11 results on '"Gräf DD"'
Search Results
2. The life cycle of vaccines evaluated by the European Medicines Agency.
- Author
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Gräf DD, Westphal L, and Hallgreen CE
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- Humans, Drug Approval, Risk Assessment, COVID-19 prevention & control, Cohort Studies, COVID-19 Vaccines immunology, SARS-CoV-2 immunology, European Union, Vaccines administration & dosage, Vaccines immunology
- Abstract
Background: vaccines are complex products used in healthy populations. They should be carefully regulated, and benefits should clearly outweigh risks., Objectives: To describe the evidence used to support benefit-risk evaluations of vaccines centrally assessed by the European Medicines Agency (EMA), and to identify if real-world data (RWD) was used throughout the vaccine life cycle., Methods: Cohort study of vaccines approved in the European Union. Inclusion criteria comprised having ATC code J07 and being centrally approved between 2012 and 2022. We collected data from regulatory documents, study protocols, and, when necessary, from scientific publications. Vaccines were followed from initial approval up to March 2023., Results: We included 31 vaccines addressing 17 therapeutic areas. More than 390 studies were used in the process of initial marketing authorisation (MA) and monitoring, and 174 studies were listed in initial risk management plans. We also identified 93 studies in the EU PAS register. At MA, all vaccines had at least one pivotal trial and 27 vaccines had at least one supportive study. Most pivotal trials were randomized, double-blinded and active-controlled, with immunogenicity endpoints as primary outcome. RWD was used for extension of indications and monitoring of at least 4 vaccines, and the undertaking of RWE studies was foreseen in the RMP of at least 17 vaccines., Discussion: Our study revealed an important reliance on randomized controlled trials with individual-level randomization, and a significant focus on immunogenicity endpoints. The use of RWD in vaccine assessments so far has been restricted to COVID-19, and despite its challenges and limitations, we believe that efforts to expand adoption of RWE in continuous benefit-risk assessments should be made. We further highlight the need to enhance data transparency and reporting standards since heterogeneity among regulatory documents made it difficult to identify all the studies considered in vaccine evaluations., Competing Interests: Declaration of competing interest CEH is employed by the Copenhagen Centre for Regulatory Sciences (CORS), Department of Pharmacy, University of Copenhagen. CORS is a cross-faculty university-anchored institution involving various public (the Danish Medicines Agency, Copenhagen University) and private stakeholders (Novo Nordisk, Lundbeck, Ferring Pharmaceuticals, LEO Pharma) as well as patient organizations (Rare Diseases Denmark). The centre is purely devoted to the scientific aspects of the regulatory field and has a patient-oriented focus, and the research is not a company-specific product or directly company related. In the last three years, CORS and CEH have received funding from Novo Nordisk for projects not related to this study. LFW is a PhD student at CORS and his PhD fellowship is funded by a grant to CORS from Novo Nordisk A/S. However, the company was not involved in any aspect of the described work. DDG is also a PhD student at CORS, and she declares no competing interests. The authors declare no other known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.) more...
- Published
- 2024
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3. The impact of an online course on agreement rates of the certainty of evidence assessment using Grading of Recommendations, Assessment, Development, and Evaluation Approach: a before-and-after study.
- Author
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Dorneles G, Stein C, Araujo CP, Parahiba S, da Rosa B, Gräf DD, Belli KC, Basmaji J, Maior MDCLS, Vidal ÁT, Colpani V, and Falavigna M
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- Humans, Brazil, Observer Variation, Female, Male, Internet, Adult, Education, Distance standards, Education, Distance methods, Reproducibility of Results, Evidence-Based Medicine standards
- Abstract
Background and Objective: The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach is a systematic method for assessing the certainty of evidence (CoE) and strength of recommendations in health care. We aimed to verify the effects of an online-based GRADE course on multirater consistency in the evaluation of the CoE in systematic reviews (SRs) analysis., Study Design and Settings: Sixty-five Brazilian methodologists and researchers participated in an online course over 8 weeks. Asynchronous lessons and weekly synchronous meetings addressed the GRADE system in the context of CoE assessment. We asked participants to evaluate the CoE of random SRs (two before and another two after the course). Analyzes focused on the multirater agreement with a standard response, in the interrater agreement, and before-after changes in the proportion of participants that rated down the domains., Results: 48 individuals completed the course. Participants presented improvements in the raters' assessment of the CoE using the GRADE approach after the course. The multirater consistency of indirectness, imprecision, and the overall CoE increased after the course, as well as the agreement between raters and the standard response. Furthermore, interrater reliability increased for risk of bias, inconsistency, indirectness, publication bias, and overall CoE, indicating progress in between-raters consistency. After the course, approximately 78% of individuals rated down the overall CoE to a low/very low degree, and participants presented more explanations for the judgment of each domain., Conclusion: An online GRADE course improved the consistency and agreement of the CoE assessment by Brazilian researchers. Online training courses have the potential to improve skills in guideline methodology development., Competing Interests: Declaration of competing interest The methodological coordination for the development of these studies was funded by the Institutional Development Program of the Brazilian Unified Health System (PROADI-SUS) together with Hospital Moinhos de Vento., (Copyright © 2024 Elsevier Inc. All rights reserved.) more...
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- 2024
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4. The II Brazilian Guidelines for the pharmacological treatment of patients hospitalized with COVID-19 Joint Guidelines of the Associação Brasileira de Medicina de Emergência, Associação de Medicina Intensiva Brasileira, Associação Médica Brasileira, Sociedade Brasileira de Angiologia e Cirurgia Vascular, Sociedade Brasileira de Infectologia, Sociedade Brasileira de Pneumologia e Tisiologia and Sociedade Brasileira de Reumatologia.
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Falavigna M, Araujo CLP, Barbosa AN, Belli KC, Colpani V, Dal-Pizzol F, Silva RMD, Azevedo LCP, Dias MBS, Amaral JLGD, Dorneles GP, Ferreira JC, Freitas APDR, Gräf DD, Guimarães HP, Lobo SMA, Machado FR, Nunes MS, Oliveira MS, Parahiba SM, Rosa RG, Santos VCC, Sobreira ML, Veiga VC, Xavier RM, Zavascki AP, Stein C, and Carvalho CRR more...
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- Humans, Brazil epidemiology, COVID-19 Serotherapy, Adrenal Cortex Hormones, Oxygen, COVID-19, Thromboembolism
- Abstract
Objective: To update the recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil., Methods: Experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method., Results: Twenty-one recommendations were generated, including strong recommendations for the use of corticosteroids in patients using supplemental oxygen and conditional recommendations for the use of tocilizumab and baricitinib for patients on supplemental oxygen or on noninvasive ventilation and anticoagulants to prevent thromboembolism. Due to suspension of use authorization, it was not possible to make recommendations regarding the use of casirivimab + imdevimab. Strong recommendations against the use of azithromycin in patients without suspected bacterial infection, hydroxychloroquine, convalescent plasma, colchicine, and lopinavir + ritonavir and conditional recommendations against the use of ivermectin and remdesivir were made., Conclusion: New recommendations for the treatment of hospitalized patients with COVID-19 were generated, such as those for tocilizumab and baricitinib. Corticosteroids and prophylaxis for thromboembolism are still recommended, the latter with conditional recommendation. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and to promote resource economy. more...
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- 2023
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5. Brazilian guidelines for the treatment of outpatients with suspected or confirmed COVID-19. A joint guideline of the Brazilian Association of Emergency Medicine (ABRAMEDE), Brazilian Medical Association (AMB), Brazilian Society of Angiology and Vascular Surgery (SBACV), Brazilian Society of Geriatrics and Gerontology (SBGG), Brazilian Society of Infectious Diseases (SBI), Brazilian Society of Family and Community Medicine (SBFMC), and Brazilian Thoracic Society (SBPT).
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Falavigna M, Belli KC, Barbosa AN, Zavascki AP, Nastri ACSS, Santana CM, Stein C, Gräf DD, Cadegiani FA, Guimarães HP, Monteiro JT, Ferreira JC, de Azevedo LCP, Magri MMC, Sobreira ML, Dias MBGS, de Oliveira MS, Corradi MFDB, Rosa R, Heinzelmann RS, da Silva RM, Junior RB, Cimerman S, Colpani V, Veiga VC, and de Carvalho CRR more...
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- Azithromycin, Brazil, Community Medicine, Humans, Immunization, Passive, Outpatients, Vascular Surgical Procedures, COVID-19 Serotherapy, COVID-19 therapy, Cardiology, Communicable Diseases, Emergency Medicine, Geriatrics, COVID-19 Drug Treatment
- Abstract
Background: Several therapies have been used or proposed for the treatment of COVID-19, although their effectiveness and safety have not been properly evaluated. The purpose of this document is to provide recommendations to support decisions about the drug treatment of outpatients with COVID-19 in Brazil., Methods: A panel consisting of experts from different clinical fields, representatives of the Brazilian Ministry of Health, and methodologists (37 members in total) was responsible for preparing these guidelines. A rapid guideline development method was used, based on the adoption and/or adaptation of recommendations from existing international guidelines combined with additional structured searches for primary studies and new recommendations whenever necessary (GRADE-ADOLOPMENT). The rating of quality of evidence and the drafting of recommendations followed the GRADE method., Results: Ten technologies were evaluated, and 10 recommendations were prepared. Recommendations were made against the use of anticoagulants, azithromycin, budesonide, colchicine, corticosteroids, hydroxychloroquine/chloroquine alone or combined with azithromycin, ivermectin, nitazoxanide, and convalescent plasma. It was not possible to make a recommendation regarding the use of monoclonal antibodies in outpatients, as their benefit is uncertain and their cost is high, with limitations of availability and implementation., Conclusion: To date, few therapies have demonstrated effectiveness in the treatment of outpatients with COVID-19. Recommendations are restricted to what should not be used, in order to provide the best treatment according to the principles of evidence-based medicine and to promote resource savings by aboiding ineffective treatments., Competing Interests: Conflicts of interest The list of participants and the declaration of conflicts of interest are presented in the Supplementary Material., (Copyright © 2022 Sociedade Brasileira de Infectologia. Published by Elsevier España, S.L.U. All rights reserved.) more...
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- 2022
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6. Brazilian Guidelines for the pharmacological treatment of patients hospitalized with COVID-19: Joint guideline of Associação Brasileira de Medicina de Emergência, Associação de Medicina Intensiva Brasileira, Associação Médica Brasileira, Sociedade Brasileira de Angiologia e Cirurgia Vascular, Sociedade Brasileira de Infectologia, Sociedade Brasileira de Pneumologia e Tisiologia, Sociedade Brasileira de Reumatologia.
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Falavigna M, Stein C, Amaral JLGD, Azevedo LCP, Belli KC, Colpani V, Cunha CAD, Dal-Pizzol F, Dias MBS, Ferreira JC, Freitas APDR, Gräf DD, Guimarães HP, Lobo SMA, Monteiro JT, Nunes MS, Oliveira MS, Prado CCL, Santos VCC, Silva RMD, Sobreira ML, Veiga VC, Vidal ÁT, Xavier RM, Zavascki AP, Machado FR, and Carvalho CRR more...
- Subjects
- Adrenal Cortex Hormones therapeutic use, Anti-Bacterial Agents, Antibodies, Monoclonal, Humanized, Brazil, Humans, Immunization, Passive, Oxygen, COVID-19 Serotherapy, COVID-19 therapy, Thromboembolism, COVID-19 Drug Treatment
- Abstract
Objective: Several therapies are being used or proposed for COVID-19, and many lack appropriate evaluations of their effectiveness and safety. The purpose of this document is to develop recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil., Methods: A group of 27 experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method., Results: Sixteen recommendations were generated. They include strong recommendations for the use of corticosteroids in patients using supplemental oxygen, the use of anticoagulants at prophylactic doses to prevent thromboembolism and the nonuse of antibiotics in patients without suspected bacterial infection. It was not possible to make a recommendation regarding the use of tocilizumab in patients hospitalized with COVID-19 using oxygen due to uncertainties regarding the availability of and access to the drug. Strong recommendations against the use of hydroxychloroquine, convalescent plasma, colchicine, lopinavir + ritonavir and antibiotics in patients without suspected bacterial infection and also conditional recommendations against the use of casirivimab + imdevimab, ivermectin and rendesivir were made., Conclusion: To date, few therapies have proven effective in the treatment of hospitalized patients with COVID-19, and only corticosteroids and prophylaxis for thromboembolism are recommended. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and promote economical resource use. more...
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- 2022
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7. Prevalence and inequalities in contraceptive use among adolescents and young women: data from a birth cohort in Brazil.
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Machado AKF, Gräf DD, Höfs F, Hellwig F, Barros KS, Moreira LR, Crespo PA, and Silveira MF
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- Adolescent, Adult, Brazil, Contraception, Female, Humans, Prevalence, Young Adult, Birth Cohort, Contraceptive Agents
- Abstract
Monitoring trends of contraceptive use and identifying the groups with less coverage are needed to guide public policies and make them more efficient. But, in Brazil, recent data about these aspects are limited. This study aimed to investigate the prevalence of contraceptive use and its inequalities during adolescence and early adulthood. Data from the 1993 Pelotas birth cohort, Rio Grande do Sul State, Brazil, were used. At 15, 18 and 22 years, respectively, 335, 1,458 and 1,711 women reported having started their sexual lives and were included in analysis. Prevalence and 95% confidence intervals were obtained to describe the most used contraceptive methods. Inequalities in modern contraceptive use were evaluated according to wealth index, scholastic backwardness and ethnicity. In all follow-ups, more than 80% of women used at least one modern method. The use of barrier methods decreased with age; at 22 this prevalence was 36.3%. Such use concomitant with other modern methods was lower than 50% in all follow-ups. We observed inequalities in the use of modern contraceptive methods, mainly in barrier methods used with other modern methods. These findings may contribute and improve the public policies in family planning. more...
- Published
- 2021
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8. Clinical characteristics and predictors of mechanical ventilation in patients with COVID-19 hospitalized in Southern Brazil.
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Bastos GAN, Azambuja AZ, Polanczyk CA, Gräf DD, Zorzo IW, Maccari JG, Haygert LS, Nasi LA, Gazzana MB, Bessel M, Pitrez PM, Oliveira RP, and Scotta MC
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- Adult, Age Factors, Aged, Aged, 80 and over, Brazil, COVID-19 complications, COVID-19 physiopathology, Cohort Studies, Female, Humans, Length of Stay, Male, Middle Aged, Respiratory Insufficiency therapy, Respiratory Insufficiency virology, Retrospective Studies, Risk Factors, COVID-19 therapy, Hospitalization, Intensive Care Units statistics & numerical data, Respiration, Artificial statistics & numerical data, Respiratory Insufficiency epidemiology
- Abstract
Objective: This study aims to describe the clinical characteristics and predictors of mechanical ventilation of adult inpatients with COVID-19 in a single center., Methods: A retrospective cohort study was performed and included adult inpatients hospitalized from March 17th to May 3rd, 2020, who were diagnosed with SARS-CoV-2 infection. Clinical and demographic characteristics were extracted from electronic medical records., Results: Overall, 88 consecutive patients were included in this study. The median age of the patients was 63 years (IQR 49 - 71); 59 (67%) were male, 65 (86%) had a college degree and 67 (76%) had at least one comorbidity. Twenty-nine (33%) patients were admitted to the intensive care unit, 18 (20%) patients needed mechanical ventilation, and 9 (10.2%) died during hospitalization. The median length of stay in the intensive care unit and the median duration of mechanical ventilation was 23 and 29.5 days, respectively. An age ≥ 65 years was an independent risk factor for mechanical ventilation (OR 8.4 95%CI 1.3 - 55.6 p = 0.02)., Conclusion: Our findings describe the first wave of Brazilian patients hospitalized for COVID-19. Age was the strongest predictor of respiratory insufficiency and the need for mechanical ventilation in our population. more...
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- 2020
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9. Guidelines for the pharmacological treatment of COVID-19. The task-force/consensus guideline of the Brazilian Association of Intensive Care Medicine, the Brazilian Society of Infectious Diseases and the Brazilian Society of Pulmonology and Tisiology.
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Falavigna M, Colpani V, Stein C, Azevedo LCP, Bagattini AM, Brito GV, Chatkin JM, Cimerman S, Corradi MFDB, Cunha CAD, Medeiros FC, Oliveira Junior HA, Fritscher LG, Gazzana MB, Gräf DD, Marra LP, Matuoka JY, Nunes MS, Pachito DV, Pagano CGM, Parreira PCS, Riera R, Silva A Júnior, Tavares BM, Zavascki AP, Rosa RG, and Dal-Pizzol F more...
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- COVID-19, Humans, Pandemics, Coronavirus Infections drug therapy, Pneumonia, Viral drug therapy
- Abstract
Introduction: Different therapies are currently used, considered, or proposed for the treatment of COVID-19; for many of those therapies, no appropriate assessment of effectiveness and safety was performed. This document aims to provide scientifically available evidence-based information in a transparent interpretation, to subsidize decisions related to the pharmacological therapy of COVID-19 in Brazil., Methods: A group of 27 experts and methodologists integrated a task-force formed by professionals from the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB), the Brazilian Society of Infectious Diseases (Sociedad Brasileira de Infectologia - SBI) and the Brazilian Society of Pulmonology and Tisiology (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT). Rapid systematic reviews, updated on April 28, 2020, were conducted. The assessment of the quality of evidence and the development of recommendations followed the GRADE system. The recommendations were written on May 5, 8, and 13, 2020., Results: Eleven recommendations were issued based on low or very-low level evidence. We do not recommend the routine use of hydroxychloroquine, chloroquine, azithromycin, lopinavir/ritonavir, corticosteroids, or tocilizumab for the treatment of COVID-19. Prophylactic heparin should be used in hospitalized patients, however, no anticoagulation should be provided for patients without a specific clinical indication. Antibiotics and oseltamivir should only be considered for patients with suspected bacterial or influenza coinfection, respectively., Conclusion: So far no pharmacological intervention was proven effective and safe to warrant its use in the routine treatment of COVID-19 patients; therefore such patients should ideally be treated in the context of clinical trials. The recommendations herein provided will be revised continuously aiming to capture newly generated evidence. more...
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- 2020
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10. Risky sexual behavior and associated factors in undergraduate students in a city in Southern Brazil.
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Gräf DD, Mesenburg MA, and Fassa AG
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- Adolescent, Adult, Alcohol Drinking epidemiology, Alcohol Drinking psychology, Brazil epidemiology, Coitus psychology, Cross-Sectional Studies, Female, Humans, Male, Prevalence, Sex Factors, Sexual Behavior psychology, Sexual Partners psychology, Sexually Transmitted Diseases epidemiology, Sexually Transmitted Diseases psychology, Socioeconomic Factors, Students psychology, Young Adult, Censuses, Health Risk Behaviors, Sexual Behavior statistics & numerical data, Students statistics & numerical data
- Abstract
Objective: To describe the sexual behavior of freshmen undergraduate students according to demographic, economic, psychosocial and behavioral characteristics, and evaluate the prevalence of risky sexual behavior and its associated factors., Methods: A cross-sectional study of the census type with undergraduate students over 18 years old of 80 undergraduate courses of the Universidade Federal de Pelotas (UFPel), in Rio Grande do Sul (RS), who entered in the first semester of 2017 and remained enrolled in the second semester. Undergraduate students who reported having had sex were evaluated. We considered as risky sexual behavior having more than one sexual partner within the last three months and not having used condoms in the last sexual intercourse., Results: The prevalence of risky sexual behavior was 9% (95%CI 7.6-10.5). Men presented more risky behavior than women, with a prevalence of 10.8% and 7.5%, respectively. Of the undergraduate students, 45% did not use condoms in the last sexual intercourse, and 24% had two partners or more within three months before the survey. Smartphone applications for sexual purposes were used by 23% of students within three months before the survey. Risky sexual behavior was associated with gender, age at first sexual intercourse, frequency of alcohol consumption, consumption of psychoactive substances before the last sexual intercourse and use of smartphone applications for sexual purposes., Conclusion: Although undergraduate students are expected to be an informed population, the prevalence of risky sexual behavior was important, indicating the need to expand public investment in sexual education and awareness actions. more...
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- 2020
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11. Risk Factors for Workplace Bullying: A Systematic Review.
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Feijó FR, Gräf DD, Pearce N, and Fassa AG
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- Europe, Humans, Leadership, Organizational Culture, Risk Factors, Sex Factors, Stress, Psychological epidemiology, Workplace psychology, Bullying statistics & numerical data
- Abstract
Objective : The goal of this study was to systematically review risk factors for workplace bullying. Methods : The search was carried out in two databases. Studies with estimates of risk factors for workplace bullying were included in the review. We assessed the quality of the selected studies using an adapted version of the Downs and Black checklist. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analyses of Observational Studies in Epidemiology (MOOSE) guidelines were used for reporting papers. Results : Fifty-one papers were included, and 70.6% were from European countries. Women were reported to be at higher risk of being bullied in most studies (odds ratio (OR) from 1.17 to 2.77). Authoritarian and laissez-faire leadership styles were positively associated with bullying. Several psychosocial factors, such as stress (OR from 1.37 to 4.96), and occupational risks related to work organization, such as flexible work methods, role conflict, role ambiguity, monotonous or rotating tasks, high demands, pressure of work, and unclarity of duties were strongly associated with bullying. Discussion : The findings highlight the central role of organizational factors in bullying. Policies to prevent bullying must address the culture of organizations, facing the challenge of developing a new management and leadership framework. more...
- Published
- 2019
- Full Text
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