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Nanocrystalline silver dressings can reduce the number of changes, facilitating burn wound management. However, the evidence regarding their efficacy and cost-consequences compared to well-established treatments, such as 1% silver sulfadiazine, is still scarce.To determine the efficacy, safety, and costs of nanocrystalline silver dressings compared to 1% silver sulfadiazine dressings to treat adult patients with burns.Randomized, single-center, single-blind trial conducted at a referral hospital in São Paulo, Brazil.100 adult patients were randomized 1:1 to nanocrystalline silver (n = 50) or 1% silver sulfadiazine (n = 50). The primary outcome was the proportion of participants with complete re-epithelization at day 15 after randomization. Secondary outcomes included the number of dressing changes, direct medical costs (in international dollars, I$), pain intensity, the incidence of infections, number of patients undergoing surgery, and adverse events.On day 15, the proportion of patients who reached the primary outcome did not differ significantly between participants treated with nanocrystalline silver dressings (24 [48%]) and those treated with 1% silver sulfadiazine dressings (26 [52%]); risk difference of -4.0 percentage points (95% confidence interval [CI], -17 to 9; P = 0.56). The number of patients undergoing surgical intervention was similar between groups (6% vs. 6%), and no local or serious adverse events were reported. The mean (standard deviation, SD) number of dressing changes in the nanocrystalline silver group was 4.1 (2.3), and the corresponding estimate in the 1% silver sulfadiazine group was 9.6 (6.7); mean difference of -5.56 (95% CI), -7.57 to -3.55, P0.001). Treatment with nanocrystalline silver dressing incurred significant cost reductions in medical materials, human resources, and administrative labor. However, the mean total cost with nanocrystalline silver dressing was higher compared to 1% silver sulfadiazine dressings: I$496.37 (445.90) vs. I$274.73 (182.76); mean difference = 221.63 (95% CI, 89.04 to 354.23, P = 0.001). The main driver of higher mean total costs among nanocrystalline silver-treated participants was the purchase cost of the dressings, representing 79.3% of the total cost in the nanocrystalline silver group but only 15.2% in the 1% silver sulfadiazine group.We found no evidence of a difference between nanocrystalline silver and 1% silver sulfadiazine dressings regarding efficacy and safety outcomes. Nanocrystalline silver dressings were associated with an increase in the total costs, but they could result in important savings for an institution (less changes of dressings, reducing human resources burden), especially if acquisition costs can be decreased. Additional cost-effectiveness studies are warranted.NCT02108535.

Rationale: The American Thoracic Society (ATS) developed a clinical practice guideline on initiating pharmacologic treatment in tobacco-dependent adults. Controller pharmacotherapies treat tobacco dependence effectively when taken as prescribed, but relapse after pharmacologic discontinuation is common. Objectives: To evaluate the effectiveness and safety of initiating controller for an extended (.12 wk) versus a standard duration (6-12 wk) in tobacco-dependent adults. Methods: We systematically searched PubMed, ExcerptaMedica Database, Cumulative Index toNursing and Allied Health Literature, and Cochrane Central Register of Controlled Trials fromdatabase inception toDecember 2021 to identify randomized controlled trials comparing extended versus standard duration of controllers for tobacco-dependent adults. We conductedmeta-analyses using the Mantel-Haenszelmethod with random effectsmodel.Outcomes of interest include point-prevalent abstinence at 1-year follow-up or longer, relapse, adverse events, quality of life, and withdrawal symptoms. Subgroup analyses were conducted according to types of treatment and duration of extended therapy when feasible.We assessed the certainty of the estimate following the grading of recommendations, assessment, development and evaluationmethodology. Results: We included 13 randomized controlled trials including 8,695 participants that directly compared extended- (.12 wk) versus standard-duration controller therapy with varenicline, bupropion, or nicotine replacement therapy. Compared with standard-duration controller therapy, extendedduration controller therapy probably increased abstinence at 1-year follow-up, measured as 7-day point-prevalence abstinence (relative risk, 1.18; 95% confidence interval [CI], 1.05-1.33; moderate certainty). Extended-duration controller therapy probably reduced relapse compared with standardduration controller therapy, assessed at 12-18 months after initiation of therapy (hazard ratio, 0.43; 95% CI, 0.29-0.64; moderate certainty). Moderate certainty evidence also suggested that extended-duration controller therapy probably did not increase risk of serious adverse events (relative risk, 1.37; 95% CI, 0.79-2.36). Conclusions: This systematic review supported the recommendation for extended-duration therapy with controllers. Further studies on optimal extended duration are warranted.

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 p p 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.

ObjectivesTo develop and validate an instrument to measure Brazilian healthcare professionals’ perceptions, behaviour, self-efficacy and attitudes towards evidence-based health practice.DesignValidation 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).SettingNational Register of Health Establishments database.ParticipantsWe included clinical health professionals who were working in the Brazilian public health system.ResultsThe 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, pConclusionsThe results of the psychometric analysis of the I-SABE confirm the good quality of this tool. The I-SABE can be used both in educational activities as well as an assessment tool among healthcare professionals in the Brazilian public health settings.

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.

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.

IntroductionAntiretroviral therapy (ART) for HIV/AIDS is associated with adverse events (AEs). However, little is known about the differences in the risk of AEs between women and men living with HIV/AIDS. This study aims to determine (1) whether there are sex differences in the risk of AEs in people with HIV/AIDS treated with ART and (2) the prevalence of AEs to the reproductive system and bone mineral density in women.Methods and analysisThis systematic review (SR) will include randomised trials evaluating ART in people living with HIV/AIDS with at least 12 weeks of duration follow-up. Searches will be conducted in Medline, Embase, Cochrane Library, Epistemonikos, Lilacs, trial registries and grey literature databases, without restriction on publication status, year of publication and language. The primary outcome will be the risk of ART discontinuation or drop-outs/withdrawals of ART due to AEs and the number of any treatment-emergent AE. The secondary outcomes are the incidence of serious clinic or laboratory (grade 3 and/or 4) treatment-emergent AEs, hospitalisation, death and AEs specific to the reproductive system and bone mineral density (osteoporosis, osteopenia and fractures) of women. Selection, data extraction and quality assessment will be performed by pairs of reviewers. Cochrane collaboration tools will be used to assess the risk of bias. If appropriate, a meta-analysis will be conducted to synthesise results. The overall quality of the evidence for each outcome will be determined by the Grades of Recommendation, Assessment, Development and Evaluation.Ethics and disseminationThe results of this SR will assist the formulation of public policies aimed at the management and monitoring of AEs of ART in people living with HIV/AIDS. A deliberative dialogue will be scheduled with the Department of Chronic Conditions and Sexually Transmitted Infections of Brazil’s Ministry of Health to align the project with policymakers’ interests.PROSPERO registration numberCRD42021251051.

IntroductionThe 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.ObjectiveTo assess the quality of the guidelines and recommendations for the treatment of schizophrenia in this population.MethodsCPGs 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.ResultsThe 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.ConclusionThere 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 numberCRD42020164899.

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.

A Síndrome Inflamatória Multissistêmica em Crianças (MIS-C) é uma doença rara e grave, associada ao vírus SARS-CoV-2. As manifestações clínicas são variadas e as evidências sobre tratamento farmacológico ainda são limitadas, sendo observado o uso de medicamentos anti-inflamatórios e imunomoduladores. [Objetivo] Descrever características clínicas, laboratoriais e tratamento farmacológico de um grupo de crianças com MIS-C. [Método] Estudo de casos de crianças e adolescentes com MIS-C internadas em hospital universitário entre abril e dezembro de 2020. O diagnóstico e caracterização considerou os critérios descritos pela Organização Mundial da Saúde. As crianças foram acompanhadas desde sua entrada no hospital até os primeiros três meses após a alta. [Resultados] Doze crianças foram incluídas no estudo e onze demandaram cuidados em Unidade de Terapia Intensiva Pediátrica (UTIP). A mediana de idade foi igual a oito anos. Oito crianças eram do sexo masculino e oito eram declaradas como pretas ou pardas. Todos os pacientes apresentaram febre. Outros achados relacionaram-se a dor abdominal (oito crianças); erupção cutânea (sete); conjuntivite (seis); vômitos e diarreia (quatro). Entre os pacientes internados na UTIP, cinco necessitaram de ventilação mecânica. Todos receberam antibioticoterapia. A imunoglobulina intravenosa foi utilizada em onze (91,7%) crianças. O uso de enoxaparina, ácido acetilsalicílico e metilprednisolona ocorreu em onze, dez e oito pacientes, respectivamente. Todas as crianças evoluíram bem após alta. [Conclusão] Nesta amostra, houve predomínio do sexo masculino e da raça negra/parda. A boa evolução clínica, laboratorial e ecocardiográfica com alta hospitalar e durante o primeiro trimestre de acompanhamento levanta hipóteses favoráveis sobre os tratamentos instituídos.

ObjectiveTo identify factors and assess to what extent they impact the magnitude of the treatment effect of acupuncture therapies across therapeutic areas.Data sourceMedline, 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 selectionThe 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 analysisThe 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.Results1304 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 (ConclusionPatients, clinicians and policy-makers should consider penetrating over non-penetrating acupuncture and more frequent treatment sessions when feasible and acceptable. When designing future acupuncture RCTs, trialists should consider factors that impact acupuncture treatment effects.

Para realizar un inventario de fuentes de datos nacionales sobre utilización de medicamentos en Argentina y verificar las fuentes de datos disponibles públicamente, llevamos a cabo un estudio transversal que investiga la existencia de bases de datos nacionales y provinciales sobre utilización de medicamentos. En julio de 2020, realizamos una búsqueda en sitios web de instituciones gubernamentales, una búsqueda sistemática en bases de datos bibliográficas sobre “drug utilization research” en Argentina y una encuesta de expertos. Se identificaron 31 fuentes de datos de utilización de medicamentos, solo una era de acceso público y conveniente, cinco publicaban datos agregados y proporcionaban un acceso más detallado mediante solicitud formal, solo siete fuentes (23%) informaban datos nacionales, y la mayoría de ellas (n=29) incluían solo datos del sector pública de salud. Aunque se han encontrado fuentes de datos de utilización de medicamentos en Argentina, el acceso a investigadores y legisladores sigue siendo una barrera importante. Aumentar la transparencia de los datos de salud a través de fuentes disponibles públicamente para analizar la información de salud pública es crucial para construir un sistema de salud más sólido. 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. Fil: Cañás, Martín. Universidad Nacional Arturo Jauretche; Argentina Fil: Marin, Gustavo Horacio. Universidad Nacional de La Plata. Facultad de Ciencias Médicas. Departamento de Articulación de Ciencias Básicas y Clínicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina Fil: Urtasun, Martín Alejandro. Universidad Nacional Arturo Jauretche; Argentina Fil: Leal, Lisiane Freitas. Université Mcgill; Canadá Fil: Salas, Maribel. State University of Pennsylvania; Estados Unidos Fil: Elseviers, Monique. University of Ghent; Bélgica

ObjectivesIt 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.DesignSystematic review.MethodsRandomised 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.ResultsA 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.ConclusionsGiven 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 numberCRD42017057142.

Producing and sharing knowledge have been the main goals of the Graduate Program in Pharmaceutical Sciences of the University of Sorocaba. With a focus on the rational use of medicines, the importance of the event is justified by highlighting one of the main concerns worldwide, with an important impact on society, health systems, institutions, and communities. The improvement of professional practices depends on the engagement of researchers, health professionals, managers, students, and others interested in improving health policies, programs, services, and actions. Developing and applying scientific methods in producing and using the best evidence is the path we have chosen. Therefore, everyone was invited to discuss relevant topics in this field of knowledge, including Drug Utilization Research; Health Technology Assessment; Global Health Systems and Environment; and Innovation and Development of Health Technologies. Experts from several countries in deprescribing, interactive teaching approaches, implementation science and policy, environment and pharmaceutical care joined us sharing their experiences and encouraging debate. We are sure that the social distancing, essential in this period, did not represent an obstacle in making new connections, and effective and bright collaborations that are able to transform reality.

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.

Producing and sharing knowledge have been the main goals of the Graduate Program in Pharmaceutical Sciences of the University of Sorocaba. With a focus on the rational use of medicines, the importance of the event is justified by highlighting one of the main concerns worldwide, with an important impact on society, health systems, institutions, and communities. The improvement of professional practices depends on the engagement of researchers, health professionals, managers, students, and others interested in improving health policies, programs, services, and actions. Developing and applying scientific methods in producing and using the best evidence is the path we have chosen. Therefore, everyone was invited to discuss relevant topics in this field of knowledge, including Drug Utilization Research; Health Technology Assessment; Global Health Systems and Environment; and Innovation and Development of Health Technologies. Experts from several countries in deprescribing, interactive teaching approaches, implementation science and policy, environment and pharmaceutical care joined us sharing their experiences and encouraging debate. We are sure that the social distancing, essential in this period, did not represent an obstacle in making new connections, and effective and bright collaborations that are able to transform reality

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

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.

This systematic review evaluated the rigor of the development of clinical practice guidelines (CPG). 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

IntroductionThe number of clinical practice guidelines (CPGs) have increased substantially mainly in the paediatric area of mental health. However, little is known about the quality or how recommendations for the treatment of disorders such as schizophrenia in children and adolescents have changed over time. The aim of this study will be to assess the quality of the development of CPGs for the treatment and management of schizophrenia in children and adolescents over time using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool and to compare the recommendations and interventions described in these documents.Methods and analysisCPGs will be identified using a prospective protocol through a systematic search of multiple databases (Medline, Embase, Health Systems Evidence, Epistemonikos, Lilacs, etc) and guideline websites from 2004 to December 2020. The quality of the guidelines will be assessed by three reviewers, independently using the AGREE II. CPGs will be considered of high-quality if they scored ≥60% in four or more domains of the AGREE II instrument. Non-parametric tests will be used to test for the change of quality over time. We will summarise the different evidence grading systems and compare the recommendations.Ethics and disseminationEthical approval is not required since it is a literature-based study. Future results of the research can be submitted for publication in scientific journals of high impact, peer reviewed and also published in national and international conferences. The results derived from this study will contribute to the improvement of health institutions and policies, informing about existing recommendation guidelines and about deficiencies and qualities found in those. This study may also identify key areas for future research. This study may guide the search and choice for high quality CPGs by health policy makers and health professionals and subsidise future adaptations.Protocol registration numberCRD42020164899.

Background: Current tobacco treatment guidelines have established the efficacy of available interventions, but they do not provide detailed guidance for common implementation questions frequently faced in the clinic. An evidence-based guideline was created that addresses several pharmacotherapy-initiation questions that routinely confront treatment teams. Methods: Individuals with diverse expertise related to smoking cessation were empaneled to prioritize questions and outcomes important to clinicians. An evidence-synthesis team conducted systematic reviews, which informed recommendations to answer the questions. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach was used to rate the certainty in the estimated effects and the strength of recommendations. Results: The guideline panel formulated five strong recommendations and two conditional recommendations regarding pharmacotherapy choices. Strong recommendations include using varenicline rather than a nicotine patch, using varenicline rather than bupropion, using varenicline rather than a nicotine patch in adults with a comorbid psychiatric condition, initiating varenicline in adults even if they are unready to quit, and using controller therapy for an extended treatment duration greater than 12 weeks. Conditional recommendations include combining a nicotine patch with varenicline rather than using varenicline alone and using varenicline rather than electronic cigarettes. Conclusions: Seven recommendations are provided, which represent simple practice changes that are likely to increase the effectiveness of tobacco-dependence pharmacotherapy.

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.

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.

Made available in DSpace on 2022-04-28T19:46:32Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-11-01 Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Background: Dengue, Zika and Chikungunya viruses represent a serious public health problem. No evidence is available on the efficacy of repellents commercially available in Brazil. This systematic review assessed the efficacy and safety of products containing repellents commercially available in Brazil for protection against bites from Aedes aegypti and Aedes albopictus. Methods: We performed a systematic review using the CENTRAL, MEDLINE, EMBASE, CINAHL, Web of Science, AMED, LILACS and Scopus databases. Randomized clinical trials and non-randomized clinical trials comparing topical repellent products registered with the Brazilian Health Surveillance Agency were included. Main outcomes of interest investigated were adverse effects, percentage repellency and protection time against bites. Pairs of reviewers selected the studies, extracted the data and evaluated the risk of bias. Results: Sixteen studies were included. No adverse effects were reported by the studies. Against Ae. aegypti: protection time using DEET (10% and 20%-spray) was similar to IR3535 (10% and 20%-spray) and longer than citronella (5%-spray). DEET (25%-solution) had longer protection time than eucalyptus (25%-solution), while DEET (20%-lotion) had longer protection time than citronella (10%-lotion). There was no difference in protection time between herbal repellents. DEET (7% and 15%- spray) had higher percentage repellency compared to both icaridin (7%-spray) and IR3535 (20%-spray). Against Ae. albopictus: DEET (15%-spray) had a similar protection time to icaridin (20%-spray), but longer than citronella (10%-spray). Conclusion: DEET proved more effective than the other synthetic and natural repellents marketed in Brazil for protecting against bites from the mosquito species investigated. All repellents studied exhibited satisfactory safety profile. São Paulo State University (UNESP) School of Agricultural Sciences Department of Bioprocesses and Biotechnology Multiuser Central Laboratory University of Sorocaba (UNISO) Graduate Program in Pharmaceutical Sciences São Paulo State University (UNESP) School of Pharmaceutical Science Department of Clinical Analysis University of São Paulo (USP) School of Pharmaceutical Sciences of Ribeirão Preto Department of Pharmaceutical Sciences São Paulo State University (UNESP) School of Agricultural Sciences Department of Bioprocesses and Biotechnology Multiuser Central Laboratory São Paulo State University (UNESP) School of Pharmaceutical Science Department of Clinical Analysis FAPESP: 2017/07813-8 FAPESP: 2017/07813–8

This Research Topic covers 30 articles focusing on recent advancements related to the balance in innovation technology and the rational use of medicine for better decision making.

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, Sao 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.

Background: There is lack of national studies that assess the risks associated with the drugs provided under the Brazilian public health system for treating Alzheimer’s disease. Then, this study determined the prevalence and severity of self-reported adverse drug reactions (ADRs) to medications prescribed to patients with Alzheimer’s disease in the Brazilian public health system. Methods: A cross-sectional study was carried out based on public data from the MEDEX system (information on dispensing data, known as exceptional dispensing medications) and interviews with patients and/or caregivers who get access to Alzheimer’s drugs at a public pharmacy in a large Brazilian city, between July and September 2017, inquiring about medication-related adverse drug reactions (ADRs) and serious adverse events (SAEs). Results: The subjects were asked about ADRs and serious adverse events (SAEs) related to the use of donepezil, galantamine, rivastigmine and memantine. Out of 285 patients enrolled on the database, 250 participated in the study (87.7%). Among the participants, approximately 63.0% were female, 70.3% aged ≥75 years and 70.3% had comorbidities. Overall, 209 patients (83.6%) reported at least one ADR (total 1,149 ADRs) and rivastigmine was associated with the largest number of ADRs per patient (7.9 ADRs/patient). The predominant adverse effects were psychiatric disorders with common frequency (57.1%) and mild severity (89.0%). Six patients (2.4%) had SAEs that required hospitalization. The use of antipsychotics was the variable associated with ADR (OR= 4.95; 95%CI: 1.45–16.93; p=0.011). Conclusions: There was a large number of reported ADRs and most of them were of common frequency and mild severity, being mainly related to psychiatric disorders. Considering the fragility of these patients, it is important to improve safety-related care in the use of drugs for treating this disease. Keywords: older adults, Alzheimer’s disease, adverse reaction to drugs, safety, pharmacoepidemiology, safety.

Background: Knowledge 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 deinstitutionalisation 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 deinstitutionalised people with severe mental disorders in Brazil. Methods: We used the Supporting Policy relevant Reviews and Trials (SUPPORT) Tools for evidence-informed health Policymaking (STP) 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 deinstitutionalisation; 5) facilitating policy dialogue (PD); 6) the evaluation of the EB and PD; 7) post-dialogue mini-interviews; and 8) dissemination of the findings. Results: Capacity 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 defence) 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 favourable and helpful. Conclusions: The 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 policy dialogues can influence practice by promoting greater engagement among stakeholders who formulate or revise mental health policies.