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1.
Syst Rev ; 8(1): 288, 2019 11 26.
Artigo em Inglês | MEDLINE | ID: mdl-31771635

RESUMO

BACKGROUND: Obesity and its consequences are worldwide epidemic problem; therefore, studies with strategies and mechanisms that favor weight loss to improve outcomes in health are necessary. Effects of mushrooms on body weight are uncertain. The aim of this systematic review is to determine the efficacy of mushrooms in weight loss in animal preclinical models. METHOD: This is a systematic review of preclinical studies of animal models of obesity (any type of non-aquatic mammal), which were exposed to edible and medicinal mushrooms orally in comparison with the control. The following databases will be used: MEDLINE (PubMed), Web of Science, BIOSIS, SCOPUS, and gray literature. There will be no restriction of language, date, or publication status. The primary outcome will be body weight loss. And the secondary outcomes include the total amount of food consumed by the animals, analysis of metabolic parameters, inflammatory mediators, mortality for any causes, and any adverse effect reported. A team of reviewers will select, in pairs and independently, the titles and abstracts, extract data from qualifying studies, and assess bias risk (using SYstematic Review Centre for Laboratory animal Experimentation SYRCLE's risk of bias tool and the Collaborative Approach to Meta-Analysis and Review of Animal Data from Experimental Studies (CAMARADES) checklist). The standardized mean difference (SMD) will be calculated to measure treatment effect, with 95% confidence intervals (95% CI). The heterogeneity between-study will be calculated by I2 inconsistency values and Cochran's Q statistical test, where I2 > 50% and/or p < 0.10 suggest high heterogeneity meta-analyses of random effects will be conducted as possible. DISCUSSION: Although many experimental studies about the effects of mushrooms on obesity have already been published, there is still no consensus in the literature. This study will provide evidences of preclinical research on mushrooms and their relation to body weight loss in animal models of obesity, being non-aquatic mammals. Also, this systematic review will show the limitations and strengths of the studies available in the literature, as well as it will to encourage the financing of new studies by public health managers and governmental entities. SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42019125299).

2.
Ann Intern Med ; 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31569214

RESUMO

Background: Cancer incidence has continuously increased over the past few centuries and represents a major health burden worldwide. Purpose: To evaluate the possible causal relationship between intake of red and processed meat and cancer mortality and incidence. Data Sources: Embase, Cochrane Central Register of Controlled Trials, Web of Science, CINAHL, and ProQuest from inception until July 2018 and MEDLINE from inception until April 2019 without language restrictions. Study Selection: Cohort studies that included more than 1000 adults and reported the association between consumption of unprocessed red and processed meat and cancer mortality and incidence. Data Extraction: Teams of 2 reviewers independently extracted data and assessed risk of bias; 1 reviewer evaluated the certainty of evidence, which was confirmed or revised by the senior reviewer. Data Synthesis: Of 118 articles (56 cohorts) with more than 6 million participants, 73 articles were eligible for the dose-response meta-analyses, 30 addressed cancer mortality, and 80 reported cancer incidence. Low-certainty evidence suggested that an intake reduction of 3 servings of unprocessed meat per week was associated with a very small reduction in overall cancer mortality over a lifetime. Evidence of low to very low certainty suggested that each intake reduction of 3 servings of processed meat per week was associated with very small decreases in overall cancer mortality over a lifetime; prostate cancer mortality; and incidence of esophageal, colorectal, and breast cancer. Limitation: Limited causal inferences due to residual confounding in observational studies, risk of bias due to limitations in diet assessment and adjustment for confounders, recall bias in dietary assessment, and insufficient data for planned subgroup analyses. Conclusion: The possible absolute effects of red and processed meat consumption on cancer mortality and incidence are very small, and the certainty of evidence is low to very low. Primary Funding Source: None. (PROSPERO: CRD42017074074).

3.
Front Pharmacol ; 10: 965, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31572173

RESUMO

Background: Biological agents used for the treatment of psoriatic arthritis (PsA) and rheumatoid arthritis (RA) are associated with serious adverse effects (SAEs). Although several biologics have demonstrated good efficacy and tolerability in short-term trials, treatment guidelines recommend them as third line therapies due to a relative lack of long-term safety data. Objective: To determine the frequency and severity of adverse effects associated with the long-term use of biologics in the treatment of PsA and RA, and possible risk factors for such events in a real-life setting. Methods: We conducted a longitudinal study in PsA and RA patients only taking long-term biological agents from 2003 to 2011. Sources of information included dispensing pharmacy data and interviews with patients. Research staff conducted telephone interviews with patients inquiring about any apparent medication-related adverse drug reactions (ADRs) or SAEs. ADR/SAE's data was based on pharmacy reports. We conducted a multivariate analysis to identify the factors associated with the risk of ADRs. Results: Of the 305 patients identified, we interviewed 268 patients. Most of these were taking adalimumab 127 (47.4%), 52 (19.4%) etanercept, 42 (15.7%) infliximab, 25 (9.3%) rituximab, 10 (3.7%) abatacept, 9 (3.4%) efalizumab, and 3 (1.1%) tocilizumab. Of the 268 patients, 116 (43.3%) experienced one or more adverse events related to biological agents with 1.6 events per patient, and of these 29 (25%) experienced one or more SAEs, with majority subjected to hospitalizations. The most frequently reported ADRs were administration site reactions as observed in 73 patients (27.2%), infections in 30 patients (11.2%), effects on nervous system in 22 patients (8.2%), and 15 (5.6%) patients withdrew due to ADRs. The use of rituximab was related with less risk of ADR [PR 0.42, 95% CI 0.18-0.96; p = 0.04] than other agents. No other predisposing factors were associated with risk of ADR. The monitoring of patients (medical consultation and laboratory test) was only completed by 48 patients (30.4%). Conclusion: These data showed the early biological experience in Brazil that were associated with ADRs, withdrawals due to ADRs and SAEs. The quantification of adverse effects (serious or nonserious) considering close monitoring and patients' perceptions are increasingly important for future decision-making.

4.
Front Pharmacol ; 10: 984, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31607900

RESUMO

Health technology assessment (HTA) is the systematic evaluation of the properties and impacts of health technologies and interventions. In this article, we presented a discussion of HTA and its evolution in Brazil, as well as a description of secondary data sources available in Brazil with potential applications to generate evidence for HTA and policy decisions. Furthermore, we highlighted record linkage, ongoing record linkage initiatives in Brazil, and the main linkage tools developed and/or used in Brazilian data. Finally, we discussed the challenges and opportunities of using secondary data for research in the Brazilian context. In conclusion, we emphasized the availability of high quality data and an open, modern attitude toward the use of data for research and policy. This is supported by a rigorous but enabling legal framework that will allow the conduct of large-scale observational studies to evaluate clinical, economical, and social impacts of health technologies and social policies.

5.
BMJ Open ; 9(10): e028019, 2019 Oct 17.
Artigo em Inglês | MEDLINE | ID: mdl-31628122

RESUMO

OBJECTIVE: We aimed to develop and validate a new instrument called Questionnaire for the assessment of the knowledge, management and reporting ADR in Paediatrics by Healthcare teams (QUESA-P). DESIGN: This is a cross-sectional study. SETTINGS AND PARTICIPANTS: Teams of healthcare professionals (HCP) that lead with pharmacological therapy in Paediatrician's sector (Paediatric-HCP) in seven public hospitals in Brazil. OUTCOME: An assessment of the knowledge and current management of ADR in Paediatric-HCP. METHODS: We developed and validated QUESA-P, using a standardised procedure which included item development and psychometric prevalidation using Cronbach's Alpha, item-total correlation and test-retest validity for internal consistency and reliability. External criterion was used as criterion validation (the instrument was applied to the focus group expert vs focus group team of Paediatric-HCP in hospitals). The focus group of experts who participated in psychometrics was asked to respond to the QUESA-P twice in order to assess test-retest reliability. The content validity of the initial questionnaire was assessed by the Delphi method and pilot test. Subsequently, we made minor revisions and finalized the QUESA-P RESULTS: Selection of domains and facets were based on literature review made in duplicate by authors. Content validity was done by trial of different examiners (panellists, n=16), conducting analysis through Delphi method (three rounds). The QUESA-P was constructed with three domains. The intraclass correlations (0.80) and the Cronbach's alpha coefficient (0.82), indicated adequate test-retest reliability and internal consistency for each domain. The application of the QUESA to 61 Paediatric-HCP in hospital resulted in lower mean score of 42.1 ± 3.4 in all domains when compared with expert teams (n= 46) 48.2 ± 3.7 (p <0.001) indicating that the instrument is valid to discriminate QUESA experts and Paediatric-HCP. CONCLUSION: The selected domains can be used to check weaknesses in the identification, management and reporting of suspected ADR by Paediatric-HCP in Brazil.

6.
Front Pharmacol ; 10: 1075, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31616298

RESUMO

Background: The vaccine against the rotavirus is an effective measure in reducing hospitalizations and mortality caused by the virus. However, its use can result in serious adverse effects. The available evidence on Kawasaki disease has not yet been reported in the literature. This study investigated the risk of developing Kawasaki disease with the use of rotavirus vaccines in children. Methods: This is a systematic review of data collected from studies retrieved on the following databases: Cochrane, MEDLINE, Embase, CINAHL, Scopus, Web of Science, HealthSTAR, Lilacs, Clinical trial.gov, and International Clinical Trials Registry Platform, up to the 15th of August 2018, with no restrictions on language or date of publication. The outcomes measured were incidence of Kawasaki disease, risk of developing the disease, and rate of discontinuation of the vaccination schedule. Four reviewers independently selected the studies, performed data extraction, and assessed the quality of evidence. A meta-analysis of random effects was performed. Results: A total of 13 publications were included, with a population of 164,434 children included in the meta-analysis. The incidence of Kawasaki disease (24 cases per 100,000, 95% CI = 11.98-48.26) in the vaccinated children was low. No difference between the vaccines was found in the prevalence rate of adverse effects (RR = 1.55, 95% CI = 0.41-5.93). Use of the vaccines was not associated with risk of developing Kawasaki disease (low-quality evidence). None of the studies reported the rate of discontinuation of the vaccination schedule. Conclusions: The vaccines were associated with a low incidence of developing Kawasaki disease, showing no association with this serious adverse effect.

7.
Front Pharmacol ; 10: 973, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31619986

RESUMO

Randomized clinical trials (RCT) are accepted as the gold-standard approaches to measure effects of intervention or treatment on outcomes. They are also the designs of choice for health technology assessment (HTA). Randomization ensures comparability, in both measured and unmeasured pretreatment characteristics, of individuals assigned to treatment and control or comparator. However, even adequately powered RCTs are not always feasible for several reasons such as cost, time, practical and ethical constraints, and limited generalizability. RCTs rely on data collected on selected, homogeneous population under highly controlled conditions; hence, they provide evidence on efficacy of interventions rather than on effectiveness. Alternatively, observational studies can provide evidence on the relative effectiveness or safety of a health technology compared to one or more alternatives when provided under the setting of routine health care practice. In observational studies, however, treatment assignment is a non-random process based on an individual's baseline characteristics; hence, treatment groups may not be comparable in their pretreatment characteristics. As a result, direct comparison of outcomes between treatment groups might lead to biased estimate of the treatment effect. Propensity score approaches have been used to achieve balance or comparability of treatment groups in terms of their measured pretreatment covariates thereby controlling for confounding bias in estimating treatment effects. Despite the popularity of propensity scores methods and recent important methodological advances, misunderstandings on their applications and limitations are all too common. In this article, we present a review of the propensity scores methods, extended applications, recent advances, and their strengths and limitations.

8.
Front Pharmacol ; 10: 866, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31447671

RESUMO

The management of patients who undergo dental surgical procedures and receive oral anticoagulant therapy requires particular attention due to the risk of bleeding that may occur during the procedure. Bleeding rates in these trans- or post-operative patients tend to be unpredictable. The aim of this study was to conduct a systematic review in order to assess the risk of bleeding during and after performing oral surgery in patients administered oral anticoagulants compared with a group that discontinued anticoagulant therapy. For the purposes of this review, we searched the databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid), and the Virtual Health Library (VHL) from inception of the database to December 2018. The primary outcome was defined as the occurrence of local bleeding during and after oral surgical procedures. Four reviewers, independently and in pairs, screened titles and abstracts for full-text eligibility. Data regarding participant characteristics, interventions, and design and outcomes of the included studies were extracted. The data were pooled using random-effects meta-analyses and described as risk ratios (RRs) with a 95% confidence interval (95% CI). The confidence for the pooled estimates was ascertained through the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, and the protocol of this review was recorded in PROSPERO (CRD42017056986). A total of 58 eligible studies were identified, of which three randomized controlled trials were included in the meta-analysis, covering a total of 323 adult participants, among whom 167 were taking anticoagulants at the time they underwent dental surgery. Of these patients, 14.2% had reported bleeding. The risk of bleeding was found to be one to almost three times greater in patients taking warfarin compared with patients who discontinued the use of anticoagulant during the trans-operative period (RR = 1.67, 95% CI = 0.97 to 2.89) and in the post-operative period (RR = 1.44, 95% CI = 0.71 to 2.92), although the quality of evidence was very low. The results indicate that there is no evidence that the use of anticoagulants eliminates the risk of bleeding during surgical dental procedures.

9.
Medicine (Baltimore) ; 98(33): e16698, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415362

RESUMO

BACKGROUND: Urinary incontinence is a common complaint in all parts of the world, cause of distress, as well as significant costs for both individuals and society. The aim of this study will be to evaluate the rigor of the development of clinical practice guidelines and to identify the recommendations of interventions for urinary incontinence in adult women. METHODS: In this systematic review, clinical practice guidelines will be identified using a prospective protocol through a systematic search of: MEDLINE (via Ovid); EMBASE (Excerpt Medical Database, via Ovid); Web of Science and Virtual Health Library. Specific databases of guidelines for clinical practice will also be searched (National Institute for Health and Care Excellence, American Urological Association, and others). Reviewers, independently and in duplicate, will assess the quality of the guidelines using the Appraisal of Guidelines Research and Evaluation (AGREE II). The results will be checked for discrepancies. Differences between the scores equal to or greater than 2 will be considered as discrepant and the final result will be decided by consensus. A comparison of the recommendations of interventions and information about the level of evidence, the degree of recommendation, the level of agreement and the level of acceptance will be described. This step will also be done independently and in duplicate, and the result will be decided by consensus. The results will be presented in tables and the descriptive statistics will be calculated for all domains of the AGREE II instrument as mean (standard deviation) and median (interquartile range). RESULTS: The results derived from this study will increase the knowledge about the development of recommendations guidelines for urinary incontinence of high methodological rigor. This study may also identify key areas for future research. CONCLUSION: This study may guide health professionals, policy makers, and health policy managers in choosing the guidelines for recommendation in clinical practice. PROTOCOL REGISTRATION: PROSPERO - CRD42018116517.


Assuntos
Guias de Prática Clínica como Assunto , Incontinência Urinária , Urologia/normas , Feminino , Humanos , Masculino , Projetos de Pesquisa , Revisão Sistemática como Assunto
10.
BMJ Open ; 9(5): e023729, 2019 05 24.
Artigo em Inglês | MEDLINE | ID: mdl-31129571

RESUMO

OBJECTIVE: To summarise the effects of herbal medications for the prevention of anxiety, depression, pain, and postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic, obstetrical/gynaecological or cardiovascular surgical procedures. METHODS: Searches of MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and LILACS up until January 2018 were performed to identify randomised controlled trials (RCTs). We included RCTs or quasi-RCTs evaluating any herbal medication among adults undergoing laparoscopic, obstetrical/gynaecological or cardiovascular surgeries. The primary outcomes were anxiety, depression, pain and PONV. We used the Grading of Recommendations Assessment, Development and Evaluation approach to rate overall certainty of the evidence for each outcome. RESULTS: Eleven trials including 693 patients were eligible. Results from three RCTs suggested a statistically significant reduction in vomiting (relative risk/risk ratio (RR) 0.57; 95% CI 0.38 to 0.86) and nausea (RR 0.69; 95% CI 0.50 to 0.96) with the use of Zingiber officinale (ginger) compared with placebo in both laparoscopic and obstetrical/gynaecological surgeries. Results suggested a non-statistically significantly reduction in the need for rescue medication for pain (RR 0.52; 95% CI 0.13 to 2.13) with Rosa damascena (damask rose) and ginger compared with placebo in laparoscopic and obstetrical/gynaecological surgery. None of the included studies reported on adverse events (AEs). CONCLUSIONS: There is very low-certainty evidence regarding the efficacy of both Zingiber officinale and Rosa damascena in reducing vomiting (200 fewer cases per 1000; 288 fewer to 205 fewer), nausea (207 fewer cases per 1000; 333 fewer to 27 fewer) and the need for rescue medication for pain (666 fewer cases per 1000; 580 fewer to 752 more) in patients undergoing either laparoscopic or obstetrical/gynaecological surgeries. Among our eligible studies, there was no reported evidence on AEs. PROSPERO REGISTRATION NUMBER: CRD42016042838.

11.
Medicine (Baltimore) ; 98(11): e14792, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30882653

RESUMO

BACKGROUND: The awakening and breathing coordination of daily sedation and ventilator removal trials, delirium monitoring and management, and early mobility and exercise (ABCDE) and assessment, prevent and manage pain, both spontaneous awakening and spontaneous breathing trials, choice of analgesia and sedation, assess, prevent and manage delirium, early mobility and exercise, family engagement (ABCDEF) bundles are part of the science of the liberation of the intensive care unit (ICU). There are not enough studies that have evaluated the effectiveness and safety of the implementation of these bundles. This study will analyze the implementation process, estimate their effectiveness and safety, and identify barriers, facilitators and attitudes that have influenced the implementation process. METHODS: Qualitative and quantitative studies will be eligible for our systematic review with adult patients who have been exposed to the implementation of the ABCDE or ABCDEF bundles compared to the usual care in the ICU. In order to search the implementation interventions of the bundles, we will search electronically: MEDLINE (PubMed); Excerpta Medica Database (Ovid); Cumulative Index to Nursing and Allied Health Literature (EBSCO); The Cochrane Library (Wiley); Web of Science; Virtual Health Library; and OpenGrey. We will not impose any language restrictions or publication status. Outcomes of interest include ICU and hospital length of stay; mechanical ventilation time; incidence and prevalence of delirium or coma; level of agitation and sedation; early mobilization; mortality in ICU and hospital; change in perception, attitude or behavior of the stakeholders; and change in knowledge of health professionals. The team of reviewers will independently screen search results, extract data from eligible studies, and assess risk of bias. Disagreements between the reviewers will be solved through consensus or arbitration by a third-party investigator. To assess the quality and risk of bias in randomized and quasi-randomized trials we will use the domain-based evaluation recommended by The Cochrane Handbook. Studies with other methodological designs will be evaluated using the Critical Appraisal Tools developed by The Joanna Briggs Institute. Other instruments may be used, if necessary. RESULTS: The evidence derived from this study will increase the knowledge of effectiveness and safety of the implementation process of ABCDE and ABCDEF bundles. CONCLUSION: The results could guide patients and healthcare practitioners by helping to facilitate evidence-based shared care decision making. PROTOCOL REGISTRATION: PROSPERO CRD42019121307.


Assuntos
Cuidados Críticos , Implementação de Plano de Saúde , Unidades de Terapia Intensiva , Pacotes de Assistência ao Paciente , Humanos , Revisão Sistemática como Assunto
12.
Medicine (Baltimore) ; 98(12): e14921, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30896650

RESUMO

Taking into consideration the progress in cancer treatment, an increase in the number of adult survivors of childhood cancer is expected. These survivors will have received treatment that predisposes them to late morbidity and increased risk of early mortality. The aim of this single-center retrospective cohort study was to describe the frequency and identify risk factors associated with late adverse events related to cancer treatment in survivors of childhood and adolescent cancer.Patients were recruited from 2010 to 2014. All possible late adverse effects identified, were classified according to CTCAE grading system version 4.0. The variables were characterized and stratified according to the presence or not of late effects. Odds ratio was used as a measure of association in bivariate analysis to identify characteristics associated with the late effects of treatment. Among 111 potentially eligible participants, 62 survivors met the inclusion criteria; 17 (27.4%) had abnormal test results observed in the systems: 8 (47%) in the endocrine and metabolic, 7 (41.2%) in the cardiovascular, 5 (29.4%) in the musculoskeletal, and 1 (5.9%) in auditory and renal systems. Frequency and severity of late adverse events were not affected by treatments employed; except for radiotherapy which was associated with a higher risk of late adverse effect occurrences.


Assuntos
Antineoplásicos/efeitos adversos , Sobreviventes de Câncer/estatística & dados numéricos , Nível de Saúde , Radioterapia/efeitos adversos , Adolescente , Idade de Início , Criança , Pré-Escolar , Humanos , Razão de Chances , Estudos Retrospectivos , Índice de Gravidade de Doença , Adulto Jovem
13.
JBJS Rev ; 7(2): e1, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30724762

RESUMO

BACKGROUND: Evidence with regard to antibiotic prophylaxis for patients with open fractures of the extremities is limited. We therefore conducted a systematic survey addressing current practice and recommendations. METHODS: We included publications from January 2007 to June 2017. We searched Embase, MEDLINE, CINAHL, the Cochrane Central Registry of Controlled Trials (CENTRAL), and the Cochrane Database of Systematic Reviews for clinical studies and surveys of surgeons; WorldCat for textbooks; and web sites for guidelines and institutional protocols. RESULTS: We identified 223 eligible publications that reported 100 clinical practice patterns and 276 recommendations with regard to systemic antibiotic administration, and 3 recommendations regarding local antibiotic administration alone. Most publications of clinical practice patterns used regimens with both gram-positive and gram-negative coverage and continued the administration for 2 to 3 days. Most publications recommended prophylactic systemic antibiotics. Most recommendations suggested gram-positive coverage for less severe injuries and administration duration of 3 days or less. For more severe injuries, most recommendations suggested broad antimicrobial coverage continued for 2 to 3 days. Most publications reported intravenous administration of antibiotics immediately. CONCLUSIONS: Current practice and recommendations strongly support early systemic antibiotic prophylaxis for patients with open fractures of the extremities. Differences in antibiotic regimens, doses, and durations of administration remain in both practice and recommendations. Consensus with regard to optimal practice will likely require well-designed randomized controlled trials. CLINICAL RELEVANCE: The current survey of literature systematically provides surgeons' practice and the available expert recommendations from 2007 to 2017 on the use of prophylactic antibiotics in the management of open fractures of extremities.

14.
J Clin Epidemiol ; 106: 18-31, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30300676

RESUMO

BACKGROUND AND OBJECTIVE: Missing data for the outcomes of participants in randomized controlled trials (RCTs) are a key element of risk of bias assessment. However, it is not always clear from RCT reports whether some categories of participants were followed-up or not (i.e., do or do not have missing data) nor how the RCT authors dealt with missing data in their analyses. Our objectives were to describe how RCT authors (1) report on different categories of participants that might have missing data, (2) handle these categories in the analysis, and (3) judge the risk of bias associated with missing data. METHODS: We surveyed all RCT reports included in 100 clinical intervention systematic reviews (SRs), half of which were Cochrane SRs. Eligible SRs reported a group-level meta-analysis of a patient-important dichotomous efficacy outcome, with a statistically significant effect estimate. Eleven reviewers, working in pairs, independently extracted data from the primary RCT reports included in the SRs. We predefined 19 categories of participants that might have missing data. Then, we classified these participants as follows: "explicitly followed-up," "explicitly not followed-up" (i.e., definitely missing data), or "unclear follow-up status" (i.e., potentially missing data). RESULTS: Of 638 eligible RCTs, 400 (63%) reported on at least one of the predefined categories of participants that might have missing data. The median percentage of participants who were explicitly not followed-up was 5.8% (interquartile range 2.2-14.8%); it was 9.7% (4.1-14.9%) for participants with unclear follow up status; and 11.7% (interquartile range 5.6-23.7%) for participants who were explicitly not followed-up and with unclear follow-up status. When authors explicitly reported not following-up participants, they most often conducted complete case analysis (54%). Most RCTs neither reported on missing data separately for different outcomes (99%) nor reported using a method for judging risk of bias associated with missing data (95%). CONCLUSION: "Potentially missing data" are considerably more frequent than "definitely missing data." Adequate reporting of missing data will require development of explicit standards on which editors insist and to which RCT authors adhere.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Confiabilidade dos Dados , Humanos , Resultado do Tratamento
15.
Medicine (Baltimore) ; 97(48): e13158, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30508894

RESUMO

BACKGROUND: Antimicrobial resistance is currently considered the main risk to global health. A variety of microbial species have been isolated from endodontic and periodontal infections. However, clinical endodontic and periodontics bacterial isolates have not been sufficiently characterized with regard to their capacity for antibiotic resistance. We aim to assess the existing evidence to estimate the prevalence of the main antimicrobial resistance and multidrug resistant organisms in endodontics and periodontics and to describe their geographic distribution in Latin America. METHODS: All types of designs and will be restricted to Latin American studies will be included in this systematic review. MEDLINE, Embase, CINAHL, BVS (LILACS, BBO - bvsalud.org), IBECS (bases.bireme.br), Google Scholar, Cochrane Central Register of Controlled Trials, and Web of Science databases will be searched from 2013 to December 31, 2018 for all types of study designs that report microbial infection in endodontics and periodontics and their resistance and that define the microbiological methods used to identify microorganisms. The selection of articles for inclusion will be performed by 2 reviewers using predefined eligibility criteria. The Cochrane and ROBINS-I risk of bias assessment tools will be used to assess the methodological quality of randomized control trials. The Newcastle-Ottawa scale will be used to assess the quality of methodology in observational studies. The overall quality of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE) using the same principles and domains applied in the quality assessment of prognostic studies. The heterogeneity of the findings will be assessed using both the χ test and the I statistic. Sensitivity analysis will be performed by subgroup analyses and meta-regression to investigate the effect of study-level characteristics, such as age, gender, and methodological quality score, whenever possible. Publication bias across studies will be evaluated by visual inspection of the funnel plots and Begg's test for the results covered in 10 or more studies. RESULTS: The evidence derived by this study will inform best practices for patients with endodontic and periodontal problems receiving antimicrobial agents. CONCLUSION: Successful completion will significantly impact clinical practice and contribute to improved prescribing competency. PROTOCOL REGISTRATION: PROSPERO-CRD42018077810.


Assuntos
Anti-Infecciosos/farmacologia , Anti-Infecciosos/uso terapêutico , Infecções Bacterianas/tratamento farmacológico , Resistência Microbiana a Medicamentos , Doenças Periodontais/tratamento farmacológico , Técnicas Bacteriológicas , Humanos , América Latina/epidemiologia , Periodontite Periapical/tratamento farmacológico , Projetos de Pesquisa
16.
Medicine (Baltimore) ; 97(49): e13364, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30544404

RESUMO

Research shows an instability in the way workers in the healthcare field live, and a prevalence of an unhealthy lifestyle. Exhaustion, an overload of obligations and responsibilities and dissatisfaction are all factors that may result in both physical and mental disorders. The aim of our study is to analyze the association between individual and occupational aspects of hospital workers and their job satisfaction, burnout syndrome, and depressive symptoms, as well as the relationship between these 3 factors.A transversal study was carried out from August to November 2016 in a teaching hospital that is a reference in healthcare to 13 cities in the State of São Paulo, Brazil. Workers with an employment relationship of a period of 3 months or longer were included in the study. Subjects for the study were recruited through random probability sampling. Data were collected using psychometric tools in order to analyze job satisfaction (Job Satisfaction Survey [JSS]), the presence of burnout syndrome (Maslach Burnout Inventory [MBI]) and depressive symptoms (Patient Health Questionnaire-9). Adjusted analyses were conducted and the prevalence ratio (PR) was calculated using Poisson regression. The partial least squares structural equation modeling (PLS-SEM) was used for the analyses.The final sample of this study comprised 271 professionals. Administrative workers or technical support workers from the hospital showed to be more satisfied in their jobs compared to the healthcare professionals (P = .02). Time of professional activity was also associated with job satisfaction (P = .03). Men displayed burnout syndrome approximately twice as often as women (PR = 1.98; 95% CI: 1.03-3.79; P = .04). Workers who had a low household income presented a predominance twice as high of depressive symptoms (PR = 2.84; 95% CI: 1.24-6.51; P = .01). PLS-SEM confirmed the causal and inverse relationship between burnout syndrome and job satisfaction (P < .001). Depressive symptoms were considered predictors for professional exhaustion (P < .001).Personal and occupational factors of hospital workers were associated with job satisfaction, burnout syndrome, and depressive symptoms. The absence of burnout was identified as a predictive aspect for job satisfaction, and depressive symptoms as a predictor for professional exhaustion.


Assuntos
Pessoal Administrativo/psicologia , Esgotamento Profissional/complicações , Depressão/complicações , Pessoal de Saúde/psicologia , Hospitais de Ensino , Satisfação no Emprego , Adolescente , Adulto , Brasil , Esgotamento Profissional/epidemiologia , Estudos Transversais , Depressão/epidemiologia , Feminino , Humanos , Renda , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Síndrome , Fatores de Tempo , Adulto Jovem
17.
BMJ Open ; 8(7): e023761, 2018 07 25.
Artigo em Inglês | MEDLINE | ID: mdl-30049703

RESUMO

OBJECTIVE: To examine the relative impact of three management options in patients aged <60 years with cryptogenic stroke and a patent foramen ovale (PFO): PFO closure plus antiplatelet therapy, antiplatelet therapy alone and anticoagulation alone. DESIGN: Systematic review and network meta-analysis (NMA) supported by complementary external evidence. DATA SOURCES: Medline, EMBASE and Cochrane CENTRAL. STUDY SELECTION: Randomised controlled trials (RCTs) addressing PFO closure and/or medical therapies in patients with PFO and cryptogenic stroke. REVIEW METHODS: We conducted an NMA complemented with external evidence and rated certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS: Ten RCTs in eight studies proved eligible (n=4416). Seven RCTs (n=3913) addressed PFO closure versus medical therapy. Of these, three (n=1257) addressed PFO closure versus antiplatelet therapy, three (n=2303) addressed PFO closure versus mixed antiplatelet and anticoagulation therapies and one (n=353) addressed PFO closure versus anticoagulation. The remaining three RCTs (n=503) addressed anticoagulant versus antiplatelet therapy. PFO closure versus antiplatelet therapy probably results in substantial reduction in ischaemic stroke recurrence (risk difference per 1000 patients over 5 years (RD): -87, 95% credible interval (CrI) -100 to -33; moderate certainty). Compared with anticoagulation, PFO closure may confer little or no difference in ischaemic stroke recurrence (low certainty) but probably has a lower risk of major bleeding (RD -20, 95% CrI -27 to -2, moderate certainty). Relative to either medical therapy, PFO closure probably increases the risk of persistent atrial fibrillation (RD 18, 95% CI +5 to +56, moderate certainty) and device-related adverse events (RD +36, 95% CI +23 to +50, high certainty). Anticoagulation, compared with antiplatelet therapy, may reduce the risk of ischaemic stroke recurrence (RD -71, 95% CrI -100 to +17, low certainty), but probably increases the risk of major bleeding (RD +12, 95% CrI -5 to +65, moderate certainty). CONCLUSIONS: In patients aged <60 years, PFO closure probably confers an important reduction in ischaemic stroke recurrence compared with antiplatelet therapy alone but may make no difference compared with anticoagulation. PFO closure incurs a risk of persistent atrial fibrillation and device-related adverse events. Compared with alternatives, anticoagulation probably increases major bleeding. PROSPERO REGISTRATION NUMBER: CRD42017081567.


Assuntos
Anticoagulantes/uso terapêutico , Isquemia Encefálica/prevenção & controle , Procedimentos Cirúrgicos Cardíacos/métodos , Forame Oval Patente/terapia , Inibidores da Agregação de Plaquetas/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Fibrilação Atrial/epidemiologia , Isquemia Encefálica/etiologia , Terapia Combinada , Forame Oval Patente/complicações , Humanos , Meta-Análise em Rede , Complicações Pós-Operatórias/epidemiologia , Recidiva , Prevenção Secundária , Acidente Vascular Cerebral/etiologia
18.
BMJ Open ; 8(6): e018400, 2018 06 04.
Artigo em Inglês | MEDLINE | ID: mdl-29866718

RESUMO

BACKGROUND: In Brazil, as in most countries nowadays, there is a pursuit for healthcare quality improvement and sustainability in public and private systems. Healthcare professionals' perceptions, knowledge and attitudes determine evidence-based practice (EBP), which remain uncertain among Brazilian practitioners. A standardised national instrument whose wide use will identify gaps and flaws in establishing an EBP could contribute to an effective resources allocation from health professionals willing to use an EBP. OBJECTIVES: To present a study protocol on the development and validation of an instrument to measure Brazilian healthcare professionals' behaviour, skills, self-efficacy, knowledge and attitudes towards EBP. METHODS: This is a validation study with Brazilian healthcare professionals to develop a valid and reliable questionnaire, including selection of domains and formulation of questions. Construct and content validity will be assess by a panel of experts, with data collection and analysis following a Delphi-like methodology. Further, a pilot survey will be accomplished with a representative sample of different healthcare professionals from all main Brazilian regions. An exploratory factor analysis and a confirmatory factor analysis will be conducted afterwards. The ratio of χ2 and df (χ2/df), comparative fit index, goodness of fit index and root mean square error of approximation will be used for assessing the model fit. In addition, the reliability of the instrument will be estimated by test-retest reproducibility and Cronbach's alpha coefficient (α). ETHICS AND DISSEMINATION: This study has received ethical approval from the Pharmaceutical Sciences Faculty of the São Paulo State University (1.425.808). The use among a wide national sample is expected to promote an extensive view of evidence-based decision-making, identifying the knowledge gaps in this area. Study findings will be circulated to healthcare professionals and scientists in the field through the publication in peer-reviewed journals and conference presentations.


Assuntos
Atitude do Pessoal de Saúde , Prática Clínica Baseada em Evidências/métodos , Conhecimentos, Atitudes e Prática em Saúde , Brasil , Estudos Transversais , Técnica Delfos , Análise Fatorial , Humanos , Estudos de Validação como Assunto
19.
BMJ Open ; 8(4): e018956, 2018 04 07.
Artigo em Inglês | MEDLINE | ID: mdl-29627806

RESUMO

OBJECTIVE: The aims of the study were to investigate the prevalence of long-term use of benzodiazepines in patients taking antidepressants and to identify the risk factors associated with the prolonged use of benzodiazepines. DESIGN: Cross-sectional study. SETTING: Public health system in Brazil. PARTICIPANTS: Outpatients using antidepressants from January 2008 to December 2009 were included. The data were obtained from pharmacy databases and medical records. All individuals in the database were included in the study and were classified into two categories: (1) patients who had not used benzodiazepines combined with antidepressants or had combined the use of antidepressants with benzodiazepines for a short period (up to 4 weeks), and (2) those who used antidepressants plus benzodiazepines for a longer period (more than 4 weeks). MAIN OUTCOME MEASURE: The outcome measure is prolonged use of benzodiazepines (more than 4 weeks). We conducted a multivariate analysis to identify the factors associated with prolonged use of benzodiazepines. RESULTS: Forty per cent of the 870 patients evaluated had prolonged use of benzodiazepines (more than 4 weeks). The risk factors associated with prolonged use were age above 35 years (prevalence ratio (PR): 2.18, 95% CI 1.55 to 3.06, P<0.001), female sex (PR: 1.47, 95% CI 1.07 to 2.02, P=0.019), diagnosis at least 3 years prior (PR: 2.1, 95% CI 1.6 to 2.8, P<0.001), use of selective serotonin reuptake inhibitor antidepressants (PR: 1.7, 95% CI 1.3 to 2.2, P<0.001) and having a prescription from a psychiatrist (PR: 6.5, 95% CI 3.2 to 13.2, P<0.001). CONCLUSIONS: Prolonged use of benzodiazepines occurs more frequently in women, adults diagnosed several years earlier, users of selective serotonin reuptake inhibitor antidepressants and those who received a prescription from a psychiatrist. Education of clinicians, especially with regard to these populations, may decrease the overuse and misuse of benzodiazepines.


Assuntos
Antidepressivos , Benzodiazepinas , Adulto , Antidepressivos/administração & dosagem , Benzodiazepinas/administração & dosagem , Brasil , Estudos Transversais , Feminino , Humanos , Masculino , Saúde Pública
20.
J Clin Epidemiol ; 99: 14-23, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29505859

RESUMO

OBJECTIVES: To describe how systematic review authors report and address categories of participants with potential missing outcome data of trial participants. STUDY DESIGN AND SETTING: Methodological survey of systematic reviews reporting a group-level meta-analysis. RESULTS: We included a random sample of 50 Cochrane and 50 non-Cochrane systematic reviews. Of these, 25 reported in their methods section a plan to consider at least one of the 10 categories of missing outcome data; 42 reported in their results, data for at least one category of missing data. The most reported category in the methods and results sections was "unexplained loss to follow-up" (n = 34 in methods section and n = 6 in the results section). Only 19 reported a method to handle missing data in their primary analyses, which was most often complete case analysis. Few reviews (n = 9) reported in the methods section conducting sensitivity analysis to judge risk of bias associated with missing outcome data at the level of the meta-analysis; and only five of them presented the results of these analyses in the results section. CONCLUSION: Most systematic reviews do not explicitly report sufficient information on categories of trial participants with potential missing outcome data or address missing data in their primary analyses.


Assuntos
Viés , Metanálise como Assunto , Revisão Sistemática como Assunto , Confiabilidade dos Dados , Interpretação Estatística de Dados , /métodos
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