Background
Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.
Methods
We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.
Results
A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P=1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P=1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
Conclusions
Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number,
NCT04322123
.)
Based on empirical data, we have developed a brief and easy-to-use screening strategy with higher accuracy and some practical advantages compared with commonly used tools.
The instrument developed in this study proved to be a practical tool for classifying the majority of spontaneously reported cognitive complaints with high reliability. Further studies are needed to investigate clinical usefulness of this approach.
ResumoIntrodução: Quedas são um problema clínico comum nos idosos, que pode reduzir sua mobilidade e independência. O uso de instrumentos simples para detecção do risco de quedas é fundamental para prevenção e tratamento de tais eventos. Não há, porém, consenso quanto aos testes mais adequados para cada situação. A revisão mostrou que os dois testes podem ser bons preditores de quedas, mas os artigos diferiram quanto à definição de queda e caidor, tipo de estudo, quantidade e característica da amostra e avaliação de quedas, levando a diferentes resultados quanto a nota de corte, sensibilidade, especificidade e predição de quedas. Há controvérsias quanto à capacidade de predição em perfis específicos, como os idosos ativos. Conclusão: Os testes avaliados são eficazes para predição de quedas, desde que adaptados para cada perfil. Novos estudos devem ser realizados com metodologia homogênea, a fim de favorecer a comparação de resultados sobre a eficácia desses testes.
AbstractIntroduction: Fall is a common problem in the elderly and it can reduce their mobility and independence. The use of simple tools to detect risk of falls is essential to prevent and treat such events. However, there is no consensus about the most appropriate tools for each situation. Objective: To review studies about efficacy, sensitivity and specificity of Timed Up and Go Test (TUGT) and Berg Balance Scale (BBS) in order to ascertain which is the most appropriate to predict falls in the elderly. Methods: We performed a literature review from MEDLINE, PubMed, ISI, LILACS and Portal de Periódicos
BackgroundFalling in older age is a major public health concern due to its costly and disabling consequences. However very few randomised controlled trials (RCTs) have been conducted in developing countries, in which population ageing is expected to be particularly substantial in coming years. This article describes the design of an RCT to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls in community-dwelling older people.Methods/designMulticentre parallel-group RCT involving 612 community-dwelling men and women aged 60 years and over, who have fallen at least once in the previous year. Participants will be recruited in multiple settings in Sao Paulo, Brazil and will be randomly allocated to a control group or an intervention group. The usual care control group will undergo a fall risk factor assessment and be referred to their clinicians with the risk assessment report so that individual modifiable risk factors can be managed without any specific guidance. The intervention group will receive a 12-week Multifactorial Falls Prevention Program consisting of: an individualised medical management of modifiable risk factors, a group-based, supervised balance training exercise program plus an unsupervised home-based exercise program, an educational/behavioral intervention. Both groups will receive a leaflet containing general information about fall prevention strategies. Primary outcome measures will be the rate of falls and the proportion of fallers recorded by monthly falls diaries and telephone calls over a 12 month period. Secondary outcomes measures will include risk of falling, fall-related self-efficacy score, measures of balance, mobility and strength, fall-related health services use and independence with daily tasks. Data will be analysed using the intention-to-treat principle.The incidence of falls in the intervention and control groups will be calculated and compared using negative binomial regression analysis.DiscussionThis study is the first trial to be conducted in Brazil to evaluate the effectiveness of an intervention to prevent falls. If proven to reduce falls this study has the potential to benefit older adults and assist health care practitioners and policy makers to implement and promote effective falls prevention interventions.Trial registrationClinicalTrials.gov (NCT01698580)
OBJECTIVE:This study aimed to evaluate if posturography can be considered a recurrent fall predictor in elderly individuals. METHODS: This was a cross-sectional study. A total of 124 subjects aged 60 to 88 years were evaluated and divided into two groups-the recurrent fallers (89) and single fallers (35) groups. Patients' sociodemographic characteristics were assessed, and clinical testing was performed. The functional test assessment instruments used were timed up and go test (TUGT), Berg Balance Scale (BBS), five times sit-to-stand test, and Falls Efficacy Scale (to measure fear of falling). Static posturography was performed in a force platform in the following three different situations-eyes open (EO), eyes closed (EC), and EO dual task. RESULTS: There were significant differences between the single and recurrent fallers groups regarding the fear of falling, the Geriatric Depression Scale score, the mean speed calculated from the total displacement of the center point of pressure (COP) in all directions with EO, and the root mean square of the displacement from the COP in the mediolateral axis with EC. Based on the hierarchical logistic regression model, none of the studied posturographic variables was capable of significantly increasing the power of differentiation between the recurrent and single fallers groups. Only TUGT with a cognitive distractor (po0.05) and the BBS (po0.01) presented with significant independent predictive power. CONCLUSION: TUGT with a cognitive distractor and the BBS were considered recurrent fall predictors in elderly fallers.
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