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1.
BMJ Open ; 11(1): e043004, 2021 01 06.
Artigo em Inglês | MEDLINE | ID: mdl-33408209

RESUMO

BACKGROUND: Testing used in screening, diagnosis and follow-up of COVID-19 has been a subject of debate. Several organisations have developed formal advice about testing for COVID-19 to assist in the control of the disease. We collated, delineated and appraised current worldwide recommendations about the role and applications of tests to control SARS-CoV-2/COVID-19. METHODS: We searched for documents providing recommendations for COVID-19 testing in PubMed, EMBASE, LILACS, the Coronavirus Open Access Project living evidence database and relevant websites such as TRIP database, ECRI Guidelines Trust, the GIN database, from inception to 21 September 2020. Two reviewers applied the eligibility criteria to potentially relevant citations without language or geographical restrictions. We extracted data in duplicate, including assessment of methodological quality using the Appraisal of Guidelines for Research and Evaluation-II tool. RESULTS: We included 47 relevant documents and 327 recommendations about testing. Regarding the quality of the documents, we found that the domains with the lowest scores were 'Editorial independence' (Median=4%) and 'Applicability' (Median=6%). Only six documents obtained at least 50% score for the 'Rigour of development' domain. An important number of recommendations focused on the diagnosis of suspected cases (48%) and deisolation measures (11%). The most frequently recommended test was the reverse transcription-PCR (RT-PCR) assay (87 recommendations) and the chest CT (38 recommendations). There were 22 areas of agreement among guidance developers, including the use of RT-PCR for SARS-Cov-2 confirmation, the limited role of bronchoscopy, the use chest CT and chest X-rays for grading severity and the co-assessment for other respiratory pathogens. CONCLUSION: This first scoping review of recommendations for COVID-19 testing showed many limitations in the methodological quality of included guidance documents that could affect the confidence of clinicians in their implementation. Future guidance documents should incorporate a minimum set of key methodological characteristics to enhance their applicability for decision making.


Assuntos
/normas , Guias de Prática Clínica como Assunto , Tomografia Computadorizada por Raios X/métodos , /epidemiologia , Humanos , Pandemias
2.
PLoS One ; 15(12): e0242958, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33301459

RESUMO

BACKGROUND: A false-negative case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is defined as a person with suspected infection and an initial negative result by reverse transcription-polymerase chain reaction (RT-PCR) test, with a positive result on a subsequent test. False-negative cases have important implications for isolation and risk of transmission of infected people and for the management of coronavirus disease 2019 (COVID-19). We aimed to review and critically appraise evidence about the rate of RT-PCR false-negatives at initial testing for COVID-19. METHODS: We searched MEDLINE, EMBASE, LILACS, as well as COVID-19 repositories, including the EPPI-Centre living systematic map of evidence about COVID-19 and the Coronavirus Open Access Project living evidence database. Two authors independently screened and selected studies according to the eligibility criteria and collected data from the included studies. The risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We calculated the proportion of false-negative test results using a multilevel mixed-effect logistic regression model. The certainty of the evidence about false-negative cases was rated using the GRADE approach for tests and strategies. All information in this article is current up to July 17, 2020. RESULTS: We included 34 studies enrolling 12,057 COVID-19 confirmed cases. All studies were affected by several risks of bias and applicability concerns. The pooled estimate of false-negative proportion was highly affected by unexplained heterogeneity (tau-squared = 1.39; 90% prediction interval from 0.02 to 0.54). The certainty of the evidence was judged as very low due to the risk of bias, indirectness, and inconsistency issues. CONCLUSIONS: There is substantial and largely unexplained heterogeneity in the proportion of false-negative RT-PCR results. The collected evidence has several limitations, including risk of bias issues, high heterogeneity, and concerns about its applicability. Nonetheless, our findings reinforce the need for repeated testing in patients with suspicion of SARS-Cov-2 infection given that up to 54% of COVID-19 patients may have an initial false-negative RT-PCR (very low certainty of evidence). SYSTEMATIC REVIEW REGISTRATION: Protocol available on the OSF website: https://tinyurl.com/vvbgqya.

3.
Vaccine ; 2020 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-32972737

RESUMO

INTRODUCTION: Maternal immunization is aimed at reducing morbidity and mortality in pregnant women and their newborns. Updated evidence synthesis of maternal-fetal outcomes is constantly needed to ensure that the risk-benefit of vaccination during pregnancy remains positive. METHODS: An overview of systematic reviews (OoSRs) was performed. We searched The Cochrane Library, MEDLINE and EMBASE for SRs including recommended vaccines for maternal immunization reporting the following: abortion, stillbirth, chorioamnionitis, congenital anomalies, microcephaly, neonatal death, neonatal infection, preterm birth (PTB), low birth weight (LBW), maternal death and small for gestational age (SGA) from 2010 to April 2019. Quality and overlap of SRs was assessed. RESULTS: Seventeen SRs were identified, eight of them included meta-analysis; quality was high in three SRs, moderate in six SRs, low in two SRs, and critically low in six SRs. Stillbirth and PTB were the most frequently reported outcomes by 15 and 13 SRs, respectively, followed by abortion (9 SRs), congenital anomalies (9 SRs), SGA (8 SRs), neonatal death (8 SRs), LBW (4 SRs), chorioamnionitis (3 SRs), maternal death (1 SR). SRs included mainly observational evidence for influenza and Tdap vaccines (11 SRs and 4 SRs, respectively); limited evidence was found for hepatitis (1 SR), yellow fever (1 SR), and meningococcal (1 SR) vaccines. Most of the SRs found no effect. Eight SRs found benefit/protection of influenza vaccine (for stillbirth, neonatal death, preterm birth, LBW), or Tdap vaccine (for preterm birth and SGA); one found a probable risk (chorioamnionitis/Tdap). The SRs for Hepatitis B, meningococcal and yellow fever vaccines were inconclusive. CONCLUSIONS: Definite risks were not identified for any vaccine and outcome; however better evidence is needed for all outcomes and vaccines. The available evidence in the SRs to support vaccine safety was based mainly on observational data. More RCTs with adequate reporting of maternal-fetal outcomes and larger high-quality observational studies are needed.

4.
Medwave ; 20(5): e7938, 2020 Jun 24.
Artigo em Espanhol | MEDLINE | ID: mdl-32603320

RESUMO

Introduction: Oral cancer has a 5-year survival rate of 50% because diagnosis is commonly performed at an advanced stage of the disease, so new diagnostic tools are needed. Nowadays, there is a vast number of publications suggesting the use of salivary biomarkers for oral cancer and potentially malignant disorders diagnosis, but their diagnostic accuracy is unclear. Thus, the goal of this systematic review is to evaluate the diagnostic accuracy of salivary biomarkers for oral cancer and potentially malignant disorders. Methods: This protocol is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). We will include primary studies assessing the diagnostic accuracy of salivary biomarkers for oral cancer and potentially malignant disorders. Studies must report data about sensitivity and specificity; gold standard must be the histopathology diagnosis. We will search MEDLINE, EMBASE, the Cochrane Library, and gray literature. Two authors will independently select the studies and extract the data. The methodology quality of studies will be determined using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2). Expected results and conclusion: Our findings will provide information about the diagnostic accuracy of salivary biomarkers for oral cancer and potentially malignant disorders.

5.
Medwave ; 20(5)26-06-2020.
Artigo em Inglês, Espanhol | LILACS-Express | LILACS | ID: biblio-1116885

RESUMO

Introducción El cáncer oral tiene una tasa de supervivencia a los cinco años de 50%, debido a que frecuentemente su diagnóstico es realizado en estadios avanzados. Por lo tanto, son necesarias nuevas ayudas diagnósticas. Actualmente, existe un número significativo de publicaciones científicas sugiriendo el uso de biomarcadores salivales para el diagnóstico de cáncer oral. Sin embargo, son desconocidas las propiedades diagnósticas de estos biomarcadores. El objetivo de esta revisión sistemática es evaluar la evidencia sobre la precisión diagnóstica de biomarcadores salivales usados en la identificación de cáncer oral y desórdenes potencialmente malignos. Métodos Este protocolo es reportado en concordancia con el Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). Se incluirán estudios evaluando la precisión diagnóstica de biomarcadores salivales para cáncer oral y desórdenes potencialmente malignos. Estos deberán reportar sensibilidad y especificidad, y utilizar como estándar de referencia un diagnóstico histopatológico. Se realizará una búsqueda en MEDLINE, EMBASE, Cochrane Library y literatura gris. Dos autores independientemente seleccionarán los estudios y extraerán los datos. La calidad metodológica de los estudios será determinada usando The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2). Resultados esperados y conclusión Los hallazgos de esta revisión sistemática proporcionarán información acerca de la precisión diagnóstica de los biomarcadores salivales para diagnóstico de cáncer oral y desórdenes potencialmente malignos.


Introduction Oral cancer has a 5-year survival rate of 50% because diagnosis is commonly performed at an advanced stage of the disease, so new diagnostic tools are needed. Nowadays, there is a vast number of publications suggesting the use of salivary biomarkers for oral cancer and potentially malignant disorders diagnosis, but their diagnostic accuracy is unclear. Thus, the goal of this systematic review is to evaluate the diagnostic accuracy of salivary biomarkers for oral cancer and potentially malignant disorders. Methods This protocol is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). We will include primary studies assessing the diagnostic accuracy of salivary biomarkers for oral cancer and potentially malignant disorders. Studies must report data about sensitivity and specificity; gold standard must be the histopathology diagnosis. We will search MEDLINE, EMBASE, the Cochrane Library, and gray literature. Two authors will independently select the studies and extract the data. The methodology quality of studies will be determined using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2). Expected results and conclusion Our findings will provide information about the diagnostic accuracy of salivary biomarkers for oral cancer and potentially malignant disorders.

6.
BMC Med Res Methodol ; 20(1): 115, 2020 05 13.
Artigo em Inglês | MEDLINE | ID: mdl-32404051

RESUMO

BACKGROUND: Rapid reviews (RRs) have emerged as an efficient alternative to time-consuming systematic reviews-they can help meet the demand for accelerated evidence synthesis to inform decision-making in healthcare. The synthesis of diagnostic evidence has important methodological challenges. Here, we performed an international survey to identify the current practice of producing RRs for diagnostic tests. METHODS: We developed and administered an online survey inviting institutions that perform RRs of diagnostic tests from all over the world. RESULTS: All participants (N = 25) reported the implementation of one or more methods to define the scope of the RR; however, only one strategy (defining a structured question) was used by ≥90% of participants. All participants used at least one methodological shortcut including the use of a previous review as a starting point (92%) and the use of limits on the search (96%). Parallelization and automation of review tasks were not extensively used (48 and 20%, respectively). CONCLUSION: Our survey indicates a greater use of shortcuts and limits for conducting diagnostic test RRs versus the results of a recent scoping review analyzing published RRs. Several shortcuts are used without knowing how their implementation affects the results of the evidence synthesis in the setting of diagnostic test reviews. Thus, a structured evaluation of the challenges and implications of the adoption of these RR methods is warranted.

7.
Rev. colomb. enferm ; 19(1): 1-9, 20200416.
Artigo em Espanhol | LILACS, BDENF - Enfermagem, COLNAL | ID: biblio-1118868

RESUMO

Objetivo: identificar la inclusión de la propuesta temática curricular de la Federación Latinoamericana de Obstetricia y Ginecología (FLASOG) sobre salud sexual y reproductiva en programas de pregrado (Medicina) y posgrado (Obstetricia y Ginecología) en un grupo de universidades e instituciones de educación superior de Latinoamérica y el Caribe. Método: estudio descriptivo de corte transversal en el cual se aplicó una encuesta a universidades de Latinoamérica y El Caribe durante el año 2017 para determinar si los contenidos de los programas con relación a salud sexual y reproductiva corresponden a la propuesta temática de la FLASOG, tanto en pregrado (Medicina) como en posgrado (Obstetricia y Ginecología). Resultados: todos los programas de pregrado evaluados incluyen dentro del currículo los siguientes temas: m étodos anticonceptivos, aborto y morbimortalidad materna y el 36,4 % contemplan salud sexual en la tercera edad. Todos los programas de posgrado evaluados estudian métodos anticonceptivos, anticoncepci ón en posparto y posaborto, morbimortalidad materna, aborto, y maternidad saludable. Solo el 55,6 % de ellos tienen temáticas relacionadas con interrupción voluntaria del embarazo y salud sexual en la tercera edad. Conclusiones: los programas evaluados cuentan con docentes dedicados a educación en salud sexual y reproductiva en sus programas, aunque en la mayoría de las instituciones (76,9 % ) no existe un proceso formal de evaluación y retroalimentación. Todas las universidades que respondieron la encuesta trabajan tres temas en sus contenidos curriculares de pregrado: aborto, anticoncepción y morbimortalidad materna, t ópicos que han sido considerados de alto impacto en la salud sexual y reproductiva de las mujeres. La interrupción voluntaria del embarazo se discute en dos de cada tres universidades que respondieron la encuesta. El tema de salud sexual en la tercera edad no se incluye en los programas.


Objective: to identify if Latin American and Caribbean higher education institutions include in their curriculum the sexual and reproductive health topics proposed by the Latin American Federation of Obstetrics and Gynecology (FLASOG for its acronym in Spanish) in undergraduate and graduate programs. Methods: descriptive, cross sectional study developed in the year 2017. A survey was sent to universities in Latin America and the Caribbean to evaluate if the sexual and reproductive health contents in the curriculum of undergraduate (medicine) and graduate schools (obstetrics and gynecology) correspond to the ones proposed by FLASOG. Results: 100 % of assessed undergraduate programs include the following topics in their curriculum: birth control methods, abortion, maternal morbidity and mortality, and 36.4 % include sexual health in the elderly. 100 % of graduate programs evaluated include: birth control methods, maternal morbidity and mortality, abortion, and healthy maternity, and 55.6 % include legal pregnancy termination and sexual health in the elderly. Conclusions: All the higher education programs evaluated have faculty for sexual and reproductive health, but most institutions (76 .9 % ) do not have a formal process for evaluation and feedback. All the universities include in their undergraduate programs the following topics: abortion, birth control methods and maternal morbidity and mortality, all of which have been considered of high impact in sexual and reproductive health of women. However, topics such as legal termination of pregnancy are only included in two out of three universities evaluated, and sexual health in the elderly is rarely included in the curriculum.


Objetivo: identificar a inclusão da proposta temática da Federação Latino-Americana de Obstetrícia e Ginecologia (FLASOG) em saúde sexual e reprodutiva nos programas de graduação (Medicina) e pós-graduação (Obstetrícia e Ginecologia) em um grupo de universidades e instituições de ensino superior da América Latina e do Caribe. Método: estudo descritivo transversal. Foi aplicado um questionário em programas de cursos de graduação e pós-graduação de universidades da América Latina e do Caribe em 2017, para determinar se o conteúdo dos programas relacionados à saúde sexual e reprodutiva correspondem à proposta temática da FLASOG no nível de graduação (Medicina) e de pós-graduação (Obstetrícia e Ginecologia). Resultados: todos os programas de graduação avaliados incluíram os seguintes tópicos no currículo: métodos contraceptivos, aborto e morbimortalidade materna; ainda, 36,4% dos programas abrangem temas relacionados à saúde sexual nos idosos. Todos os programas de pós-graduação avaliados estudam métodos contraceptivos, contracepção no pós-parto e pós-aborto, morbimortalidade materna, aborto e maternidade saudável. Apenas 55,6% desses programas têm tópicos relacionados à interrupção voluntária da gravidez e sobre a saúde sexual em idosos. Conclusões: os programas avaliados têm professores enfocados na educação da saúde sexual e reprodutiva, embora na maioria das instituições (76,9%) não exista um processo formal de avaliação e feedback. Todas as universidades que responderam à pesquisa trabalham com três tópicos em seu conteúdo curricular de graduação: aborto, contracepção e morbimortalidade materna, considerados de alto impacto na saúde sexual e reprodutiva das mulheres. A interrupção voluntária da gravidez é discutida em uma proporção de duas em cada três universidades que responderam ao questionário. A saúde sexual em idosos não está incluída nos programas


Assuntos
Humanos , Educação Superior , Saúde Sexual e Reprodutiva , América Latina
8.
BMC Complement Med Ther ; 20(1): 12, 2020 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-32020875

RESUMO

BACKGROUND: Although cannabis and cannabinoids are widely used with therapeutic purposes, their claimed efficacy is highly controversial. For this reason, medical cannabis use is a broad field of research that is rapidly expanding. Our objectives are to identify, characterize, appraise, and organize the current available evidence surrounding therapeutic use of cannabis and cannabinoids, using evidence maps. METHODS: We searched PubMed, EMBASE, The Cochrane Library and CINAHL, to identify systematic reviews (SRs) published from their inception up to December 2017. Two authors assessed eligibility and extracted data independently. We assessed methodological quality of the included SRs using the AMSTAR tool. To illustrate the extent of use of medical cannabis, we organized the results according to identified PICO questions using bubble plots corresponding to different clinical scenarios. RESULTS: A total of 44 SRs published between 2001 and 2017 were included in this evidence mapping with data from 158 individual studies. We extracted 96 PICO questions in the following medical conditions: multiple sclerosis, movement disorders (e.g. Tourette Syndrome, Parkinson Disease), psychiatry conditions, Alzheimer disease, epilepsy, acute and chronic pain, cancer, neuropathic pain, symptoms related to cancer (e.g. emesis and anorexia related with chemotherapy), rheumatic disorders, HIV-related symptoms, glaucoma, and COPD. The evidence about these conditions is heterogeneous regarding the conclusions and the quality of the individual primary studies. The quality of the SRs was moderate to high according to AMSTAR scores. CONCLUSIONS: Evidence on medical uses of cannabis is broad. However, due to methodological limitations, conclusions were weak in most of the assessed comparisons. Evidence mapping methodology is useful to perform an overview of available research, since it is possible to systematically describe the extent and distribution of evidence, and to organize scattered data.


Assuntos
Canabinoides/uso terapêutico , Cannabis , Maconha Medicinal/uso terapêutico , Humanos , Revisões Sistemáticas como Assunto
9.
J Clin Epidemiol ; 121: 62-70, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-31982539

RESUMO

OBJECTIVE: The objective of this study was to provide guidance on the use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to determine certainty in estimates of association between prognostic factors and future outcomes. STUDY DESIGN AND SETTING: We developed our guidance through an iterative process that involved review of published systematic reviews and meta-analyses of prognostic factors, consultation with members, feedback, presentation, and discussion at the GRADE Working Group meetings. RESULTS: For questions of prognosis, a body of observational evidence (potentially including patients enrolled in randomized controlled trials) begins as high certainty in the evidence. The five domains of GRADE for rating down certainty in the evidence, that is, risk of bias, imprecision, inconsistency, indirectness, and publication bias, as well as the domains for rating up, also apply to estimates of associations between prognostic factors and outcomes. One should determine if their ratings do not consider (noncontextualized) or consider (contextualized) the clinical context as this will may result in variable judgments on certainty of the evidence. CONCLUSIONS: The same principles GRADE proposed for bodies of evidence addressing treatment and overall prognosis work well in assessing individual prognostic factors, both in noncontextualized and contextualized settings.

10.
J Clin Epidemiol ; 117: 138-148, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31112801

RESUMO

OBJECTIVE: The objective of the study was to clarify how the Grading of Recommendations Assessment, Development and Evaluation (GRADE) concept of certainty of evidence applies to certainty ratings of test accuracy. STUDY DESIGN AND SETTING: After initial brainstorming with GRADE Working Group members, we iteratively refined and clarified the approaches for defining ranges when assessing the certainty of evidence for test accuracy within a systematic review, health technology assessment, or guideline. RESULTS: Ranges can be defined both for single test accuracy and for comparative accuracy of multiple tests. For systematic reviews and health technology assessments, approaches for defining ranges include some that do not require value judgments regarding downstream health outcomes. Key challenges arise in the context of a guideline that requires ranges for sensitivity and specificity that are set considering possible effects on all critical outcomes. We illustrate possible approaches and provide an example from a systematic review of a direct comparison between two test strategies. CONCLUSIONS: This GRADE concept paper provides a framework for assessing, presenting, and making decisions based on the certainty of evidence for test accuracy. More empirical research is needed to support future GRADE guidance on how to best operationalize the candidate approaches.


Assuntos
Técnicas e Procedimentos Diagnósticos/normas , Avaliação da Tecnologia Biomédica/métodos , Tomada de Decisões , Humanos , Sensibilidade e Especificidade , Revisões Sistemáticas como Assunto
11.
J Clin Epidemiol ; 116: 98-105, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31521724

RESUMO

BACKGROUND AND OBJECTIVES: Rapid reviews provide an efficient alternative to standard systematic reviews in response to a high priority or urgent need. Although rapid reviews of interventions have been extensively evaluated, little is known about the characteristics of rapid reviews of diagnostic evidence. STUDY DESIGN AND SETTING: We performed a scoping review for rapid reviews of medical tests published from 2013 to 2018. We extracted information on review characteristics and methods used to assess the evidence. RESULTS: We identified 191 rapid reviews. All reviews were developed within a short time (less than 12 months) and were relatively concise (less than 10 pages). The reviews involved multiple index tests (44%), multiple outcomes (88%), and several test applications (29%). Well-known methodological tailoring strategies were infrequently used. Although reporting of several key features was limited, we found that, in general, rapid reviews have similar characteristics to broader knowledge syntheses. CONCLUSION: Our scoping review is the first to describe the characteristics and methods of rapid reviews of diagnostic evidence. Future research should identify the most appropriate methods for performing rapid reviews of medical tests. Standards for reporting of rapid reviews are needed.


Assuntos
Projetos de Pesquisa/normas , Medicina Baseada em Evidências , Humanos , Literatura de Revisão como Assunto , Fatores de Tempo
12.
Diagn Progn Res ; 3: 7, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31093577

RESUMO

Background: Assessment of diagnostic tests, broadly defined as any element that aids in the collection of additional information for further clarification of a patient's health status, has increasingly become a critical issue in health policy and decision-making. Diagnostic evidence, including the accuracy of a medical test for a target condition, is commonly appraised using standard systematic review methodology. Owing to the considerable time and resources required to conduct these, rapid reviews have emerged as a pragmatic alternative by tailoring methods according to the decision maker's circumstances. However, it is not known if streamlining methodological aspects has an impact on the validity of evidence synthesis. Furthermore, due to the particular nature and complexity of the appraisal of diagnostic accuracy, there is need for detailed guidance on how to conduct rapid reviews of diagnostic tests. In this study, we aim to identify the methods currently used by rapid review developers to synthesize evidence on diagnostic test accuracy, as well as to analyze potential shortcomings and challenges related to these methods. Methods: We will carry out a two-fold approach: (1) an international survey of professionals working in organizations that develop rapid reviews of diagnostic tests, in terms of the methods and resources used by these agencies when conducting rapid reviews, and (2) semi-structured interviews with senior-level individuals to further explore and validate the findings from the survey and to identify challenges in conducting rapid reviews. We will use STATA 15.0 for quantitative analyses and framework analysis for qualitative analyses. We will ensure protection of data during all stages. Discussion: The main result of this research will be a map of methods and resources currently used for conducting rapid reviews of diagnostic test accuracy, as well as methodological shortcomings and potential solutions in diagnostic knowledge synthesis that require further research.

13.
Cochrane Database Syst Rev ; 4: CD011811, 2019 04 30.
Artigo em Inglês | MEDLINE | ID: mdl-31038735

RESUMO

BACKGROUND: The definition of sepsis has evolved over time, along with the clinical and scientific knowledge behind it. For years, sepsis was defined as a systemic inflammatory response syndrome (SIRS) in the presence of a documented or suspected infection. At present, sepsis is defined as a life-threatening organ dysfunction resulting from a dysregulated host response to infection. Even though sepsis is one of the leading causes of mortality in critically ill patients, and the World Health Organization (WHO) recognizes it as a healthcare priority, it still lacks an accurate diagnostic test. Determining the accuracy of interleukin-6 (IL-6) concentrations in plasma, which is proposed as a new biomarker for the diagnosis of sepsis, might be helpful to provide adequate and timely management of critically ill patients, and thus reduce the morbidity and mortality associated with this condition. OBJECTIVES: To determine the diagnostic accuracy of plasma interleukin-6 (IL-6) concentration for the diagnosis of bacterial sepsis in critically ill adults. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, LILACS, and Web of Science on 25 January 2019. We screened references in the included studies to identify additional studies. We did not apply any language restriction to the electronic searches. SELECTION CRITERIA: We included diagnostic accuracy studies enrolling critically ill adults aged 18 years or older under suspicion of sepsis during their hospitalization, where IL-6 concentrations were evaluated by serological measurement. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the references to identify relevant studies and extracted data. We assessed the methodological quality of studies using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We estimated a summary receiver operating characteristic (SROC) curve by fitting a hierarchical summary ROC (HSROC) non-linear mixed model. We explored sources of heterogeneity using the HSROC model parameters. We conducted all analyses in the SAS statistical software package and R software. MAIN RESULTS: We included 23 studies (n = 4192) assessing the accuracy of IL-6 for the diagnosis of sepsis in critically ill adults. Twenty studies that were available as conference proceedings only are awaiting classification. The included participants were heterogeneous in terms of their distribution of age, gender, main diagnosis, setting, country, positivity threshold, sepsis criteria, year of publication, and origin of infection, among other factors. Prevalence of sepsis greatly varied across studies, ranging from 12% to 78%. We considered all studies to be at high risk of bias due to issues related to the index test domain in QUADAS-2. The SROC curve showed a great dispersion in individual studies accuracy estimates (21 studies, 3650 adult patients), therefore the considerable heterogeneity in the collected data prevented us from calculating formal accuracy estimates. Using a fixed prevalence of sepsis of 50% and a fixed specificity of 74%, we found a sensitivity of 66% (95% confidence interval 60 to 72). If we test a cohort 1000 adult patients under suspicion of sepsis with IL-6, we will find that 330 patients would receive appropriate and timely antibiotic therapy, while 130 patients would be wrongly considered to have sepsis. In addition, 370 out of 1000 patients would avoid unnecessary antibiotic therapy, and 170 patients would have been undiagnosed of sepsis. This numerical approach should be interpreted with caution due to the limitations described above. AUTHORS' CONCLUSIONS: Our evidence assessment of plasma interleukin-6 concentrations for the diagnosis of sepsis in critically ill adults reveals several limitations. High heterogeneity of collected evidence regarding the main diagnosis, setting, country, positivity threshold, sepsis criteria, year of publication, and the origin of infection, among other factors, along with the potential number of misclassifications, remain significant constraints for its implementation. The 20 conference proceedings assessed as studies awaiting classification may alter the conclusions of the review once they are fully published and evaluated. Further studies about the accuracy of interleukin-6 for the diagnosis of sepsis in adults that apply rigorous methodology for conducting diagnostic test accuracy studies are needed. The conclusions of the review will likely change once the 20 studies pending publication are fully published and included.


Assuntos
Interleucina-6/sangue , Sepse/diagnóstico , Biomarcadores/sangue , Estado Terminal , Diagnóstico Diferencial , Humanos
14.
Cardiol Res Pract ; 2019: 7543917, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30931154

RESUMO

Background: Leukocytes contained in the allogeneic packed red blood cell (PRBC) are the cause of certain adverse reactions associated with blood transfusion. Leukoreduction consists of eliminating leukocytes in all blood products below the established safety levels for any patient type. In this systematic review, we appraise the clinical effectiveness of allogeneic leukodepleted (LD) PRBC transfusion for preventing infections and death in patients undergoing major cardiovascular surgical procedures. Methods: We searched randomized controlled trials (RCT), enrolling patients undergoing a major cardiovascular surgical procedure and transfused with LD-PRBC. Data were extracted, and risk of bias was assessed according to Cochrane guidelines. In addition, trial sequential analysis (TSA) was used to assess the need of conducting additional trials. Quality of the evidence was assessed using the GRADE approach. Results: Seven studies met the eligibility criteria. Quality of the evidence was rated as moderate for both outcomes. The risk ratio for death from any cause comparing the LD-PRBC versus non-LD-PRBC group was 0.69 (CI 95% = 0.53 to 0.90; I 2 = 0%). The risk ratio for infection in the same comparison groups was 0.77 (CI 95% = 0.66 to 0.91; I 2 = 0%). TSA showed a conclusive result in this outcome. Conclusions: We found evidence that supports the routine use of leukodepletion in patients undergoing a major cardiovascular surgical procedure requiring PRBC transfusion to prevent death and infection. In the case of infection, the evidence should be considered sufficient and conclusive and hence indicated that further trials would not be required.

15.
Cochrane Database Syst Rev ; 4: CD013315, 2019 04 23.
Artigo em Inglês | MEDLINE | ID: mdl-31012483

RESUMO

BACKGROUND: High altitude illness (HAI) is a term used to describe a group of mainly cerebral and pulmonary syndromes that can occur during travel to elevations above 2500 metres (˜ 8200 feet). Acute mountain sickness (AMS), high altitude cerebral oedema (HACE), and high altitude pulmonary oedema (HAPE) are reported as potential medical problems associated with high altitude ascent. In this, the third of a series of three reviews about preventive strategies for HAI, we assessed the effectiveness of miscellaneous and non-pharmacological interventions. OBJECTIVES: To assess the clinical effectiveness and adverse events of miscellaneous and non-pharmacological interventions for preventing acute HAI in people who are at risk of developing high altitude illness in any setting. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) in January 2019. We adapted the MEDLINE strategy for searching the other databases. We used a combination of thesaurus-based and free-text search terms. We scanned the reference lists and citations of included trials and any relevant systematic reviews that we identified for further references to additional trials. SELECTION CRITERIA: We included randomized controlled trials conducted in any setting where non-pharmacological and miscellaneous interventions were employed to prevent acute HAI, including preacclimatization measures and the administration of non-pharmacological supplements. We included trials involving participants who are at risk of developing high altitude illness (AMS or HACE, or HAPE, or both). We included participants with, and without, a history of high altitude illness. We applied no age or gender restrictions. We included trials where the relevant intervention was administered before the beginning of ascent. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures employed by Cochrane. MAIN RESULTS: We included 20 studies (1406 participants, 21 references) in this review. Thirty studies (14 ongoing, and 16 pending classification (awaiting)) will be considered in future versions of this suite of three reviews as appropriate. We report the results for the primary outcome of this review (risk of AMS) by each group of assessed interventions.Group 1. Preacclimatization and other measures based on pressureUse of simulated altitude or remote ischaemic preconditioning (RIPC) might not improve the risk of AMS on subsequent exposure to altitude, but this effect is uncertain (simulated altitude: risk ratio (RR) 1.18, 95% confidence interval (CI) 0.82 to 1.71; I² = 0%; 3 trials, 140 participants; low-quality evidence. RIPC: RR 3.0, 95% CI 0.69 to 13.12; 1 trial, 40 participants; low-quality evidence). We found evidence of improvement of this risk using positive end-expiratory pressure (PEEP), but this information was derived from a cross-over trial with a limited number of participants (OR 3.67, 95% CI 1.38 to 9.76; 1 trial, 8 participants; low-quality evidence). We found scarcity of evidence about the risk of adverse events for these interventions.Group 2. Supplements and vitaminsSupplementation of antioxidants, medroxyprogesterone, iron or Rhodiola crenulata might not improve the risk of AMS on exposure to high altitude, but this effect is uncertain (antioxidants: RR 0.58, 95% CI 0.32 to 1.03; 1 trial, 18 participants; low-quality evidence. Medroxyprogesterone: RR 0.71, 95% CI 0.48 to 1.05; I² = 0%; 2 trials, 32 participants; low-quality evidence. Iron: RR 0.65, 95% CI 0.38 to 1.11; I² = 0%; 2 trials, 65 participants; low-quality evidence. R crenulata: RR 1.00, 95% CI 0.78 to 1.29; 1 trial, 125 participants; low-quality evidence). We found evidence of improvement of this risk with the administration of erythropoietin, but this information was extracted from a trial with issues related to risk of bias and imprecision (RR 0.41, 95% CI 0.20 to 0.84; 1 trial, 39 participants; very low-quality evidence). Regarding administration of ginkgo biloba, we did not perform a pooled estimation of RR for AMS due to considerable heterogeneity between the included studies (I² = 65%). RR estimates from the individual studies were conflicting (from 0.05 to 1.03; low-quality evidence). We found scarcity of evidence about the risk of adverse events for these interventions.Group 3. Other comparisonsWe found heterogeneous evidence regarding the risk of AMS when ginkgo biloba was compared with acetazolamide (I² = 63%). RR estimates from the individual studies were conflicting (estimations from 0.11 (95% CI 0.01 to 1.86) to 2.97 (95% CI 1.70 to 5.21); low-quality evidence). We found evidence of improvement when ginkgo biloba was administered along with acetazolamide, but this information was derived from a single trial with issues associated to risk of bias (compared to ginkgo biloba alone: RR 0.43, 95% CI 0.26 to 0.71; 1 trial, 311 participants; low-quality evidence). Administration of medroxyprogesterone plus acetazolamide did not improve the risk of AMS when compared to administration of medroxyprogesterone or acetazolamide alone (RR 1.33, 95% CI 0.50 to 3.55; 1 trial, 12 participants; low-quality evidence). We found scarcity of evidence about the risk of adverse events for these interventions. AUTHORS' CONCLUSIONS: This Cochrane Review is the final in a series of three providing relevant information to clinicians, and other interested parties, on how to prevent high altitude illness. The assessment of non-pharmacological and miscellaneous interventions suggests that there is heterogeneous and even contradictory evidence related to the effectiveness of these prophylactic strategies. Safety of these interventions remains as an unclear issue due to lack of assessment. Overall, the evidence is limited due to its quality (low to very low), the relative paucity of that evidence and the number of studies pending classification for the three reviews belonging to this series (30 studies either awaiting classification or ongoing). Additional studies, especially those comparing with pharmacological alternatives (such as acetazolamide) are required, in order to establish or refute the strategies evaluated in this review.


Assuntos
Doença da Altitude/prevenção & controle , Acetazolamida/uso terapêutico , Edema Encefálico/prevenção & controle , Humanos , Hipertensão Pulmonar/prevenção & controle , Medroxiprogesterona/uso terapêutico , Extratos Vegetais/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
J Clin Epidemiol ; 111: 69-82, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30738926

RESUMO

OBJECTIVES: This article describes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group's framework of moving from test accuracy to patient or population-important outcomes. We focus on the common scenario when studies directly evaluating the effect of diagnostic and other tests or strategies on health outcomes are not available or are not providing the best available evidence. STUDY DESIGN AND SETTING: Using practical examples, we explored how guideline developers and other decision makers can use information from test accuracy to develop a recommendation by linking evidence that addresses downstream consequences. Guideline panels should develop an analytic framework that summarizes the actions that follow from applying a test and the consequences. RESULTS: We describe GRADE's current thinking about the overall certainty of the evidence (also known as quality of the evidence or confidence in the estimates) arising from consideration of the often complex pathways that involve multiple tests and management options. Each link in the evidence can-and often does-lower the overall certainty of the evidence required to formulate recommendations and make decisions about tests. The frequency with which an outcome occurs and its importance will influence whether or not a particular step in the linked evidence is critical to decision-making. CONCLUSIONS: Overall certainty may be expressed by the weakest critical step in the linked evidence. The linked approach to addressing optimal testing will often require the use of decision analytic approaches. We present an example that involves decision modeling in a GRADE Evidence to Decision framework for cervical cancer screening. However, because resources and time of guideline developers may be limited, we describe alternative, pragmatic strategies for developing recommendations addressing test use.


Assuntos
Abordagem GRADE , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/normas , Humanos
17.
Cochrane Database Syst Rev ; 1: CD011451, 2019 01 05.
Artigo em Inglês | MEDLINE | ID: mdl-30610762

RESUMO

BACKGROUND: Hepatic encephalopathy is a common and devastating neuropsychiatric complication of acute liver failure or chronic liver disease. Ammonia content in the blood seems to play a role in the development of hepatic encephalopathy. Treatment for hepatic encephalopathy is complex. Acetyl-L-carnitine is a substance that may reduce ammonia toxicity. This review assessed the benefits and harms of acetyl-L-carnitine for patients with hepatic encephalopathy. OBJECTIVES: To assess the benefits and harms of acetyl-L-carnitine for patients with hepatic encephalopathy. SEARCH METHODS: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, LILACS, and Science Citation Index Expanded for randomised clinical trials. We sought additional randomised clinical trials from the World Health Organization Clinical Trials Search Portal and ClinicalTrials.gov. We performed all electronic searches until 10 September 2018. We looked through the reference lists of retrieved publications and review articles, and we searched the FDA and EMA websites. SELECTION CRITERIA: We searched for randomised clinical trials in any setting, recruiting people with hepatic encephalopathy. Trials were eligible for inclusion if they compared acetyl-L-carnitine plus standard care (e.g. antibiotics, lactulose) versus placebo or no acetyl-L-carnitine plus standard care. We are well aware that by selecting randomised clinical trials, we placed greater focus on potential benefits than on potential harms. DATA COLLECTION AND ANALYSIS: We selected randomised clinical trials, assessed risk of bias in eight domains, and extracted data in a duplicate and independent fashion. We estimated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes. We measured statistical heterogeneity using I² and D² statistics. We subjected our analyses to fixed-effect and random-effects model meta-analyses. We assessed bias risk domains to control systematic errors. We assessed overall quality of the data for each individual outcome by using the GRADE approach. MAIN RESULTS: We identified five randomised clinical trials involving 398 participants. All trials included only participants with cirrhosis as the underlying cause of hepatic encephalopathy. Trials included participants with covert or overt hepatic encephalopathy. All trials were conducted in Italy by a single team and assessed acetyl-L-carnitine compared with placebo. Oral intervention was the most frequent route of administration. All trials were at high risk of bias and were underpowered. None of the trials were sponsored by the pharmaceutical industry.None of the identified trials reported information on all-cause mortality, serious adverse events, or days of hospitalisation. Only one trial assessed quality of life using the Short Form (SF)-36 scale (67 participants; very low-quality evidence). The effects of acetyl-L-carnitine compared with placebo on general health at 90 days are uncertain (MD -6.20 points, 95% confidence interval (CI) -9.51 to -2.89). Results for additional domains of the SF-36 are also uncertain. One trial assessed fatigue using the Wessely and Powell test (121 participants; very low-quality evidence). The effects are uncertain in people with moderate-grade hepatic encephalopathy (mental fatigue: MD 0.40 points, 95% CI -0.21 to 1.01; physical fatigue: MD -0.20 points, 95% CI -0.92 to 0.52) and mild-grade hepatic encephalopathy (mental fatigue: -0.80 points, 95% CI -1.48 to -0.12; physical fatigue: 0.20 points, 95% CI -0.72 to 1.12). Meta-analysis showed a reduction in blood ammonium levels favouring acetyl-L-carnitine versus placebo (MD -13.06 mg/dL, 95% CI -17.24 to -8.99; 387 participants; 5 trials; very low-quality evidence). It is unclear whether acetyl-L-carnitine versus placebo increases the risk of non-serious adverse events (8/126 (6.34%) vs 3/120 (2.50%); RR 2.51, 95% CI 0.68 to 9.22; 2 trials; very low-quality evidence). Overall, adverse events data were poorly reported and harms may have been underestimated. AUTHORS' CONCLUSIONS: This Cochrane systematic review analysed a heterogeneous group of five trials at high risk of bias and with high risk of random errors conducted by only one research team. We assessed acetyl-L-carnitine versus placebo in participants with cirrhosis with covert or overt hepatic encephalopathy. Hence, we have no data on the drug for hepatic encephalopathy in acute liver failure. We found no information about all-cause mortality, serious adverse events, or days of hospitalisation. We found no clear differences in effect between acetyl-L-carnitine and placebo regarding quality of life, fatigue, and non-serious adverse events. Acetyl-L-carnitine reduces blood ammonium levels compared with placebo. We rated all evidence as of very low quality due to pitfalls in design and execution, inconsistency, small sample sizes, and very few events. The harms profile for acetyl-L-carnitine is presently unclear. Accordingly, we need further randomised clinical trials to assess acetyl-L-carnitine versus placebo conducted according to the SPIRIT statements and reported according to the CONSORT statements.


Assuntos
Acetilcarnitina/uso terapêutico , Quelantes/uso terapêutico , Encefalopatia Hepática/tratamento farmacológico , Amônia/sangue , Fadiga/etiologia , Feminino , Encefalopatia Hepática/sangue , Encefalopatia Hepática/etiologia , Humanos , Cirrose Hepática/complicações , Masculino , Fadiga Mental/etiologia , Pessoa de Meia-Idade , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
J Evid Based Med ; 12(2): 113-124, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30511477

RESUMO

BACKGROUND: Red blood cell (RBC) transfusions are essential in health care. The quality of recommendations included in clinical practice guidelines (CPG), regarding this intervention, has not been systematically evaluated. This paper systematically assessed CPGs for RBC-transfusion, to appraise their methodological quality, to explore changes in quality over time, and to assess the consistency of the hemoglobin threshold (HT) recommendations. METHODS: We searched for CPGs that included recommendations of RBC-transfusion in generic databases, compiler entities, registries, clearinghouses and guideline developers. Three reviewers extracted data on CPGs characteristics and HT recommendations, independently appraised the quality of the studies using AGREE II and resolved disagreements by consensus. RESULTS: We examined 16 CPGs. Mean scores (mean ± SD) were: scope and purpose (59.4% ± 19.8%), stakeholder involvement (43.2% ± 22.6%), rigor of development (50% ± 25%), clarity of presentation (74.4% ± 12.6%), applicability (19.4% ± 18.8%), and editorial independence (41% ± 30%). Seven CPGs recommended a restrictive strategy for RBC transfusion; four CPGs gave a guarded statement considering an HT of 7 g/dL, as safe to prescribe an RBC transfusion. Eight CPGs did not provide an HT stating that RBC transfusions should not be prescribed by HT alone. CONCLUSIONS: Only 3 out of the 16 evaluated CPGs were "recommended" by the independent evaluators. Four domains "stakeholder involvement," "rigor of development," applicability," and "editorial independence" had serious shortcomings. Recommendations about the use of an HT for RBC-transfusion were heterogeneous among guidelines. Greater efforts are needed to provide high-quality CPGs in the RBC-transfusion practice.


Assuntos
Transfusão de Eritrócitos , Guias de Prática Clínica como Assunto/normas , Políticas Editoriais , Hemoglobinas/metabolismo , Humanos , Participação dos Interessados
19.
Artigo em Inglês | MEDLINE | ID: mdl-30577567

RESUMO

We aimed to evaluate the evidence on screening and treatment for two parasitic infections-schistosomiasis and strongyloidiasis-among migrants from endemic countries arriving in the European Union and European Economic Area (EU/EEA). We conducted a systematic search of multiple databases to identify systematic reviews and meta-analyses published between 1 January 1993 and 30 May 2016 presenting evidence on diagnostic and treatment efficacy and cost-effectiveness. We conducted additional systematic search for individual studies published between 2010 and 2017. We assessed the methodological quality of reviews and studies using the AMSTAR, Newcastle⁻Ottawa Scale and QUADAS-II tools. Study synthesis and assessment of the certainty of the evidence was performed using GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. We included 28 systematic reviews and individual studies in this review. The GRADE certainty of evidence was low for the effectiveness of screening techniques and moderate to high for treatment efficacy. Antibody-detecting serological tests are the most effective screening tests for detection of both schistosomiasis and strongyloidiasis in low-endemicity settings, because they have higher sensitivity than conventional parasitological methods. Short courses of praziquantel and ivermectin were safe and highly effective and cost-effective in treating schistosomiasis and strongyloidiasis, respectively. Economic modelling suggests presumptive single-dose treatment of strongyloidiasis with ivermectin for all migrants is likely cost-effective, but feasibility of this strategy has yet to be demonstrated in clinical studies. The evidence supports screening and treatment for schistosomiasis and strongyloidiasis in migrants from endemic countries, to reduce morbidity and mortality.


Assuntos
Programas de Rastreamento/organização & administração , Esquistossomose/diagnóstico , Estrongiloidíase/diagnóstico , Migrantes , Análise Custo-Benefício , Doenças Endêmicas , União Europeia , Humanos , Programas de Rastreamento/economia , Esquistossomose/epidemiologia , Testes Sorológicos
20.
SAGE Open Med ; 6: 2050312118801710, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30302249

RESUMO

Few Orthopaedics and Traumatology journals from Latin America and Spain are indexed in major databases; controlled clinical trials published in these journals cannot be exhaustively retrieved using electronic literature searches. We aimed to identify, describe and assess the quality of controlled clinical trials published in Orthopaedics and Traumatology journals from Latin America and Spain through handsearching and evidence mapping methods. We identified controlled clinical trials published in eligible Orthopaedics/Traumatology journals in Spanish until July 2017 by handsearching. Data were extracted for controlled clinical trials main characteristics and the Cochrane risk of bias tool was used to assess the controlled clinical trials methodological quality. In addition, we mapped the main findings of these trials. As a result, we assessed 5631 references in 29 eligible journals of which 57 were controlled clinical trials (1.0%). Controlled clinical trials were published between 1995 and 2017 at a rate of 2.5 per year. Journals from Spain and Mexico published around 63% of the controlled clinical trials identified. The median sample size of patients enrolled was 60 (range = 30-300 participants). About conditions assessed, 38.5% of controlled clinical trials assessed issues related to knee conditions, 15.7% about hip and 10.5% about trauma or spine. The risk of bias domains most affected was selective reporting bias and random sequence generation. In addition, only two and seven trials had low risk of bias in all items related to participant/personnel and outcome assessment blindings, respectively. More than 40% of studies did not report differences on benefits/harms between the interventions assessed. As a conclusion, the number of controlled clinical trials published in Orthopaedics/Traumatology journals from Latin America and Spain is low. These controlled clinical trials had important methodological shortcomings and were judged as unclear or high risk of bias. These trials are now available in CENTRAL for their potential inclusion in systematic reviews and other documents of synthesis.

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