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1.
N Engl J Med ; 386(21): 1986-1997, 2022 05 26.
Article in English | MEDLINE | ID: covidwho-1864788

ABSTRACT

BACKGROUND: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS: We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS: A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P = 0.04 for noninferiority). CONCLUSIONS: Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).


Subject(s)
Antifibrinolytic Agents , Tranexamic Acid , Antifibrinolytic Agents/adverse effects , Antifibrinolytic Agents/therapeutic use , Canada , Hemorrhage/etiology , Hemorrhage/prevention & control , Humans , Surgical Procedures, Operative , Thrombosis/chemically induced , Thrombosis/drug therapy , Tranexamic Acid/adverse effects , Tranexamic Acid/therapeutic use
2.
Rev Panam Salud Publica ; 45: e108, 2021.
Article in Spanish | MEDLINE | ID: covidwho-1819044

ABSTRACT

OBJECTIVE: To describe the role of statistical literacy and proper risk communication in communication strategies related to COVID-19 vaccination. METHODS: A scoping review was carried out in January 2021, with the keywords "statistical literacy," "risk communication," "health communication," and "pandemic," in the Pan American Health Organization Virtual Health Library, PubMed, Web of Science, EBSCO, and Google Scholar databases. No filters were applied for dates, language, or publication type. RESULTS: Of the 87 articles identified, four met the inclusion criteria. Four main messages were recognized that relate statistical literacy and risk communication: 1) risk communication and statistical literacy level affect individual and collective decision-making; 2) communication of uncertainty should include what is known and not known with regard to statistics and risks; 3) the use of graphics and visuals is key to appropriately informing the population; and 4) different formats should be used to improve communication, always adjusted to the population's statistical literacy level. CONCLUSIONS: Statistical literacy plays a key role in communicating risks related to health in general and COVID-19 vaccination in particular. In health emergencies, proper communication of risk and associated uncertainty should be clear, transparent, and timely.


OBJETIVO: Descrever o papel da literacia estatística e da comunicação correta de riscos nas estratégias de comunicação relacionadas à vacinação contra a COVID-19. MÉTODOS: Em janeiro de 2021, foi realizada uma revisão de escopo com as palavras-chave "statistical literacy", "risk communication", "health communication" e "pandemic" nos bancos de dados da Biblioteca Virtual em Saúde da Organização Pan-Americana da Saúde, PubMed, Web of Science, EBSCO e Google Scholar. Não foi aplicado filtro de data, idioma ou tipo de publicação. RESULTADOS: Dos 87 artigos identificados, quatro atenderam aos critérios de inclusão. Foram reconhecidas quatro mensagens principais relacionadas à literacia estatística e à comunicação de risco: 1) a comunicação de risco e o nível de literacia estatística afetam a tomada de decisão individual e coletiva; 2) a comunicação da incerteza deve incluir o que é conhecido e desconhecido sobre estatísticas e riscos; 3) o uso de gráficos e visualizações é fundamental para informar adequadamente a população; e 4) devem ser usados diferentes formatos para melhorar a comunicação, sempre ajustados ao nível de literacia estatística da população. CONCLUSÕES: A literacia estatística desempenha um papel fundamental na comunicação dos riscos relacionados à saúde em geral e à vacinação contra a COVID-19 em particular. Em situações de emergência de saúde, a comunicação correta do risco e da incerteza a ele associada deve ser clara, transparente e oportuna.

3.
BMJ ; 374: n2209, 2021 09 30.
Article in English | MEDLINE | ID: covidwho-1448003

ABSTRACT

OBJECTIVE: To determine if virtual care with remote automated monitoring (RAM) technology versus standard care increases days alive at home among adults discharged after non-elective surgery during the covid-19 pandemic. DESIGN: Multicentre randomised controlled trial. SETTING: 8 acute care hospitals in Canada. PARTICIPANTS: 905 adults (≥40 years) who resided in areas with mobile phone coverage and were to be discharged from hospital after non-elective surgery were randomised either to virtual care and RAM (n=451) or to standard care (n=454). 903 participants (99.8%) completed the 31 day follow-up. INTERVENTION: Participants in the experimental group received a tablet computer and RAM technology that measured blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, and body weight. For 30 days the participants took daily biophysical measurements and photographs of their wound and interacted with nurses virtually. Participants in the standard care group received post-hospital discharge management according to the centre's usual care. Patients, healthcare providers, and data collectors were aware of patients' group allocations. Outcome adjudicators were blinded to group allocation. MAIN OUTCOME MEASURES: The primary outcome was days alive at home during 31 days of follow-up. The 12 secondary outcomes included acute hospital care, detection and correction of drug errors, and pain at 7, 15, and 30 days after randomisation. RESULTS: All 905 participants (mean age 63.1 years) were analysed in the groups to which they were randomised. Days alive at home during 31 days of follow-up were 29.7 in the virtual care group and 29.5 in the standard care group: relative risk 1.01 (95% confidence interval 0.99 to 1.02); absolute difference 0.2% (95% confidence interval -0.5% to 0.9%). 99 participants (22.0%) in the virtual care group and 124 (27.3%) in the standard care group required acute hospital care: relative risk 0.80 (0.64 to 1.01); absolute difference 5.3% (-0.3% to 10.9%). More participants in the virtual care group than standard care group had a drug error detected (134 (29.7%) v 25 (5.5%); absolute difference 24.2%, 19.5% to 28.9%) and a drug error corrected (absolute difference 24.4%, 19.9% to 28.9%). Fewer participants in the virtual care group than standard care group reported pain at 7, 15, and 30 days after randomisation: absolute differences 13.9% (7.4% to 20.4%), 11.9% (5.1% to 18.7%), and 9.6% (2.9% to 16.3%), respectively. Beneficial effects proved substantially larger in centres with a higher rate of care escalation. CONCLUSION: Virtual care with RAM shows promise in improving outcomes important to patients and to optimal health system function. TRIAL REGISTRATION: ClinicalTrials.gov NCT04344665.


Subject(s)
Aftercare/methods , Monitoring, Ambulatory/methods , Surgical Procedures, Operative/nursing , Telemedicine/methods , Aged , COVID-19/epidemiology , Canada/epidemiology , Female , Humans , Male , Medication Errors/statistics & numerical data , Middle Aged , Pain, Postoperative/epidemiology , Pandemics , Patient Discharge , Postoperative Period , Surgical Procedures, Operative/mortality
4.
Rev Panam Salud Publica ; 45: e108, 2021.
Article in Spanish | MEDLINE | ID: covidwho-1413355

ABSTRACT

OBJECTIVE: To describe the role of statistical literacy and proper risk communication in communication strategies related to COVID-19 vaccination. METHODS: A scoping review was carried out in January 2021, with the keywords "statistical literacy," "risk communication," "health communication," and "pandemic," in the Pan American Health Organization Virtual Health Library, PubMed, Web of Science, EBSCO, and Google Scholar databases. No filters were applied for dates, language, or publication type. RESULTS: Of the 87 articles identified, four met the inclusion criteria. Four main messages were recognized that relate statistical literacy and risk communication: 1) risk communication and statistical literacy level affect individual and collective decision-making; 2) communication of uncertainty should include what is known and not known with regard to statistics and risks; 3) the use of graphics and visuals is key to appropriately informing the population; and 4) different formats should be used to improve communication, always adjusted to the population's statistical literacy level. CONCLUSIONS: Statistical literacy plays a key role in communicating risks related to health in general and COVID-19 vaccination in particular. In health emergencies, proper communication of risk and associated uncertainty should be clear, transparent, and timely.


OBJETIVO: Descrever o papel da literacia estatística e da comunicação correta de riscos nas estratégias de comunicação relacionadas à vacinação contra a COVID-19. MÉTODOS: Em janeiro de 2021, foi realizada uma revisão de escopo com as palavras-chave "statistical literacy", "risk communication", "health communication" e "pandemic" nos bancos de dados da Biblioteca Virtual em Saúde da Organização Pan-Americana da Saúde, PubMed, Web of Science, EBSCO e Google Scholar. Não foi aplicado filtro de data, idioma ou tipo de publicação. RESULTADOS: Dos 87 artigos identificados, quatro atenderam aos critérios de inclusão. Foram reconhecidas quatro mensagens principais relacionadas à literacia estatística e à comunicação de risco: 1) a comunicação de risco e o nível de literacia estatística afetam a tomada de decisão individual e coletiva; 2) a comunicação da incerteza deve incluir o que é conhecido e desconhecido sobre estatísticas e riscos; 3) o uso de gráficos e visualizações é fundamental para informar adequadamente a população; e 4) devem ser usados diferentes formatos para melhorar a comunicação, sempre ajustados ao nível de literacia estatística da população. CONCLUSÕES: A literacia estatística desempenha um papel fundamental na comunicação dos riscos relacionados à saúde em geral e à vacinação contra a COVID-19 em particular. Em situações de emergência de saúde, a comunicação correta do risco e da incerteza a ele associada deve ser clara, transparente e oportuna.

5.
Rev Panam Salud Publica ; 45: e108, 2021.
Article in Spanish | MEDLINE | ID: covidwho-1395691

ABSTRACT

OBJECTIVE: To describe the role of statistical literacy and proper risk communication in communication strategies related to COVID-19 vaccination. METHODS: A scoping review was carried out in January 2021, with the keywords "statistical literacy," "risk communication," "health communication," and "pandemic," in the Pan American Health Organization Virtual Health Library, PubMed, Web of Science, EBSCO, and Google Scholar databases. No filters were applied for dates, language, or publication type. RESULTS: Of the 87 articles identified, four met the inclusion criteria. Four main messages were recognized that relate statistical literacy and risk communication: 1) risk communication and statistical literacy level affect individual and collective decision-making; 2) communication of uncertainty should include what is known and not known with regard to statistics and risks; 3) the use of graphics and visuals is key to appropriately informing the population; and 4) different formats should be used to improve communication, always adjusted to the population's statistical literacy level. CONCLUSIONS: Statistical literacy plays a key role in communicating risks related to health in general and COVID-19 vaccination in particular. In health emergencies, proper communication of risk and associated uncertainty should be clear, transparent, and timely.


OBJETIVO: Descrever o papel da literacia estatística e da comunicação correta de riscos nas estratégias de comunicação relacionadas à vacinação contra a COVID-19. MÉTODOS: Em janeiro de 2021, foi realizada uma revisão de escopo com as palavras-chave "statistical literacy", "risk communication", "health communication" e "pandemic" nos bancos de dados da Biblioteca Virtual em Saúde da Organização Pan-Americana da Saúde, PubMed, Web of Science, EBSCO e Google Scholar. Não foi aplicado filtro de data, idioma ou tipo de publicação. RESULTADOS: Dos 87 artigos identificados, quatro atenderam aos critérios de inclusão. Foram reconhecidas quatro mensagens principais relacionadas à literacia estatística e à comunicação de risco: 1) a comunicação de risco e o nível de literacia estatística afetam a tomada de decisão individual e coletiva; 2) a comunicação da incerteza deve incluir o que é conhecido e desconhecido sobre estatísticas e riscos; 3) o uso de gráficos e visualizações é fundamental para informar adequadamente a população; e 4) devem ser usados diferentes formatos para melhorar a comunicação, sempre ajustados ao nível de literacia estatística da população. CONCLUSÕES: A literacia estatística desempenha um papel fundamental na comunicação dos riscos relacionados à saúde em geral e à vacinação contra a COVID-19 em particular. Em situações de emergência de saúde, a comunicação correta do risco e da incerteza a ele associada deve ser clara, transparente e oportuna.

6.
CMAJ Open ; 9(1): E142-E148, 2021.
Article in English | MEDLINE | ID: covidwho-1115548

ABSTRACT

BACKGROUND: After nonelective (i.e., semiurgent, urgent and emergent) surgeries, patients discharged from hospitals are at risk of readmissions, emergency department visits or death. During the coronavirus disease 2019 (COVID-19) pandemic, we are undertaking the Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM) trial to determine if virtual care with remote automated monitoring (RAM) compared with standard care will increase the number of days adult patients remain alive at home after being discharged following nonelective surgery. METHODS: We are conducting a randomized controlled trial in which 900 adults who are being discharged after nonelective surgery from 8 Canadian hospitals are randomly assigned to receive virtual care with RAM or standard care. Outcome adjudicators are masked to group allocations. Patients in the experimental group learn how to use the study's tablet computer and RAM technology, which will measure their vital signs. For 30 days, patients take daily biophysical measurements and complete a recovery survey. Patients interact with nurses via the cellular modem-enabled tablet, who escalate care to preassigned and available physicians if RAM measurements exceed predetermined thresholds, patients report symptoms, a medication error is identified or the nurses have concerns they cannot resolve. The primary outcome is number of days alive at home during the 30 days after randomization. INTERPRETATION: This trial will inform management of patients after discharge following surgery in the COVID-19 pandemic and offer insights for management of patients who undergo nonelective surgery in a nonpandemic setting. Knowledge dissemination will be supported through an online multimedia resource centre, policy briefs, presentations, peer-reviewed journal publications and media engagement. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT04344665.


Subject(s)
Aftercare/trends , Monitoring, Ambulatory/methods , Patient Discharge/standards , Remote Consultation/instrumentation , Adult , COVID-19/diagnosis , COVID-19/epidemiology , Canada/epidemiology , Computers, Handheld/supply & distribution , Humans , Middle Aged , Postoperative Period , SARS-CoV-2/genetics , User-Computer Interface
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