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1.
BMJ Open ; 11(8): e044312, 2021 08 02.
Artigo em Inglês | MEDLINE | ID: mdl-34341031

RESUMO

BACKGROUND: Deprescribing is the planned and supervised process of dose reduction or stopping of medication that might be causing harm, or no longer be of benefit. It is an activity that should be a normal part of care/the prescribing cycle. Although now broadly recognised, there are still challenges in its effective implementation. OBJECTIVES: To develop and validate an instrument to measure Brazilian healthcare professionals' knowledge, attitudes and practices towards deprescribing. METHODS: This study will include the following steps: (1) development of the preliminary instrument; (2) content validation; (3) pilot study; (4) evaluation of psychometric characteristics. After the elaboration of items of the instrument through the literature review, we will use a hybrid Delphi method to develop and establish the content validity of the instrument. Further, a pilot survey will be performed with 30 healthcare professionals. Finally, for the evaluation of psychometric characteristics, a cross-sectional study will be accomplished with a representative sample of different healthcare professionals from different Brazilian states using respondent-driven sampling. Exploratory factor analysis and confirmatory factor analysis will be performed. For assessing the model fit, we will use the ratio of χ2 and df (χ2/df), comparative fit index, the goodness of fit index and root mean square error of approximation. In addition, the reliability of the instrument will be estimated by test-retest reproducibility and Cronbach's alpha coefficient (α). ETHICS AND DISSEMINATION: The Ethics Committee for Research at the University of Sorocaba (ethics approval number: 3.848.916) approved the study. Study findings will be circulated to healthcare professionals and scientists in the field through publication in peer-reviewed journals and conference presentations.


Assuntos
Desprescrições , Conhecimentos, Atitudes e Prática em Saúde , Brasil , Estudos Transversais , Análise Fatorial , Humanos , Projetos Piloto , Psicometria , Reprodutibilidade dos Testes , Inquéritos e Questionários
2.
BMJ Open ; 11(7): e044357, 2021 07 15.
Artigo em Inglês | MEDLINE | ID: mdl-34266837

RESUMO

OBJECTIVES: There is a lack of evidence about the use of local anaesthetics (LAs) in patients with cardiovascular diseases (CVD) in dental procedures. Thus, this study evaluated the safety of using LA with vasoconstrictor to determine the risk of cardiovascular events in patients with CVD. DESIGN: Systematic review and meta-analysis. METHODS: We have searched in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid), Healthstar (via Ovid), CINAHL, Web of Science and ClinicalTrials.gov for randomised controlled trials (RCTs) up to January 2020. We have included RCTs involving adults with CVD within two groups: intervention group with LA with vasoconstrictor and control group with LA without vasoconstrictor. The primary outcomes assessed were death, mortality by a specific cause, stroke, acute myocardial infarction, hospitalisation, pain, bleeding and arrhythmias. The secondary outcomes were ST segment depression, anxiety, adverse effects and changes in haemodynamic parameters. The data were pooled using random effects meta-analyses and the confidence in the estimates was verified using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Ten RCTs (n=478 participants) were included. Most of them had a high risk of bias. There were more cases of pain and bleeding in groups without vasoconstrictor. Meta-analysis demonstrated a decrease in the systolic blood pressure with the use of LA with vasoconstrictor (standard mean difference -0.95, 95% CI -1.35 to -0.55) after procedure. Overall, for the other outcomes assessed there was no statistical difference. The quality of evidence was considered low according to the GRADE profile. CONCLUSIONS: The results suggest that the use of LA with vasoconstrictors (epinephrine in low doses) is safe in patients with some types of CVD. However, the low quality of evidence demonstrated that literature needs further studies in order to confirm these results. PROTOCOL REGISTRATION: PROSPERO (CRD42016045421).


Assuntos
Doenças Cardiovasculares , Infarto do Miocárdio , Adulto , Anestesia Local , Anestésicos Locais , Humanos , Vasoconstritores/uso terapêutico
3.
BMC Psychiatry ; 21(1): 320, 2021 06 29.
Artigo em Inglês | MEDLINE | ID: mdl-34187418

RESUMO

BACKGROUND: The use of atypical antipsychotics for the treatment of schizophrenia and other mental disorders in populations under 18 years of age is increasing worldwide. Little is known about treatment patterns and the influence of gender differences, which may be a predictor of clinical outcomes. The aim of this study was to investigate gender differences in the use of atypical antipsychotics in patients with early-onset schizophrenia (EOS) assisted by the public health system in Brazil. METHODS: We conducted a cross-sectional study of outpatients with EOS aged 10 to 17 years who received at least one provision of atypical antipsychotics (clozapine, olanzapine, risperidone, quetiapine or ziprasidone) from a large Brazilian pharmaceutical assistance programme. Data were retrieved from a nationwide administrative database from 2008 to 2017. RESULTS: Of the 49,943 patients with EOS, 63.5% were males, and the mean age was 13.6 years old. The patients were using risperidone (62.5%), olanzapine (19.6%), quetiapine (12.4%), ziprasidone (3.3%) and clozapine (2.2%). We found gender differences, especially in the 13-17 year age group (65.1% for males vs. 34.9% for females, p < 0.001), in the use of risperidone (72.1% for males vs. 27.9% for females, p < 0.001) and olanzapine (66.5% for males vs. 33.5% for females, p < 0.001). Only in the 13 to 17 years age group were the prescribed doses of olanzapine (p = 0.012) and quetiapine (p = 0.041) slightly higher for males than for females. CONCLUSIONS: Our findings showed gender differences among patients diagnosed with EOS and who received atypical antipsychotics. More attention should be devoted to gender differences in research and clinical practice.


Assuntos
Antipsicóticos , Esquizofrenia , Adolescente , Antipsicóticos/uso terapêutico , Benzodiazepinas/uso terapêutico , Brasil , Estudos Transversais , Feminino , Humanos , Masculino , Fumarato de Quetiapina/uso terapêutico , Esquizofrenia/tratamento farmacológico , Esquizofrenia/epidemiologia , Fatores Sexuais
4.
Salud Colect ; 17: e3339, 2021 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-34105332

RESUMO

In order to compile an inventory of national data sources for drug utilization research (DUR) in Argentina and to verify publicly available data sources, we performed a cross-sectional study that sought to identify national and provincial databases of drug use. In July 2020, we searched the websites of government institutions, carried out a systematic query of bibliographic databases for "drug utilization research" conducted in Argentina, and conducted a survey with local experts. Data collected included: the institution responsible for the database, population covered, accessibility, source of the data, healthcare setting, geographic information, and whether data were individual or aggregated. Descriptive analyses were then performed. We identified 31 data sources for DUR; only one was publicly and conveniently accessible. Five published aggregated data and provide more detailed access by formal request. Only seven sources (23%) reported national data, and most (n=29) included only data from the public healthcare sector. Although data sources for DUR have been found in Argentina, limited access by researchers and policymakers is still an significant obstacle. Increasing health data transparency by making data sources publicly available for the purpose of analyzing public health information is crucial for building a stronger health system.

5.
PLoS One ; 16(4): e0248866, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33826610

RESUMO

Evidence on the use of non-steroidal anti-inflammatory drugs (NSAIDs) and corticoids for rheumatoid arthritis (RA) is inconclusive and is not up to date. This systematic review assessed the effectiveness and safety of these anti-inflammatories (AI) in the treatment of RA. COCHRANE (CENTRAL), MEDLINE, EMBASE, CINAHL, Web of Science and Virtual Health Library were searched to identify randomized controlled trials (RCT) with adults which used AI (dose represented in mg/day) compared with placebo or active controls and was carried out up to December of 2019. Reviewers, in pairs and independently, selected studies, performed the data extraction and assessed the risk of bias. The quality of the evidence was assessed by GRADE. Network meta-analyses were performed using the Stata v.14.2. Twenty-six articles were selected (NSAIDs = 21 and corticoids = 5). Naproxen 1,000 improved physical function, reduced pain and the number of painful joints compared to placebo. Etoricoxib 90 reduced the number of painful joints compared to placebo. Naproxen 750 reduced the number of swollen joints, except for etoricoxib 90. Naproxen 1,000, etoricoxib 90 and diclofenac 150 were better than placebo regarding patient assessment. Assessment physician showed that NSAIDs were better than placebo. Meta-analyses were not performed for prednisolone and prednisone. Naproxen 1,000 was the most effective drug and celecoxib 200 showed fewer adverse events. However, the low quality of the evidence observed for the outcomes with NSAIDs, the absence of meta-analyses to assess the outcomes with corticoids, as well as the risk of bias observed, indicate that future RCT can confirm such findings.


Assuntos
Corticosteroides/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Metanálise em Rede
6.
Front Public Health ; 9: 536342, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33898367

RESUMO

Background: Adolescent pregnancy is a public health concern and many studies have evaluated neonatal outcomes, but few have compared younger adolescents with older using adequate prenatal care. Objective: To compare the risks of adverse neonatal outcomes in younger pregnant adolescents who are properly followed through group prenatal care (GPC) delivered by specialized public services. Methods: This retrospective cohort study followed pregnant adolescents (aged 10-17 years) who received GPC from specialized public services in Brazil from 2009 to 2014. Data were obtained from medical records and through interviews with a multidisciplinary team that treated the patients. The neonatal outcomes (low birth weight, prematurity, Apgar scores with 1 and 5 min, and neonatal death) of newborns of adolescents aged 10-13 years were compared to those of adolescents aged 14-15 years and 16-17 years. Incidence was calculated with 95% confidence intervals (CIs) and compared over time using a chi-squared test to observe trends. Poisson Multivariate logistic regression was used to adjust for confounding variables. The results are presented as adjusted relative risks or adjusted mean differences. Results: Of the 1,112 adolescents who were monitored, 758 were included in this study. The overall incidence of adverse neonatal outcomes (low birth weight and prematurity) was measured as 10.2% (95% CI: 9.7-11.5). Apgar scores collected at 1 and 5 min were found to be normal, and no instance of fetal death occurred. The incidence of low birth weight was 16.1% for the 10-13 age group, 8.7% for the 14-15 age group and 12.1% for the 16-17 age group. The incidence of preterm was measured at 12, 8.5, and 12.6% for adolescents who were 10-13, 14-15, and 16-17 years of age, respectively. Neither low birth weight nor prematurity levels significantly differed among the groups (p > 0.05). The infants born to mothers aged 10-13 years presented significantly (p < 0.05) lower Apgar scores than other age groups, but the scores were within the normal range. Conclusions: Our findings showed lower incidence of neonatal adverse outcomes and no risk difference of neonatal outcomes in younger pregnancy adolescents. It potentially suggests that GPC model to care pregnant adolescents is more important than the age of pregnant adolescent, however further research is needed.


Assuntos
Complicações na Gravidez , Gravidez na Adolescência , Adolescente , Brasil/epidemiologia , Criança , Feminino , Política de Saúde , Humanos , Recém-Nascido , Gravidez , Cuidado Pré-Natal , Estudos Retrospectivos
7.
Int Urogynecol J ; 32(10): 2647-2656, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33704538

RESUMO

INTRODUCTION AND HYPOTHESIS: This systematic review evaluated the rigor of the development of clinical practice guidelines (CPG). METHODS: The searched sources were MEDLINE, EMBASE, Web of Science, Scopus, and specific databases of CPG. Reviewers, organized in triplicate and independently, selected the studies and assessed the quality of the guidelines using the Appraisal of Guidelines Research and Evaluation (AGREE II) instrument, which contains six domains for classification. The classification of the CPGs prioritized the domain 3 (developmental rigor) considering: high (score > 60%), moderate (score 30-60%), or low quality (score < 30%). The results were checked for discrepancies and decided by consensus. The interventions were described. Descriptive statistics presented the results. RESULTS: Of the ten CPGs evaluated, five were of high methodological quality, three were of moderate quality, and two of low quality. Three documents were not recommended for use. The domains with the highest scores were scope and purpose (mean = 90.1%) and clarity of presentation (mean = 88.9%). The domains of editorial independence (mean = 41.4%) and applicability (mean = 29.3%) were those with the lowest score. The most cited interventions in CPGs were the nonpharmacological, such as lifestyle interventions, bladder training, or re-education and pelvic floor muscle training. CONCLUSION: Most guidelines showed rigor in development and were recommended for use; however, editorial independence and applicability were domains that need to be improved in these documents. Our findings can guide the choice of CPG for the treatment of urinary incontinence.

8.
Medicine (Baltimore) ; 100(12): e25015, 2021 Mar 26.
Artigo em Inglês | MEDLINE | ID: mdl-33761656

RESUMO

ABSTRACT: Older adults are the leading users of medications, where this can be associated with a high number of potentially inappropriate medications (PIMs) and of potentially inappropriate prescribing (PIP) and consequent harm to health. No Brazilian study evaluating potentially inappropriate prescribing in older patients with Alzheimer's disease (AD) was found. This study determined and analyzed the prevalence of PIP and PIM prescribed for older people with AD.A cross-sectional study was carried out at the Specialty Drugs Pharmacy in the city of Sorocaba, São Paulo State, Brazil. The MEDEX system provided the register in older people with AD and data were collected during interviews with patients and/or caregivers between June and September 2017. The PIMs were identified according to the 2019 Beers Criteria. The association between PIMs and independent variables was analyzed by Poisson regression.This study included 234 older patients with AD. The prevalence of PIP prescribed was 66.7% (n = 156). Of the 1073 medications prescribed, 30.5% (n = 327) were inappropriate with most affecting the central nervous system or cardiovascular, particularly quetiapine (12.8%) and acetylsalicylic acid (11.6%), respectively. Around 45.2% of the PIMs should be avoided in older people, especially sertraline (14.2%) and clonazepam (7.4%). After adjusted analysis, the PIMs were associated with the diagnosis of depression (P = 0.010) and the number of comorbidities (P = 0.005).There was a high number of PIMs among older people, a substantial number of which should have been avoided in this population. Health care professionals can apply these findings to improve safety in the use of medications for treating patients with AD.


Assuntos
Doença de Alzheimer/tratamento farmacológico , Prescrição Inadequada/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Aspirina/efeitos adversos , Aspirina/uso terapêutico , Brasil , Fármacos Cardiovasculares/efeitos adversos , Fármacos Cardiovasculares/uso terapêutico , Fármacos do Sistema Nervoso Central/efeitos adversos , Fármacos do Sistema Nervoso Central/uso terapêutico , Clonazepam/efeitos adversos , Clonazepam/uso terapêutico , Estudos Transversais , Interações Medicamentosas , Feminino , Humanos , Masculino , Polimedicação , Fumarato de Quetiapina/efeitos adversos , Fumarato de Quetiapina/uso terapêutico , Sertralina/efeitos adversos , Sertralina/uso terapêutico
9.
BMJ Open ; 11(1): e043363, 2021 01 25.
Artigo em Inglês | MEDLINE | ID: mdl-33495257

RESUMO

OBJECTIVES: It can be challenging to manage patients who are anxious during dental procedures. There is a lack of evidence regarding the effectiveness and safety of oral sedation in adults. This study evaluated the effectiveness and safety of oral sedation in patients undergoing dental procedures. DESIGN: Systematic review. METHODS: Randomised clinical trials (RCTs) compared the oral use of benzodiazepines and other medications with a placebo or other oral agents in adult patients. A search of the Cochrane (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid) and Cumulative Index to Nursing and Allied Health Literature (via Ovid) databases was conducted, without any restrictions on language or date of publication. The primary outcomes included the adverse effects and anxiety level. The secondary outcomes included sedation, satisfaction with the treatment, heart rate, respiratory rate, blood pressure and oxygen saturation. Reviewers, independently and in pairs, assessed each citation for eligibility, performed the data extraction and assessed the risk of bias. A narrative synthesis of the data was provided. RESULTS: A number of RCTs (n=327 patients) assessed the use of benzodiazepines (n=9) and herbal medicines (n=3). We found good satisfaction with treatment after the use of midazolam 7.5 mg or clonidine 150 µg and reduced anxiety with alprazolam (0.5 and 0.75 mg). Midazolam 15 mg promoted greater anxiety reduction than Passiflora incarnata L. 260 mg, while Valeriana officinalis 100 mg and Erythrina mulungu 500 mg were more effective than a placebo. More patients reported adverse effects with midazolam 15 mg. Diazepam 15 mg and V. officinalis 100 mg promoted less change in the heart rate and blood pressure than a placebo. CONCLUSIONS: Given the limitations of the findings due to the quality of the included studies and the different comparisons made between interventions, further RCTs are required to confirm the effectiveness and safety of oral sedation in dentistry. PROSPERO REGISTRATION NUMBER: CRD42017057142.


Assuntos
Anestesia , Midazolam , Adulto , Alprazolam , Benzodiazepinas/efeitos adversos , Diazepam , Humanos
10.
BMJ Open ; 10(9): e035120, 2020 09 13.
Artigo em Inglês | MEDLINE | ID: mdl-32928847

RESUMO

OBJECTIVE: Some patients with dengue fever tend to develop thrombocytopenia during the course of infection and are thus vulnerable to haemorrhagic manifestations and other complications. However, the factors associated with the development of thrombocytopenia are unknown. We aimed to identify factors associated with an increased risk of thrombocytopenia and haematological changes in patients with confirmed dengue fever. DESIGN: Retrospective cohort study. SETTING: Brazilian multicentre primary care databases. PARTICIPANTS: 387 patients had positive laboratory serological confirmation of dengue infection during 2014. The data were identified from two databases: Notification of Injury Information System (SINAN) and Municipal Laboratory. MAIN OUTCOME MEASURE: The presence of thrombocytopenia (platelet count <1 50×109/L). The associations of factors that predisposed patients to thrombocytopenia and haematological changes were analysed using logistic regression. ORs and 95% CIs were calculated. RESULTS: Among 387 patients, 156 had both dengue and thrombocytopenia. The risk factors associated with thrombocytopenia included male sex (OR: 1.77, 95% CI: 1.16 to 2.71, p=0.007), age of 46-64 years (OR: 2.20, 95% CI: 1.15 to 4.21, p=0.009) or ≥65 years (OR: 3.02, 95% CI: 1.40 to 6.50, p=0.002), presence of leucopenia (OR: 6.85, 95% CI: 4.27 to 10.99, p<0.001) and high mean corpuscular haemoglobin (MCH) levels (OR: 2.00, 95% CI: 1.29 to 3.12, p=0.005). CONCLUSION: Older age, male sex, presence of leucopenia and high MCH levels were identified as risk factors associated with the development of thrombocytopenia in this population.


Assuntos
Dengue , Trombocitopenia , Idoso , Brasil/epidemiologia , Dengue/complicações , Dengue/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Contagem de Plaquetas , Estudos Retrospectivos , Trombocitopenia/complicações , Trombocitopenia/epidemiologia
11.
BMJ ; 370: m2898, 2020 08 26.
Artigo em Inglês | MEDLINE | ID: mdl-32847800

RESUMO

OBJECTIVE: To assess the risk of bias associated with missing outcome data in systematic reviews. DESIGN: Imputation study. SETTING: Systematic reviews. POPULATION: 100 systematic reviews that included a group level meta-analysis with a statistically significant effect on a patient important dichotomous efficacy outcome. MAIN OUTCOME MEASURES: Median percentage change in the relative effect estimate when applying each of the following assumption (four commonly discussed but implausible assumptions (best case scenario, none had the event, all had the event, and worst case scenario) and four plausible assumptions for missing data based on the informative missingness odds ratio (IMOR) approach (IMOR 1.5 (least stringent), IMOR 2, IMOR 3, IMOR 5 (most stringent)); percentage of meta-analyses that crossed the threshold of the null effect for each method; and percentage of meta-analyses that qualitatively changed direction of effect for each method. Sensitivity analyses based on the eight different methods of handling missing data were conducted. RESULTS: 100 systematic reviews with 653 randomised controlled trials were included. When applying the implausible but commonly discussed assumptions, the median change in the relative effect estimate varied from 0% to 30.4%. The percentage of meta-analyses crossing the threshold of the null effect varied from 1% (best case scenario) to 60% (worst case scenario), and 26% changed direction with the worst case scenario. When applying the plausible assumptions, the median percentage change in relative effect estimate varied from 1.4% to 7.0%. The percentage of meta-analyses crossing the threshold of the null effect varied from 6% (IMOR 1.5) to 22% (IMOR 5) of meta-analyses, and 2% changed direction with the most stringent (IMOR 5). CONCLUSION: Even when applying plausible assumptions to the outcomes of participants with definite missing data, the average change in pooled relative effect estimate is substantive, and almost a quarter (22%) of meta-analyses crossed the threshold of the null effect. Systematic review authors should present the potential impact of missing outcome data on their effect estimates and use this to inform their overall GRADE (grading of recommendations assessment, development, and evaluation) ratings of risk of bias and their interpretation of the results.


Assuntos
Metanálise como Assunto , Projetos de Pesquisa/normas , Revisões Sistemáticas como Assunto , Viés , Interpretação Estatística de Dados , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
12.
Front Pharmacol ; 11: 1128, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32848747

RESUMO

Background: The judicialization of health care is a social claim concerning the right to the access to health care. It usually occurs due to gaps in public policy or failures in its application. In Brazil, several public institutions have implemented strategies to approach this phenomenon. However, these strategies have not yet been systematized into functional categories. Objective: To categorize and analyze the strategies implemented by public institutions in Brazil to approach the judicialization of health care. Method: A systematic scoping review was developed following the method proposed by the Joanna Briggs Institute. The descriptor 'judicialization of health' was used to conduct the searches for studies in 18 electronic databases and other types of documents in the gray literature until March 2019. Documents containing the reports of strategies implemented in public institutions to approach the judicialization of health care in Brazil were included. Two independent reviewers assessed the eligibility of the documents and extracted the data. The strategies identified were categorized using definitions from the World Health Organization and existing Brazilian legislation. Results: Seventy eight implemented strategies were identified and organized into nine categories: i. Technical support to the judiciary; ii. State health committees; iii. Organization of assistance; iv. Compliance with court orders, v. Computerized information systems; vi. Administrative proceeding; vii. Defense of the public authority; viii. Pharmacy and therapeutics committee; ix. Alternative dispute resolution. These categories are not mutually exclusive and often act in concert or complement each other's activities. They represent services either existing or provided for in legal provisions by the public administration to meet various types of demands. Conclusions: The categories proposed to approach the judicialization of health care represent some of the recommendations for qualifying public administration or are provided for in Brazilian legislation, or both. The existence of recommendations and legislation facilitate, but do not guarantee, the implementation of strategies by public institutions.

14.
J Clin Epidemiol ; 127: 49-58, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32512186

RESUMO

BACKGROUND: The main objective of this study was to document details of both individual and institutional financial conflicts of interest (FCOIs) reported by the authors of clinical trials. An additional objective was to assess the predictors of having at least one author reporting any FCOI. METHODS: We used a sample of randomized controlled trials from a previous cross-sectional survey and included the trials, which reported at least one FCOI disclosure. We categorized the types of disclosed FCOI as grant, employment income, personal fees, nonmonetary support, drug or equipment supplies, patent, stocks, and other types. We collected data on the characteristics of the included RCTs, of the authors, and of the reported FCOI disclosures. We conducted descriptive analyses and a regression analysis to assess the predictors of having at least one author reporting any FCOI. RESULTS: All 108 included RCTs reported being funded, with 58% reporting funding by a private-for-profit source. Out of 1,687 authors, 814 (48%) reported at least one, and a median of 2, FCOI disclosures. Of the 814 reporting disclosures, far more reported individual FCOIs (99%) than institutional FCOIs (6%). The most commonly reported individual FCOI subtypes were grant (49%), personal fees (48%), and employment income (22%). Of the 99% of disclosures that included the source of FCOI, a private-for-profit entity provided the funds in 85%. Reporting about the relation of the FCOI source's to the product investigated in the trial, the timing of FCOI, and monetary value of FCOI was limited. Reporting of FCOIs proved most strongly associated with author affiliation being an academic institution (OR = 2.981; 95% CI: 2.415-3.680) and trial funding from entity other than a private-for-profit entity (OR = 2.809; 95% CI: 2.274-3.470). CONCLUSION: Approximately half of the trial authors report individual FCOIs, often three or more, but seldom provide details related to source's relation to the trial, or the timing and monetary value of the FCOI.


Assuntos
Autoria , Conflito de Interesses/economia , Revelação/estatística & dados numéricos , Ética Institucional , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Estudos Transversais , Honorários e Preços/estatística & dados numéricos , Organização do Financiamento/estatística & dados numéricos , Humanos , Renda/estatística & dados numéricos , Afiliação Institucional , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Análise de Regressão , Apoio à Pesquisa como Assunto/economia , Apoio à Pesquisa como Assunto/estatística & dados numéricos
15.
Clin Epidemiol ; 12: 527-535, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32547244

RESUMO

Background: How systematic review authors address missing data among eligible primary studies remains uncertain. Objective: To assess whether systematic review authors are consistent in the way they handle missing data, both across trials included in the same meta-analysis, and with their reported methods. Methods: We first identified 100 eligible systematic reviews that included a statistically significant meta-analysis of a patient-important dichotomous efficacy outcome. Then, we successfully retrieved 638 of the 653 trials included in these systematic reviews' meta-analyses. From each trial report, we extracted statistical data used in the analysis of the outcome of interest to compare with the data used in the meta-analysis. First, we used these comparisons to classify the "analytical method actually used" for handling missing data by the systematic review authors for each included trial. Second, we assessed whether systematic reviews explicitly reported their analytical method of handling missing data. Third, we calculated the proportion of systematic reviews that were consistent in their "analytical method actually used" across trials included in the same meta-analysis. Fourth, among systematic reviews that were consistent in the "analytical method actually used" across trials and explicitly reported on a method for handling missing data, we assessed whether the "analytical method actually used" and the reported methods were consistent. Results: We were unable to determine the "analytical method reviews actually used" for handling missing outcome data among 397 trials. Among the remaining 241, systematic review authors most commonly conducted "complete case analysis" (n=128, 53%) or assumed "none of the participants with missing data had the event of interest" (n=58, 24%). Only eight of 100 systematic reviews were consistent in their approach to handling missing data across included trials, but none of these reported methods for handling missing data. Among seven reviews that did explicitly report their analytical method of handling missing data, only one was consistent in their approach across included trials (using complete case analysis), and their approach was inconsistent with their reported methods (assumed all participants with missing data had the event). Conclusion: The majority of systematic review authors were inconsistent in their approach towards reporting and handling missing outcome data across eligible primary trials, and most did not explicitly report their methods to handle missing data. Systematic review authors should clearly identify missing outcome data among their eligible trials, specify an approach for handling missing data in their analyses, and apply their approach consistently across all primary trials.

16.
PLoS One ; 15(4): e0231444, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32298300

RESUMO

Acupuncture is one of the therapeutic resources used for the management of chronic pain. Variability in outcome measurements in randomized clinical trials of non-oncologic chronic pain (RCT-NOCP) generates inconsistencies in determining effects of treatments. The objective of this survey was to assess the adherence to the recommendations made by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) in the measurement of RCT-NOCP of acupuncture. This methodological research made a systematic search for eligible studies from different sources of information. Eligible studies included those with number of patients ≥100, who randomized and allocated patients with chronic non-oncologic pain to be treated with acupuncture or with "sham" acupuncture, or non-acupuncture. This research included the recommendations for IMMPACT in the measurement of RCT-NOCP: presence of outcomes pain, physical function, emotional state and improvement perception of patient, the source of the outcome information pain and the tools used to measure such domains. From a total of 1,386 studies, 24 were included in this survey. Eleven studies presented low risk of bias. Pain outcome was measured in 23 studies, physical function in 22 studies, emotional state in 14 studies and improvement perception of patient in one study. As for the pain outcome, the patient was the information source in 50% of the studies. The measurement tools recommended for IMMPACT were included in eight studies (35%) that evaluated pain, one study that evaluated the emotional state (7%), and one study that evaluated the improvement perception and satisfaction of patient. It was observed that studies which did not adhere to the recommendations had more favorable results for acupuncture in the outcome pain. This study concludes that randomized clinical trials that used acupuncture to manage chronic pain failed to adhere to IMMPACT recommendations. Clinical societies and IMMPACT do not share the same recommendations. This fact reflects in the diversity of outcomes and instruments adopted in the studies, making it difficult to compare the results.


Assuntos
Analgesia por Acupuntura/métodos , Dor Crônica/terapia , Medição da Dor/métodos , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Inquéritos e Questionários
17.
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).


Assuntos
Agaricales , Obesidade/terapia , Perda de Peso , Animais , Modelos Animais de Doenças , Metanálise como Assunto , Projetos de Pesquisa , Revisões Sistemáticas como Assunto
18.
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.

19.
Ann Intern Med ; 171(10): 711-720, 2019 11 19.
Artigo em Inglês | MEDLINE | ID: mdl-31569214

RESUMO

This article has been corrected. The original version (PDF) is appended to this article as a Supplement. 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).


Assuntos
Produtos da Carne/efeitos adversos , Neoplasias/mortalidade , Carne Vermelha/efeitos adversos , Dieta/efeitos adversos , Humanos , Incidência
20.
BMJ Open ; 9(10): e028019, 2019 10 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.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , Gestão do Conhecimento , Equipe de Assistência ao Paciente/organização & administração , Pediatria , Inquéritos e Questionários , Brasil , Estudos Transversais , Técnica Delfos , Feminino , Grupos Focais , Pessoal de Saúde , Humanos , Masculino , Psicometria , Reprodutibilidade dos Testes
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