Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 11 de 11
Filter
1.
Infect Dis Health ; 27(2): 81-95, 2022 05.
Article in English | MEDLINE | ID: covidwho-1768145

ABSTRACT

BACKGROUND: Millions of people have acquired and died from SARS-CoV-2 infection during the COVID-19 pandemic. Healthcare workers (HCWs) are required to wear personal protective equipment (PPE), including surgical masks and P2/N95 respirators, to prevent infection while treating patients. However, the comparative effectiveness of respirators and masks in preventing SARS-CoV-2 infection and the likelihood of experiencing adverse events (AEs) with wear are unclear. METHODS: Searches were carried out in PubMed, Europe PMC and the Cochrane COVID-19 Study Register to 14 June 2021. A systematic review of comparative epidemiological studies examining SARS-CoV-2 infection or AE incidence in HCWs wearing P2/N95 (or equivalent) respirators and surgical masks was performed. Article screening, risk of bias assessment and data extraction were duplicated. Meta-analysis of extracted data was carried out in RevMan. RESULTS: Twenty-one studies were included, with most having high risk of bias. There was no statistically significant difference in respirator or surgical mask effectiveness in preventing SARS-CoV-2 infection (OR 0.85, [95%CI 0.72, 1.01]). Healthcare workers experienced significantly more headaches (OR 2.62, [95%CI 1.18, 5.81]), respiratory distress (OR 4.21, [95%CI 1.46, 12.13]), facial irritation (OR 1.80, [95%CI 1.03, 3.14]) and pressure-related injuries (OR 4.39, [95%CI 2.37, 8.15]) when wearing respirators compared to surgical masks. CONCLUSION: The existing epidemiological evidence does not enable definitive assessment of the effectiveness of respirators compared to surgical masks in preventing infection. Healthcare workers wearing respirators may be more likely to experience AEs. Effective mitigation strategies are important to ensure the uptake and correct use of respirators by HCWs.


Subject(s)
COVID-19 , COVID-19/prevention & control , Humans , N95 Respirators/adverse effects , Pandemics/prevention & control , Personal Protective Equipment , SARS-CoV-2
2.
J Clin Epidemiol ; 146: 22-31, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1693303

ABSTRACT

OBJECTIVE: To investigate the completeness and currency of published systematic reviews of remdesivir for COVID-19 and to compare this with a living guidelines approach. STUDY DESIGN AND SETTING: In this cross-sectional study, we searched Europe PMC on May 20, 2021 for systematic reviews of remdesivir (including preprints, living review updates). Completeness and currency were based on the inclusion of four major randomized trials of remdesivir available at the time of publication of the review (including as preliminary results and preprints). RESULTS: We included 38 reviews (45 reports), equivalent to a new publication every 9 days. 23 (51%) reports were out of date at the time of publication. Eleven reviews that were current on publication had a median survival time of 10 days (range 4-57). A third of reviews cited other systematic reviews, but only four provided justifications for why another review was necessary. Eight (21%) of the reviews were registered in PROSPERO. The Australian COVID-19 Clinical Evidence Taskforce living guidelines were updated within 14 days for three of the remdesivir trials, and within 28 days for the fourth. CONCLUSION: There was considerable duplication of systematic reviews of remdesivir, and half were already out of date at the time of publication.


Subject(s)
COVID-19 , Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Australia , COVID-19/drug therapy , Cross-Sectional Studies , Humans , Systematic Reviews as Topic
3.
PLoS One ; 17(1): e0261479, 2022.
Article in English | MEDLINE | ID: covidwho-1613353

ABSTRACT

INTRODUCTION: The Australian National COVID-19 Clinical Evidence Taskforce is producing living, evidence-based, national guidelines for treatment of people with COVID-19 which are updated each week. To continually improve the process and outputs of the Taskforce, and inform future living guideline development, we undertook a concurrent process evaluation examining Taskforce activities and experience of team members and stakeholders during the first 5 months of the project. METHODS: The mixed-methods process evaluation consisted of activity and progress audits, an online survey of all Taskforce participants; and semi-structured interviews with key contributors. Data were collected through five, prospective 4-weekly timepoints (beginning first week of May 2020) and three, fortnightly retrospective timepoints (March 23, April 6 and 20). We collected and analysed quantitative and qualitative data. RESULTS: An updated version of the guidelines was successfully published every week during the process evaluation. The Taskforce formed in March 2020, with a nominal start date of March 23. The first version of the guideline was published two weeks later and included 10 recommendations. By August 24, in the final round of the process evaluation, the team of 11 staff, working with seven guideline panels and over 200 health decision-makers, had developed 66 recommendations addressing 58 topics. The Taskforce website had received over 200,000 page views. Satisfaction with the work of the Taskforce remained very high (>90% extremely or somewhat satisfied) throughout. Several key strengths, challenges and methods questions for the work of the Taskforce were identified. CONCLUSIONS: In just over 5 months of activity, the National COVID-19 Clinical Evidence Taskforce published 20 weekly updates to the evidence-based national treatment guidelines for COVID-19. This process evaluation identified several factors that enabled this achievement (e.g. an extant skill base in evidence review and convening), along with challenges that needed to be overcome (e.g. managing workloads, structure and governance) and methods questions (pace of updating, and thresholds for inclusion of evidence) which may be useful considerations for other living guidelines projects. An impact evaluation is also being conducted separately to examine awareness, acceptance and use of the guidelines.


Subject(s)
COVID-19/therapy , Outcome and Process Assessment, Health Care/trends , Process Assessment, Health Care/methods , Australia , Health Policy/trends , Humans , SARS-CoV-2/pathogenicity , Stakeholder Participation
5.
J Clin Epidemiol ; 143: 11-21, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1536636

ABSTRACT

BACKGROUND AND OBJECTIVE: The Australian National COVID-19 Clinical Evidence Taskforce is developing living, evidence-based, national guidelines for treatment of people with COVID-19. These living guidelines are updated each week. We undertook an impact evaluation to understand the extent to which health professionals providing treatment to people with COVID 19 were aware of, valued and used the guidelines, and the factors that enabled or hampered this. METHODS: A mixed methods approach was used for the evaluation. Surveys were conducted to collect both quantitative and qualitative data and were supplemented with qualitative interviews. Australian healthcare practitioners potentially providing care to individuals with suspected or confirmed COVID-19 were invited to participate. Data were collected on guideline awareness, relevance, ease of use, trustworthiness, value, importance of updating, use, and strengths and opportunities for improvement. RESULTS: A total of 287 people completed the surveys and 10 interviews were conducted during November 2020. Awareness of the work of the Taskforce was high and the vast majority of respondents reported that the guidelines were very or extremely relevant, easy to use, trustworthy and valuable. More than 50% of respondents had used the guidelines to support their own clinical decision-making; and 30% were aware of other examples of the guidelines being used. Qualitative data revealed that amongst an overwhelming morass of evidence and opinions during the COVID-19 pandemic, the guidelines have been a reliable, united source of evidence-based advice; participants felt the guidelines built confidence and provided reassurance in clinical decision-making. Opportunities to improve awareness and accessibility to the guidelines were also explored. CONCLUSIONS: As of June 2021, the guidelines have been published and updated more than 40 times, include more than 140 recommendations and are being used to inform clinical decisions. The findings of this impact evaluation will be used to improve processes and outputs of the Taskforce and guidelines project, and to inform future living guideline projects.

6.
Crit Care Med ; 49(3): 503-516, 2021 03 01.
Article in English | MEDLINE | ID: covidwho-1010657

ABSTRACT

OBJECTIVES: Respiratory failure, multiple organ failure, shortness of breath, recovery, and mortality have been identified as critically important core outcomes by more than 9300 patients, health professionals, and the public from 111 countries in the global coronavirus disease 2019 core outcome set initiative. The aim of this project was to establish the core outcome measures for these domains for trials in coronavirus disease 2019. DESIGN: Three online consensus workshops were convened to establish outcome measures for the four core domains of respiratory failure, multiple organ failure, shortness of breath, and recovery. SETTING: International. PATIENTS: About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Respiratory failure, assessed by the need for respiratory support based on the World Health Organization Clinical Progression Scale, was considered pragmatic, objective, and with broad applicability to various clinical scenarios. The Sequential Organ Failure Assessment was recommended for multiple organ failure, because it was routinely used in trials and clinical care, well validated, and feasible. The Modified Medical Research Council measure for shortness of breath, with minor adaptations (recall period of 24 hr to capture daily fluctuations and inclusion of activities to ensure relevance and to capture the extreme severity of shortness of breath in people with coronavirus disease 2019), was regarded as fit for purpose for this indication. The recovery measure was developed de novo and defined as the absence of symptoms, resumption of usual daily activities, and return to the previous state of health prior to the illness, using a 5-point Likert scale, and was endorsed. CONCLUSIONS: The coronavirus disease 2019 core outcome set recommended core outcome measures have content validity and are considered the most feasible and acceptable among existing measures. Implementation of the core outcome measures in trials in coronavirus disease 2019 will ensure consistency and relevance of the evidence to inform decision-making and care of patients with coronavirus disease 2019.


Subject(s)
COVID-19/epidemiology , COVID-19/prevention & control , Clinical Trials as Topic , Outcome Assessment, Health Care/standards , Practice Guidelines as Topic , Research Design , Dyspnea , Humans , Multiple Organ Failure , Recovery of Function , Reproducibility of Results , Respiratory Insufficiency
7.
J Clin Epidemiol ; 131: 11-21, 2021 03.
Article in English | MEDLINE | ID: covidwho-922037

ABSTRACT

BACKGROUND AND OBJECTIVES: The Australian National COVID-19 Clinical Evidence Taskforce is a consortium of 31 Australian health professional organisations developing living, evidence-based guidelines for care of people with COVID-19, which are updated weekly. This article describes the methods used to develop and maintain the guidelines. METHODS: The guidelines use the GRADE methods and are designed to meet Australian NHMRC standards. Each week, new evidence is reviewed, current recommendations are revised, and new recommendations made. These are published in MAGIC and disseminated through traditional and social media. Relevant new questions to be addressed are continually sought from stakeholders and practitioners. For prioritized questions, the evidence is actively monitored and updated. Evidence surveillance combines horizon scans and targeted searches. An evidence team appraises and synthesizes evidence and prepares evidence-to-decision frameworks to inform development of recommendations. A guidelines leadership group oversees the development of recommendations by multidisciplinary guidelines panels and is advised by a consumer panel. RESULTS: The Taskforce formed in March 2020, and the first recommendations were published 2 weeks later. The guidelines have been revised and republished on a weekly basis for 24 weeks, and as of October 2020, contain over 90 treatment recommendations, suggesting that living methods are feasible in this context. CONCLUSIONS: The Australian guidelines for care of people with COVID-19 provide an example of the feasibility of living guidelines and an opportunity to test and improve living evidence methods.


Subject(s)
COVID-19/therapy , Evidence-Based Medicine/organization & administration , Practice Guidelines as Topic , Australia , Clinical Decision-Making , Humans , Patient Care Team
8.
Crit Care Med ; 48(11): 1622-1635, 2020 11.
Article in English | MEDLINE | ID: covidwho-720988

ABSTRACT

OBJECTIVES: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient relevance, limiting their applicability for clinical decision-making. The aim of this workshop was to establish a core outcomes set for trials in people with suspected or confirmed coronavirus disease 2019. DESIGN: Four international online multistakeholder consensus workshops were convened to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019, informed by a survey involving 9,289 respondents from 111 countries. The transcripts were analyzed thematically. The workshop recommendations were used to finalize the core outcomes set. SETTING: International. SUBJECTS: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public and health professionals (including clinicians, policy makers, regulators, funders, researchers). INTERVENTIONS: None. MEASUREMENTS: None. MAIN RESULTS: Six themes were identified. "Responding to the critical and acute health crisis" reflected the immediate focus on saving lives and preventing life-threatening complications that underpinned the high prioritization of mortality, respiratory failure, and multiple organ failure. "Capturing different settings of care" highlighted the need to minimize the burden on hospitals and to acknowledge outcomes in community settings. "Encompassing the full trajectory and severity of disease" was addressing longer term impacts and the full spectrum of illness (e.g. shortness of breath and recovery). "Distinguishing overlap, correlation and collinearity" meant recognizing that symptoms such as shortness of breath had distinct value and minimizing overlap (e.g. lung function and pneumonia were on the continuum toward respiratory failure). "Recognizing adverse events" refers to the potential harms of new and evolving interventions. "Being cognizant of family and psychosocial wellbeing" reflected the pervasive impacts of coronavirus disease 2019. CONCLUSIONS: Mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in coronavirus disease 2019 trials.


Subject(s)
Betacoronavirus , Coronavirus Infections/therapy , Outcome Assessment, Health Care/organization & administration , Pneumonia, Viral/therapy , Randomized Controlled Trials as Topic/standards , Adult , Aged , COVID-19 , Coronavirus Infections/drug therapy , Coronavirus Infections/prevention & control , Female , Health Services Accessibility/standards , Humans , Male , Middle Aged , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Research Design , SARS-CoV-2 , Symptom Assessment
9.
Crit Care Med ; 48(11): 1612-1621, 2020 11.
Article in English | MEDLINE | ID: covidwho-720987

ABSTRACT

OBJECTIVES: There are over 4,000 trials conducted in people with coronavirus disease 2019. However, the variability of outcomes and the omission of patient-centered outcomes may diminish the impact of these trials on decision-making. The aim of this study was to generate a consensus-based, prioritized list of outcomes for coronavirus disease 2019 trials. DESIGN: In an online survey conducted in English, Chinese, Italian, Portuguese, and Spanish languages, adults with coronavirus disease 2019, their family members, health professionals, and the general public rated the importance of outcomes using a 9-point Likert scale (7-9, critical importance) and completed a Best-Worst Scale to estimate relative importance. Participant comments were analyzed thematically. SETTING: International. SUBJECTS: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public, and health professionals (including clinicians, policy makers, regulators, funders, and researchers). INTERVENTIONS: None. MEASUREMENTS: None. MAIN RESULTS: In total, 9,289 participants from 111 countries (776 people with coronavirus disease 2019 or family members, 4,882 health professionals, and 3,631 members of the public) completed the survey. The four outcomes of highest priority for all three groups were: mortality, respiratory failure, pneumonia, and organ failure. Lung function, lung scarring, sepsis, shortness of breath, and oxygen level in the blood were common to the top 10 outcomes across all three groups (mean > 7.5, median ≥ 8, and > 70% of respondents rated the outcome as critically important). Patients/family members rated fatigue, anxiety, chest pain, muscle pain, gastrointestinal problems, and cardiovascular disease higher than health professionals. Four themes underpinned prioritization: fear of life-threatening, debilitating, and permanent consequences; addressing knowledge gaps; enabling preparedness and planning; and tolerable or infrequent outcomes. CONCLUSIONS: Life-threatening respiratory and other organ outcomes were consistently highly prioritized by all stakeholder groups. Patients/family members gave higher priority to many patient-reported outcomes compared with health professionals.


Subject(s)
Betacoronavirus , Coronavirus Infections/therapy , Health Priorities/organization & administration , Pneumonia, Viral/therapy , Randomized Controlled Trials as Topic/standards , Adult , Aged , COVID-19 , Coronavirus Infections/drug therapy , Coronavirus Infections/prevention & control , Female , Health Services Accessibility/standards , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Research Design , SARS-CoV-2 , Symptom Assessment
10.
BMJ ; 370: m2980, 2020 07 30.
Article in English | MEDLINE | ID: covidwho-691120

ABSTRACT

OBJECTIVE: To compare the effects of treatments for coronavirus disease 2019 (covid-19). DESIGN: Living systematic review and network meta-analysis. DATA SOURCES: WHO covid-19 database, a comprehensive multilingual source of global covid-19 literature, up to 1 March 2021 and six additional Chinese databases up to 20 February 2021. Studies identified as of 12 February 2021 were included in the analysis. STUDY SELECTION: Randomised clinical trials in which people with suspected, probable, or confirmed covid-19 were randomised to drug treatment or to standard care or placebo. Pairs of reviewers independently screened potentially eligible articles. METHODS: After duplicate data abstraction, a bayesian network meta-analysis was conducted. Risk of bias of the included studies was assessed using a modification of the Cochrane risk of bias 2.0 tool, and the certainty of the evidence using the grading of recommendations assessment, development, and evaluation (GRADE) approach. For each outcome, interventions were classified in groups from the most to the least beneficial or harmful following GRADE guidance. RESULTS: 196 trials enrolling 76 767 patients were included; 111 (56.6%) trials and 35 098 (45.72%) patients are new from the previous iteration; 113 (57.7%) trials evaluating treatments with at least 100 patients or 20 events met the threshold for inclusion in the analyses. Compared with standard care, corticosteroids probably reduce death (risk difference 20 fewer per 1000 patients, 95% credible interval 36 fewer to 3 fewer, moderate certainty), mechanical ventilation (25 fewer per 1000, 44 fewer to 1 fewer, moderate certainty), and increase the number of days free from mechanical ventilation (2.6 more, 0.3 more to 5.0 more, moderate certainty). Interleukin-6 inhibitors probably reduce mechanical ventilation (30 fewer per 1000, 46 fewer to 10 fewer, moderate certainty) and may reduce length of hospital stay (4.3 days fewer, 8.1 fewer to 0.5 fewer, low certainty), but whether or not they reduce mortality is uncertain (15 fewer per 1000, 30 fewer to 6 more, low certainty). Janus kinase inhibitors may reduce mortality (50 fewer per 1000, 84 fewer to no difference, low certainty), mechanical ventilation (46 fewer per 1000, 74 fewer to 5 fewer, low certainty), and duration of mechanical ventilation (3.8 days fewer, 7.5 fewer to 0.1 fewer, moderate certainty). The impact of remdesivir on mortality and most other outcomes is uncertain. The effects of ivermectin were rated as very low certainty for all critical outcomes, including mortality. In patients with non-severe disease, colchicine may reduce mortality (78 fewer per 1000, 110 fewer to 9 fewer, low certainty) and mechanical ventilation (57 fewer per 1000, 90 fewer to 3 more, low certainty). Azithromycin, hydroxychloroquine, lopinavir-ritonavir, and interferon-beta do not appear to reduce risk of death or have an effect on any other patient-important outcome. The certainty in effects for all other interventions was low or very low. CONCLUSION: Corticosteroids and interleukin-6 inhibitors probably confer important benefits in patients with severe covid-19. Janus kinase inhibitors appear to have promising benefits, but certainty is low. Azithromycin, hydroxychloroquine, lopinavir-ritonavir, and interferon-beta do not appear to have any important benefits. Whether or not remdesivir, ivermectin, and other drugs confer any patient-important benefit remains uncertain. SYSTEMATIC REVIEW REGISTRATION: This review was not registered. The protocol is publicly available in the supplementary material. READERS' NOTE: This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication. This is the fourth version of the original article published on 30 July 2020 (BMJ 2020;370:m2980), and previous versions can be found as data supplements. When citing this paper please consider adding the version number and date of access for clarity.


Subject(s)
Antiviral Agents/therapeutic use , Betacoronavirus/isolation & purification , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Respiration, Artificial/statistics & numerical data , Adenosine Monophosphate/analogs & derivatives , Adenosine Monophosphate/therapeutic use , Alanine/analogs & derivatives , Alanine/therapeutic use , Betacoronavirus/pathogenicity , COVID-19 , Centers for Disease Control and Prevention, U.S./statistics & numerical data , China/epidemiology , Coronavirus Infections/diagnosis , Coronavirus Infections/drug therapy , Coronavirus Infections/mortality , Coronavirus Infections/virology , Databases, Factual/statistics & numerical data , Drug Combinations , Evidence-Based Medicine/methods , Evidence-Based Medicine/statistics & numerical data , Glucocorticoids/therapeutic use , Humans , Hydroxychloroquine/therapeutic use , Lopinavir/therapeutic use , Network Meta-Analysis , Pandemics , Pneumonia, Viral/diagnosis , Pneumonia, Viral/mortality , Pneumonia, Viral/virology , Randomized Controlled Trials as Topic , Ritonavir/therapeutic use , SARS-CoV-2 , Severity of Illness Index , Standard of Care , Treatment Outcome , United States/epidemiology
11.
Health Res Policy Syst ; 18(1): 52, 2020 Jun 01.
Article in English | MEDLINE | ID: covidwho-459227

ABSTRACT

The global health crisis created by COVID-19 is providing valuable insights into the strengths of our health research system and, perhaps even more clearly, displaying its weaknesses. Much of what is being shown so plainly in the current context is not truly new. We are being reminded that health research systems are slow and noisy as well as that there is a desire for research to inform decision-making, that researchers are great collaborators, and that the walls we are so quick to erect between health research and health practice are unhelpful facades. It is our hope that the clarity with which these issues are being demonstrated by COVID-19 might provide the impetus to address these challenges and seize these opportunities to improve our health research system, for the benefit for communities facing COVID-19 now, and for the benefit of us all in facing the further health challenges that are sure to come.


Subject(s)
Betacoronavirus , Biomedical Research , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , COVID-19 , Cooperative Behavior , Diffusion of Innovation , Health Policy , Humans , Information Dissemination , Publications , Research Personnel , SARS-CoV-2
SELECTION OF CITATIONS
SEARCH DETAIL