The objective of our systematic review is to identify prognostic factors that may be used in decision-making related to the care of patients infected with COVID-19.
We conducted highly sensitive ...searches in PubMed/MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL) and Embase. The searches covered the period from the inception date of each database until April 28, 2020. No study design, publication status or language restriction were applied.
We included studies that assessed patients with confirmed or suspected SARS-CoV-2 infectious disease and examined one or more prognostic factors for mortality or disease severity. Reviewers working in pairs independently screened studies for eligibility, extracted data and assessed the risk of bias. We performed meta-analyses and used GRADE to assess the certainty of the evidence for each prognostic factor and outcome.
We included 207 studies and found high or moderate certainty that the following 49 variables provide valuable prognostic information on mortality and/or severe disease in patients with COVID-19 infectious disease: Demographic factors (age, male sex, smoking), patient history factors (comorbidities, cerebrovascular disease, chronic obstructive pulmonary disease, chronic kidney disease, cardiovascular disease, cardiac arrhythmia, arterial hypertension, diabetes, dementia, cancer and dyslipidemia), physical examination factors (respiratory failure, low blood pressure, hypoxemia, tachycardia, dyspnea, anorexia, tachypnea, haemoptysis, abdominal pain, fatigue, fever and myalgia or arthralgia), laboratory factors (high blood procalcitonin, myocardial injury markers, high blood White Blood Cell count (WBC), high blood lactate, low blood platelet count, plasma creatinine increase, high blood D-dimer, high blood lactate dehydrogenase (LDH), high blood C-reactive protein (CRP), decrease in lymphocyte count, high blood aspartate aminotransferase (AST), decrease in blood albumin, high blood interleukin-6 (IL-6), high blood neutrophil count, high blood B-type natriuretic peptide (BNP), high blood urea nitrogen (BUN), high blood creatine kinase (CK), high blood bilirubin and high erythrocyte sedimentation rate (ESR)), radiological factors (consolidative infiltrate and pleural effusion) and high SOFA score (sequential organ failure assessment score).
Identified prognostic factors can help clinicians and policy makers in tailoring management strategies for patients with COVID-19 infectious disease while researchers can utilise our findings to develop multivariable prognostic models that could eventually facilitate decision-making and improve patient important outcomes.
Prospero registration number: CRD42020178802. Protocol available at: https://www.medrxiv.org/content/10.1101/2020.04.08.20056598v1.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Correspondence to: A D Oxman oxman@online.no Summary points Clinicians, guideline developers, and policymakers sometimes neglect important criteria, give undue weight to criteria, and do not use the ...best available evidence to inform their judgments Explicit and transparent systems for decision making can help to ensure that all important criteria are considered and that decisions are informed by the best available research evidence The purpose of Evidence to Decision (EtD) frameworks is to help people use evidence in a structured and transparent way to inform decisions in the context of clinical recommendations, coverage decisions, and health system or public health recommendations and decisions EtD frameworks have a common structure that includes formulation of the question, an assessment of the evidence, and drawing conclusions, though there are some differences between frameworks for each type of decision EtD frameworks inform users about the judgments that were made and the evidence supporting those judgments by making the basis for decisions transparent to target audiences EtD frameworks also facilitate dissemination of recommendations and enable decision makers in other jurisdictions to adopt recommendations or decisions, or adapt them to their context Introduction Healthcare decision making is complex. Decision-making processes and the factors (criteria) that decision makers should consider vary for different types of decisions, including clinical recommendations, coverage decisions, and health system or public health recommendations or decisions.1 2 3 4 However, some criteria are relevant for all of these decisions, including the anticipated effects of the options being considered, the certainty of the evidence for those effects (also referred to as quality of evidence or confidence in effect estimates), and the costs and feasibility of the options. Rigorously developed guidelines synthesise the available relevant research, facilitating the translation of evidence into recommendations for clinical practice.9 However, the quality of guidelines is often suboptimal.10 11 If guidelines are not developed systematically and transparently, clinicians are not able to decide whether to rely on them or to explore disagreements when faced with conflicting recommendations.12 The GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group has previously developed and refined a system to assess the certainty of evidence of effects and strength of recommendations.13 14 15 More than 100 organisations globally, including the World Health Organization, the Cochrane Collaboration, and the National Institute for Health and Care Excellence (NICE) now use or have adopted the principles of the GRADE system. Cure by 120 weeks, adverse drug reactions (clinical and biological serious adverse events), mortality, time to culture conversion, culture conversion at 24 weeks, acquired resistance to fluoroquinolone and injectable drugs Setting: Global, MDR-TB clinics Perspective: Population perspective (health system) Subgroups: Patients with extensively drug-resistant (XDR) or pre-XDR tuberculosis or those with resistance or contraindication to fluoroquinolones or injectables Background: The emergence of drug resistance is a major threat to global tuberculosis care and control.
Idiopathic pulmonary fibrosis (IPF) is a progressive disease with poor prognosis. In the last decades pirfenidone an anti-inflammatory and anti-fibrotic agent has shown benefit in inhibit collagen ...production and has also demonstrated benefit in decline progression in IPF in physiological outcomes as Forced vital capacity (FVC), in clinical outcomes such as progression free survival (PFS) and a benefit in mortality but no in clinically relevant outcomes as exacerbations or worsening of IPF.
We conducted a systematic review to evaluate the effectiveness of physiological and clinical outcomes of pirfenidone compared to placebo in IPF. We performed a search with no language restriction. Two researchers performed literature search, quality assessment, data extraction and analysis. And was performed a summary of findings table following the GRADE approach.
We included 5 RCTs (Randomized controlled trials) in analysis. The meta-analysis resulted in a decrease in all cause-mortality (RR 0.52 IC 0.32-0.88) and IPF related mortality (RR 0.32 IC 0.14-0.75); other outcomes evaluated were worsening of IPF (RR 0.64 IC 0.50-0.83) and acute exacerbation (RR: 0.72 IC 0.30-1.66 respectively). Also there was a decrease in the risk of progression (RR of PFS: 0.82 IC 0.73–0.92) compared to placebo. Conclusions: We observed significant differences in physiologic and clinically relevant outcomes such as reduction in all-cause mortality, IPF related mortality, worsening of IPF and improvement of PFS. So pirfenidone treatment should be considered not only for its benefits in pulmonary function tests but also by its clinically relevant outcomes corrected.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
To describe a framework for people making and using evidence-informed health system and public health recommendations and decisions.
We developed the GRADE Evidence to Decision (EtD) framework for ...health system and public health decisions as part of the DECIDE project, in which we simultaneously developed frameworks for these and other types of healthcare decisions, including clinical recommendations, coverage decisions and decisions about diagnostic tests.
Building on GRADE EtD tables, we used an iterative approach, including brainstorming, consultation of the literature and with stakeholders, and an international survey of policy-makers. We applied the framework to diverse examples, conducted workshops and user testing with health system and public health guideline developers and policy-makers, and observed and tested its use in real-life guideline panels.
All the GRADE EtD frameworks share the same basic structure, including sections for formulating the question, making an assessment and drawing conclusions. Criteria listed in the assessment section of the health system and public health framework cover the important factors for making these types of decisions; in addition to the effects and economic impact of an option, the priority of the problem, the impact of the option on equity, and its acceptability and feasibility are important considerations that can inform both whether and how to implement an option. Because health system and public health interventions are often complex, detailed implementation considerations should be made when making a decision. The certainty of the evidence is often low or very low, but decision-makers must still act. Monitoring and evaluation are therefore often important considerations for these types of decisions. We illustrate the different components of the EtD framework for health system and public health decisions by presenting their application in a framework adapted from a real-life guideline.
This framework provides a structured and transparent approach to support policy-making informed by the best available research evidence, while making the basis for decisions accessible to those whom they will affect. The health system and public health EtD framework can also be used to facilitate dissemination of recommendations and enable decision-makers to adopt, and adapt, recommendations or decisions.
Ownership of healthcare providers has been considered as one factor that might influence their health and healthcare related performance. The aim of this article was to provide an overview of what is ...known about the effects on economic, administrative and health related outcomes of different types of ownership of healthcare providers--namely public, private non-for-profit (PNFP) and private for-profit (PFP)--based on the findings of systematic reviews (SR).
An overview of systematic reviews was performed. Different databases were searched in order to select SRs according to an explicit comprehensive criterion. Included SRs were assessed to determine their methodological quality. Of the 5918 references reviewed, fifteen SR were included, but six of them were rated as having major limitations, so they weren't incorporated in the analyses. According to the nine analyzed SR, ownership does seem to have an effect on health and healthcare related outcomes. In the comparison of PFP and PNFP providers, significant differences in terms of mortality of patients and payments to facilities have been found, both being higher in PFP facilities. In terms of quality and economic indicators such as efficiency, there are no concluding results. When comparing PNFP and public providers, as well as for PFP and public providers, no clear differences were found.
PFP providers seem to have worst results than their PNFP counterparts, but there are still important evidence gaps in the literature that needs to be covered, including the comparison between public and both PFP and PNFP providers. More research is needed in low and middle income countries to understand the impact on and development of healthcare delivery systems.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The role of health communication in vaccination programmes cannot be overemphasized: it has contributed significantly to creating and sustaining demand for vaccination services and improving ...vaccination coverage. In Nigeria, numerous communication approaches have been deployed but these interventions are not without challenges. We therefore aimed to explore factors affecting the delivery of vaccination communication in Nigeria.
We used a qualitative approach and conducted the study in two states: Bauchi and Cross River States in northern and southern Nigeria respectively. We identified factors affecting the implementation of communication interventions through interviews with relevant stakeholders involved in vaccination communication in the health services. We also reviewed relevant documents. Data generated were transcribed verbatim and analysed using thematic analysis.
We used the SURE framework to organise the identified factors (barriers and facilitators) affecting vaccination communication delivery. We then grouped these into health systems and community level factors. Some of the commonly reported health system barriers amongst stakeholders interviewed included: funding constraints, human resource factors (health worker shortages, training deficiencies, poor attitude of health workers and vaccination teams), inadequate infrastructure and equipment and weak political will. Community level factors included the attitudes of community stakeholders and of parents and caregivers. We also identified factors that appeared to facilitate communication activities. These included political support, engagement of traditional and religious institutions and the use of organised communication committees.
Communication activities are a crucial element of immunization programmes. It is therefore important for policy makers and programme managers to understand the barriers and facilitators affecting the delivery of vaccination communication so as to be able to implement communication interventions more effectively.
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Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Provide a timely, rigorous, and continuously updated summary of the evidence on the role of lopinavir/ritonavir in the treatment of patients with COVID-19.
We conducted searches in the special L·OVE ...(Living OVerview of Evidence) platform for COVID-19, a system that performs regular searches in PubMed, Embase, CENTRAL, and other 33 sources. We searched for randomized trials and non-randomized studies evaluating the effect of lopinavir/ritonavir versus placebo or no treatment in patients with COVID-19. Two reviewers independently evaluated potentially eligible studies, according to predefined selection criteria, and extracted data using a predesigned standardized form. We performed meta-analyses using random-effect models and assessed overall certainty in evidence using the GRADE approach. A living, web-based version of this review will be openly available during the COVID-19 pandemic.
Our search strategy yielded 862 references. Finally, we identified 12 studies, including two randomized trials, evaluating lopinavir/ritonavir, in addition to standard care versus standard care alone in 250 adult inpatients with COVID-19. The evidence from randomized trials shows lopinavir/ritonavir may reduce mortality (relative risk: 0.77; 95% confidence interval: 0.45 to 1.3; low certainty evidence), but the anticipated magnitude of the absolute reduction in mortality, varies across different risk groups. Lopinavir/ritonavir also had a slight reduction in the risk of requiring invasive mechanical ventilation, developing respiratory failure, or acute respiratory distress syndrome. However, it did not lead to any difference in the duration of hospitalization and may lead to an increase in the number of total adverse effects. The overall certainty of the evidence was low or very low.
For severe and critical patients with COVID-19, lopinavir/ritonavir might play a role in improving outcomes, but the available evidence is still limited. A substantial number of ongoing studies should provide valuable evidence to inform researchers and decision-makers soon.
The COVID-19 pandemic has underlined the need for reliable information for clinical decision-making and public health policies. As such, evidence-based medicine (EBM) is essential in identifying and ...evaluating scientific documents pertinent to novel diseases, and the accurate classification of biomedical text is integral to this process. Given this context, we introduce a comprehensive, curated dataset composed of COVID-19-related documents.
This dataset includes 20,047 labeled documents that were meticulously classified into five distinct categories: systematic reviews (SR), primary study randomized controlled trials (PS-RCT), primary study non-randomized controlled trials (PS-NRCT), broad synthesis (BS), and excluded (EXC). The documents, labeled by collaborators from the Epistemonikos Foundation, incorporate information such as document type, title, abstract, and metadata, including PubMed id, authors, journal, and publication date.
Uniquely, this dataset has been curated by the Epistemonikos Foundation and is not readily accessible through conventional web-scraping methods, thereby attesting to its distinctive value in this field of research. In addition to this, the dataset also includes a vast evidence repository comprising 427,870 non-COVID-19 documents, also categorized into SR, PS-RCT, PS-NRCT, BS, and EXC. This additional collection can serve as a valuable benchmark for subsequent research. The comprehensive nature of this open-access dataset and its accompanying resources is poised to significantly advance evidence-based medicine and facilitate further research in the domain.
Background
Sudden cardiac death (SCD) is one of the main causes of cardiac death. There are two main strategies to prevent it: managing cardiovascular risk factors and reducing the risk of ...ventricular arrhythmias. Implantable cardiac defibrillators (ICDs) constitute the standard therapy for both primary and secondary prevention; however, they are not widely available in settings with limited resources. The antiarrhythmic amiodarone has been proposed as an alternative to ICD.
Objectives
To evaluate the effectiveness of amiodarone for primary or secondary prevention in SCD compared with placebo or no intervention or any other antiarrhythmic drugs in participants at high risk (primary prevention) or who have recovered from a cardiac arrest or a syncope due to Ventricular Tachycardia/Ventricular Fibrillation, or VT/VF (secondary prevention).
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), EMBASE (OVID), CINAHL (EBSCO) and LILACS on 26 March 2015. We reviewed reference lists of included studies and selected reviews on the topic, contacted authors of included studies, screened relevant meetings and searched in registers for ongoing trials. We applied no language restrictions.
Selection criteria
Randomised and quasi‐randomised trials assessing the efficacy of amiodarone versus placebo, no intervention, or other antiarrhythmics in adults. For primary prevention we considered participants at high risk for SCD. For secondary prevention we considered participants recovered from cardiac arrest or syncope due to ventricular arrhythmias.
Data collection and analysis
Two authors independently assessed the trials for inclusion and extracted relevant data. We contacted trial authors for missing data. We performed meta‐analyses using a random‐effects model. We calculated risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CIs). Three studies included more than one comparison.
Main results
We included 24 studies (9,997 participants). Eighteen studies evaluated amiodarone for primary prevention and six for secondary prevention. Only three studies used an ICD concomitantly with amiodarone for the comparison (all of them for secondary prevention).
For primary prevention, amiodarone compared to placebo or no intervention (17 studies, 8383 participants) reduced SCD (RR 0.76; 95% CI 0.66 to 0.88), cardiac mortality (RR 0.86; 95% CI 0.77 to 0.96) and all‐cause mortality (RR 0.88; 95% CI 0.78 to 1.00). The quality of the evidence was low.
Compared to other antiarrhythmics (three studies, 540 participants), amiodarone reduced SCD (RR 0.44; 95% CI 0.19 to 1.00), cardiac mortality (RR 0.41; 95% CI 0.20 to 0.86) and all‐cause mortality (RR 0.37; 95% CI 0.18 to 0.76). The quality of the evidence was moderate.
For secondary prevention, amiodarone compared to placebo or no intervention (two studies, 440 participants) appeared to increase the risk of SCD (RR 4.32; 95% CI 0.87 to 21.49) and all‐cause mortality (RR 3.05; 1.33 to 7.01). However, the quality of the evidence was very low. Compared to other antiarrhythmics (four studies, 839 participants) amiodarone appeared to increase the risk of SCD (RR 1.40; 95% CI 0.56 to 3.52; very low quality of evidence), but there was no effect in all‐cause mortality (RR 1.03; 95% CI 0.75 to 1.42; low quality evidence).
Amiodarone was associated with an increase in pulmonary and thyroid adverse events.
Authors' conclusions
There is low to moderate quality evidence that amiodarone reduces SCD, cardiac and all‐cause mortality when compared to placebo or no intervention for primary prevention, and its effects are superior to other antiarrhythmics.
It is uncertain if amiodarone reduces or increases SCD and mortality for secondary prevention because the quality of the evidence was very low.
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