measure; Preparedness. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9376895/ | 536 | 1471-2318 | BMC Geriatrics | London : BioMed Central | |
| 237244 | 8 | 임상 | Diagnosis | Term | diagnosis | abstract | 진단 | 31371 | 10.1007/s10067-021-05759-8 | Ability and willingness to utilize telemedicine among rheumatology patients-a cross-sectional survey | Steve S Kong@@@Lilian A Otalora Rojas@@@Amnie Ashour@@@Mathew Robinson@@@Tyler Hosterman@@@Neha Bhanusali | 202112 | Observational Study | PMC | {{{ Abstract }}} !!{{ Introduction/objectives: }} This study aims to assess the patients' ability and willingness to utilize telemedicine (TM) along with identifying some of the barriers to a more widespread adoption of TM in rheumatology. !!{{ Methods: }} An observational, cross-sectional study of patients visiting a rheumatology clinic was conducted in 2018. We used a survey to assess patients' attitude on the perceived effectiveness when comparing TM versus in-person visits, as well as patients' access to technology, distance traveled by the patient to attend the clinic visit, and demographic parameters. !!{{ Results: }} A total of 214 patients were included. Negative correlations were found between the increase in age and access to technologies (front-facing camera (mean age difference - 12.8), telephone (mean age difference - 14.4), and stable internet connection (mean age difference - 15.1)), as well as believing that their needs could be met through TM (r - .224, p < 0.001) and thinking that TM could be an appropriate alternative method of healthcare (r - .298, p < 0.001). Younger patients reported more conflict between appointments and work hours (mean age difference - 11.73). Follow-up patients were more likely to feel that their visit could have been possible over the phone (mean difference - 1.13) or video conferencing (mean difference - 1.13) compared to new patients. Older patients were less likely to think that the purpose of their rheumatology visits could be achieved over the phone (r - .207, p = 0.003) or video conferencing (r - .331, p = 0.001). The further the distance traveled, the more the patients were willing to utilize TM compared to in-person visits (r 0.167, p = 0.019). !!{{ Conclusion: }} Out of necessity due to the COVID-19 pandemic, rheumatology clinics are increasingly turning to TM. The results of this study suggest that access and familiarity with technology may still be limited in certain demographics, particularly the elderly. Furthermore, this study helps to understand some of the additional barriers to more widespread adoption and patients' perceived limitations of TM. Key Points ? This study aimed to assess rheumatology patients' willingness to utilize telemedicine (TM) while determining the factors and barriers that may exist for a more widespread adoption of TM, using a cross-sectional survey in the setting of a rheumatologic clinic. ? The age of the patient was the most significant contributing factor in a patient's perception of TM, with older patients being less likely to think that the purpose of their rheumatology visits could be achieved over the phone or via videoconferencing. ? The social trend of limited access to technology among the elderly population was reinforced by the results in this study. ? Patients who had a greater commute to the clinic were more likely to willing to utilize TM consultations. ? The results of this study highlight the elevated difficulty elderly patient populations have in utilizing TM. ? With the current outbreak of COVID-19, the importance of utilizing TM specifically among the elderly population could prove vital. Future studies to focus on the elderly population and methods for helping these patients become familiar with TM would be beneficial. ? Studies such as this can help to orchestrate future guidelines for TM in the field of rheumatology. Based on our study results, the new-patient encounter should be an in-person face-to-face encounter whenever possible, followed by TM visits for established patients who are able and open to using it, depending on the diagnosis and symptoms of the individual patients. !!{{ Keywords: }} Rheumatology; Technology; Telemedicine. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8255091/ | 836 | 0770-3198 | Clinical Rheumatology | Heidelberg : Springer. | |
| 232898 | 8 | 임상 | Prevent | Term | prevent | abstract | abnormality | 31255 | 10.1016/j.msard.2022.104003 | COVID-19 infection after two doses of SARS-CoV-2 mRNA vaccine in multiple sclerosis, AQP4-antibody NMOSD and MOGAD | Tianrong Yeo@@@Amy May Lin Quek@@@Kok Pin Yong@@@Janis Siew Noi Tye@@@Pavanni Ratnagopal@@@Derek Tuck Loong Soon@@@Kevin Tan | 202209 | Observational Study | PMC | {{{ Abstract }}} !!{{ Background: }} In pre-vaccinated people with multiple sclerosis (MS), certain disease-modifying therapies (DMTs), particularly the anti-CD20 treatments, appear to be associated with an increased risk of COVID-19 infection and indeed with severe infection. It is still not known if such observations extend to vaccinated individuals and there have been considerably fewer studies in aquaporin-4-antibody neuromyelitis optica spectrum disorder (AQP4-NMOSD) and myelin oligodendrocyte glycoprotein-antibody associated disease (MOGAD) patients. In this study, we investigated the rates of symptomatic COVID-19 infection in adult patients with MS, AQP4-NMOSD and MOGAD who had received 2 doses of SARS-CoV-2 mRNA vaccine. !!{{ Methods: }} This was a prospective observational study conducted at the 2 main neuroimmunology referral centres in Singapore. Only patients on active follow-up were recruited to ensure robust data collection. Data on demographics, disease history, DMTs and SARS-CoV-2 mRNA vaccinations were recorded, and for those infected with COVID-19, data on COVID-19 infection was collected. !!{{ Results: }} Nineteen (13 MS, 5 AQP4-NMOSD, 1 MOGAD) out of 365 (231 MS, 106 AQP4-NMOSD, 28 MOGAD) patients had COVID-19 infection despite 2 doses of SARS-CoV-2 mRNA vaccine. Amongst the infected patients, 11 patients were on DMTs (3 rituximab, 2 interferons, 1 azathioprine, 1 mycophenolate, 1 prednisolone, 1 cladribine, 1 alemtuzumab, 1 fingolimod), while 8 patients were untreated. The crude infection rate was calculated using time-at-risk analysis, revealing that rituximab had the highest infection rate amongst all the DMTs. A lower crude infection rate was observed in patients who received a third vaccination. The majority of infections were mild and no patients required oxygen supplementation. !!{{ Conclusion: }} Our findings suggest that patients on rituximab are still at risk of COVID-19 infection after 2 vaccinations and the receipt of a third vaccination may help to prevent infection. Future large scale studies will be required to better delineate the infection risk of different DMTs after the second and subsequent vaccinations. !!{{ Keywords: }} COVID-19; MOGAD; Multiple sclerosis; Neuromyelitis optica; Vaccination; Vaccine. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9233746/ | 349 | 2211-0348 | Multiple sclerosis and related disorders | [Amsterdam] : Elsevier B. V. | |
| 237252 | 8 | 임상 | helping | Term | helping | abstract | abnormality | 31371 | 10.1007/s10067-021-05759-8 | Ability and willingness to utilize telemedicine among rheumatology patients-a cross-sectional survey | Steve S Kong@@@Lilian A Otalora Rojas@@@Amnie Ashour@@@Mathew Robinson@@@Tyler Hosterman@@@Neha Bhanusali | 202112 | Observational Study | PMC | {{{ Abstract }}} !!{{ Introduction/objectives: }} This study aims to assess the patients' ability and willingness to utilize telemedicine (TM) along with identifying some of the barriers to a more widespread adoption of TM in rheumatology. !!{{ Methods: }} An observational, cross-sectional study of patients visiting a rheumatology clinic was conducted in 2018. We used a survey to assess patients' attitude on the perceived effectiveness when comparing TM versus in-person visits, as well as patients' access to technology, distance traveled by the patient to attend the clinic visit, and demographic parameters. !!{{ Results: }} A total of 214 patients were included. Negative correlations were found between the increase in age and access to technologies (front-facing camera (mean age difference - 12.8), telephone (mean age difference - 14.4), and stable internet connection (mean age difference - 15.1)), as well as believing that their needs could be met through TM (r - .224, p < 0.001) and thinking that TM could be an appropriate alternative method of healthcare (r - .298, p < 0.001). Younger patients reported more conflict between appointments and work hours (mean age difference - 11.73). Follow-up patients were more likely to feel that their visit could have been possible over the phone (mean difference - 1.13) or video conferencing (mean difference - 1.13) compared to new patients. Older patients were less likely to think that the purpose of their rheumatology visits could be achieved over the phone (r - .207, p = 0.003) or video conferencing (r - .331, p = 0.001). The further the distance traveled, the more the patients were willing to utilize TM compared to in-person visits (r 0.167, p = 0.019). !!{{ Conclusion: }} Out of necessity due to the COVID-19 pandemic, rheumatology clinics are increasingly turning to TM. The results of this study suggest that access and familiarity with technology may still be limited in certain demographics, particularly the elderly. Furthermore, this study helps to understand some of the additional barriers to more widespread adoption and patients' perceived limitations of TM. Key Points ? This study aimed to assess rheumatology patients' willingness to utilize telemedicine (TM) while determining the factors and barriers that may exist for a more widespread adoption of TM, using a cross-sectional survey in the setting of a rheumatologic clinic. ? The age of the patient was the most significant contributing factor in a patient's perception of TM, with older patients being less likely to think that the purpose of their rheumatology visits could be achieved over the phone or via videoconferencing. ? The social trend of limited access to technology among the elderly population was reinforced by the results in this study. ? Patients who had a greater commute to the clinic were more likely to willing to utilize TM consultations. ? The results of this study highlight the elevated difficulty elderly patient populations have in utilizing TM. ? With the current outbreak of COVID-19, the importance of utilizing TM specifically among the elderly population could prove vital. Future studies to focus on the elderly population and methods for helping these patients become familiar with TM would be beneficial. ? Studies such as this can help to orchestrate future guidelines for TM in the field of rheumatology. Based on our study results, the new-patient encounter should be an in-person face-to-face encounter whenever possible, followed by TM visits for established patients who are able and open to using it, depending on the diagnosis and symptoms of the individual patients. !!{{ Keywords: }} Rheumatology; Technology; Telemedicine. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8255091/ | 836 | 0770-3198 | Clinical Rheumatology | Heidelberg : Springer. | |
| 236894 | 8 | 임상 | TID | Term | TID | abstract | None | 31363 | 10.1186/s12967-022-03488-3 | Oxaloacetate Treatment For Mental And Physical Fatigue In Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long-COVID fatigue patients: a non-randomized controlled clinical trial | Alan Cash@@@David Lyons Kaufman | 202206 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} There is no approved pharmaceutical intervention for Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS). Fatigue in these patients can last for decades. Long COVID may continue to ME/CFS, and currently, it is estimated that up to 20 million Americans have significant symptoms after COVID, and the most common symptom is fatigue. Anhydrous Enol-Oxaloacetate, (AEO) a nutritional supplement, has been anecdotally reported to relieve physical and mental fatigue and is dimished in ME/CFS patients. Here, we examine the use of higher dosage AEO as a medical food to relieve pathological fatigue. !!{{ Methods: }} ME/CFS and Long-COVID patients were enrolled in an open label dose escalating Proof of Concept non-randomized controlled clinical trial with 500 mg AEO capsules. Control was provided by a historical ME/CFS fatigue trial and supporting meta-analysis study, which showed average improvement with oral placebo using the Chalder Scale of 5.9% improvement from baseline. At baseline, 73.7% of the ME/CFS patients were women, average age was 47 and length of ME/CFS from diagnosis was 8.9 years. The Long-COVID patients were a random group that responded to social media advertising (Face Book) with symptoms for at least 6 months. ME/CFS patients were given separate doses of 500 mg BID (N = 23), 1,000 mg BID (N = 29) and 1000 mg TID (N = 24) AEO for six weeks. Long COVID patients were given 500 mg AEO BID (N = 22) and 1000 mg AEO (N = 21), again over a six-week period. The main outcome measure was to compare baseline scoring with results at 6 weeks with the Chalder Fatigue Score (Likert Scoring) versus historical placebo. The hypothesis being tested was formulated prior to data collection. !!{{ Results: }} 76 ME/CFS patients (73.7% women, median age of 47) showed an average reduction in fatigue at 6 weeks as measured by the Chalder Fatigue Questionnaire of 22.5% to 27.9% from baseline (P < 0.005) (Likert scoring). Both physical and mental fatigue were significantly improved over baseline and historical placebo. Fatigue amelioration in ME/CFS patients increased in a dose dependent manner from 21.7% for 500 mg BID to 27.6% for 1000 mg Oxaloacetate BID to 33.3% for 1000 mg TID. Long COVID patients' fatigue was significantly reduced by up to 46.8% in 6-weeks. !!{{ Conclusions: }} Significant reductions in physical and metal fatigue for ME/CFS and Long-COVID patients were seen after 6 weeks of treatment. As there has been little progress in providing fatigue relief for the millions of ME/CFS and Long COVID patients, anhydrous enol oxaloacetate may bridge this important medical need. Further study of oxaloacetate supplementation for the treatment of ME/CFS and Long COVID is warranted. Trial Registration https://clinicaltrials.gov/ct2/show/NCT04592354 Registered October 19, 2020. 1,000 mg BID Normalized Fatigue Data for Baseline, 2-weeks and 6-weeks evaluated by 3 Validated Fatigue Scoring Questionnaires. !!{{ Keywords: }} Anhydrous enol oxaloacetate; COVID fatigue; Chronic fatigue syndrome; Long COVID; ME/CFS; ME/CFS clinical; ME/CFS treatment; Oxaloacetate; Post viral fatigue. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9238249/ | 78 | 1479-5876 | Journal of Translational Medicine | [London] : BioMed Central | |
| 238542 | 8 | 임상 | Contact | Term | contact | abstract | 접촉 | 31416 | 10.1002/ehf2.13075 | Increased mortality and worse cardiac outcome of acute myocardial infarction during the early COVID-19 pandemic | Uwe Primessnig@@@Burkert M Pieske@@@Mohammad Sherif | 202102 | Observational Study | PMC | {{{ Abstract }}} !!{{ Aims: }} This study aimed to evaluate the impact of coronavirus disease 2019 (Covid-19) outbreak on admissions for acute myocardial infarction (AMI) and related mortality, severity of presentation, major cardiac complications and outcome in a tertiary-care university hospital in Berlin, Germany. !!{{ Methods and results: }} In a single-centre cross-sectional observational study, we included 355 patients with AMI containing ST-elevation or non-ST-elevation myocardial infarction (STEMI or NSTEMI), admitted for emergency cardiac catheterization between January and April 2020 and the equivalent time in 2019. During the early phase of the Covid-19 pandemic (e-COV) in Berlin (March and April 2020), admissions for AMI halved compared with those in the pre-Covid-19 time (January and February 2020; pre-COV) and with those in the corresponding months in 2019. However, mortality for AMI increased substantially from 5.2% pre-COV to 17.7% (P < 0.05) during e-COV. Severity of presentation for AMI was more pronounced during e-COV [increased levels of cardiac enzymes, reduced left ventricular ejection fraction (LVEF), an increase in the need of inotropic support by 25% (P < 0.01)], while patients' demographic and angiographic characteristics did not differ between pre-COV and e-COV. Time from symptom onset to first medical contact was prolonged in all AMI during e-COV (presentation > 72 h +21% in STEMI, p = 0.04 and presentation > 72 h in NSTEMI +22%, p = 0.02). Door to balloon time was similar in STEMI patients, while time from first medical contact to revascularization was significantly delayed in NSTEMI patients (p = 0.02). Major cardiac complications after AMI occurred significantly more often, and cardiac recovery was worse in e-COV than in pre-COV, demonstrated by a significantly lower LVEF (39 ± 16 vs. 46 ± 16, p < 0.05) at hospital discharge and substantially higher NTproBNP levels. !!{{ Conclusions: }} The Covid-19 outbreak affects hospital admissions for acute coronary syndromes. During the first phase of the pandemia, significantly less patients with AMI were admitted, but those admitted presented with a more severe phenotype and had a higher mortality, more complications, and a worse short-term outcome. Therefore, our data indicate that Covid-19 had relevant impact on non-infectious disease states, such as acute coronary syndromes. !!{{ Keywords: }} Acute myocardial infarction; Covid-19; NSTEMI; Percutaneous coronary intervention; SARS-CoV-2; STEMI. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7835606/ | 248 | 2055-5822 | ESC heart failure | [Oxford] : John Wiley & Sons Ltd on behalf of the European Society of Cardiology | |
| 237987 | 8 | 임상 | prospectivo | Term | prospectivo | abstract | None | 31400 | 10.1016/j.medine.2021.02.006 | Outcomes of renal replacement therapy in the critically ill with COVID-19 | E Burke@@@E Haber@@@C W Pike@@@R Sonti | 202108 | Observational Study | PMC | {{{ Abstract in English, Spanish }}} !!{{ Objective: }} To describe outcomes of critically ill patients with COVID-19, particularly the association of renal replacement therapy to mortality. !!{{ Design: }} A single-center prospective observational study was carried out. !!{{ Setting: }} ICU of a tertiary care center. !!{{ Patients: }} Consecutive adults with COVID-19 admitted to the ICU. !!{{ Intervention: }} Renal replacement therapy. !!{{ Main variables of interest: }} Demographic data, medical history, illness severity, type of oxygen therapy, laboratory data and use of renal replacement therapy to generate a logistic regression model describing independent risk factors for mortality. !!{{ Results: }} Of the total of 166 patients, 51% were mechanically ventilated and 26% required renal replacement therapy. The overall hospital mortality rate was 36%, versus 56% for those requiring renal replacement therapy, and 68% for those with both mechanical ventilation and renal replacement therapy. The logistic regression model identified four independent risk factors for mortality: age (adjusted OR 2.8 [95% CI 1.8-4.4] for every 10-year increase), mechanical ventilation (4.2 [1.7-10.6]), need for continuous venovenous hemofiltration (2.3 [1.3-4.0]) and C-reactive protein (1.1 [1.0-1.2] for every 10mg/L increase). !!{{ Conclusions: }} In our cohort, acute kidney injury requiring renal replacement therapy was associated to a high mortality rate similar to that associated to the need for mechanical ventilation, while multiorgan failure necessitating both techniques implied an extremely high mortality risk. !!{{ Objetivo: }} Describir los resultados de pacientes cr?ticamente enfermos con COVID-19, especialmente la asociaci?n de la terapia de reemplazo renal con la mortalidad. !!{{ Dise?o: }} Estudio observacional, prospectivo y unic?ntrico. !!{{ ?mbito: }} En la unidad de cuidados intensivos (UCI) de un centro de atenci?n terciaria. !!{{ Pacientes: }} Pacientes adultos con COVID-19 ingresados de forma consecutiva en la UCI. !!{{ Intervenci?n: }} Administraci?n de terapia de reemplazo renal. !!{{ Variables de inter?s principales: }} Datos demogr?ficos, antecedentes m?dicos, gravedad de la enfermedad, tipo de oxigenoterapia, datos anal?ticos y uso de terapia de reemplazo renal para generar un modelo de regresi?n log?stica que describa factores de riesgo independientes de la mortalidad. !!{{ Resultados: }} De los 166 pacientes, el 51% recibieron ventilaci?n mec?nica (VM) y el 26% requiri? terapia de reemplazo renal (TRR). La mortalidad hospitalaria global fue del 36%, frente al 56% en el caso de los pacientes que requirieron TRR y el 68% en el subconjunto de pacientes que necesit? tanto VM como RTT. Un modelo de regresi?n log?stica se?ala cuatro factores de riesgo independientes de la mortalidad: edad (OR ajustada: 2,8 [IC del 95%: 1,8-4,4] por cada incremento de 10 a?os), ventilaci?n mec?nica (4,2 [1,7-10,6]), necesidad de hemofiltraci?n venovenosa continua (HVVC) (2,3 [1,3-4,0]), y prote?na C reactiva (1,1 [1,0-1,2] por cada incremento de 10 mg/L). !!{{ Conclusiones: }} En nuestra cohorte, la lesi?n renal aguda que necesita TRR se asocia con una mortalidad similarmente elevada a la de los pacientes que requieren VM, y la insuficiencia multiorg?nica que hace necesarias ambas intervenciones se asocia con un riesgo de mortalidad extremadamente alta. !!{{ Keywords: }} ARDS; COVID-19; Reemplazo renal; Renal replacement; SARD. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8294005/ | 907 | 2173-5727 | Medicina intensiva | English ed. [Barcelona?] : Elsevier Espan?a | |
| 238570 | 8 | 임상 | pandemic | Term | pandemic | abstract | 범유행_전염병 | 31416 | 10.1002/ehf2.13075 | Increased mortality and worse cardiac outcome of acute myocardial infarction during the early COVID-19 pandemic | Uwe Primessnig@@@Burkert M Pieske@@@Mohammad Sherif | 202102 | Observational Study | PMC | {{{ Abstract }}} !!{{ Aims: }} This study aimed to evaluate the impact of coronavirus disease 2019 (Covid-19) outbreak on admissions for acute myocardial infarction (AMI) and related mortality, severity of presentation, major cardiac complications and outcome in a tertiary-care university hospital in Berlin, Germany. !!{{ Methods and results: }} In a single-centre cross-sectional observational study, we included 355 patients with AMI containing ST-elevation or non-ST-elevation myocardial infarction (STEMI or NSTEMI), admitted for emergency cardiac catheterization between January and April 2020 and the equivalent time in 2019. During the early phase of the Covid-19 pandemic (e-COV) in Berlin (March and April 2020), admissions for AMI halved compared with those in the pre-Covid-19 time (January and February 2020; pre-COV) and with those in the corresponding months in 2019. However, mortality for AMI increased substantially from 5.2% pre-COV to 17.7% (P < 0.05) during e-COV. Severity of presentation for AMI was more pronounced during e-COV [increased levels of cardiac enzymes, reduced left ventricular ejection fraction (LVEF), an increase in the need of inotropic support by 25% (P < 0.01)], while patients' demographic and angiographic characteristics did not differ between pre-COV and e-COV. Time from symptom onset to first medical contact was prolonged in all AMI during e-COV (presentation > 72 h +21% in STEMI, p = 0.04 and presentation > 72 h in NSTEMI +22%, p = 0.02). Door to balloon time was similar in STEMI patients, while time from first medical contact to revascularization was significantly delayed in NSTEMI patients (p = 0.02). Major cardiac complications after AMI occurred significantly more often, and cardiac recovery was worse in e-COV than in pre-COV, demonstrated by a significantly lower LVEF (39 ± 16 vs. 46 ± 16, p < 0.05) at hospital discharge and substantially higher NTproBNP levels. !!{{ Conclusions: }} The Covid-19 outbreak affects hospital admissions for acute coronary syndromes. During the first phase of the pandemia, significantly less patients with AMI were admitted, but those admitted presented with a more severe phenotype and had a higher mortality, more complications, and a worse short-term outcome. Therefore, our data indicate that Covid-19 had relevant impact on non-infectious disease states, such as acute coronary syndromes. !!{{ Keywords: }} Acute myocardial infarction; Covid-19; NSTEMI; Percutaneous coronary intervention; SARS-CoV-2; STEMI. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7835606/ | 248 | 2055-5822 | ESC heart failure | [Oxford] : John Wiley & Sons Ltd on behalf of the European Society of Cardiology | |
| 244177 | 8 | 임상 | Psychological distress | Term | psychological distress | abstract | 심리적 고통 | 31548 | 10.1016/S2215-0366(21)00074-2 | Maternal depressive and anxiety symptoms before and during the COVID-19 pandemic in Canada: a longitudinal analysis | Nicole Racine@@@Erin Hetherington@@@Brae Anne McArthur@@@Sheila McDonald@@@Sarah Edwards@@@Suzanne Tough@@@Sheri Madigan | 202105 | Observational Study | PMC | {{{ Abstract }}} !!{{ Background: }} Parents have faced substantial social and economic challenges during the COVID-19 pandemic. Preliminary cross-sectional research has demonstrated increases in mental health problems in mothers during the COVID-19 pandemic compared with pre-pandemic estimates. We aimed to study an existing longitudinal cohort of mothers to assess changes in the prevalence of maternal depression and anxiety symptoms as a result of the COVID-19 pandemic over time and at the individual level. !!{{ Methods: }} In this longitudinal observational study, women who took part in the All Our Families pregnancy cohort in Canada were invited to complete a COVID-19 impact survey between May 20 and July 15, 2020. Women who had not agreed to additional research, had discontinued, were lost to follow-up, or who were not contactable via email were excluded. Maternal depression and anxiety symptoms during the COVID-19 pandemic were compared with three previous estimates collected at 3, 5, and 8-year timepoints (between April, 2012, and October, 2019). Depression symptoms were assessed using the 10-item Center for Epidemiological Studies Depression scale and anxiety symptoms were assessed using the short form of the Spielberger State-Trait Anxiety Inventory. Repeated cross-sectional analyses were done to assess temporal trends and fixed-effects regression models were fitted to assess within-person change over time. !!{{ Findings: }} Of the 3387 women included in the All Our Families study, 2445 women were eligible and were invited to participate in the COVID-19 impact study, of whom 1333 consented to participate, and 1301 were included in the longitudinal analysis. At the COVID-19 impact survey timepoint, a higher proportion of mothers had clinically significant depression (35·21%, 95% CI 32·48-38·04) and anxiety symptoms (31·39%, 28·76-34·15) than at all previous data collection timepoints. The mean depression score (8·31, 95% CI 7·97-8·65) and anxiety score (11·90, 11·66-12·13) at the COVID-19 pandemic timepoint were higher than previous data collection waves at the 3-year timepoint (mean depression score 5·05, 4·85-5·25; mean anxiety score 9·51, 9·35-9·66), 5-year timepoint (mean depression score 5·43, 5·20-5·66; mean anxiety score 9·49, 9·33-9·65), and 8-year timepoint (mean depression score 5·79, 5·55-6·02; mean anxiety score 10·26, 10·10-10·42). For the within-person comparisons, depression scores were a mean of 2·30 points (95% CI 1·95-2·65) higher and anxiety scores were a mean of 1·04 points (0·65-1·43) higher at the COVID-19 pandemic timepoint, after controlling for time trends. Larger increases in depression and anxiety symptoms were observed for women who had income disruptions, difficulty balancing home schooling with work responsibilities, and those with difficulty obtaining childcare. White mothers had greater increases in anxiety scores than non-white mothers and health-care workers had smaller increases in depressive symptoms than non-health-care workers. !!{{ Interpretation: }} Compared with previous estimates, the prevalence of maternal depression and anxiety among mothers in a Canadian cohort increased during the COVID-19 pandemic. Financial support, childcare provision, and avoiding the closure of schools, might be key priorities for preventing future increases in maternal psychological distress. !!{{ Funding: }} Alberta Innovates Health Solutions Interdisciplinary Team, Canadian Institutes of Health Research, Alberta Innovates, and Alberta Children's Hospital Foundation. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8824360/ | 2392 | 2215-0366 | The lancet. Psychiatry | Kidlington, Oxford : Elsevier | |
| 248686 | 8 | 임상 | Inspection | Term | inspection | abstract | None | 31664 | 10.1111/acem.14348 | The impact of COVID-19 on the sensitivity of D-dimer for pulmonary embolism | Samuel J Elberts@@@Ryan Bateman@@@Alexandra Koutsoubis@@@Kory S London@@@Jennifer L White@@@J Matthew Fields | 202110 | Observational Study | PMC | {{{ Abstract }}} !!{{ Objective: }} This study seeks to evaluate the test characteristics of D-dimer for pulmonary embolism (PE) in patients with a concurrent diagnosis of COVID-19. We hypothesized that the sensitivity of D-dimer for PE at current institutional cut points would be similar to those without COVID-19. !!{{ Methods: }} This is a multicenter retrospective observational cohort study across five urban and suburban EDs in the same health care system. The electronic health record was queried for all computed tomography pulmonary angiography (CTPA) studies from December 1, 2019, to October 22, 2020. All ED patients who underwent CTPA had D-dimer and COVID-19 testing completed in a single encounter were included in the study. Baseline demographics were obtained. Test characteristics of D-dimer for PE were calculated for patients with and without COVID-19. Additionally, receiver operator characteristics (ROC) curves were constructed for two different D-dimer assays. !!{{ Results: }} There were 1158 patient encounters that met criteria for analysis. Performance of D-dimer testing for PE was similar between COVID-19-positive and -negative patients. In COVID-19-positive patients, the sensitivity was 100% (95% confidence interval [CI] = 87.6%-100%), specificity was 11.9% (95% CI = 7.9%-17.1%), and negative predictive value (NPV) was 100%. In COVID-19-negative patients the sensitivity was 97.6% (95% CI = 91.5%-99.7%), specificity was 14.4% (95% CI = 12.1%-17%), and NPV was 98.3% (95% CI = 93.8%-99.6%). For assay 1 the area under the curve (AUC) for COVID-19-positive patients was 0.76 (95% CI = 0.68-0.83), and for COVID-19-negative patients, 0.73 (95% CI = 0.69-0.77). For assay 2, AUC for COVID-19-positive patients was 0.85 (95% CI = 0.77-0.92), and for COVID-19-negative patients, 0.80 (95% CI = 0.77-0.84). Inspection of the ROC curve for assay 1 revealed that 100% sensitivity was maintained up to a threshold of 0.67 FEU (fibrinogen equivalent units; from 0.50 FEU) with an increase in specificity to 29% (from 18.7%), and for assay 2, 100% sensitivity was maintained up to a threshold of 662 D-dimer units (DDU; from 230 DDU) with an increased specificity to 59% (from 6.1%). !!{{ Conclusion: }} Results from this multicenter retrospective study did not find a significant difference in sensitivity of D-dimer for PE due to concomitant COVID-19 infection. Further study is required to determine if PE can safely be excluded based on D-dimer results alone in patients with suspected or proven COVID-19 or if adjusted D-dimer levels could have a role in management. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8653093/ | 1281 | 1069-6563 | Academic emergency medicine : official journal of | Hoboken, N.J. : Wiley. | |
| 240150 | 8 | 임상 | adjusted hazard ratio | Term | adjusted hazard ratio | abstract | None | 31482 | 10.1001/jama.2021.11035 | Association Between BNT162b2 Vaccination and Incidence of SARS-CoV-2 Infection in Pregnant Women | Inbal Goldshtein@@@Daniel Nevo@@@David M Steinberg@@@Ran S Rotem@@@Malka Gorfine@@@Gabriel Chodick@@@Yaakov Segal | 202108 | Observational Study | PMC | {{{ Abstract }}} !!{{ Importance: }} Data on BNT162b2 messenger RNA (mRNA) vaccine (Pfizer-BioNTech) effectiveness and safety in pregnancy are currently lacking because pregnant women were excluded from the phase 3 trial. !!{{ Objective: }} To assess the association between receipt of BNT162b2 mRNA vaccine and risk of SARS-CoV-2 infection among pregnant women. !!{{ Design, setting, and participants: }} This was a retrospective cohort study within the pregnancy registry of a large state-mandated health care organization in Israel. Pregnant women vaccinated with a first dose from December 19, 2020, through February 28, 2021, were 1:1 matched to unvaccinated women by age, gestational age, residential area, population subgroup, parity, and influenza immunization status. Follow-up ended on April 11, 2021. !!{{ Exposures: }} Exposure was defined by receipt of the BNT162b2 mRNA vaccine. To maintain comparability, nonexposed women who were subsequently vaccinated were censored 10 days after their exposure, along with their matched pair. !!{{ Main outcomes and measures: }} The primary outcome was polymerase chain reaction-validated SARS-CoV-2 infection at 28 days or more after the first vaccine dose. !!{{ Results: }} The cohort included 7530 vaccinated and 7530 matched unvaccinated women, 46% and 33% in the second and third trimester, respectively, with a mean age of 31.1 years (SD, 4.9 years). The median follow-up for the primary outcome was 37 days (interquartile range, 21-54 days; range, 0-70). There were 118 SARS-CoV-2 infections in the vaccinated group and 202 in the unvaccinated group. Among infected women, 88 of 105 (83.8%) were symptomatic in the vaccinated group vs 149 of 179 (83.2%) in the unvaccinated group (P ≥ .99). During 28 to 70 days of follow-up, there were 10 infections in the vaccinated group and 46 in the unvaccinated group. The hazards of infection were 0.33% vs 1.64% in the vaccinated and unvaccinated groups, respectively, representing an absolute difference of 1.31% (95% CI, 0.89%-1.74%), with an adjusted hazard ratio of 0.22 (95% CI, 0.11-0.43). Vaccine-related adverse events were reported by 68 patients; none was severe. The most commonly reported symptoms were headache (n = 10, 0.1%), general weakness (n = 8, 0.1%), nonspecified pain (n = 6, <0.1%), and stomachache (n = 5, <0.1%). !!{{ Conclusions and relevance: }} In this retrospective cohort study of pregnant women, BNT162b2 mRNA vaccination compared with no vaccination was associated with a significantly lower risk of SARS-CoV-2 infection. Interpretation of study findings is limited by the observational design. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276131/ | 1093 | 0098-7484 | JAMA | Chicago : American Medical Association | |
| 240480 | 8 | 임상 | evaluate | Action | evaluate | abstract | None | 31462 | 10.1016/j.clnesp.2021.06.016 | Energy requirements of long-term ventilated COVID-19 patients with resolved SARS-CoV-2 infection | Janusz von Renesse@@@Simone von Bonin@@@Hanns-Christoph Held@@@Ralph Schneider@@@Adrian M Seifert@@@Lena Seifert@@@Peter Spieth@@@J?rgen Weitz@@@Thilo Welsch@@@Ronny Meisterfeld | 202108 | Observational Study | PMC | {{{ Abstract }}} !!{{ Background & aims: }} Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection can rapidly progress into acute respiratory distress syndrome accompanied by multi-organ failure requiring invasive mechanical ventilation and critical care treatment. Nutritional therapy is a fundamental pillar in the management of hospitalized patients. It is broadly acknowledged that overfeeding and underfeeding of intensive care unit (ICU) patients are associated with increased morbidity and mortality. This study aimed to assess the energy demands of long-term ventilated COVID-19 patients using indirect calorimetry and to evaluate the applicability of established predictive equations to estimate their energy expenditure. !!{{ Methods: }} We performed a retrospective, single-center study in 26 mechanically ventilated COVID-19 patients with resolved SARS-CoV-2 infection in three independent intensive care units. Resting energy expenditure (REE) was evaluated by repetitive indirect calorimetry (IC) measurements. Simultaneously the performance of 12 predictive equations was examined. Patient's clinical data were retrieved from electronic medical charts. Bland-Altman plots were used to assess agreement between measured and calculated REE. !!{{ Results: }} Mean mREE was 1687 kcal/day and 20.0 kcal relative to actual body weight (ABW) per day (kcal/kg/day). Longitudinal mean mREE did not change significantly over time, although mREE values had a high dispersion (SD of mREE ±487). Obese individuals were found to have significantly increased mREE, but lower energy expenditure relative to their body mass. Calculated REE showed poor agreement with mREE ranging from 33 to 54%. !!{{ Conclusion: }} Resolution of SARS-CoV-2 infection confirmed by negative PCR leads to stabilization of energy demands at an average 20 kcal/kg in ventilated critically ill patients. Due to high variations in mREE and low agreement with calculated energy expenditure IC remains the gold standard for the guidance of nutritional therapy. !!{{ Keywords: }} COVID-19; Critical care; Energy expenditure; Indirect calorimetry; Predictive equations; SARS-CoV-2. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238638/ | 314 | 2405-4577 | Clinical nutrition ESPEN | [Oxford] : Elsevier Ltd. | |
| 241618 | 8 | 임상 | the disease | Disease | the disease | abstract | None | 31491 | 10.1016/j.recot.2020.07.008 | Telephone consultation service in orthopedics during COVID-19 pandemic | S M Miguela ?lvarez@@@A Bartra Ylla@@@J Salvador Carre?o@@@P Castill?n@@@C Garc?a Cardona@@@F Angl?s Crespo | 202105 | Observational Study | PMC | {{{ Abstract }}} !!{{ Background and aim: }} The current COVID-19 pandemic scenario has driven surgical departments to a transformation. The worldwide spread of the disease has led to a public health quarantine where health care professionals are at high risk of infection. In this context, telemedicine has been promoted and scaled up to reduce the risk of transmission. This study aims to demonstrate that a combined framework based on telematics and in-person clinical encounter not only ensures medical care but the safety of healthcare professionals and patients. !!{{ Material and method: }} Descriptive observational study on the follow-up of patients during the COVID19 Pandemic, combining telephone and traditional. !!{{ Results: }} A total of 5031 telephone calls were made, differentiating between medical referrals, specialized primary care visits, and outpatient consultation. They were classified as successful, required an in-person visit, or no successful telephone contact. Furthermore, we divided them into 2 groups: resolved and unresolved. 53% of all telematic visits were successful. !!{{ Conclusions: }} Telematic medical systems are a feasible option in a orthopedics department and an interesting resource to preserve once the pandemic is resolved. Future lines of research should be opened to improve system success, analyze its cost-effectiveness ratio, and correct any legal conflicts that may exist. !!{{ Keywords: }} COVID-19; Consultas; Consultations; Telef?nica; Telemedicina; Telemedicine; Telephone; Visitas; Visits. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7832733/ | 2434 | Rev Esp Cir Ortop Traumatol (Engl Ed) | Ediciones Doyma, S.L. | ||
| 243658 | 8 | 임상 | outcomes | Term | outcome | abstract | 결과 | 31538 | 10.1016/j.jstrokecerebrovasdis.2022.106306 | Management and Outcomes of COVID - 19 Associated Cerebral Venous Sinus Thrombosis | Angel Miraclin T@@@Dr Sanjith Aaron@@@Ajith Sivadasan@@@Kenneth Benjamin@@@Vanjare Harshad@@@Shalini Nair@@@Kpp Abhilash@@@Prabhakar At@@@Vivek Mathew | 202204 | Observational Study | PMC | {{{ Abstract }}} !!{{ Background: }} Systemic hyper-coagulabilty leading to micro and macro thrombosis is a known complication of Coronavirus disease - 2019(COVID -19). The postulated mechanism appears to be the viral activation of endothelium, triggering the coagulation pathways. Thrombosis of the cerebral veins and sinuses (CVT), a potentially serious condition, has been increasingly reported with COVID - 19 infection. In this clinical study we attempt to describe the clinical profile, investigations and outcomes of patients with COVID- 19 associated CVT. !!{{ Methods: }} This is a single center prospective observational study from South India. The study included patients (aged >18 years) with concomitant COVID infection and CVT. The clinical, laboratory, imaging characteristics, management and outcomes were described and compared with COVID negative CVT patients. !!{{ Results: }} Out of 97 cases of CVT treated at our center during the first and second waves of the COVID pandemic 11/97 (11%) were COVID related CVT. Among these 11 patients, 9 (81%) had presented with only CVT related symptoms and signs and were tested positive for COVID - 19 infection during the pre-hospitalization screening. Respiratory symptoms were absent in 90% of the patients. Headache (100%) and seizures (90%) were the common presenting symptoms. The median time to diagnosis was 6 hours, from presentation to the emergency department. Transverse sinus was involved 10/11 (90%) and majority of them (9/11) had Haemorrhagic Venous Infarction (HVI). Acute inflammatory markers were elevated in comparison with non COVID CVT patients, with the mean serum D-dimer being 2462.75 ng/ml and the C-reactive protein was 64.5 mg/dl. Three patients (30%) underwent decompressive hemicraniectomy (DHC) because of large hemispheric HVI. All patients survived in the COVID CVT group while the mortality in the non COVID group was 4%. At 6 months follow up excellent outcome (modified Rankin Scale (mRS) score of 0-2) was noted equally in both groups. !!{{ Conclusions: }} Symptoms and signs of CVT may be the only presentation of COVID-19 infection. Prompt recognition and aggressive medical management including DHC offers excellent outcomes. !!{{ Keywords: }} COVID-19; Cerebral venous thrombosis; Decompressive hemicraniectomy. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8743463/ | 1162 | 1052-3057 | Journal of stroke and cerebrovascular diseases : t | Philadelphia, PA : Saunders. | |
| 243623 | 8 | 임상 | Support | Term | support | abstract | None | 31537 | 10.1016/j.ijcard.2020.09.062 | The role of anti-hypertensive treatment, comorbidities and early introduction of LMWH in the setting of COVID-19: A retrospective, observational study in Northern Italy | Antonio Desai@@@Giuseppe Voza@@@Silvia Paiardi@@@Francesca Ilaria Teofilo@@@Giuseppe Caltagirone@@@Marta Ripoll Pons@@@Monia Aloise@@@Maria Kogan@@@Tobia Tommasini@@@Victor Savevski@@@Giulio Stefanini@@@Claudio Angelini@@@Michele Ciccarelli@@@Salvatore Badalamenti@@@Ana Lleo De Nalda@@@Alessio Aghemo@@@Maurizio Cecconi@@@Filippo Martinelli Boneschi@@@Antonio Voza@@@Humanitas COVID-19 task force | 202102 | Observational Study | PMC | {{{ Abstract }}} !!{{ Background: }} There is a great deal of debate about the role of cardiovascular comorbidities and the chronic use of antihypertensive agents (such as ACE-I and ARBs) on mortality on COVID-19 patients. Of note, ACE2 is responsible for the host cell entry of the virus. !!{{ Methods: }} We extracted data on 575 consecutive patients with laboratory-confirmed SARS-CoV-2 infection admitted to the Emergency Department (ED) of Humanitas Center, between February 21 and April 14, 2020. The aim of the study was to evaluate the role of chronic treatment with ACE-I or ARBs and other clinical predictors on in-hospital mortality in a cohort of COVID-19 patients. !!{{ Results: }} Multivariate analysis showed that a chronic intake of ACE-I was associated with a trend in reduction of mortality (OR: 0.53; 95% CI: 0.27-1.03; p = 0.06), differently from a chronic intake of ARB (OR: 1.1; 95% CI: 0.5-2.8; p=0.8). Increased age (ORs ranging from 3.4 to 25.2 and to 39.5 for 60-70, 70-80 and >80 years vs <60) and cardiovascular comorbidities (OR: 1.90; 95% CI: 1.1-3.3; p = 0.02) were confirmed as important risk factors for COVID-19 mortality. Timely treatment with low-molecular-weight heparin (LMWH) in ED was found to be protective (OR: 0.36; 95% CI: 0.21-0.62; p < 0.0001). !!{{ Conclusions: }} This study can contribute to understand the reasons behind the high mortality rate of patients in Lombardy, a region which accounts for >50% of total Italian deaths. Based on our findings, we support that daily intake of antihypertensive medications in the setting of COVID-19 should not be discontinued and that a timely LMWH administration in ED has shown to decrease in-hospital mortality. !!{{ Keywords: }} ACE-I; ARBs; Cardiovascular; Epidemiology; Hypertension; RAAS. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7516574/ | 1248 | 0167-5273 | International journal of cardiology | Amsterdam : Elsevier. | |
| 245534 | 8 | 임상 | Primary outcome | Term | primary outcome | abstract | None | 31581 | 10.1186/s12877-022-03371-2 | Efficacy of care manager-led support for family caregivers of people with dementia during the COVID-19 pandemic: a randomized controlled study | Kana Kazawa@@@Tatsuhiko Kubo@@@Hiroki Ohge@@@Shinya Ishii | 202208 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} A prolonged COVID-19 pandemic could exacerbate the risk of infection and undesirable effects associated with infection control measures of older people with dementia (PWD), and the care burden of families. In this study, we examined the efficacy of care manager-led information provision and practical support for families of older PWD who need care, regarding appropriate infection prevention, prevention of deterioration of cognitive and physical functions, and preparedness in cases of infection spread or infection during the pandemic. !!{{ Methods: }} Fifty-three family members (aged ≥20 years) who were primary caregivers living with older PWD using public long-term care services were enrolled in an one-month randomized controlled trial. This duration was set based on behavior modification theory and with consideration of ethical issue that the most vulnerable people not benefiting from the intervention. The intervention group (IG) received care manager-led information provision and practical support, and the control group (CG) received usual care. Care burden (primary outcome) was measured using the Zarit Caregiver Burden Interview, and secondary outcomes were analyzed using Patient Health Questionnaire-9 (PHQ9), the Fear of COVID-19 Scale, and salivary α-amylase activity. Data were collected at baseline and after 1 month. Multiple regression analysis was conducted to examine the efficacy of the intervention. The participants evaluated the care managers' support. !!{{ Results: }} The participants were randomly divided into IG (n = 27) and CG (n = 26) groups. After the intervention, compared with the CG, there was a decrease in PHQ-9 (β = -.202, p = 0.044) and α-amylase activity in saliva (β = -.265, p = 0.050) in IG. IG also showed an increased fear of COVID-19 after the intervention (β = .261, p = 0.003). With the care managers' support, 57.2% of the participants felt secure in their daily lives and 53.1% agreed that they were able to practice infection prevention suitable for older PWD. !!{{ Conclusions: }} Our findings suggest that the care manager-led intervention may be useful for families of older PWD to enhance behavioral changes in preventing COVID-19 infection and improve their psychological outcomes in the COVID-19 era. !!{{ Trial registration: }} This study was registered on April 2, 2021 (No. UMIN000043820). !!{{ Keywords: }} COVID-19; Care burden; Dementia; Family; Infection control measure; Preparedness. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9376895/ | 536 | 1471-2318 | BMC Geriatrics | London : BioMed Central | |
| 244268 | 8 | 임상 | remained | Action | remained | abstract | None | 31550 | 10.1136/bmjopen-2021-058205 | Trends in bacterial sepsis incidence and mortality in France between 2015 and 2019 based on National Health Data System (Syst?me National des donn?es de Sant? (SNDS)): a retrospective observational study | Fanny Pandolfi@@@Didier Guillemot@@@Laurence Watier@@@Christian Brun-Buisson | 202205 | Observational Study | PMC | {{{ Abstract }}} !!{{ Objective: }} This study aims to provide a case definition of sepsis of presumed bacterial aetiology based on 10th revision of the International Classification of Diseases (ICD-10) codes, to assess trends in sepsis incidence and mortality between 2015 and 2019 in France, and to describe the characteristics of affected patients and hospital stays. !!{{ Design: }} Nationwide, population-based, retrospective observational study. !!{{ Setting: }} Metropolitan France between 2015 and 2019. !!{{ Participants: }} Between 2015 and 2019, 1 224 433 patients with sepsis of presumed bacterial aetiology were selected from the French National Hospital Discharge Database (Programme de M?dicalisation des Syst?mes d'Information) and were identified from corresponding ICD-10 codes for explicit sepsis or implicit sepsis. !!{{ Main outcomes measures: }} Annual overall and age-specific and gender-specific incidence and 95% CI, as well as trends in sepsis incidence and mortality, were estimated. Comorbidities, length of hospital stay and outcomes were described. !!{{ Results: }} The sex-standardised and age-standardised incidence per 100 000 (95% CI) increased from 357 (356.0 to 359.0) in 2015 to 403 (401.9 to 405.0) in 2019 and remained higher for males compared with females. Children under 1 year and patients over 75 years consistently had the highest incidence. The most common comorbidities were cancer and chronic heart failure. The median hospital length of stay was 12 days. Most patients came from home, but only half returned home after their hospital stay and approximately 15% were discharged to long-term care. In-hospital mortality was about 25% and declined along the study period. !!{{ Conclusions: }} Medico-administrative databases can be used to provide nationwide estimates of the in-hospital burden of bacterial sepsis. The results confirm the high burden of sepsis in France. These data should be complemented by estimating the additional burden associated with fungal and viral infections during the COVID-19 pandemic. !!{{ Keywords: }} epidemiology; infectious diseases; intensive & critical care; public health. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9125708/ | 8 | 2044-6055 | BMJ Open | [London] : BMJ Publishing Group Ltd | |
| 244392 | 8 | 임상 | randomised controlled trial | Term | randomised controlled trial | title,abstract | 무작위 대조 시험 | 31553 | 10.1136/thoraxjnl-2021-217382 | A telerehabilitation programme in post-discharge COVID-19 patients (TERECO): a randomised controlled trial | Jian'an Li@@@Wenguang Xia@@@Chao Zhan@@@Shouguo Liu@@@Zhifei Yin@@@Jiayue Wang@@@Yufei Chong@@@Chanjuan Zheng@@@Xiaoming Fang@@@Wei Cheng@@@Jan D Reinhardt | 202207 | Article | PMC | {{{ Abstract }}} !!{{ Objectives: }} To investigate superiority of a telerehabilitation programme for COVID-19 (TERECO) over no rehabilitation with regard to exercise capacity, lower limb muscle strength (LMS), pulmonary function, health-related quality of life (HRQOL) and dyspnoea. !!{{ Design: }} Parallel-group randomised controlled trial with 1:1 block randomisation. !!{{ Setting: }} Three major hospitals from Jiangsu and Hubei provinces, China. !!{{ Participants: }} 120 formerly hospitalised COVID-19 survivors with remaining dyspnoea complaints were randomised with 61 allocated to control and 59 to TERECO. !!{{ Intervention: }} Unsupervised home-based 6-week exercise programme comprising breathing control and thoracic expansion, aerobic exercise and LMS exercise, delivered via smartphone, and remotely monitored with heart rate telemetry. !!{{ Outcomes: }} Primary outcome was 6 min walking distance (6MWD) in metres. Secondary outcomes were squat time in seconds; pulmonary function assessed by spirometry; HRQOL measured with Short Form Health Survey-12 (SF-12) and mMRC-dyspnoea. Outcomes were assessed at 6 weeks (post-treatment) and 28 weeks (follow-up). !!{{ Results: }} Adjusted between-group difference in change in 6MWD was 65.45 m (95% CI 43.8 to 87.1; p<0.001) at post-treatment and 68.62 m (95% CI 46.39 to 90.85; p<0.001) at follow-up. Treatment effects for LMS were 20.12 s (95% CI 12.34 to 27.9; p<0.001) post-treatment and 22.23 s (95% CI 14.24 to 30.21; p<0.001) at follow-up. No group differences were found for lung function except post-treatment maximum voluntary ventilation. Increase in SF-12 physical component was greater in the TERECO group with treatment effects estimated as 3.79 (95% CI 1.24 to 6.35; p=0.004) at post-treatment and 2.69 (95% CI 0.06 to 5.32; p=0.045) at follow-up. !!{{ Conclusions: }} This trial demonstrated superiority of TERECO over no rehabilitation for 6MWD, LMS, and physical HRQOL. !!{{ Trial registration number: }} ChiCTR2000031834. !!{{ Keywords: }} COVID-19; pulmonary rehabilitation. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8318721/ | 1149 | 0040-6376 | Thorax | London : British Medical Assn. | 2.309 |
| 245542 | 8 | 임상 | Saliva | Term | saliva | abstract | 타액 | 31581 | 10.1186/s12877-022-03371-2 | Efficacy of care manager-led support for family caregivers of people with dementia during the COVID-19 pandemic: a randomized controlled study | Kana Kazawa@@@Tatsuhiko Kubo@@@Hiroki Ohge@@@Shinya Ishii | 202208 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} A prolonged COVID-19 pandemic could exacerbate the risk of infection and undesirable effects associated with infection control measures of older people with dementia (PWD), and the care burden of families. In this study, we examined the efficacy of care manager-led information provision and practical support for families of older PWD who need care, regarding appropriate infection prevention, prevention of deterioration of cognitive and physical functions, and preparedness in cases of infection spread or infection during the pandemic. !!{{ Methods: }} Fifty-three family members (aged ≥20 years) who were primary caregivers living with older PWD using public long-term care services were enrolled in an one-month randomized controlled trial. This duration was set based on behavior modification theory and with consideration of ethical issue that the most vulnerable people not benefiting from the intervention. The intervention group (IG) received care manager-led information provision and practical support, and the control group (CG) received usual care. Care burden (primary outcome) was measured using the Zarit Caregiver Burden Interview, and secondary outcomes were analyzed using Patient Health Questionnaire-9 (PHQ9), the Fear of COVID-19 Scale, and salivary α-amylase activity. Data were collected at baseline and after 1 month. Multiple regression analysis was conducted to examine the efficacy of the intervention. The participants evaluated the care managers' support. !!{{ Results: }} The participants were randomly divided into IG (n = 27) and CG (n = 26) groups. After the intervention, compared with the CG, there was a decrease in PHQ-9 (β = -.202, p = 0.044) and α-amylase activity in saliva (β = -.265, p = 0.050) in IG. IG also showed an increased fear of COVID-19 after the intervention (β = .261, p = 0.003). With the care managers' support, 57.2% of the participants felt secure in their daily lives and 53.1% agreed that they were able to practice infection prevention suitable for older PWD. !!{{ Conclusions: }} Our findings suggest that the care manager-led intervention may be useful for families of older PWD to enhance behavioral changes in preventing COVID-19 infection and improve their psychological outcomes in the COVID-19 era. !!{{ Trial registration: }} This study was registered on April 2, 2021 (No. UMIN000043820). !!{{ Keywords: }} COVID-19; Care burden; Dementia; Family; Infection control measure; Preparedness. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9376895/ | 536 | 1471-2318 | BMC Geriatrics | London : BioMed Central | |
| 244752 | 8 | 임상 | therapeutic approache | Term | therapeutic approache | abstract | None | 31562 | 10.1136/bmjopen-2020-042825 | CBmeter study: protocol for assessing the predictive value of peripheral chemoreceptor overactivation for metabolic diseases | Marlene Lages@@@Lucinda Carvalho@@@Salvato Feij?@@@Alexandra Vieira@@@Rui Fonseca-Pinto@@@Maria Pedro Guarino | 202108 | Clinical Trial | PMC | {{{ Abstract }}} !!{{ Introduction: }} Early screening of metabolic diseases is crucial since continued undiagnostic places an ever-increasing burden on healthcare systems. Recent studies suggest a link between overactivated carotid bodies (CB) and the genesis of type 2 diabetes mellitus. The non-invasive assessment of CB activity by measuring ventilatory, cardiac and metabolic responses to challenge tests may have predictive value for metabolic diseases; however, there are no commercially available devices that assess CB activity. The findings of the CBmeter study will clarify the role of the CBs in the genesis of-metabolic diseases and guide the development of new therapeutic approaches for early intervention in metabolic disturbances. Results may also contribute to patient classification and stratification for future CB modulatory interventions. !!{{ Methods: }} This is a non-randomised, multicentric, controlled clinical study. Forty participants (20 control and 20 diabetics) will be recruited from secondary and primary healthcare settings. The primary objective is to establish a new model of early diagnosis of metabolic diseases based on the respiratory and metabolic responses to transient 100% oxygen administration and ingestion of a standardised mixed meal. !!{{ Analysis: }} Raw data acquired with the CBmeter will be endorsed against gold standard techniques for heart rate, respiratory rate, oxygen saturation and interstitial glucose quantification and analysed a multivariate analysis software developed specifically for the CBmeter study (CBview). Data will be analysed using clustering analysis and artificial intelligence methods based on unsupervised learning algorithms, to establish the predictive value of diabetes diagnosis. !!{{ Ethics: }} The study was approved by the Ethics Committee of the Leiria Hospital Centre. Patients will be asked for written informed consent and data will be coded to ensure the anonymity of data. !!{{ Dissemination: }} Results will be disseminated through publication in peer-reviewed journals and relevant medical and health conferences. !!{{ Keywords: }} health informatics; physiology; protocols & guidelines. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8395299/ | 8 | 2044-6055 | BMJ Open | [London] : BMJ Publishing Group Ltd | |
| 246014 | 8 | 임상 | Course | Term | course | title | abnormality | 31597 | 10.1007/s00101-020-00862-y | [FX06-COVID: Improvement of arterial oxygenation in intensive care patients with a severe course of COVID-19] | K Zacharowski@@@Studiengruppe FX06-COVID | 202101 | Article | PMC | None | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7527783/ | 2442 | 0003-2417 | Anaesthesist | SPRINGER | |
| 248701 | 8 | 임상 | ROC | Term | roc | abstract | 큰 괴조 | 31664 | 10.1111/acem.14348 | The impact of COVID-19 on the sensitivity of D-dimer for pulmonary embolism | Samuel J Elberts@@@Ryan Bateman@@@Alexandra Koutsoubis@@@Kory S London@@@Jennifer L White@@@J Matthew Fields | 202110 | Observational Study | PMC | {{{ Abstract }}} !!{{ Objective: }} This study seeks to evaluate the test characteristics of D-dimer for pulmonary embolism (PE) in patients with a concurrent diagnosis of COVID-19. We hypothesized that the sensitivity of D-dimer for PE at current institutional cut points would be similar to those without COVID-19. !!{{ Methods: }} This is a multicenter retrospective observational cohort study across five urban and suburban EDs in the same health care system. The electronic health record was queried for all computed tomography pulmonary angiography (CTPA) studies from December 1, 2019, to October 22, 2020. All ED patients who underwent CTPA had D-dimer and COVID-19 testing completed in a single encounter were included in the study. Baseline demographics were obtained. Test characteristics of D-dimer for PE were calculated for patients with and without COVID-19. Additionally, receiver operator characteristics (ROC) curves were constructed for two different D-dimer assays. !!{{ Results: }} There were 1158 patient encounters that met criteria for analysis. Performance of D-dimer testing for PE was similar between COVID-19-positive and -negative patients. In COVID-19-positive patients, the sensitivity was 100% (95% confidence interval [CI] = 87.6%-100%), specificity was 11.9% (95% CI = 7.9%-17.1%), and negative predictive value (NPV) was 100%. In COVID-19-negative patients the sensitivity was 97.6% (95% CI = 91.5%-99.7%), specificity was 14.4% (95% CI = 12.1%-17%), and NPV was 98.3% (95% CI = 93.8%-99.6%). For assay 1 the area under the curve (AUC) for COVID-19-positive patients was 0.76 (95% CI = 0.68-0.83), and for COVID-19-negative patients, 0.73 (95% CI = 0.69-0.77). For assay 2, AUC for COVID-19-positive patients was 0.85 (95% CI = 0.77-0.92), and for COVID-19-negative patients, 0.80 (95% CI = 0.77-0.84). Inspection of the ROC curve for assay 1 revealed that 100% sensitivity was maintained up to a threshold of 0.67 FEU (fibrinogen equivalent units; from 0.50 FEU) with an increase in specificity to 29% (from 18.7%), and for assay 2, 100% sensitivity was maintained up to a threshold of 662 D-dimer units (DDU; from 230 DDU) with an increased specificity to 59% (from 6.1%). !!{{ Conclusion: }} Results from this multicenter retrospective study did not find a significant difference in sensitivity of D-dimer for PE due to concomitant COVID-19 infection. Further study is required to determine if PE can safely be excluded based on D-dimer results alone in patients with suspected or proven COVID-19 or if adjusted D-dimer levels could have a role in management. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8653093/ | 1281 | 1069-6563 | Academic emergency medicine : official journal of | Hoboken, N.J. : Wiley. | |
| 250304 | 8 | 임상 | nous | Term | nous | abstract | None | 31704 | 10.1016/j.encep.2020.07.003 | Increased in-hospital mortality from COVID-19 in patients with schizophrenia | G Fond@@@V Pauly@@@V Orleans@@@F Antonini@@@C Fabre@@@M Sanz@@@S Klay@@@M-T Jimeno@@@M Leone@@@C Lancon@@@P Auquier@@@L Boyer | 202104 | Observational Study | PMC | {{{ Abstract in English, French }}} !!{{ Background: }} There is limited information describing the presenting characteristics and outcomes of patients with schizophrenia (SCZ) requiring hospitalization for coronavirus disease 2019 (COVID-19). !!{{ Aims: }} We aimed to compare the clinical characteristics and outcomes of COVID-19 SCZ patients with those of non-SCZ patients. !!{{ Method: }} This was a case-control study of COVID-19 patients admitted to 4 AP-HM/AMU acute care hospitals in Marseille, southern France. COVID-19 infection was confirmed by a positive result on polymerase chain reaction testing of a nasopharyngeal sample and/or on chest computed scan among patients requiring hospital admission. The primary outcome was in-hospital mortality. The secondary outcome was intensive care unit (ICU) admission. !!{{ Results: }} A total of 1092 patients were included. The overall in-hospital mortality rate was 9.0%. The SCZ patients had an increased mortality compared to the non-SCZ patients (26.7% vs. 8.7%, P=0.039), which was confirmed by the multivariable analysis after adjustment for age, sex, smoking status, obesity and comorbidity (adjusted odds ratio 4.36 [95% CI: 1.09-17.44]; P=0.038). In contrast, the SCZ patients were not more frequently admitted to the ICU than the non-SCZ patients. Importantly, the SCZ patients were mostly institutionalized (63.6%, 100% of those who died), and they were more likely to have cancers and respiratory comorbidities. !!{{ Conclusions: }} This study suggests that SCZ is not overrepresented among COVID-19 hospitalized patients, but SCZ is associated with excess COVID-19 mortality, confirming the existence of health disparities described in other somatic diseases. !!{{ Contexte: }} Il existe peu d’informations d?crivant les caract?ristiques et les r?sultats des patients atteints de schizophr?nie (SCZ) n?cessitant une hospitalisation pour maladie ? coronavirus 2019 (COVID-19). !!{{ Objectifs: }} Nous avons cherch? ? comparer les caract?ristiques cliniques et les r?sultats des patients SCZ atteints de COVID-19 avec ceux des patients non SCZ. !!{{ M?thode: }} Il s’agissait d’une ?tude cas-t?moins de patients COVID-19 admis dans 4 h?pitaux de soins aigus AP?HM/AMU ? Marseille, dans le sud de la France. L’infection par COVID-19 a ?t? confirm?e par un r?sultat positif au test d’amplification en cha?ne par polym?rase d’un ?chantillon nasopharyng? et/ou au scanner thoracique effectu? chez les patients n?cessitant une hospitalisation. Le principal crit?re de jugement a ?t? la mortalit? hospitali?re. Le crit?re de jugement secondaire ?tait l’admission en unit? de soins intensifs (USI). !!{{ R?sultats: }} Un total de 1092 patients a ?t? inclus. Le taux global de mortalit? hospitali?re ?tait de 9,0 %. Les patients SCZ ont eu une mortalit? accrue par rapport aux autres patients (26,7 % contre 8,7 %, p = 0,039), ce qui a ?t? confirm? par l’analyse multivari?e apr?s ajustement pour l’?ge, le sexe, le tabagisme, l’ob?sit? et les comorbidit?s ( odds ratio ajust? de 4,36 [IC95 % : 1,09?17,44] ; p = 0,038). En revanche, les patients SCZ n’ont pas ?t? plus souvent admis ? l’unit? de soins intensifs que les patients non SCZ. Il est important de noter que les patients des SCZ ?taient pour la plupart institutionnalis?s (63,6 %, soit 100 % des d?c?s) et qu’ils ?taient plus susceptibles d’avoir des cancers et des comorbidit?s respiratoires. !!{{ Conclusions: }} Cette ?tude sugg?re que les SCZ ne sont pas surrepr?sent?es parmi les patients hospitalis?s pour COVID-19, mais que la SCZ est associ?e ? une surmortalit? due ? COVID-19, confirmant l’existence de disparit?s de sant? d?crites dans d’autres maladies somatiques. !!{{ Keywords: }} COVID-19; Maladie mentale; Mortalit?; Observational study; Psychiatrie; Psychiatry; Sant? mentale; Schizophrenia; Schizophr?nie; ?tude d’observation. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7392112/ | 2449 | 0013-7006 | L'Enc?phale | Paris Masson. | |
| 251179 | 8 | 임상 | children | Patient | children | abstract | 자식 | 31729 | 10.1016/S2215-0366(20)30482-X | Trajectories of anxiety and depressive symptoms during enforced isolation due to COVID-19 in England: a longitudinal observational study | Daisy Fancourt@@@Andrew Steptoe@@@Feifei Bu | 202102 | Observational Study | PMC | {{{ Abstract }}} !!{{ Background: }} There is major concern about the impact of the global COVID-19 outbreak on mental health. Several studies suggest that mental health deteriorated in many countries before and during enforced isolation (ie, lockdown), but it remains unknown how mental health has changed week by week over the course of the COVID-19 pandemic. This study aimed to explore the trajectories of anxiety and depression over the 20 weeks after lockdown was announced in England, and compare the growth trajectories by individual characteristics. !!{{ Methods: }} In this prospective longitudinal observational study, we analysed data from the UCL COVID-19 Social Study, a panel study weighted to population proportions, which collects information on anxiety (using the Generalised Anxiety Disorder assessment) and depressive symptoms (using the Patient Health Questionnaire) weekly in the UK since March 21, 2020. We included data from adults living in England who had at least three repeated measures between March 23 and Aug 9, 2020. Analyses were done using latent growth models, which were fitted to account for sociodemographic and health covariates. !!{{ Findings: }} Between March 23, and Aug 9, data from over 70 000 adults were collected in the UCL COVID-19 Social Study. When including participants living in England with three follow-up measures and no missing values, our analytic sample consisted of 36 520 participants. The average depression score was 6·6 (SD=6·0, range 0-27) and the average anxiety score 5·7 (SD=5·6, range 0-21) in week 1. Anxiety and depression levels both declined across the first 20 weeks following the introduction of lockdown in England (b=-1·93, SE=0·26, p<0·0001 for anxiety; b=-2·52, SE=0·28, p<0·0001 for depressive symptoms). The fastest decreases were seen across the strict lockdown period (between weeks 2 and 5), with symptoms plateauing as further lockdown easing measures were introduced (between weeks 16 and 20). Being a woman or younger, having lower educational attainment, lower income, or pre-existing mental health conditions, and living alone or with children were all risk factors for higher levels of anxiety and depression at the start of lockdown. Many of these inequalities in experiences were reduced as lockdown continued, but differences were still evident 20 weeks after the start of lockdown. !!{{ Interpretation: }} These data suggest that the highest levels of depression and anxiety occurred in the early stages of lockdown but declined fairly rapidly, possibly because individuals adapted to circumstances. Our findings emphasise the importance of supporting individuals in the lead-up to future lockdowns to try to reduce distress, and highlight that groups already at risk for poor mental health before the pandemic have remained at risk throughout lockdown and its aftermath. !!{{ Funding: }} Nuffield Foundation, UK Research and Innovation, Wellcome Trust. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7820109/ | 2392 | 2215-0366 | The lancet. Psychiatry | Kidlington, Oxford : Elsevier | |
| 270306 | 8 | 임상 | death | Term | death | abstract | 사망 | 7147 | 10.1186/s13063-021-05487-z | Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial | 202109 | Letter | PMC | Objectives The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients with moderate severity. Trial design This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework. Participants Quinquagenarian and sexagenarian patients with moderate COVID-19 symptoms and positive severe respiratory syndrome coronavirus -2 (SARS-CoV-2) PCR will be included. Participants with co-morbidities and pregnant women will be excluded. Patient recruitment will be done in Shaikh Zayed Medical Complex, Doctors Lounge and Ali Clinic in Lahore (Pakistan). Intervention and comparator The registered patients will be allocated in 6 groups (30 participants each). Patients will be taking subcutaneous IVM at 200 μg/kg/48 h (Arm A) or subcutaneous IVM at 200 μg/kg/48 h and oral Zn 20mg/8 h (Arm B) or oral IVM at 0.2 mg/kg/day (Arm C) or oral IVM at 0.2 mg/kg/day and oral Zn 20mg/8 h (Arm D) or alone oral Zn 20mg/8 h (Arm E) or placebo alone (Arm X). Patients in all arms will receive standard care and respective placebo (empty capsule 8 hourly and/or subcutaneous normal saline 2ml/48 h). Main outcomes Primary endpoints will be duration of symptomatic phase and SARS-CoV-2 clearance along with high resolution CT (HRCT) chest score and clinical grade scale (CGS) on day 6. 30-day mortality will be documented as a secondary endpoint. SARS-CoV-2 clearance will be calculated by second PCR on day 7. HRCT chest score will be measured by the percentage and lung lobes involvement on day 6 with a maximum score of 25. CGS will be recorded on a seven-point scale; grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death). Randomisation A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups. Blinding (masking) Patients, primary care physicians, outcome assessors and the data collection team will be blinded. Numbers to be randomised (sample size) 180 participants will be randomized into six arms with five investigational and one placebo group. Trial Status Institutional Review Board Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan has approved the protocol (version 2.3) with ID SZMC/IRB/Internal0056/2020. The trial was approved on July 14, 2020, and enrolment started on July 30, 2020. The estimated completion date is October 30, 2021. Trial registration Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05487-z. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419386/ | 54 | 1745-6215 | Trials | [London] : BioMed Central | ||
| 270311 | 8 | 임상 | element | Term | element | abstract | None | 7147 | 10.1186/s13063-021-05487-z | Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial | 202109 | Letter | PMC | Objectives The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients with moderate severity. Trial design This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework. Participants Quinquagenarian and sexagenarian patients with moderate COVID-19 symptoms and positive severe respiratory syndrome coronavirus -2 (SARS-CoV-2) PCR will be included. Participants with co-morbidities and pregnant women will be excluded. Patient recruitment will be done in Shaikh Zayed Medical Complex, Doctors Lounge and Ali Clinic in Lahore (Pakistan). Intervention and comparator The registered patients will be allocated in 6 groups (30 participants each). Patients will be taking subcutaneous IVM at 200 μg/kg/48 h (Arm A) or subcutaneous IVM at 200 μg/kg/48 h and oral Zn 20mg/8 h (Arm B) or oral IVM at 0.2 mg/kg/day (Arm C) or oral IVM at 0.2 mg/kg/day and oral Zn 20mg/8 h (Arm D) or alone oral Zn 20mg/8 h (Arm E) or placebo alone (Arm X). Patients in all arms will receive standard care and respective placebo (empty capsule 8 hourly and/or subcutaneous normal saline 2ml/48 h). Main outcomes Primary endpoints will be duration of symptomatic phase and SARS-CoV-2 clearance along with high resolution CT (HRCT) chest score and clinical grade scale (CGS) on day 6. 30-day mortality will be documented as a secondary endpoint. SARS-CoV-2 clearance will be calculated by second PCR on day 7. HRCT chest score will be measured by the percentage and lung lobes involvement on day 6 with a maximum score of 25. CGS will be recorded on a seven-point scale; grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death). Randomisation A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups. Blinding (masking) Patients, primary care physicians, outcome assessors and the data collection team will be blinded. Numbers to be randomised (sample size) 180 participants will be randomized into six arms with five investigational and one placebo group. Trial Status Institutional Review Board Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan has approved the protocol (version 2.3) with ID SZMC/IRB/Internal0056/2020. The trial was approved on July 14, 2020, and enrolment started on July 30, 2020. The estimated completion date is October 30, 2021. Trial registration Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05487-z. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419386/ | 54 | 1745-6215 | Trials | [London] : BioMed Central | ||
| 270331 | 8 | 임상 | Intention | Term | intention | abstract | 의도 | 7147 | 10.1186/s13063-021-05487-z | Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial | 202109 | Letter | PMC | Objectives The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients with moderate severity. Trial design This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework. Participants Quinquagenarian and sexagenarian patients with moderate COVID-19 symptoms and positive severe respiratory syndrome coronavirus -2 (SARS-CoV-2) PCR will be included. Participants with co-morbidities and pregnant women will be excluded. Patient recruitment will be done in Shaikh Zayed Medical Complex, Doctors Lounge and Ali Clinic in Lahore (Pakistan). Intervention and comparator The registered patients will be allocated in 6 groups (30 participants each). Patients will be taking subcutaneous IVM at 200 μg/kg/48 h (Arm A) or subcutaneous IVM at 200 μg/kg/48 h and oral Zn 20mg/8 h (Arm B) or oral IVM at 0.2 mg/kg/day (Arm C) or oral IVM at 0.2 mg/kg/day and oral Zn 20mg/8 h (Arm D) or alone oral Zn 20mg/8 h (Arm E) or placebo alone (Arm X). Patients in all arms will receive standard care and respective placebo (empty capsule 8 hourly and/or subcutaneous normal saline 2ml/48 h). Main outcomes Primary endpoints will be duration of symptomatic phase and SARS-CoV-2 clearance along with high resolution CT (HRCT) chest score and clinical grade scale (CGS) on day 6. 30-day mortality will be documented as a secondary endpoint. SARS-CoV-2 clearance will be calculated by second PCR on day 7. HRCT chest score will be measured by the percentage and lung lobes involvement on day 6 with a maximum score of 25. CGS will be recorded on a seven-point scale; grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death). Randomisation A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups. Blinding (masking) Patients, primary care physicians, outcome assessors and the data collection team will be blinded. Numbers to be randomised (sample size) 180 participants will be randomized into six arms with five investigational and one placebo group. Trial Status Institutional Review Board Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan has approved the protocol (version 2.3) with ID SZMC/IRB/Internal0056/2020. The trial was approved on July 14, 2020, and enrolment started on July 30, 2020. The estimated completion date is October 30, 2021. Trial registration Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05487-z. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419386/ | 54 | 1745-6215 | Trials | [London] : BioMed Central | ||
| 270332 | 8 | 임상 | Invasive mechanical ventilation | Treatment | invasive mechanical ventilation | abstract | None | 7147 | 10.1186/s13063-021-05487-z | Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial | 202109 | Letter | PMC | Objectives The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients with moderate severity. Trial design This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework. Participants Quinquagenarian and sexagenarian patients with moderate COVID-19 symptoms and positive severe respiratory syndrome coronavirus -2 (SARS-CoV-2) PCR will be included. Participants with co-morbidities and pregnant women will be excluded. Patient recruitment will be done in Shaikh Zayed Medical Complex, Doctors Lounge and Ali Clinic in Lahore (Pakistan). Intervention and comparator The registered patients will be allocated in 6 groups (30 participants each). Patients will be taking subcutaneous IVM at 200 μg/kg/48 h (Arm A) or subcutaneous IVM at 200 μg/kg/48 h and oral Zn 20mg/8 h (Arm B) or oral IVM at 0.2 mg/kg/day (Arm C) or oral IVM at 0.2 mg/kg/day and oral Zn 20mg/8 h (Arm D) or alone oral Zn 20mg/8 h (Arm E) or placebo alone (Arm X). Patients in all arms will receive standard care and respective placebo (empty capsule 8 hourly and/or subcutaneous normal saline 2ml/48 h). Main outcomes Primary endpoints will be duration of symptomatic phase and SARS-CoV-2 clearance along with high resolution CT (HRCT) chest score and clinical grade scale (CGS) on day 6. 30-day mortality will be documented as a secondary endpoint. SARS-CoV-2 clearance will be calculated by second PCR on day 7. HRCT chest score will be measured by the percentage and lung lobes involvement on day 6 with a maximum score of 25. CGS will be recorded on a seven-point scale; grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death). Randomisation A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups. Blinding (masking) Patients, primary care physicians, outcome assessors and the data collection team will be blinded. Numbers to be randomised (sample size) 180 participants will be randomized into six arms with five investigational and one placebo group. Trial Status Institutional Review Board Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan has approved the protocol (version 2.3) with ID SZMC/IRB/Internal0056/2020. The trial was approved on July 14, 2020, and enrolment started on July 30, 2020. The estimated completion date is October 30, 2021. Trial registration Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05487-z. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419386/ | 54 | 1745-6215 | Trials | [London] : BioMed Central | ||
| 269919 | 8 | 임상 | Impact Event | Term | impact event | abstract | None | 5531 | 10.1136/bmjopen-2020-041133 | Mental health of Urban Mothers (MUM) study: a multicentre randomised controlled trial, study protocol | Simone Eliane Schwank@@@Ho-Fung Chung@@@Mandy Hsu@@@Shih-Chien Fu@@@Li Du@@@Liping Zhu@@@Hsuan-Ying Huang@@@Ewa Andersson@@@Ganesh Acharya | 202011 | Global Health | PMC | Introduction Mental health disorders are common during pregnancy and the postnatal period and can have serious adverse effects on women and their children. The consequences for global mental health due to COVID-19 are likely to be significant and may have a long-term impact on the global burden of disease. Besides physical vulnerability, pregnant women are at increased risk of mental health problems such as anxiety, depression and post-traumatic stress disorder due to the consequences of social distancing. It can result in altered healthcare routines, less support from the family and friends, and in some cases, partners not being allowed to be present during prenatal visits, labour and delivery. Higher than expected, rates of perinatal anxiety and depression have been already reported during the pandemic. Pregnant women may also feel insecure and worried about the effects of COVID-19 on their unborn child if they get infected during pregnancy. Today, young urban women are used to using internet services frequently and efficiently. Therefore, providing mental health support to pregnant women via internet may be effective in ameliorating their anxiety/depression, reducing the risk of serious mental health disorders, and lead to improved maternal and perinatal outcomes. Overarching aim Our aim is to explore the effectiveness of a web-based psychosocial peer-to-peer support intervention in reducing the risk and severity of perinatal mental health disorders and preventing adverse pregnancy outcomes among pregnant women living in metropolitan urban settings. Methods and analysis We plan to conduct a multicentre prospective randomised controlled trial, Mental health of Urban Mothers trial. Pregnant women living in large metropolitan cities will be recruited using internet-based application through non-profit organisations’ websites. The women who consent will be randomised to receive a web-based peer-to-peer support intervention or usual care. Data will be analysed to identify the effects of intervention on Edinburgh Postnatal Depression Score and Generalised Anxiety Disorder 7 scores as well as pregnancy outcomes. The impact of COVID-19 pandemic on maternal stress will be assesed using Impact Event Scale-R. Any differences in outcomes between cities will be addressed in subgroup analyses. Ethics and dissemination The study will be conducted according to the principles of Good Clinical Practice and will follow the ethical principles of the Declaration of Helsinki. The study protocol has been approved by the ethical review board of Chinese University of Hong Kong (IRB number 2019-8170) and Shanghai Center for Women’s and Children’s Health (international review board (IRB) number 2020-F001-12). The results will be disseminated at national and international scientific conferences, published in peer-reviewed medical journals and spread to the public through social media, news outlets and podcasts. Trial registration number NCT04363177 ; Trial sponsor Karolinska Institute, CLINTEC, Stockholm, Sweden. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7703424/ | 8 | 2044-6055 | BMJ Open | [London] : BMJ Publishing Group Ltd | |
| 270338 | 8 | 임상 | no evidence of | Term | no evidence of | abstract | None | 7147 | 10.1186/s13063-021-05487-z | Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial | 202109 | Letter | PMC | Objectives The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients with moderate severity. Trial design This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework. Participants Quinquagenarian and sexagenarian patients with moderate COVID-19 symptoms and positive severe respiratory syndrome coronavirus -2 (SARS-CoV-2) PCR will be included. Participants with co-morbidities and pregnant women will be excluded. Patient recruitment will be done in Shaikh Zayed Medical Complex, Doctors Lounge and Ali Clinic in Lahore (Pakistan). Intervention and comparator The registered patients will be allocated in 6 groups (30 participants each). Patients will be taking subcutaneous IVM at 200 μg/kg/48 h (Arm A) or subcutaneous IVM at 200 μg/kg/48 h and oral Zn 20mg/8 h (Arm B) or oral IVM at 0.2 mg/kg/day (Arm C) or oral IVM at 0.2 mg/kg/day and oral Zn 20mg/8 h (Arm D) or alone oral Zn 20mg/8 h (Arm E) or placebo alone (Arm X). Patients in all arms will receive standard care and respective placebo (empty capsule 8 hourly and/or subcutaneous normal saline 2ml/48 h). Main outcomes Primary endpoints will be duration of symptomatic phase and SARS-CoV-2 clearance along with high resolution CT (HRCT) chest score and clinical grade scale (CGS) on day 6. 30-day mortality will be documented as a secondary endpoint. SARS-CoV-2 clearance will be calculated by second PCR on day 7. HRCT chest score will be measured by the percentage and lung lobes involvement on day 6 with a maximum score of 25. CGS will be recorded on a seven-point scale; grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death). Randomisation A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups. Blinding (masking) Patients, primary care physicians, outcome assessors and the data collection team will be blinded. Numbers to be randomised (sample size) 180 participants will be randomized into six arms with five investigational and one placebo group. Trial Status Institutional Review Board Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan has approved the protocol (version 2.3) with ID SZMC/IRB/Internal0056/2020. The trial was approved on July 14, 2020, and enrolment started on July 30, 2020. The estimated completion date is October 30, 2021. Trial registration Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05487-z. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419386/ | 54 | 1745-6215 | Trials | [London] : BioMed Central | ||
| 270352 | 8 | 임상 | patient recruitment | Term | patient recruitment | abstract | None | 7147 | 10.1186/s13063-021-05487-z | Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial | 202109 | Letter | PMC | Objectives The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients with moderate severity. Trial design This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework. Participants Quinquagenarian and sexagenarian patients with moderate COVID-19 symptoms and positive severe respiratory syndrome coronavirus -2 (SARS-CoV-2) PCR will be included. Participants with co-morbidities and pregnant women will be excluded. Patient recruitment will be done in Shaikh Zayed Medical Complex, Doctors Lounge and Ali Clinic in Lahore (Pakistan). Intervention and comparator The registered patients will be allocated in 6 groups (30 participants each). Patients will be taking subcutaneous IVM at 200 μg/kg/48 h (Arm A) or subcutaneous IVM at 200 μg/kg/48 h and oral Zn 20mg/8 h (Arm B) or oral IVM at 0.2 mg/kg/day (Arm C) or oral IVM at 0.2 mg/kg/day and oral Zn 20mg/8 h (Arm D) or alone oral Zn 20mg/8 h (Arm E) or placebo alone (Arm X). Patients in all arms will receive standard care and respective placebo (empty capsule 8 hourly and/or subcutaneous normal saline 2ml/48 h). Main outcomes Primary endpoints will be duration of symptomatic phase and SARS-CoV-2 clearance along with high resolution CT (HRCT) chest score and clinical grade scale (CGS) on day 6. 30-day mortality will be documented as a secondary endpoint. SARS-CoV-2 clearance will be calculated by second PCR on day 7. HRCT chest score will be measured by the percentage and lung lobes involvement on day 6 with a maximum score of 25. CGS will be recorded on a seven-point scale; grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death). Randomisation A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups. Blinding (masking) Patients, primary care physicians, outcome assessors and the data collection team will be blinded. Numbers to be randomised (sample size) 180 participants will be randomized into six arms with five investigational and one placebo group. Trial Status Institutional Review Board Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan has approved the protocol (version 2.3) with ID SZMC/IRB/Internal0056/2020. The trial was approved on July 14, 2020, and enrolment started on July 30, 2020. The estimated completion date is October 30, 2021. Trial registration Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05487-z. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419386/ | 54 | 1745-6215 | Trials | [London] : BioMed Central | ||
| 263344 | 8 | 임상 | implication | Term | implication | abstract | None | 32020 | 10.1186/s12884-022-04657-4 | Group Clinical Supervision for midwives and burnout: a cluster randomized controlled trial | Christine Catling@@@Helen Donovan@@@Hala Phipps@@@Simeon Dale@@@Sungwon Chang | 202204 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} There are major shortfalls in the midwifery workforce which has been exacerbated by the COVID 19 pandemic. Midwives have high levels of burnout and many, often early career midwives, are planning to leave the profession. There are reports of a poor workplace culture in maternity units, including bullying. Support is essential for the welfare of the workforce to be able to cope with the demands of their jobs. Supportive strategies, such as Clinical Supervision, a recognised approach in healthcare, enable reflection in a facilitated, structured way, and can enhance professional standards. The purpose of this research is to study burnout levels in midwives, those exiting their workplace and perceptions of workplace culture in relation to access to, and attendance of, monthly Clinical Supervision. !!{{ Methods: }} This study will be a cluster randomised controlled trial of maternity sites within Sydney and the surrounding districts. Twelve sites will be recruited and half will receive monthly Clinical Supervision for up to two years. Midwives from all sites will be requested to complete 6-monthly surveys comprising validated measurement tools: the Copenhagen Burnout Inventory (CBI), the Australian Midwifery Workplace Culture (AMWoC) tool and the Clinical Supervision Evaluation Questionnaire (CSEQ) (the latter for intervention sites only). Primary outcomes are the levels of burnout in midwives (using the CBI). Secondary outcomes will be the quality of the intervention (using the CSEQ), perceptions of workplace culture (using the AMWoC tool) and midwives' intention to stay in their role/profession, as well as sick leave rates and numbers of exiting staff. We will also determine the dose effect - ie the impact in relation to how many Clinical Supervision sessions the midwives have attended, as well as other supportive workplace strategies such as mentoring/coaching on outcomes. !!{{ Discussion: }} Through attending monthly Clinical Supervision we hypothesise that midwives will report less burnout and more positive perceptions of workplace culture than those in the control sites. The potential implications of which are a productive workforce giving high quality care with the flow-on effect of having physically and psychologically well women and their babies. !!{{ Trial registration: }} The ACTRN Registration number is ACTRN12621000545864p , dated 10/05/2021,. !!{{ Keywords: }} Burnout; Clinical supervision; Cluster randomised controlled trial; Midwifery; Support; Workplace culture. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8999988/ | 27 | 1471-2393 | BMC Pregnancy and Childbirth | London : BioMed Central | |
| 263364 | 8 | 임상 | sick | Symptom | sick | abstract | None | 32020 | 10.1186/s12884-022-04657-4 | Group Clinical Supervision for midwives and burnout: a cluster randomized controlled trial | Christine Catling@@@Helen Donovan@@@Hala Phipps@@@Simeon Dale@@@Sungwon Chang | 202204 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} There are major shortfalls in the midwifery workforce which has been exacerbated by the COVID 19 pandemic. Midwives have high levels of burnout and many, often early career midwives, are planning to leave the profession. There are reports of a poor workplace culture in maternity units, including bullying. Support is essential for the welfare of the workforce to be able to cope with the demands of their jobs. Supportive strategies, such as Clinical Supervision, a recognised approach in healthcare, enable reflection in a facilitated, structured way, and can enhance professional standards. The purpose of this research is to study burnout levels in midwives, those exiting their workplace and perceptions of workplace culture in relation to access to, and attendance of, monthly Clinical Supervision. !!{{ Methods: }} This study will be a cluster randomised controlled trial of maternity sites within Sydney and the surrounding districts. Twelve sites will be recruited and half will receive monthly Clinical Supervision for up to two years. Midwives from all sites will be requested to complete 6-monthly surveys comprising validated measurement tools: the Copenhagen Burnout Inventory (CBI), the Australian Midwifery Workplace Culture (AMWoC) tool and the Clinical Supervision Evaluation Questionnaire (CSEQ) (the latter for intervention sites only). Primary outcomes are the levels of burnout in midwives (using the CBI). Secondary outcomes will be the quality of the intervention (using the CSEQ), perceptions of workplace culture (using the AMWoC tool) and midwives' intention to stay in their role/profession, as well as sick leave rates and numbers of exiting staff. We will also determine the dose effect - ie the impact in relation to how many Clinical Supervision sessions the midwives have attended, as well as other supportive workplace strategies such as mentoring/coaching on outcomes. !!{{ Discussion: }} Through attending monthly Clinical Supervision we hypothesise that midwives will report less burnout and more positive perceptions of workplace culture than those in the control sites. The potential implications of which are a productive workforce giving high quality care with the flow-on effect of having physically and psychologically well women and their babies. !!{{ Trial registration: }} The ACTRN Registration number is ACTRN12621000545864p , dated 10/05/2021,. !!{{ Keywords: }} Burnout; Clinical supervision; Cluster randomised controlled trial; Midwifery; Support; Workplace culture. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8999988/ | 27 | 1471-2393 | BMC Pregnancy and Childbirth | London : BioMed Central | |
| 263365 | 8 | 임상 | supervision | Term | supervision | title,abstract | None | 32020 | 10.1186/s12884-022-04657-4 | Group Clinical Supervision for midwives and burnout: a cluster randomized controlled trial | Christine Catling@@@Helen Donovan@@@Hala Phipps@@@Simeon Dale@@@Sungwon Chang | 202204 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} There are major shortfalls in the midwifery workforce which has been exacerbated by the COVID 19 pandemic. Midwives have high levels of burnout and many, often early career midwives, are planning to leave the profession. There are reports of a poor workplace culture in maternity units, including bullying. Support is essential for the welfare of the workforce to be able to cope with the demands of their jobs. Supportive strategies, such as Clinical Supervision, a recognised approach in healthcare, enable reflection in a facilitated, structured way, and can enhance professional standards. The purpose of this research is to study burnout levels in midwives, those exiting their workplace and perceptions of workplace culture in relation to access to, and attendance of, monthly Clinical Supervision. !!{{ Methods: }} This study will be a cluster randomised controlled trial of maternity sites within Sydney and the surrounding districts. Twelve sites will be recruited and half will receive monthly Clinical Supervision for up to two years. Midwives from all sites will be requested to complete 6-monthly surveys comprising validated measurement tools: the Copenhagen Burnout Inventory (CBI), the Australian Midwifery Workplace Culture (AMWoC) tool and the Clinical Supervision Evaluation Questionnaire (CSEQ) (the latter for intervention sites only). Primary outcomes are the levels of burnout in midwives (using the CBI). Secondary outcomes will be the quality of the intervention (using the CSEQ), perceptions of workplace culture (using the AMWoC tool) and midwives' intention to stay in their role/profession, as well as sick leave rates and numbers of exiting staff. We will also determine the dose effect - ie the impact in relation to how many Clinical Supervision sessions the midwives have attended, as well as other supportive workplace strategies such as mentoring/coaching on outcomes. !!{{ Discussion: }} Through attending monthly Clinical Supervision we hypothesise that midwives will report less burnout and more positive perceptions of workplace culture than those in the control sites. The potential implications of which are a productive workforce giving high quality care with the flow-on effect of having physically and psychologically well women and their babies. !!{{ Trial registration: }} The ACTRN Registration number is ACTRN12621000545864p , dated 10/05/2021,. !!{{ Keywords: }} Burnout; Clinical supervision; Cluster randomised controlled trial; Midwifery; Support; Workplace culture. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8999988/ | 27 | 1471-2393 | BMC Pregnancy and Childbirth | London : BioMed Central | |
| 263368 | 8 | 임상 | Workplace | Term | workplace | abstract | 사업장 | 32020 | 10.1186/s12884-022-04657-4 | Group Clinical Supervision for midwives and burnout: a cluster randomized controlled trial | Christine Catling@@@Helen Donovan@@@Hala Phipps@@@Simeon Dale@@@Sungwon Chang | 202204 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} There are major shortfalls in the midwifery workforce which has been exacerbated by the COVID 19 pandemic. Midwives have high levels of burnout and many, often early career midwives, are planning to leave the profession. There are reports of a poor workplace culture in maternity units, including bullying. Support is essential for the welfare of the workforce to be able to cope with the demands of their jobs. Supportive strategies, such as Clinical Supervision, a recognised approach in healthcare, enable reflection in a facilitated, structured way, and can enhance professional standards. The purpose of this research is to study burnout levels in midwives, those exiting their workplace and perceptions of workplace culture in relation to access to, and attendance of, monthly Clinical Supervision. !!{{ Methods: }} This study will be a cluster randomised controlled trial of maternity sites within Sydney and the surrounding districts. Twelve sites will be recruited and half will receive monthly Clinical Supervision for up to two years. Midwives from all sites will be requested to complete 6-monthly surveys comprising validated measurement tools: the Copenhagen Burnout Inventory (CBI), the Australian Midwifery Workplace Culture (AMWoC) tool and the Clinical Supervision Evaluation Questionnaire (CSEQ) (the latter for intervention sites only). Primary outcomes are the levels of burnout in midwives (using the CBI). Secondary outcomes will be the quality of the intervention (using the CSEQ), perceptions of workplace culture (using the AMWoC tool) and midwives' intention to stay in their role/profession, as well as sick leave rates and numbers of exiting staff. We will also determine the dose effect - ie the impact in relation to how many Clinical Supervision sessions the midwives have attended, as well as other supportive workplace strategies such as mentoring/coaching on outcomes. !!{{ Discussion: }} Through attending monthly Clinical Supervision we hypothesise that midwives will report less burnout and more positive perceptions of workplace culture than those in the control sites. The potential implications of which are a productive workforce giving high quality care with the flow-on effect of having physically and psychologically well women and their babies. !!{{ Trial registration: }} The ACTRN Registration number is ACTRN12621000545864p , dated 10/05/2021,. !!{{ Keywords: }} Burnout; Clinical supervision; Cluster randomised controlled trial; Midwifery; Support; Workplace culture. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8999988/ | 27 | 1471-2393 | BMC Pregnancy and Childbirth | London : BioMed Central | |
| 270360 | 8 | 임상 | pregnant women | Term | pregnant women | abstract | 임산부 | 7147 | 10.1186/s13063-021-05487-z | Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial | 202109 | Letter | PMC | Objectives The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients with moderate severity. Trial design This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework. Participants Quinquagenarian and sexagenarian patients with moderate COVID-19 symptoms and positive severe respiratory syndrome coronavirus -2 (SARS-CoV-2) PCR will be included. Participants with co-morbidities and pregnant women will be excluded. Patient recruitment will be done in Shaikh Zayed Medical Complex, Doctors Lounge and Ali Clinic in Lahore (Pakistan). Intervention and comparator The registered patients will be allocated in 6 groups (30 participants each). Patients will be taking subcutaneous IVM at 200 μg/kg/48 h (Arm A) or subcutaneous IVM at 200 μg/kg/48 h and oral Zn 20mg/8 h (Arm B) or oral IVM at 0.2 mg/kg/day (Arm C) or oral IVM at 0.2 mg/kg/day and oral Zn 20mg/8 h (Arm D) or alone oral Zn 20mg/8 h (Arm E) or placebo alone (Arm X). Patients in all arms will receive standard care and respective placebo (empty capsule 8 hourly and/or subcutaneous normal saline 2ml/48 h). Main outcomes Primary endpoints will be duration of symptomatic phase and SARS-CoV-2 clearance along with high resolution CT (HRCT) chest score and clinical grade scale (CGS) on day 6. 30-day mortality will be documented as a secondary endpoint. SARS-CoV-2 clearance will be calculated by second PCR on day 7. HRCT chest score will be measured by the percentage and lung lobes involvement on day 6 with a maximum score of 25. CGS will be recorded on a seven-point scale; grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death). Randomisation A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups. Blinding (masking) Patients, primary care physicians, outcome assessors and the data collection team will be blinded. Numbers to be randomised (sample size) 180 participants will be randomized into six arms with five investigational and one placebo group. Trial Status Institutional Review Board Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan has approved the protocol (version 2.3) with ID SZMC/IRB/Internal0056/2020. The trial was approved on July 14, 2020, and enrolment started on July 30, 2020. The estimated completion date is October 30, 2021. Trial registration Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05487-z. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419386/ | 54 | 1745-6215 | Trials | [London] : BioMed Central | ||
| 263334 | 8 | 임상 | COVID 19 | Term | covid 19 | abstract | 코로나 19 | 32020 | 10.1186/s12884-022-04657-4 | Group Clinical Supervision for midwives and burnout: a cluster randomized controlled trial | Christine Catling@@@Helen Donovan@@@Hala Phipps@@@Simeon Dale@@@Sungwon Chang | 202204 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} There are major shortfalls in the midwifery workforce which has been exacerbated by the COVID 19 pandemic. Midwives have high levels of burnout and many, often early career midwives, are planning to leave the profession. There are reports of a poor workplace culture in maternity units, including bullying. Support is essential for the welfare of the workforce to be able to cope with the demands of their jobs. Supportive strategies, such as Clinical Supervision, a recognised approach in healthcare, enable reflection in a facilitated, structured way, and can enhance professional standards. The purpose of this research is to study burnout levels in midwives, those exiting their workplace and perceptions of workplace culture in relation to access to, and attendance of, monthly Clinical Supervision. !!{{ Methods: }} This study will be a cluster randomised controlled trial of maternity sites within Sydney and the surrounding districts. Twelve sites will be recruited and half will receive monthly Clinical Supervision for up to two years. Midwives from all sites will be requested to complete 6-monthly surveys comprising validated measurement tools: the Copenhagen Burnout Inventory (CBI), the Australian Midwifery Workplace Culture (AMWoC) tool and the Clinical Supervision Evaluation Questionnaire (CSEQ) (the latter for intervention sites only). Primary outcomes are the levels of burnout in midwives (using the CBI). Secondary outcomes will be the quality of the intervention (using the CSEQ), perceptions of workplace culture (using the AMWoC tool) and midwives' intention to stay in their role/profession, as well as sick leave rates and numbers of exiting staff. We will also determine the dose effect - ie the impact in relation to how many Clinical Supervision sessions the midwives have attended, as well as other supportive workplace strategies such as mentoring/coaching on outcomes. !!{{ Discussion: }} Through attending monthly Clinical Supervision we hypothesise that midwives will report less burnout and more positive perceptions of workplace culture than those in the control sites. The potential implications of which are a productive workforce giving high quality care with the flow-on effect of having physically and psychologically well women and their babies. !!{{ Trial registration: }} The ACTRN Registration number is ACTRN12621000545864p , dated 10/05/2021,. !!{{ Keywords: }} Burnout; Clinical supervision; Cluster randomised controlled trial; Midwifery; Support; Workplace culture. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8999988/ | 27 | 1471-2393 | BMC Pregnancy and Childbirth | London : BioMed Central | |
| 270233 | 8 | 임상 | distress | Action | distress | abstract | 고충 | 7146 | 10.1186/s13063-021-05068-0 | Transitional care from skilled nursing facilities to home: study protocol for a stepped wedge cluster randomized trial | M. Toles@@@C. Col?n-Emeric@@@L. C. Hanson@@@M. Naylor@@@M. Weinberger@@@J. Covington@@@J. S. Preisser | 202102 | Study Protocol | PMC | Background Skilled nursing facility (SNF) patients are medically complex with multiple, advanced chronic conditions. They are dependent on caregivers and have experienced recent acute illnesses. Among SNF patients, the rate of mortality or acute care use is over 50% within 90?days of discharge, yet these patients and their caregivers often do not receive the quality of transitional care that prepares them to manage serious illnesses at home. Methods The study will test the efficacy of Connect-Home, a successfully piloted transitional care intervention targeting seriously ill SNF patients discharged to home and their caregivers. The study setting will be SNFs in North Carolina, USA, and, following discharge, in patients’ home. Using a stepped wedge cluster randomized trial design, six SNFs will transition at randomly assigned intervals from standard discharge planning to the Connect-Home intervention. The SNFs will contribute data for patients ( N = 360) and their caregivers ( N = 360), during both the standard discharge planning and Connect-Home time periods. Connect-Home is a two-step intervention: (a) SNF staff create an individualized Transition Plan of Care to manage the patient’s illness at home; and (b) a Connect-Home Activation RN visits the patient’s home to implement the written Transition Plan of Care. A key feature of the trial includes training of the SNF and Home Care Agency staff to complete the transition plan rather than using study interventionists. The primary outcomes will be patient preparedness for discharge and caregiver preparedness for caregiving role. With the proposed sample and using a two-sided test at the 5% significance level, we have 80% power to detect a 18% increase in the patient’s preparedness for discharge score. We will employ linear mixed models to compare observations between intervention and usual care periods to assess primary outcomes. Secondary outcomes include (a) patients’ quality of life, functional status, and days of acute care use and (b) caregivers’ burden and distress. Discussion Study results will determine the efficacy of an intervention using existing clinical staff to (a) improve transitional care for seriously ill SNF patients and their caregivers, (b) prevent avoidable days of acute care use in a population with persistent risks from chronic conditions, and (c) advance the science of transitional care within end-of-life and palliative care trajectories of SNF patients and their caregivers. While this study protocol was being implemented, the COVID-19 pandemic occurred and this protocol was revised to mitigate COVID-related risks of patients, their caregivers, SNF staff, and the study team. Thus, this paper includes additional material describing these modifications. Trial registration ClinicalTrials.gov NCT03810534. Registered on January 18, 2019. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7863858/ | 54 | 1745-6215 | Trials | [London] : BioMed Central | |
| 264666 | 8 | 임상 | Administered | Treatment | administered | abstract | None | 32049 | 10.1007/s12603-021-1672-9 | Practicality and Reliability of Self Vs Administered Rapid Geriatric Assessment Mobile App | L F Tan@@@Y H Chan@@@A Tay@@@J Jayasundram@@@N A Low@@@Reshma A Merchant | 202101 | Observational Study | PMC | {{{ Abstract }}} !!{{ Objectives: }} To develop and cross-validate self-administered Rapid Geriatric Assessment (SA-RGA) app against administered Rapid Geriatric Assessment (A-RGA) to identify seniors with geriatric syndromes such as frailty, sarcopenia, and anorexia of ageing who may benefit from targeted intervention. !!{{ Design: }} Prospective observational study. !!{{ Setting: }} Primary Care and Community. !!{{ Participants: }} A-RGA and SA-RGA app were administered to older adults ≥ 60 years old from December 2020 to April 2021. !!{{ Measurements: }} The RGA app screens for frailty (FRAIL), sarcopenia (SARC-F), anorexia of aging (SNAQ) and cognition (Rapid Cognitive Screen) with assisted management pathway. Patient Health Questionnaire 9 is administered for those who score positive for fatigue. The diagnostic performance of SA-RGA was compared against A-RGA as a reference by calculating the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and positive likelihood ratio (+LR). !!{{ Results: }} 123 participants with a mean age of 71 ± 5.9 years completed both the SA-RGA and A-RGA. Questions on fatigue, 5 or more illnesses, loss of weight and falls in the past year performed better with high sensitivity, specificity, NPV and +LR than self-functional assessment where SA-RGA participants reported lower prevalence on the FRAIL scale aerobic and resistance components, and higher prevalence on the SARC-F strength and rising from a chair components. !!{{ Conclusion: }} The SA-RGA app performed well in certain domains such as assessment for weight loss, falls, number of chronic illness and fatigue. Self-functional assessment can be improved further by removing ambiguity in wordings such as some or a lot and replacing it with functional difficulty scale. SA-RGA has the potential to be incorporated in the eHEALTH platforms worldwide for early identifications of older adults at risk and to reduce health inequalities, at the same time building community resilience in the era of Covid-19 pandemic. !!{{ Keywords: }} FRAIL; Rapid Geriatric Assessment; SARC-F; mobile application; self-assessment. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8432277/ | 1283 | 1279-7707 | The journal of nutrition, health & aging | Paris, France : New York, NY : Serdi Publisher ; Springer Pub. Co.,. | |
| 270242 | 8 | 임상 | IMPROVE | Action | IMPROVE | abstract | None | 7146 | 10.1186/s13063-021-05068-0 | Transitional care from skilled nursing facilities to home: study protocol for a stepped wedge cluster randomized trial | M. Toles@@@C. Col?n-Emeric@@@L. C. Hanson@@@M. Naylor@@@M. Weinberger@@@J. Covington@@@J. S. Preisser | 202102 | Study Protocol | PMC | Background Skilled nursing facility (SNF) patients are medically complex with multiple, advanced chronic conditions. They are dependent on caregivers and have experienced recent acute illnesses. Among SNF patients, the rate of mortality or acute care use is over 50% within 90?days of discharge, yet these patients and their caregivers often do not receive the quality of transitional care that prepares them to manage serious illnesses at home. Methods The study will test the efficacy of Connect-Home, a successfully piloted transitional care intervention targeting seriously ill SNF patients discharged to home and their caregivers. The study setting will be SNFs in North Carolina, USA, and, following discharge, in patients’ home. Using a stepped wedge cluster randomized trial design, six SNFs will transition at randomly assigned intervals from standard discharge planning to the Connect-Home intervention. The SNFs will contribute data for patients ( N = 360) and their caregivers ( N = 360), during both the standard discharge planning and Connect-Home time periods. Connect-Home is a two-step intervention: (a) SNF staff create an individualized Transition Plan of Care to manage the patient’s illness at home; and (b) a Connect-Home Activation RN visits the patient’s home to implement the written Transition Plan of Care. A key feature of the trial includes training of the SNF and Home Care Agency staff to complete the transition plan rather than using study interventionists. The primary outcomes will be patient preparedness for discharge and caregiver preparedness for caregiving role. With the proposed sample and using a two-sided test at the 5% significance level, we have 80% power to detect a 18% increase in the patient’s preparedness for discharge score. We will employ linear mixed models to compare observations between intervention and usual care periods to assess primary outcomes. Secondary outcomes include (a) patients’ quality of life, functional status, and days of acute care use and (b) caregivers’ burden and distress. Discussion Study results will determine the efficacy of an intervention using existing clinical staff to (a) improve transitional care for seriously ill SNF patients and their caregivers, (b) prevent avoidable days of acute care use in a population with persistent risks from chronic conditions, and (c) advance the science of transitional care within end-of-life and palliative care trajectories of SNF patients and their caregivers. While this study protocol was being implemented, the COVID-19 pandemic occurred and this protocol was revised to mitigate COVID-related risks of patients, their caregivers, SNF staff, and the study team. Thus, this paper includes additional material describing these modifications. Trial registration ClinicalTrials.gov NCT03810534. Registered on January 18, 2019. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7863858/ | 54 | 1745-6215 | Trials | [London] : BioMed Central | |
| 266922 | 8 | 임상 | p value | Term | p value | abstract | None | 32115 | 10.2196/32089 | The Effects of Theory-Based Educational Intervention and WhatsApp Follow-up on Papanicolaou Smear Uptake Among Postnatal Women in Malaysia: Randomized Controlled Trial | Zaahirah Mohammad@@@Norliza Ahmad@@@Anisah Baharom | 202206 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} Despite the availability and accessibility of free Papanicolaou (Pap) smear as a screening tool for cervical cancer, the uptake of Pap smear in Malaysia has not changed in the last 15 years. Previous studies have shown that the high uptake of Pap smear reduces the mortality rate of patients with cervical cancer. The low uptake of Pap smear is multifactorial, and the problem could be minimized through the use of mobile technologies. Nevertheless, most intervention studies focused on individual factors, while other important aspects such as mobile technologies, especially WhatsApp, have not been investigated yet. !!{{ Objective: }} This study aims to determine the effects of a theory-based educational intervention and WhatsApp follow-up (Pap smear uptake [PSU] intervention) in improving PSU among postnatal women in Seremban, Negeri Sembilan, Malaysia. !!{{ Methods: }} A 2-arm, parallel single-blind cluster randomized controlled trial was conducted among postpartum women from the Seremban district. Twelve health clinics were randomly assigned to the intervention and control groups. At baseline, both groups received a self-administered questionnaire. The intervention group received standard care and PSU intervention delivered by a researcher. This 2-stage intervention module was developed based on Social Cognitive Theory, where the first stage was conducted face-to-face and the second stage included a WhatsApp follow-up. The control group received standard care. Participants were observed immediately and at 4, 8, and 12 weeks after the intervention. The primary endpoint was PSU, whereas the secondary endpoints were knowledge, attitude, and self-efficacy scores for Pap smear screening self-assessed using a Google Forms questionnaire. A generalized mixed model was used to determine the effectiveness of the intervention. All data were analyzed using IBM SPSS (version 25), and P value of .05 was considered statistically significant. !!{{ Results: }} We analyzed 401 women, of whom 76 (response rate: 325/401, 81%) had withdrawn because of the COVID-19 pandemic, with a total of 162 respondents in the intervention group and 163 respondents in the control group. The proportion of Pap smears at the 12-week follow-up was 67.9% (110/162) in the intervention group versus 39.8% (65/163) in the control group (P<.001). Significant differences between the intervention and control groups were found for Pap smear use (F 4,1178 ; P<.001), knowledge scores (F 4,1172 =14.946; P<.001), attitude scores (F 4,1172 =24.417; P<.001), and self-efficacy scores (F 1,1172 =10.432; P<.001). !!{{ Conclusions: }} This study demonstrated that the PSU intervention is effective in increasing the uptake of Pap smear among postnatal women in Seremban district, Malaysia. This intervention module can be tested in other populations of women. !!{{ Trial registration: }} Thai Clinical Trials Registry TCTR20200205001; https://www.thaiclinicaltrials.org/show/TCTR20200205001. !!{{ Keywords: }} Malaysia; Papanicolaou test; attitude; health knowledge; practice; psychological theory; self-efficacy; social media; uterine cervical neoplasms. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9274386/ | 91 | 2291-5222 | JMIR mHealth and uHealth | Toronto: JMIR Publications Inc. | |
| 266940 | 8 | 임상 | theory | Term | theory | abstract | None | 32115 | 10.2196/32089 | The Effects of Theory-Based Educational Intervention and WhatsApp Follow-up on Papanicolaou Smear Uptake Among Postnatal Women in Malaysia: Randomized Controlled Trial | Zaahirah Mohammad@@@Norliza Ahmad@@@Anisah Baharom | 202206 | Article | PMC | {{{ Abstract }}} !!{{ Background: }} Despite the availability and accessibility of free Papanicolaou (Pap) smear as a screening tool for cervical cancer, the uptake of Pap smear in Malaysia has not changed in the last 15 years. Previous studies have shown that the high uptake of Pap smear reduces the mortality rate of patients with cervical cancer. The low uptake of Pap smear is multifactorial, and the problem could be minimized through the use of mobile technologies. Nevertheless, most intervention studies focused on individual factors, while other important aspects such as mobile technologies, especially WhatsApp, have not been investigated yet. !!{{ Objective: }} This study aims to determine the effects of a theory-based educational intervention and WhatsApp follow-up (Pap smear uptake [PSU] intervention) in improving PSU among postnatal women in Seremban, Negeri Sembilan, Malaysia. !!{{ Methods: }} A 2-arm, parallel single-blind cluster randomized controlled trial was conducted among postpartum women from the Seremban district. Twelve health clinics were randomly assigned to the intervention and control groups. At baseline, both groups received a self-administered questionnaire. The intervention group received standard care and PSU intervention delivered by a researcher. This 2-stage intervention module was developed based on Social Cognitive Theory, where the first stage was conducted face-to-face and the second stage included a WhatsApp follow-up. The control group received standard care. Participants were observed immediately and at 4, 8, and 12 weeks after the intervention. The primary endpoint was PSU, whereas the secondary endpoints were knowledge, attitude, and self-efficacy scores for Pap smear screening self-assessed using a Google Forms questionnaire. A generalized mixed model was used to determine the effectiveness of the intervention. All data were analyzed using IBM SPSS (version 25), and P value of .05 was considered statistically significant. !!{{ Results: }} We analyzed 401 women, of whom 76 (response rate: 325/401, 81%) had withdrawn because of the COVID-19 pandemic, with a total of 162 respondents in the intervention group and 163 respondents in the control group. The proportion of Pap smears at the 12-week follow-up was 67.9% (110/162) in the intervention group versus 39.8% (65/163) in the control group (P<.001). Significant differences between the intervention and control groups were found for Pap smear use (F 4,1178 ; P<.001), knowledge scores (F 4,1172 =14.946; P<.001), attitude scores (F 4,1172 =24.417; P<.001), and self-efficacy scores (F 1,1172 =10.432; P<.001). !!{{ Conclusions: }} This study demonstrated that the PSU intervention is effective in increasing the uptake of Pap smear among postnatal women in Seremban district, Malaysia. This intervention module can be tested in other populations of women. !!{{ Trial registration: }} Thai Clinical Trials Registry TCTR20200205001; https://www.thaiclinicaltrials.org/show/TCTR20200205001. !!{{ Keywords: }} Malaysia; Papanicolaou test; attitude; health knowledge; practice; psychological theory; self-efficacy; social media; uterine cervical neoplasms. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9274386/ | 91 | 2291-5222 | JMIR mHealth and uHealth | Toronto: JMIR Publications Inc. | |
| 269153 | 8 | 임상 | teledermatology | Term | teledermatology | author | Teledermatology | 35496 | 10.1016/j.jdin.2020.11.002 | Managing interventional clinical trials in the setting of COVID-19: Experience in an autoimmune skin disease unit | Robert Borucki MD@@@Josef Symon S. Concha MD@@@Julie Burroughs MA@@@Joyce Okawa RN@@@Victoria P. Werth MD | 202103 | Editorial | Sciencedirect | https://doi.org/10.1016/j.jdin.2020.11.002 | 2584 | 2666-3287 | JAAD International | New York: Elsevier Inc. | ||
| 269833 | 8 | 임상 | mild infection | Term | mild infection | abstract | None | 37303 | 10.1038/s41432-020-0105-7 | A COVID-19 pandemic guideline in evidence-based medicine |
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