Screening instruments for mental disorders in primary healthcare: a scoping review protocol (SCREENING-MD).

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.

Rates of adverse events of antiretroviral therapy in women living with HIV/AIDS: a systematic review and meta-analysis.

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.

Medical cannabis use in oncology and associated outcomes: A scoping review.

BACKGROUND: Natural and synthetic cannabinoids are being used worldwide to treat various symptoms in cancer patients. This study aims to map the therapeutic benefits and adverse effects associated with the use of cannabis-based drugs in these outcomes. METHODS: Following Joanna Briggs Institute guidelines a scoping review was conducted. The study protocol was available in the Open Science Framework public repository. An extensive search strategy involving databases like Cochrane Library, Embase, CINAHL, Medline/PubMed, Lilacs, Google Scholar, and Open Gray for gray literature analysis was executed by a skilled librarian. The inclusion criteria were primary studies (observational and randomized) that evaluated the efficacy and safety of cannabinoids in cancer patients. The review encompassed studies of diverse designs, publication years, and types, as long as they addressed cannabinoids' impact in oncology. RESULTS: Twenty-nine (82.86%) out of total of 35 were randomized and 6 (14.14%) were non-randomized. About 57.1% of studies utilized registered products as interventions, with THC being the most natural cannabinoid cited in variable doses and administration routes. Moreover, 62.85% of studies specified the cancer types (breast, lung, sarcomas, hematological and reproductive system), while only one study detailed cancer staging. The evaluated outcomes encompassed nausea and vomiting (77.14%), appetite (11.43%), pain (8.57%), and tumor regression (2.86%) across different proportions of studies. CONCLUSION: Cannabinoids show promise in managing pain, emesis, and anorexia/cachexia linked to cancer progression. New randomized clinical trials with a larger number of participants and observational studies on long-term safety are crucial to affirm their medicinal utility for cancer patients unresponsive to conventional drugs.

Multisystem inflammatory syndrome drug treatment in countries with different income profiles: a scoping review.

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.

Budget Impact Analysis of Risperidone Use and Adverse Event Monitoring in Autism Spectrum Disorder in Brazil: Assessment of Theoretical Versus Real Data.

BACKGROUND AND AIMS: Risperidone is used in autism spectrum disorder (ASD) to manage aggressive behavior. Budget impact analysis (BIA) assists managers in promoting more sustainable health systems; however, it is unclear whether BIAs underestimate or overestimate the estimates derived from real-world data. This study aimed to compare the estimated BIA values of risperidone use and the monitoring of adverse events in ASD using theoretical and real data. METHODS: Analyses were conducted based on the clinical protocol and the Brazilian therapeutic guidelines for ASD. The perspective adopted was that of the Unified Health System (SUS), considering a time horizon of 5 years. Three possible scenarios were considered based on the maximum daily dose of risperidone. Expenses related to the acquisition of risperidone and the monitoring of adverse events were taken into account using health databases in Brazil. For the calculation based on theoretical data, the prevalence of ASD was estimated using information from the scientific literature and the Brazilian demographic census. The model calculated from real data was obtained by analyzing the linear trend of the number of users assisted in the SUS from 2017 to 2021. RESULTS: The population estimated by the theoretical model compared with the model calculated from the real data was higher. Likewise, the 5-year budgetary impact of the theoretical model versus the model calculated from the real data was higher, with statistical significance in all scenarios (p < 0.001). In the real data model, the most economically advantageous scenarios were Scenario 1 for children (International dollars [I$] 7,630,040.73) and Scenario 3 for adults (I$60,329,288.17). Estimated expenditures for monitoring adverse events ranged from 17 to 74% in children and from 50% to 63% in adults. CONCLUSIONS: The data revealed significant differences in population and cost estimation between theoretical data and real-world data. The expenses associated with monitoring adverse events represented a substantial expenditure estimate for the SUS.

Empirical antimicrobial therapy based on active surveillance cultures in ICU patients

Objetivo: Avaliar o valor preditivo da colonização prévia por Acinetobacter baumannii (CRAB) e Pseudomonas aeruginosa (CRPA) resistente a carbapenêmicos estabelecida em culturas de vigilância para infecção subsequente por esses patógenos em pacientes internados em UTI. Métodos: Foi realizado um estudo de coorte com pacientes internados na unidade de terapia intensiva por pelo menos 48 h. Foram medidos os valores preditivos negativos e positivos, sensibilidade e especificidade das culturas de vigilância em CRAB e CRPA. Resultados: Foram incluídos 693 pacientes infectados. Pacientes previamente colonizados por CRAB e CRPA tiveram maior probabilidade de serem infectados por esses patógenos: OR ajustado: 10,34 (6,58 - 16,45; p < 0,001) e 2,30 (3,88 - 10,26; p < 0,001), respectivamente. Encontramos altos valores preditivos negativos de culturas de vigilância para CRAB (87,18%) e CRPA (88,30%) e alta especificidade 91,96% e 90,13%, respectivamente. Conclusões: Pacientes não colonizados por CRAB e CRPA mostraram-se menos propensos à infecção por esses patógenos. Esses achados podem contribuir para a escolha da terapia antimicrobiana empírica e desencorajar a prescrição de antibióticos contra esses patógenos em pacientes sem colonização prévia.

Objective: To assess the predictive value of prior carbapenem-resistant Acinetobacter baumannii (CRAB) and Pseudomonas aeruginosa (CRPA) colonization established in surveillance cultures for subsequent infection by these pathogens in ICU patients. Methods: A cohort study was performed with patients admitted to the intensive care unit for at least 48 h. Negative and positive predictive values, sensitivity, and specificity of surveillance cultures in CRAB and CRPA were measured. Results: 693 infected patients were included. Patients previously colonized by CRAB and CRPA were more likely to be infected by these pathogens: adjusted OR: 10.34 (6.58 - 16.45; p < 0.001) and 2.30 (3.88 - 10.26; p < 0.001), respectively. We found high negative predictive values of surveillance cultures for CRAB (87.18%) and CRPA (88.30%) and high specificity 91.96% and 90.13%, respectively. Conclusions: Patients not colonized by CRAB and CRPA were less prone to infection by these pathogens. These findings may contribute to the choice of empirical antimicrobial therapy and discourage the prescription of antibiotics against these pathogens in patients without previous colonization.

Pharmaceutical policies: effects of policies regulating drug marketing.

BACKGROUND: The costs of developing new treatments and bringing them to the market are substantial. The pharmaceutical industry uses drug promotion to gain a competitive market share, and drive sale volumes and industry profitability. This involves disseminating information about new treatments to relevant targets. However, conflicts of interest can arise when profits are prioritised over patient care and its benefits. Drug promotion regulations are complex interventions that aim to prevent potential harm associated with these activities. OBJECTIVES: To assess the effects of policies that regulate drug promotion on drug utilisation, coverage or access, healthcare utilisation, patient outcomes, adverse events and costs. SEARCH METHODS: We searched Epistemonikos for related reviews and their included studies. To find primary studies we searched MEDLINE, CENTRAL, Embase, EconLit, Global Index Medicus, Virtual Health Library, INRUD Bibliography, two trial registries and two sources of grey literature. All databases and sources were searched in January 2023. SELECTION CRITERIA: We planned to include studies that assessed policies regulating drug promotion to consumers, healthcare professionals or regulators and third-party payers, or any combination of these groups.In this review we defined policies as laws, rules, guidelines, codes of practice, and financial or administrative orders made by governments, non-government organisations or private insurers. One of the following outcomes had to be reported: drug utilisation, coverage or access, healthcare utilisation, patient health outcomes, any adverse effects (unintended consequences), and costs. The study had to be a randomised or non-randomised trial, an interrupted time series analysis (ITS), a repeated measures (RM) study or a controlled before-after (CBA) study. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed eligibility for inclusion of studies. When consensus was not reached, any disagreements were discussed with a third review author.  We planned to use the criteria suggested by Cochrane Effective Practice and Organisation of Care (EPOC) to assess the risk of bias of included studies. For randomised trials, non-randomised trials, and CBA studies, we planned to estimate relative effects, with 95% confidence intervals (CI). For dichotomous outcomes, we planned to report the risk ratio (RR) when possible and adjusted for baseline differences in the outcome measures. For ITS and RM, we planned to compute changes along two dimensions: change in level and change in slope. We planned to undertake a structured synthesis following EPOC guidance.  MAIN RESULTS: The search yielded 4593 citations, and 13 studies were selected for full-text review. No study met the inclusion criteria. AUTHORS' CONCLUSIONS: We sought to assess the effects of policies that regulate drug promotion on drug use, coverage or access, use of health services, patient outcomes, adverse events, and costs, however we did not find studies that met the review's inclusion criteria. As pharmaceutical policies that regulate drug promotion have untested effects, their impact, as well as their positive and negative influences, is currently only a matter of opinion, debate, informal or descriptive reporting. There is an urgent need to assess the effects of pharmaceutical policies that regulate drug promotion using well-conducted studies with high methodological rigour.

Use of second-generation antipsychotics in autism spectrum disorder: a systematic review and meta-analysis protocol.

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.

Microneedling with cutaneous delivery of topical agents for the treatment of melasma: A systematic review.

BACKGROUND: Melasma is an acquired hyperpigmentation disorder. Microneedling is an alternative treatment for melasma especially by improving penetration of pharmacological agents into the skin. OBJECTIVE: The main objective of this review was to systematize and analyze available evidence on the efficacy and safety of microneedling alone or associated with topical agents in reducing skin stains and improving melasma-related quality of life in adult patients. METHODS: Only randomized clinical trials were included. The following databases were consulted: MEDLINE, Embase, Cochrane, and the gray literature. The Cochrane risk-of-bias tool for randomized trials (RoB 2.0) was used to assess risk of bias. RESULTS: The search retrieved 719 records and seven studies were included. A total of 368 participants (96.19% women) were evaluated. Two studies were split-face. Most of the studies evaluated microneedling associated with tranexamic acid. High risk of bias was presented by most studies, especially in the safety outcome. A significant decrease was observed in the MASI, mMASI, or hemi-MASI scores, regardless of the topical agents associated. Meta-analysis was not possible due to the heterogeneity of the studies. CONCLUSION: Based on the results of this review, microneedling can, in association with topical agents or isolated, be used safely in the treatment of melasma in the clinical practice, obtaining results on reduction of stain severity and improvement of patients' quality of life.

Sex differences and adverse events of antiretrovirals in people living with HIV/AIDS: a systematic review and meta-analysis protocol.

INTRODUCTION: Antiretroviral 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 ANALYSIS: This 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 DISSEMINATION: The 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 NUMBER: CRD42021251051.

Increased Use of Antibiotics in the Intensive Care Unit During Coronavirus Disease (COVID-19) Pandemic in a Brazilian Hospital.

Background: Microbial drug resistance is one of the biggest public health problems. Antibiotic consumption is an essential factor for the emergence and spread of multiresistant bacteria. Therefore, we aimed to analyze the antibiotics consumption in the Intensive Care Unit (ICU), identifying trends in the antibiotics use profile and microbiological isolates throughout the COVID-19 pandemic. Methods: We performed this retrospective observational study in intensive care units of a Brazilian tertiary hospital from January 2019 to December 2020. The primary outcome was antimicrobial consumption in the ICU, measured by defined daily doses (DDDs) per 100 bed-days. As a secondary outcome, bacterial infections (microbiological isolates) were calculated in the same fashion. Outcomes trends were analyzed using Joinpoint regression models, considering constant variance (homoscedasticity) and first-order autocorrelation assumptions. A monthly percent change (MPC) was estimated for each analyzed segment. Results: Seven thousand and nine hundred fifty-three patients had data available on prescribed and received medications and were included in the analyses. Overall, the use of antibiotics increased over time in the ICU. The reserve group (World Health Organization Classification) had an increasing trend (MPC = 7.24) from February to April 2020. The azithromycin consumption (J01FA) increased rapidly, with a MPC of 5.21 from January to April 2020. Polymyxin B showed a relevant increase from March to June 2020 (MPC = 6.93). The peak of the antibiotic consumption of Reserve group did not overlap with the peak of the pathogenic agents they are intended to treat. Conclusion: Overall antimicrobial consumption in ICU has increased in the context of the COVID-19 pandemic. The peaks in the antimicrobial's use were not associated with the rise of the pathogenic agents they intended to treat, indicating an empirical use, which is especially concerning in the context of treating multidrug-resistant (MDR) infections. This fact may contribute to the depletion of the therapeutic arsenal for MDR treatment.

Medication Errors in Compounding Pharmacy / Erros de Medicação em Farmácia de Manipulação

Abstract The traditional role of compounding pharmacies is to make drugs prescribed by physicians for patients with needs that cannot be met by commercially available drugs. Medication errors have attracted attention of health authorities since they compromise the patient's assistance, enhance morbidity rates and increase the healthcare costs. This study analyzed medication errors that occurred in a compounding pharmacy school in order to identify types and periodicity and to outline strategies in the service delivery process to mitigate such errors. This is a retrospective descriptive study carried out from March to June of 2018 and based on the analysis of occurrences recorded by the service sector of a magistral pharmacy school in Rio de Janeiro. The errors were classified according to the stage in the pharmaceutical assistance process and reached 124 records, with an average of 1.03 occurrence/day. The main causes were prescription errors (95 occurrences or 76.60%), administering (12 occurrences or 9.68%), labeling (7 occurrences or 5.65%), dispensing (7 occurrences or 5.65%) and handling (3 occurrences or 2.42%). The errors in the prescription stage, the most frequent ones, were potential but intercepted and cleared before they resulted in a harmful outcome. This study identified medication errors in a magistral pharmacy. The errors were potential but intercepted and resolved before they resulted in a harmful outcome. The results points to the need for systematic surveillance of adverse events in a more active way and for standardizing the procedures throughout the process, from assessing the medical prescription to guiding the patient for proper administration and storage. (AU)

Resumo O papel tradicional das farmácias de manipulação é manipular medicamentos prescritos por médicos para pacientes com necessidades que não podem ser atendidas pelos medicamentos disponíveis no mercado. Os erros de medicação são eventos que vêm recebendo grande destaque entre autoridades sanitárias por contribuírem com o aumento das taxas de morbidade e dos custos do sistema de saúde, comprometendo a qualidade da assistência prestada ao paciente. as it involves legal and ethical aspects of impact on professional practice. Errors in the administration of medications point out the responsibility of the nursing category. An adequate performance of this role enables the prevention of real errors. The purpose of this study was to analyze nursing responsibilities in the administration of medications through a bibliographical research in the Medline and Lilacs data bases (1997/1999O presente estudo teve por objetivo analisar os principais erros de medicação observados em uma Farmácia Escola magistral localizada no sudeste do Brasil. Foi desenvolvido um estudo descritivo retrospectivo no período de março a junho de 2018, baseado na análise das ocorrências de erros de medicação registradas no período. Os erros foram classificados de acordo com as etapas da assistência farmacêutica. Um total de 124 registros foram verificados no período, com média diária de 1,03 ocorrências/dia. As principais causas destes registros foram em 95 (76,60%) devido a erros de prescrição, 3 (2,42%) referentes à erros de manipulação dos medicamentos, 7 (5,65%) erros de rotulagem, 7 (5,65%) erros de dispensação, e 12 (9,68%) referentes à erros de administração do medicamento pelo paciente. Os erros de maior frequência foram relacionados à escrituração da prescrição. Os erros verificados eram potenciais e foram interceptados e resolvidos antes que resultassem em um desfecho danoso. Os resultados indicaram a necessidade de avançar para uma vigilância sistemática de eventos adversos de forma mais ativa e padronização das condutas relacionadas aos processos desde a avaliação da qualidade da prescrição até a orientação para administração e guarda adequada do medicamento pelo paciente. (AU)