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Abstract Background Antibiotic consumption is a driver for the increase of antimicrobial resistance. The objective of this study is to analyze variations in antibiotic consumption and its appropriate use in Brazil from 2014 to 2019. Methods We conducted a time series study using the surveillance information system database (SNGPC) from the Brazilian Health Regulatory Agency. Antimicrobials sold in retail pharmacies were evaluated. All antimicrobials recorded for systemic use identified by the active ingredient were eligible. Compounded products and formulations for topic use (dermatological, gynecological, and eye/ear treatments) were excluded. The number of defined daily doses (DDDs)/1,000 inhabitants/day for each antibiotic was attributed. The number of DDDs per 1,000 inhabitants per day (DDIs) was used as a proxy for consumption. Results were stratified by regions and the average annual percentage change in the whole period studied was estimated. We used the WHO Access, Watch, and Reserve (AWaRe) framework to categorize antimicrobial drugs. Results An overall increase of 30% in consumption from 2014 to 2019 was observed in all Brazilian regions. Amoxicillin, azithromycin and cephalexin were the antimicrobials more consumed, with the Southeast region responsible for more than 50% of the antibiotic utilization. Among all antimicrobials analyzed 45.0% were classified as watch group in all Brazilian regions. Conclusion We observed a significant increase in antibiotics consumption from 2014 to 2019 in Brazil restricted to the Northeast and Central West regions. Almost half of the antibiotics consumed in Brazil were classified as watch group, highlighting the importance to promote rational use in this country.

Introduction When mental disorders go undetected until later stages, they can result in poorer health outcomes for patients. Primary healthcare (PHC) stands as a strategic setting for the early identification and management of these mental disorders, given its role as the primary care environment for health service users. This scoping review has the objective of mapping and assessing screening instruments validated for mental disorders that are applicable in PHC, particularly regarding their measurement properties.Methods and analysis This scoping review will include studies that have developed and validated screening instruments for mental disorders in the PHC context, irrespective of the age group. Searches will be conducted in MEDLINE, EMBASE, LILACS, CINAHL and PsycInfo without imposing restrictions on publication status, publication year or language. Additionally, we will scrutinise the references cited in the selected studies. Our inclusion criteria encompass studies examining any measurement property recommended by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) taxonomy. The selection process, data extraction and quality assessment of studies will be performed independently by pairs of reviewers. To evaluate the risk of bias within the selected studies, we will employ the COSMIN Risk of Bias 2 tools. The collected data will undergo analysis using descriptive statistics and will be presented in an evidence gap map format for each specific mental disorder.Ethics and dissemination The findings from this review will be discussed through deliberative dialogue with stakeholders and disseminated through peer-reviewed publications and conference presentations. The project was approved by the Ethics Committee for Research at the University of Sorocaba (number: 66993323.9.0000.5500).Trial registration number Open Science Framework - 10.17605/OSF.IO/Z6T5M.

Objective There is limited information regarding the incidence of treatment-related adverse events (AE) following antiretroviral therapy (ART) in women. So, this review aimed to describe the incidence of AE of ART in women living with HIV/AIDS.Design Systematic review and meta-analysis.Data sources Medline, Embase, Cochrane Library, Epistemonikos, Lilacs and Who Index, from inception to 9 April 2023.Eligibility criteria We included randomised controlled trials with at least 12 weeks of follow-up and evaluated AE of ART in women at any age living with HIV/AIDS, without restrictions on status, year or language of publication. We excluded post hoc or secondary analyses and open-label extensions without comparator, and trials involving pregnant or breastfeeding women or with a focus on coinfection with tuberculosis, hepatitis B or C. The primary outcomes were the incidence rate of participants with any clinical and/or laboratory AE related or not to ART and treatment discontinuation.Data extraction and synthesis Two independent reviewers extracted data and assessed the risk of bias using Cochrane’s risk of bias tool 2. We used Bayesian random-effects meta-analysis to summarise event rates. Results were presented as event rates per 1000 person-years (95% credibility intervals, 95% CrI). The pooled incidence rate per 1000 person-years adjusted for duration and loss to follow-up was estimated. We assessed the certainty of the evidence using Grading of Recommendations, Assessment, Development and Evaluation.Results A total of 24 339 studies were identified for screening, of which 10 studies (2871 women) met the eligibility criteria, with 11 different antiretrovirals (ARVs) regimens. Seven studies included exclusively women, while in the remaining three, the proportion of women ranged from 11% to 46%. Nine studies received industry funding. The pooled analysis showed a mean incidence rate of ART-related clinical and laboratory AE of 341.60 events per 1000 person-years (95% CrI 133.60–862.70), treatment discontinuation of 20.78 events per 1000 person-years (95% CrI 5.58–57.31) and ART-related discontinuation of 4.31 per 1000 person-years (95% CrI 0.13–54.72). Summary estimates were subject to significant uncertainty due to the limited number of studies and sparse data. The certainty of the evidence was graded as very low for all outcomes assessed.Conclusion Existing randomised trials do not provide sufficient evidence on the incidence rates of safety outcomes from antiretroviral treatment in women living with HIV/AIDS. Large comparative studies in well-characterised populations are needed to provide a more comprehensive landscape of the safety profile of these ARV therapies in women with HIV/AIDS.PROSPERO registration number CRD42021251051.

Introduction: Periodontal procedures can promote prolonged intense pain, particularly in clinical situations requiring surgical procedures. In this context, preemptive analgesia has also been assessed for its utility in controlling post-operative pain and discomfort in patients undergoing periodontal invasive procedures. This study assessed the efficacy and safety of preemptive oral analgesia with steroidal and non-steroidal anti-inflammatory drugs in periodontal surgeries.Methods: This systematic review performed a search in the following electronic sources: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via PubMed), EMBASE (via Ovid), Web of Science, Virtual Health Library and in clinical trials electronic databases for relevant randomized clinical trials (RCTs); published up to July 2023. Primary outcomes assessed were post-operative pain, edema and trismus. A narrative synthesis of the findings was carried out.Results: Six RCTs, involving a total of 250 participants, were included. The studies reviewed had a high risk of bias, particularly due to allocation concealment and blinding of participants and personnel. The RCTs reported only the outcome pain. The preemptive use of dexamethasone 8 mg, etoricoxib 90 mg or 120 mg and ketorolac 20 mg seems to be more effective for controlling post-operative pain than placebo.Discussion: The anti-inflammatory drugs evaluated proved to be effective for controlling post-operative pain. However, given the limitations regarding lack of studies, methodological biases, disparities in drugs and doses, report restricted the pain outcome; further RCTs confirming the effectiveness and safety of these drugs in periodontal surgical procedures are warranted.

Objective: The purpose of this study was to map and describe the studies that have investigated therapeutic alternatives for the management of paediatric multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19. Considering the origin of the studies performed (low-, middle- and high-income countries), a systematic scoping review was conducted with primary studies that reported the use of medications for the treatment of patients with MIS-C.Sources: The searches were performed in MEDLINE, Embase, Lilacs, Epistemonikos, CINAHL, and CENTRAL, in the grey literature (theses and dissertations from CAPES, ProQuest, and PROSPERO) and in clinical trial databases until May 2022. The selection and extraction of studies were performed independently by two reviewers.Summary of the findings: A total of 173 studies were included, most of which were published as case reports or series. No randomized controlled clinical trials (RCTs) were identified. The investigated drugs were immunoglobulins, glucocorticoids, monoclonal antibodies, anticoagulants, and antiplatelet agents.Conclusion: The dosages, when reported, were heterogeneous among the studies. The ethnicity and comorbidity of the participants were poorly reported. Monoclonal antibodies, drugs with higher costs, were mostly described in studies of high-income countries.

Abstract Background The judicialization of health care can be understood as a societal response to pressing healthcare needs, which probably are not being adequately addressed by the current healthcare system. This phenomenon increases the strain on service resources, both in the health sector and in the judiciary system as well, demanding an institutional reorganization to manage judicial actions. It is believed that each institution has developed strategies for coping with the problem in isolation and with little public disclosure. The purpose of this review will be to identify institutional strategies implemented and to investigate their effects in approaching the judicialization of health care. Methods Electronic searches will be conducted up to December 2021 on 11 databases, supplemented with gray literature and references lists of secondary studies. The descriptor “judicialization of health” will be the basis for conducting the main research. Studies describing any strategy implemented by public institutions to approach the judicialization of health care will be included. Results related to the quality of services provided by the implemented strategy reported in the studies and those that report accessibility, usability, and potential adverse effects or harms caused by the implemented strategy will be investigated. In addition, it will be explored if there have been changes related to the value or characteristics of health litigation. Two reviewers will independently screen all citations, abstract data, and full-text papers. The risk of bias in each study will be appraised using a tool suggested by Cochrane Effective Practice and Care Organization Group (EPOC). Subsequently, the reviewers will also extract the data of interest and classify the findings of these studies according to their performance at the institutional level. The results obtained will be described as a narrative synthesis. Discussion This review may provide evidence on the effects of the strategies implemented to approach the judicialization of health care. It will potentially benefit health care and legal professionals, decision-makers, and researchers by identifying the types and characteristics of strategies that have the potential to improve service delivery in the future. Systematic review registration PROSPERO CRD42020160608

Introduction Atypical antipsychotics have been studied to treat autism spectrum disorder (ASD). However, like little is known about whether these drugs are effective and safe when compared in controlled and non-controlled settings. This study aims to assess the efficacy and safety of second-generation antipsychotics in ASD in randomised controlled trials (RCT) and observational studies.Methods and analysis This systematic review will include RCT and prospective cohorts evaluating second-generation antipsychotics in people 5 years and older diagnosed with ASD. Searches will be conducted in Medline, Embase, Cochrane Library, Epistemonikos, Lilacs, CINAHL, PsycINFO, trial registries and grey literature databases without restriction on publication status, year of publication and language. The primary outcomes will be symptoms of aggressive behaviour, quality of life for the individual or their careers, and discontinuation or dropouts/withdrawals of antipsychotics due to adverse events. The secondary outcomes are other not serious adverse events and adherence to pharmacotherapy. Selection, data extraction, and quality assessment will be performed by pairs of reviewers, independently. The Risk of Bias 2 (RoB 2) and Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tools will be used to assess the risk of bias in the included studies. If appropriate, a meta-analysis and network meta-analysis will be conducted to synthesise the results. The overall quality of the evidence for each outcome will be determined by the Recommendation, Assessment, Development and Evaluation approach.Ethics and dissemination This study will systematically summarise the existing evidence evaluating the use of second-generation antipsychotics for treating ASD, in controlled and uncontrolled studies. The results of this review will be disseminated through peer-reviewed publications and conference presentations.PROSPERO registration number CRD42022353795.

Abstract Objective: to investigate sociodemographic and clinical characteristics of users of atypical antipsychotics receiving care via the Specialized Component of Pharmaceutical Assistance (Componente Especializado da Assistência Farmacêutica - CEAF), for the treatment of schizophrenia in Brazil, between 2008 and 2017. Methods: this was a retrospective cohort study using records of the authorizations for high complexity procedures retrieved from the Outpatient Information System of the Brazilian National Health System, from all Brazilian states. Results: of the 759,654 users, 50.5% were female, from the Southeast region (60.2%), diagnosed with paranoid schizophrenia (77.6%); it could be seen a higher prevalence of the use of risperidone (63.3%) among children/adolescents; olanzapine (34.0%) in adults; and quetiapine (47.4%) in older adults; about 40% of children/adolescents were in off-label use of antipsychotics according to age; adherence to CEAF was high (82%), and abandonment within six months was 24%. Conclusion: the findings expand knowledge about the sociodemographic and clinical profile of users and highlight the practice of off-label use.

Background: The social restrictions among coronavirus disease 2019 (COVID-19) pandemic have posed a thoughtful risk to mental health and have implications in the use of drugs, including antidepressants, anxiolytics and other psychotropics.Objective: This study analyzed the sales data of the psychotropics prescribed in Brazil, in order to verify the change in consumption trends of these drugs during the COVID-19 pandemic.Methods: This interrupted time-series analyzed psychotropic sales data, between January 2014 and July 2021, using the National System of Controlled Products Management from The Brazilian Health Regulatory Agency. The monthly mean DDDs per 1,000 inhabitants per day of psychotropic drugs was evaluated by analysis of variance (ANOVA) followed by Dunnett Multiple Comparisons Test. The changes in monthly trends in the use of the psychotropic studied were evaluated by Joinpoint regression.Results: During the period studied, clonazepam, alprazolam, zolpidem and escitalopram were the most sold psychotropic drugs in Brazil. According to Joinpoint regression, an upward trend was observed in sales during the pandemic of pregabalin, escitalopram, lithium, desvenlafaxine, citalopram, buproprion and amitriptyline. An increase in psychotropic consumption was noted throughout the pandemic period, with the maximum consumption (2.61 DDDs) occurring in April 2021, with a downward trend in consumption that accompanied the drop in the number of deaths.Conclusions: The increase in sales, mainly of antidepressants during the COVID-19 pandemic, draws attention to issues related to the mental health of the Brazilian population and on the need for greater monitoring in the dispensing of these drugs.

Introduction The production of clinical practice guidelines (CPGs) has grown in the past years. Notwithstanding, the quality of these documents and their recommendations for the treatment of schizophrenia in children and adolescents is still unknown.Objective To assess the quality of the guidelines and recommendations for the treatment of schizophrenia in this population.Methods CPGs from 2004 to December 2020 were identified through a systematic search on EMBASE, MEDLINE, PsycINFO, PubMed, Epistemonikos, VHL, Global Index Medicus and specific CPG databases. The CPGs’ quality was independently assessed by three reviewers using AGREE II and they were considered of high quality if they scored ≥60% in domains 3 and 6. The evidence classification systems were described, the quality of recommendations was assessed in pairs using AGREE-REX and the recommendations were compared.Results The database search retrieved 3182 results; 2030 were screened and 29 were selected for full-text reading. Four guidelines were selected for extraction. Two CPGs were considered of high quality in the AGREE II assessment. We described the commonly agreed recommendations for each treatment phase. The pharmacological recommendations were described in all treatment phases. Scores of AGREE-REX were lower for psychosocial recommendations.Conclusion There are still few clinical studies and CPGs regarding schizophrenia in children and adolescents. The quality of the documents was overall low, and the quality of the recommendations report has much to improve. There is also a lack of transparency about the quality of the evidence and the strength of the recommendations.Protocol registration number CRD42020164899.

Background: Drug utilization research (DUR) is used to provide evidence-based data to inform policies and make decisions. The aim of this study was to map and describe available data sources for drug utilization research in Peru.Methods: We performed a search of data sources providing information on medication use on the website of governmental organizations. We also conducted a literature review using PubMed, LILACs, and BVS. Independently, researchers screened eligible data sources. Data characterization included accessibility, coverage data provider, type of data sources, and setting. We performed a descriptive analysis.Results: We identified seven data sources, CENAFyT, ICI, IDI (SISMED), and ENSUSALUD from MINSA, and CRI-ESSALUD, SGSS/ESSI, and ENSSA from ESSALUD. These presented information on adverse drug reactions (n = 2), drug consumption, and distribution (n = 2), prescription and drug dispensing (n = 1), and surveys addressed to medication users (n = 2). ENSUSALUD was the only data source publicly available. VIGIFLOW and ENSUSALUD have a national granularity from the public and private sectors. The setting of the data sources was both hospital and ambulatory care. Two data sources have individual-level data on adverse drug reactions and one on prescriptions. Four studies on drug utilization research in Peru were derived from ENSUSALUD.Conclusion: In Peru, few data sources are available for drug utilization research. There is an increased need to monitor medications for decision-making purposes. Local and international initiatives and partnerships of the government with academic institutions and the private sector might be a good strategy to increase the transparency of health data and for supporting decision-making using drug utilization research.

ObjectiveThe aim of this study was to estimate the antimicrobial resistance in microorganisms present in periodontal diseases.MethodsA systematic review was conducted according to the PRISMA statement. The MEDLINE (PubMed/Ovid), EMBASE, BVS, CINAHL, and Web of Science databases were searched from January 2011 to December 2021 for observational studies which evaluated the antimicrobial resistance in periodontal diseases in permanent dentition. Studies that allowed the antimicrobial consumption until the time of sample collection, studies that used laboratory acquired strains, studies that only characterized the microbial strain present, assessment of cellular morphological changes, sequencing system validation, and time series were excluded. Six reviewers, working in pairs and independently, selected titles, abstracts, and full texts extracting data from all studies that met the eligibility criteria: characteristics of patients, diagnosis of infection, microbial species assessed, antimicrobial assessed, identification of resistance genes, and virulence factors. “The Joanna Briggs Institute” critical appraisal for case series was adapted to assess the risk of bias in the included studies.ResultsTwenty-four studies (N = 2.039 patients) were included. Prevotella and Porphyromonas species were the most cited microorganisms in the included studies, and the virulence factors were related to Staphylococcus aureus. The antimicrobial reported with the highest frequency of resistance in the included studies was ampicillin (39.5%) and ciprofloxacin showed the lowest frequency of resistance (3.4%). The most cited genes were related to macrolides. The quality of the included studies was considered critically low.ConclusionNo evidence was found regarding the profile of antimicrobial resistance in periodontal diseases, requiring further research that should focus on regional population studies to address this issue in the era of increasing antimicrobial resistance.Clinical relevanceThe knowledge about the present microorganism in periodontal diseases and their respective antimicrobial resistance profiles should guide dentists in prescribing complementary therapy for these infections.Systematic review registration[http://dx.doi.org/10.1097/MD.0000000000013158], identifier [CRD42018077810].

ObjectivesTo identify evidence-based strategies to improve adherence to the preventive measures against the coronavirus disease (COVID-19) at the community level.MethodThis is an evidence brief for policy, combining research evidence specific to contextual knowledge from stakeholders. A systematic search was performed in 18 electronic databases, gray literature, and a handle search, including only secondary and tertiary studies that focused on the adherence of the general population to COVID-19 preventive measures in the community. Two reviewers, independently, performed the study selection, data extraction, and assessment of the quality of the studies. Relevant evidence has been synthesized to draft evidence-based strategies to improve adherence. These strategies were circulated for external endorsement by stakeholders and final refinement. Endorsement rates >80%, 60–80% and

Objective To identify factors and assess to what extent they impact the magnitude of the treatment effect of acupuncture therapies across therapeutic areas.Data source Medline, Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc, between 2015 and 2019.Study selection The inclusion criteria were trials with a total number of randomised patients larger than 100, at least one patient-important outcome and one of two sets of comparisons.Data analysis The potential independent variables were identified by reviewing relevant literature and consulting with experts. We conducted meta-regression analyses with standardised mean difference (SMD) as effect estimate for the dependent variable. The analyses included univariable meta-regression and multivariable meta-regression using a three-level robust mixed model.Results 1304 effect estimates from 584 acupuncture randomised controlled trials (RCTs) were analysed. The multivariable analyses contained 15 independent variables . In the multivariable analysis, the following produced larger treatment effects of large magnitude (>0.4): quality of life (difference of adjusted SMDs 0.51, 95% CI 0.24 to 0.77), or pain (0.48, 95% CI 0.27 to 0.69), or function (0.41, 95% CI 0.21 to 0.61) vs major events. The following produced larger treatment effects of moderate magnitude (0.2–0.4): single-centred vs multicentred RCTs (0.38, 95% CI 0.10 to 0.66); penetration acupuncture vs non-penetration types of acupuncture (0.34, 95% CI 0.15 to 0.53); non-pain symptoms vs major events (0.32, 95% CI 0.12 to 0.52). The following produced larger treatment effects of small magnitude (

Abstract 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

Abstract. Background:. The ABCDE (Awakening and Breathing Coordination of daily sedation and ventilator removal trials, Delirium monitoring and management, and Early mobility and exercise) and ABCDEF (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) care bundles consist of small sets of evidence-based interventions and are part of the science behind Intensive Care Unit (ICU) liberation. This review sought to analyse the process of implementation of ABCDE and ABCDEF care bundles in ICUs, identifying barriers, facilitators and changes in perception and attitudes of healthcare professionals; and to estimate care bundle effectiveness and safety. Methods:. We selected qualitative and quantitative studies addressing the implementation of ABCDE and ABCDEF bundles in the ICU, identified on MEDLINE, Embase, CINAHL, The Cochrane Library, Web of Science, Epistemonikos, PsycINFO, Virtual Health Library and Open Grey, without restriction on language or date of publication, up to June 2018. The outcomes measured were 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 behaviour of the stakeholders; and change in knowledge of health professionals. Two reviewers independently selected the studies, performed data extraction, and assessed risk of bias and methodological quality. A meta-analysis of random effects was performed. Results:. Twenty studies were included, 13 of which had a predominantly qualitative and 7 a quantitative design (31,604 participants). The implementation strategies were categorized according to the taxonomy developed by the Cochrane Effective Practice and Organization of Care Group and eighty strategies were identified. The meta-analysis results showed that implementation of the bundles may reduce length of ICU stay, mechanical ventilation time, delirium, ICU and hospital mortality, and promoted early mobilization in critically-ill patients. Conclusions. : This study can contribute to the planning and execution of the implementation process of ABCDE and ABCDEF care bundles in ICUs. However, the effectiveness and safety of these bundles need to be corroborated by further studies with greater methodological rigor. Protocol registration:. PROSPERO CRD42019121307.

Objectives To develop and validate an instrument to measure Brazilian healthcare professionals’ perceptions, behaviour, self-efficacy and attitudes towards evidence-based health practice.Design Validation of an instrument using the Delphi method to ensure content validity and data from a cross-sectional survey to evaluate psychometric characteristics (psychometric sensitivity, factorial validity and reliability).Setting National Register of Health Establishments database.Participants We included clinical health professionals who were working in the Brazilian public health system.Results The Instrument to assess Evidence-Based Health (I-SABE) was constructed with five domains: self-efficacy; behaviour; attitude; results/benefits and knowledge/skills. Content validity was done by 10–12 experts (three rounds). We applied I-SABE to 217 health professionals. Bartlett’s sphericity test and the Kaiser-Meyer-Olkin (KMO) index were adequate (χ2=1455.810, p

Background: In 2019, a new type of coronavirus emerged and spread to the rest of the world. Numerous drugs were identified as possible treatments. Among the candidates for possible treatment was azithromycin alone or in combination with other drugs. As a result, many clinicians in Brazil have prescribed azithromycin in an attempt to combat or minimize the effects of COVID19.Aim: This study analyzed the sales data of the main antibiotics prescribed in Brazil to verify the change in consumption trends of these drugs during the COVID-19 pandemic.Methods: This is an interrupted time series that analyzed antimicrobial sales data between January 2014 and July 2021, publicly accessible information obtained from the Brazilian government’s website. Monthly means of “defined daily doses of DDDs” (DDDs per 1,000 inhabitants per day) of antibiotics were compared by analysis of variance, followed by the Dunnett Multiple Comparisons Test. Monthly trend changes in antibiotic use were verified using Joinpoint regression.Results: Amoxicillin (31.97%), azithromycin (18.33%), and cefalexin (16.61%) were the most sold antibiotics in Brazil during the evaluation period. Azithromycin consumption rose from 1.40 DDDs in February 2020 to 3.53 DDDs in July 2020. Azithromycin sales showed a significant increase in the pandemic period [Monthly Percent Change (MPC) 5.83%, 95% 1.80; 10.00], whereas there was a fall in amoxicillin sales (MPC −9.00%, 95% CI −14.70; −2.90) and cefalexin [MPC-2.70%, 95% (CI −6.30; −1.10)] in this same period.Conclusion: The COVID-19 pandemic changed the pattern of antibiotic consumption in Brazil, with a decrease in the use of amoxicillin and cefalexin and an increase in the consumption of azithromycin.

Background: In Brazil, studies that map electronic healthcare databases in order to assess their suitability for use in pharmacoepidemiologic research are lacking. We aimed to identify, catalogue, and characterize Brazilian data sources for Drug Utilization Research (DUR).Methods: The present study is part of the project entitled, “Publicly Available Data Sources for Drug Utilization Research in Latin American (LatAm) Countries.” A network of Brazilian health experts was assembled to map secondary administrative data from healthcare organizations that might provide information related to medication use. A multi-phase approach including internet search of institutional government websites, traditional bibliographic databases, and experts’ input was used for mapping the data sources. The reviewers searched, screened and selected the data sources independently; disagreements were resolved by consensus. Data sources were grouped into the following categories: 1) automated databases; 2) Electronic Medical Records (EMR); 3) national surveys or datasets; 4) adverse event reporting systems; and 5) others. Each data source was characterized by accessibility, geographic granularity, setting, type of data (aggregate or individual-level), and years of coverage. We also searched for publications related to each data source.Results: A total of 62 data sources were identified and screened; 38 met the eligibility criteria for inclusion and were fully characterized. We grouped 23 (60%) as automated databases, four (11%) as adverse event reporting systems, four (11%) as EMRs, three (8%) as national surveys or datasets, and four (11%) as other types. Eighteen (47%) were classified as publicly and conveniently accessible online; providing information at national level. Most of them offered more than 5 years of comprehensive data coverage, and presented data at both the individual and aggregated levels. No information about population coverage was found. Drug coding is not uniform; each data source has its own coding system, depending on the purpose of the data. At least one scientific publication was found for each publicly available data source.Conclusions: There are several types of data sources for DUR in Brazil, but a uniform system for drug classification and data quality evaluation does not exist. The extent of population covered by year is unknown. Our comprehensive and structured inventory reveals a need for full characterization of these data sources.

During the COVID-19 pandemic, people worldwide, including the scientific community, were insecure and fearful. The lack of vaccines at the beginning of the pandemic and the high mortality rate led to a search for alternative treatments for COVID-19. Among these proposals, a postulated activity of azithromycin was frequently studied in early treatment. In view of this, many countries saw an increase in the consumption of this antibiotic. Thus, the objective of this study was to evaluate, in Brazil, whether there was an increase in azithromycin prescriptions made by dentists, as they may have been prescribing this antibiotic as a probable treatment for COVID-19. This is an interrupted time series that analyzed antimicrobial prescriptions data between January 2014 and July 2021. The data were taken from the National System of Controlled Products Management, and pre- and postpandemic periods were compared. To assess changes in azithromycin consumption, Joinpoint regression and analysis of variance, followed by Dunnett’s test, were used. More than 38 million prescriptions written during the period were analyzed. Amoxicillin (72.3%), azithromycin (18.0%), cephalexin (6.1%), and metronidazole (3.58%) were the most prescribed antibiotics. At the beginning of the pandemic, there was a drop in amoxicillin prescriptions motivated by a decrease in consultations, but conversely, in less than three months, azithromycin prescriptions grew by more than 100%. The exaggerated use of this antibiotic during the pandemic will certainly have consequences in the short and medium term on indicators of bacterial resistance. The use of guidelines and respect for the therapeutic protocols of government agencies should be fundamental for collective and strategic action in the fight against health emergencies.

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.

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).

Abstract 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 I 2 inconsistency values and Cochran’s Q statistical test, where I 2 > 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).

ContextPeople with mental disorders can acquire long-term disabilities, which could impair their functioning and quality of life (QoL), requiring permanent care and social support. Systematic data on QoL and functioning, which could support a better management of these people, were not available.ObjectiveTo analyze the QoL, level of functioning and their association with sociodemographic and clinical factors of people with mental disorders who underwent deinstitutionalization using assisted living facilities.MethodsA Cross-sectional study was conducted between July 2018 and July 2019, through interviews using the World Health Organization Quality of Life (WHOQOL-BREF) to determine the QoL scores, and the World Health Organization Disability Assessment Schedule (WHODAS 2.0) to determine the level of functioning. All adults (≥18 years old) with mental disorders, who underwent deinstitutionalization, users of assisted living facilities and assisted by the Psychosocial Assistance Centers III, in a city in the state of São Paulo, Brazil, were selected. For statistical analysis of the associated factors, Student’s t-test was used for dichotomous variables and ANOVA for polynomial variables. Pearson correlation coefficient was used to measure the association between QoL and functioning scores.ResultsOut of 359 people who underwent deinstitutionalization with mental disorders, 147 met the eligibility criteria. The mean total score for the WHOQOL-BREF was 66.5 ± 13.4 and the mean score for WHODAS 2.0 was 10.4 ± 7.6. An association was found between people who were studying (n = 65.8; 95%CI, 63.5–68.1 vs. n = 73.9; 95%CI, 67.5–80.3; p = 0.04) and better WHOQOL-BREF QoL scores or WHODAS 2.0 levels of functioning (n = 10.9; 95%CI, 9.6–12.2 vs. n = 5.1; 95%CI, 2.5–7.7; p = 0.01). A weak negative correlation (r = 0.41) emerged between higher QoL scores and functioning improvement.ConclusionThis study indicates that the QoL of the sample is associated by their functioning levels, which, in turn, may reflect on their social interactions. Public policies that favor interventions increasing socialization of this population can result in better health outcomes. The QoL and functioning scores provide valuable insights to develop public policies more suited to this population profile.

Objective: Switching between second-generation antipsychotics (SGAs) is a common clinical practice in the treatment of schizophrenia and schizoaffective disorders due to differences in the drugs’ tolerability and safety profiles as well as the challenge of obtaining an ideal response. However, the factors associated with SGA switching remain uncertain and related real-world data are scarce. The main objective was to identify the factors associated with the switching of SGAs in patients with schizophrenia or schizoaffective disorder.Methods: We conducted a retrospective cohort study of outpatients with schizophrenia or schizoaffective disorder, who were aged ≥18 years and received a SGA (clozapine, olanzapine, risperidone, quetiapine or ziprasidone) from a Brazilian pharmaceutical assistance program for at least 3 months. We identified SGA users from 2008 to 2017 by using a national administrative database (Ambulatory Information System-SIA/SUS). The factors associated with the switches were evaluated by Cox proportional hazards regression and adjusted for sex and age; the confidence interval was set at 95% (95% CI).Results: In total, 563,765 patients were included. Female sex, advanced age of ≥70 years, residence in the Brazilian northeast region, and the type of antipsychotic used were associated with an increased risk of switching (p < 0.001). The incidence of switching ranged from 37.6/100 person-years for clozapine users to 58.2/100 person-years for risperidone users. Compared to the adjusted hazard ratio, for clozapine users, the corresponding ratios for risperidone, ziprasidone, quetiapine and olanzapine were 1.59 (95% CI, 1.57–1.61), 1.41 (95% CI, 1.39–1.44), 1.25 (95% CI, 1.23–1.26) and 1.11 (95% CI, 1.10–1.12) respectively.Conclusion: The groups most susceptible to SGA switching in real-life setting were older individuals, women, and those living in the Brazilian northeast region. Risperidone was associated with the highest risk of switching and as expected, clozapine was associated with the lowest risk of switching than that associated with the other SGAs.

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.

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.

Background: In the last decades, litigation has been increasingly used to access medicines in Brazil. This phenomenon has led to the development of diverse strategies to reduce its negative impact on the organization of pharmaceutical services. In spite of that, managers still face difficulties dealing with lawsuits.Objective: This study aims to report the planning and implementation of strategies to approach medicines litigation in a municipality located in the southeast region of Brazil.Methods: Mixed methods were employed through an action research cycle. A network coordination team included researchers from university and municipal managers. The scenario analysis comprised the characterization of pharmaceutical services and the profile of medicines lawsuits. Afterward, strategies were planned to deal with the central problem identified. The action plan involved educational outreach visits and distribution of printed materials for health professionals, evaluated through opinion survey. Group conversations were conducted with the users of the public health system, followed by thematic analysis of reports.Results: The characterization of pharmaceutical services in the municipality revealed that treatments supplied were in accordance with the National Medicines Policy. In addition, a sector was implemented to attend demands for non-incorporated medicines. In spite of the services available, the characterization of lawsuits indicated that the main claimants were users of the public health system, requiring non-incorporated medicines, with therapeutic alternatives available. Thus, educational outreach visits were held in 14 health units (23 physicians in total). Everyone who answered the evaluation declared that they were very satisfied with the approach. Group conversations with the users of the health system reached 227 participants in total. In regard to users’ perception about pharmaceutical services, thematic analysis of reports identified three main categories including aspects related to medicines provided, users assisted, and quality of service.Conclusion: The study described the first cycle of an action research project to develop strategies to approach medicines litigation at the municipal level. The application of educational outreach visits for health professionals and group conversations with health system users is a promising approach to improve access to information about pharmaceutical services in Brazil.

Background: The deinstitutionalization process is complex, long-term and many countries fail to achieve progress and consolidation. Informing decision-makers about appropriate strategies and changes in mental health policies can be a key factor for it. This study aimed to develop an evidence brief to summarize the best available evidence to improve care for deinstitutionalized patients with severe mental disorders in the community.Methods: We used the SUPPORT (Supporting Policy Relevant Reviews and Trials) tools to elaborate the evidence brief and to organize a policy dialogue with 24 stakeholders. A systematic search was performed in 10 electronic databases and the methodological quality of systematic reviews (SRs) was assessed by AMSTAR 2.Results: Fifteen SRs were included (comprising 378 studies and 69,736 participants), of varying methodological quality (3 high-quality SRs, 2 moderate-quality SRs, 7 low-quality SRs, 3 critically low SRs). Six strategies were identified: (i). Psychoeducation; (ii). Anti-stigma programs, (iii). Intensive case management; (iv). Community mental health teams; (v). Assisted living; and (vi). Interventions for acute psychiatric episodes. They were associated with improvements on a global status, satisfaction with the service, reduction on relapse, and hospitalization. Challenges to implementation of any of them included: stigma, the shortage of specialized human resources, limited political and budgetary support.Conclusions: These strategies could guide future actions and policymaking to improve mental health outcomes.

Purpose: The aim of the present study was to determine whether de-escalation guided by blood cultures for patients with a diagnosis of sepsis, severe sepsis or septic shock reduces mortality, and antimicrobial drug resistance (ADR).Methods: A prospective, single-center, cohort study was conducted with adults admitted to the ICU with a diagnosis of sepsis, severe sepsis, or septic shock at a public hospital in Sorocaba, State of São Paulo, Brazil, from January 2013 to December 2013. We excluded patients who had negative blood cultures. Patients who had replaced the initial empirical broad-spectrum antibiotic therapy (EAT) by the antibiotic therapy guided by blood cultures were compared with those who continued receiving EAT. The outcome included mortality and antimicrobial drug resistance. We used the Cox regression (proportional hazards regression) and the Poisson regression to analyze the association between antibiotic therapy guided by blood cultures (ATGBC) and outcomes. The statistical adjustment in all models included the following variables: sex, age, APACHE II (Acute Physiology And Chronic Health Evaluation II) score and SOFA (Sequential Organ Failure Assessment) score.Results: Among the 686 patients who were admitted to the intensive care unit, 91 were included in this study. The mean age of the patients was 52.7 years (standard deviation = 18.5 years) and 70.3% were male. EAT was replaced by ATGBC in 33 patients (36.3%) while 58 patients (63.7%) continued receiving EAT. Overall hospital mortality decreased from 56.9% in patients who received EAT to 48.5% in patients who received ATGBC [Hazard ratio- HR 0.44 (95% CI 0.24–0.82), p = 0.009]. There was no association between ATGBC and ADR [HR 0.90 (95% CI 0.78 – 1.03) p = 0.15].Conclusions: Although the early and appropriate empirical EAT is undoubtedly an important factor prognostic, ATGBC can reduce the mortality in these patients.

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.

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.

Children are exposed to drug-drug interactions (DDI) risks due to their organism’s complexity and the need for several medicines prescriptions in pediatric intensive care units (PICU). This study aimed to assess the prevalence of potential DDIs in a Brazilian PICU. We carried out a cross-sectional study at a pediatric teaching hospital from Rio de Janeiro (Brazil) over one year. Potential DDIs (pDDIs) between prescribed medicines for hospitalized children in PICU (n = 143) were analyzed according to severity using Micromedex®. Sex, age group, number of drugs prescribed, vasoactive amines use (a proxy of clinical complexity), and the PICU length of stay were summarized using descriptive statistics. Association between the PICU length stay, and variables sex, age, clinical condition complexity, number of drugs prescribed, and severity of pDDI were examined by univariate and multiple linear regression. Seventy percent of patients aged three days to 14 years old were exposed at least one potential DDIs during PICU stay. Two hundred eighty-four different types of pDDIs were identified, occurring 1,123 times. Nervous system drugs were implicated in 55% of the interactions, and fentanyl (10%) was most involving in pDDIs. Most pDDIs were classified as higher severity (56.2%), with reasonable documentation (64.6%) and unspecified onset time (63.8%). Worse clinical condition, ten or more drugs prescribed, and most severe pDDIs were associated with a longer PICU length of stay. Multiple linear regression analysis showed an increase of 9.83 days (95% confidence interval: 3.61–16.05; p = 0.002) in the PICU length of stay in children with major or contraindicated pDDIs. The results of this research may support the monitoring and prevention of pDDIs related to adverse events in children in intensive care and the design and conduction of new studies.

BackgroundThe 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.ObjectiveTo categorize and analyze the strategies implemented by public institutions in Brazil to approach the judicialization of health care.MethodA 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.ResultsSeventy 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.ConclusionsThe 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.

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.

BackgroundKnowledge translation (KT) is an effective strategy that uses the best available research evidence to bring stakeholders together to develop solutions and improve public health policy-making. Despite progress, the process of deinstitutionalization in Brazil is still undergoing consolidation, and the changes and challenges that are involved in this process are complex and necessitate evidence-informed decision-making. Accordingly, this study used KT tools to support efforts that aim to improve the care that is available to deinstitutionalized people with severe mental disorders in Brazil.MethodsWe used the Supporting Policy Relevant Reviews and Trials tools for evidence-informed health policymaking and followed eight steps: 1) capacity building; 2) identification of a priority policy issue within a Brazilian public health system; 3) meetings with policy-makers, researchers and stakeholders; 4) development of an evidence brief (EB) that addresses the problem of deinstitutionalization; 5) facilitating policy dialogue (PD); 6) the evaluation of the EB and PD; 7) post-dialogue mini-interviews; and 8) dissemination of the findings.ResultsCapacity building and meetings with key informants promoted awareness about the gap between research and practice. Local findings were used to define the problem and develop the EB. Twenty-four individuals (policy-makers, stakeholders, researchers, representatives of the civil society, and public defense) participated in the PD. They received the EB to subsidise their deliberations during the PD, which in turn were used to validate and improve the EB. The PD achieved the objective of promoting an exhaustive discussion about the problem and proposed options and improved communication and interaction among those who are involved in mental health care. The features of both the EB and PD were considered to be favorable and helpful.ConclusionsThe KT strategy helped participants understand different perspectives and values, the interpersonal tensions that exist among those who are involved in the field of mental health, and the strategies that can bridge the gap between research and policy-making. The present findings suggest that PDs can influence practice by promoting greater engagement among stakeholders who formulate or revise mental health policies.

Background Systematic reviews are increasingly used to inform health policy-making. The conflicts of interest (COI) of the authors of systematic reviews may bias their results and influence their conclusions. This may in turn lead to misguided public policies and systems level decisions. In order to mitigate the adverse impact of COI, scientific journals require authors to disclose their COIs. The objective of this study was to assess the frequency and different types of COI that authors of systematic reviews on health policy and systems research (HSPR) report. Methods We conducted a cross sectional survey. We searched the Health Systems Evidence (HSE) database of McMaster Health Forum for systematic reviews published in 2015. We extracted information regarding the characteristics of the systematic reviews and the associated COI disclosures. We conducted descriptive analyses. Results Eighty percent of systematic reviews included authors’ COI disclosures. Of the 160 systematic reviews that included COI disclosures, 15% had at least one author reporting at least one type of COI. The two most frequently reported types of COI were individual financial COI and individual scholarly COI (11% and 4% respectively). Institutional COIs were less commonly reported than individual COIs (3% and 15% respectively) and non-financial COIs were less commonly reported than financial COIs (6% and 14% respectively). Only one systematic review reported the COI disclosure by editors, and none reported disclosure by peer reviewers. All COI disclosures were in the form of a narrative statement in the main document and none in an online document. Conclusion A fifth of systematic reviews in HPSR do not include a COI disclosure statement, highlighting the need for journals to strengthen and/or better implement their COI disclosure policies. While only 15% of identified disclosure statements report any COI, it is not clear whether this indicates a low frequency of COI versus an underreporting of COI, or both.

Abstract Background The use of psychotropic drugs by elderly people is widely spread around the world, given that prevalence of inappropriate medication is frequent. Strictly speaking, in Brazil, the vulnerable population of elderly people is more likely to use Potentially Inappropriate Psychotropic (PIP) due to the impact of social-economic characteristics, to the Brazilian Public Health System, and to the lack of patient monitoring. However, neither the use pattern nor the prevalence rate of PIP have been studied in Brazil so far. The objectives of this study were to determine the prevalence of PIP in elderly outpatients taking antidepressants, and to compare the performance of two different tools (Beers, STOPP). Methods This cross-sectional study involved all the aged outpatients (≥ 60 years of age) taking antidepressants attended by the public health system in a city of the State of São Paulo, Brazil. Data were obtained from a pharmacy database and medical records. All psychotropic drugs evaluated included: antidepressants, antipsychotics, anti-epileptics and benzodiazepines. STOPP and Beers criteria were applied to detect PIP. Results One thousand one hundred forty prescriptions from 174 outpatients were subjected to two different screening tools. The average patient age was 67 (interquartile range 63–74) and the median number of drugs used was 3.0 (interquartile 2–4) per patient. The overall prevalence of PIP was 121 (69.5%). The levels of PIP observed according to tools were 39.6% (STOPP) and 29.9% (Beers).The long-term use of benzodiazepines was the most common PIP recognized, and the one which contributed more significantly to higher levels of PIP than other medications. Conclusions The prevalence of PIP was high among the elderly. STOPP criteria identified more PIP than Beers criteria. Knowledge of PIP prevalence should gear efforts to reduce the level of inappropriate prescriptions and may provide the need for developing national criteria.

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.

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.

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.

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.