Direct Oral Anticoagulants: An Updated Systematic Review of Their Clinical Pharmacology and Clinical Effectiveness and Safety in Patients With Nonvalvular Atrial Fibrillation.

Direct oral anticoagulants have been an increasingly used class of drugs in the setting of nonvalvular atrial fibrillation, defying vitamin K antagonists' monopoly when it comes to anticoagulation due to its several limitations. Direct oral anticoagulants (DOACs) have entered the market as a noninferior and safer option in comparison with vitamin K antagonists, as their respective phase III clinical trials proved. The aim of this article was to update and summarize data on their clinical pharmacology and to review real-world data to know their comparative effectiveness and safety. We performed a systematic review using PubMed, Google Scholar, Embase, and Web of Science as search engines. Regarding pharmacodynamics, there were no substantial changes reported from their original profile. There were many advances in the knowledge about clinical pharmacokinetics of DOACs that have had a direct impact on their clinical use, mainly related to drug-drug interactions. In a real-world setting, DOACs have shown to be noninferior in preventing thromboembolic events compared to vitamin K antagonists. In regards to safety, DOACs have shown a lower bleeding risk relative to warfarin. Comparison between DOACs has demonstrated rivaroxaban to have the highest bleeding risk. Overall, the evidence gathered showed few changes from the original data presented in phase III clinical trials, concluding that their real-world use coincides greatly with them.

First-line biologic therapy with tumor necrosis factor inhibitors for psoriatic arthritis: a prospective observational study

ABSTRACT BACKGROUND: Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects multiple joints. It is associated with psoriasis and treated with synthetic and biologic drugs. OBJECTIVE: The objective of this study was to assess the outcomes of patients who received biologic therapy with tumor necrosis factor (TNF) inhibitors in terms of effectiveness, safety, functionality, and quality of life. DESIGN AND SETTING: A prospective observational study was performed at a single center in Belo Horizonte, Brazil. METHODS: Patients with PsA who received their first TNF inhibitor treatment were followed up for 12 months. Disease activity was measured using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Clinical Disease Activity Index (CDAI). Functionality was measured using the Health Questionnaire Assessment (HAQ), and quality of life was evaluated using the European Quality of Life Five Dimensions (EQ-5D). Multiple linear regression was used to identify predictors of the clinical response at 12 months. RESULTS: A total of 143 patients treated with adalimumab or etanercept were evaluated. Most of the clinical measures were significantly improved at 12 months. However, 31%-51% of the patients did not achieve good clinical control. No differences were observed between adalimumab and etanercept, except for poor functionality at 12 months among patients treated with etanercept. The main predictors of a worse clinical response were female sex, etanercept use, poor functionality, or lower quality of life at baseline. The main adverse reactions were alopecia, headache, injection site reaction, sinusitis, flu, dyslipidemia, and infections. CONCLUSION: TNF inhibitor therapy was effective and safe. However, despite improvements in clinical measures, most patients did not achieve satisfactory control of the disease.

Patient navigation to address sociolegal barriers for patients with cancer: A comparative-effectiveness study.

BACKGROUND: Sociolegal barriers to cancer care are defined as health-related social needs like affordable healthy housing, stable utility service, and food security that may be remedied by public policy, law, regulation, or programming. Legal support has not been studied in cancer care. METHODS: The authors conducted a randomized controlled trial of patients who had newly diagnosed cancer at a safety-net medical center in Boston from 2014 through 2017, comparing standard patient navigation versus enhanced navigation partnered with legal advocates to identify and address sociolegal barriers. English-speaking, Spanish-speaking, or Haitian Creole-speaking patients with breast and lung cancer were eligible within 30 days of diagnosis. The primary outcome was timely treatment within 90 days of diagnosis. Secondary outcomes included patient-reported outcomes (distress, cancer-related needs, and satisfaction with navigation) at baseline and at 6 months. RESULTS: In total, 201 patients with breast cancer and 19 with lung cancer enrolled (response rate, 78%). The mean patient age was 55 years, 51% of patients were Black and 22% were Hispanic, 20% spoke Spanish and 8% spoke Haitian Creole, 73% had public health insurance, 77% reported 1 or more perceived sociolegal barrier, and the most common were barriers to housing and employment. Ninety-six percent of participants with breast cancer and 73% of those with lung cancer initiated treatment within 90 days. No significant effect of enhanced navigation was observed on the receipt of timely treatment among participants with breast cancer (odds ratio, 0.88; 95% CI, 0.17-4.52) or among those with lung cancer (odds ratio, 4.00; 95% CI, 0.35-45.4). No differences in patient-reported outcomes were observed between treatment groups. CONCLUSIONS: Navigation enhanced by access to legal consultation and support had no impact on timely treatment, patient distress, or patient needs. Although most patients reported sociolegal barriers, few required intensive legal services that could not be addressed by navigators. LAY SUMMARY: In patients with cancer, the experience of sociolegal barriers to care, such as unstable housing, utility services, or food insecurity, is discussed. Addressing these barriers through legal information and assistance may improve care. This study compares standard patient navigation versus enhanced navigation partnered with legal advocates for patients with breast and lung cancers. Almost all patients in both navigation groups received timely care and also reported the same levels of distress, needs, and satisfaction with navigation. Although 75% of patients in the study had at least 1 sociolegal barrier identified, few required legal advocacy beyond what a navigator who received legal information and coaching could provide.

Effectiveness of co-debriefing to develop clinical skills in basic life support: randomized pilot study / Eficacia del co-debriefing para desarrollo de habilidades clínicas en soporte vital básico: estudio piloto aleatorizado / Efetividade do co-debriefieng para desenvolver competências clínicas no suporte básico de vida: estudo piloto randomizado

ABSTRACT Objective To compare the effectiveness of co-debriefing with debriefing with a facilitator in the development of clinical competences in nursing students in the simulated care of cardiac arrest. Method Randomized pilot study, carried out at a university in Minas Gerais, Brazil, in August 2021, with 17 students, to compare debriefing with a facilitator (control n=8) with co-debriefing (intervention n=9). Pre- and post-test, Objective Structured Clinical Examination and scales were used to assess behavioral skills. Wilcoxon and Mann-Whitney nonparametric comparison tests were used for analysis. Results The intervention group performed better than the control for knowledge about basic life support (control=17.00±2.39 and intervention=19.22 ± 0.66, p=0.021) and psychomotor skills (control=8.12±0.13 and intervention=8.50 ± 0.001, p<0.001). There were no significant differences for behavioral skills. Conclusion Co-debriefing appears to be more effective than debriefing with a facilitator to develop clinical skills in basic life support in nursing.

RESUMEN Objetivo Comparar la efectividad del co-debriefing con el debriefing con facilitador en el desarrollo de competencias clínicas en estudiantes de enfermería en el cuidado simulado de parada cardiaca. Método Estudio piloto aleatorizado, realizado en una universidad de Minas Gerais, Brasil, en agosto de 2021, con 17 estudiantes, para comparar el debriefing con un facilitador (control n=8) con el co-debriefing (intervención n=9). Se utilizaron pruebas previas y posteriores, examen clínico objetivo estructurado y escalas para evaluar las habilidades conductuales. Para el análisis se utilizaron las pruebas de comparación no paramétrica de Wilcoxon y Mann-whitney. Resultados El grupo intervención se desempeñó mejor que el control en conocimientos sobre soporte vital básico (control=17,00±2,39 e intervención=19,22 ± 0,66, p=0,021) y psicomotricidad (control=8, 12±0,13 e intervención=8,50 ± 0,001, p <0,001). No hubo diferencias significativas para las habilidades conductuales. Conclusión El co-debriefing parece ser más efectivo que el debriefing con un facilitador para desarrollar habilidades clínicas en soporte vital básico en enfermería.

RESUMO Objetivo Comparar a efetividade entre co-debriefing com debriefing com facilitador no desenvolvimento de competências clínicas em estudantes de enfermagem no atendimento simulado da parada cardiorrespiratória. Método Estudo-piloto randomizado, realizado em uma universidade de Minas Gerais, Brasil, em agosto de 2021 com 17 estudantes, para comparar o debriefing com um facilitador (controle n=8) e com o co-debriefing (intervenção n=9). Utilizaram-se pré e pós-teste, Exame Clínico Objetivo Estruturado e escalas para avaliar as habilidades comportamentais. Adotaram-se testes de comparação não paramétricos Wilcoxon e Mann-whitney para análise. Resultados O grupo intervenção obteve desempenho superior ao controle para o conhecimento sobre o suporte básico de vida (controle=17,00±2,39 e intervenção=19,22 ± 0,66, p=0,021) e habilidades psicomotoras (controle=8,12±0,13 e intervenção=8,50 ± 0,001, p<0,001). Não houve diferenças significativas para as habilidades comportamentais. Conclusão O co-debriefing parece ser mais efetivo do que o debriefing como um facilitador para desenvolver competências clínicas no suporte básico de vida em enfermagem.

Short- Versus Prolonged-Duration Antibiotics for Outpatient Pneumonia in Children.

OBJECTIVE: To identify practice patterns in the duration of prescribed antibiotics for the treatment of ambulatory children with community-acquired pneumonia (CAP) and to compare the frequency of adverse clinical outcomes between children prescribed short-vs prolonged-duration antibiotics. STUDY DESIGN: We performed a retrospective cohort study from 2010-2016 using the IBM Watson MarketScan Medicaid Database, a claims database of publicly insured patients from 11 states. We included children 1-18 years old with outpatient CAP who filled a prescription for oral antibiotics (n = 121 846 encounters). We used multivariable logistic regression to determine associations between the duration of prescribed antibiotics (5-9 days vs 10-14 days) and subsequent hospitalizations, new antibiotic prescriptions, and acute care visits. Outcomes were measured during the 14 days following the end of the dispensed antibiotic course. RESULTS: The most commonly prescribed duration of antibiotics was 10 days (82.8% of prescriptions), and 10.5% of patients received short-duration therapy. During the follow-up period, 0.2% of patients were hospitalized, 6.2% filled a new antibiotic prescription, and 5.1% had an acute care visit. Compared with the prolonged-duration group, the aORs for hospitalization, new antibiotic prescriptions, and acute care visits in the short-duration group were 1.16 (95% CI 0.80-1.66), 0.93 (95% CI 0.85-1.01), and 1.06 (95% CI 0.98-1.15), respectively. CONCLUSIONS: Most children treated for CAP as outpatients are prescribed at least 10 days of antibiotic therapy. Among pediatric outpatients with CAP, no significant differences were found in rates of adverse clinical outcomes between patients prescribed short-vs prolonged-duration antibiotics.

The role of proton therapy in pediatric malignancies: Recent advances and future directions.

Proton radiotherapy has promised an advantage in safely treating pediatric malignancies with an increased capability to spare normal tissues, reducing the risk of both acute and late toxicity. The past decade has seen the proliferation of more than 30 proton facilities in the United States, with increased capacity to provide access to approximately 3,000 children per year who will require radiotherapy for their disease. We provide a review of the initial efforts to describe outcomes after proton therapy across the common pediatric disease sites. We discuss the main attempts to assess comparative efficacy between proton and photon radiotherapy concerning toxicity. We also discuss recent efforts of multi-institutional registries aimed at accelerating research to better define the optimal treatment paradigm for children requiring radiotherapy for cure.

Effectiveness of Passion Fruit Peel Flour (Passiflora edulis L.) versus Turmeric Flour (Curcuma longa L.) on Glycemic Control: Systematic Review and Meta-Analysis.

BACKGROUND: It is undeniable that diabetes may cause several health complications for the population. Many of these complications are associated with poor glycemic control. Due to this, strategies to handle this problem are of great clinical importance and may contribute to reducing the various complications from diabetes. OBJECTIVE: The aim of this study was to compare the effectiveness of the passion fruit peel flour versus turmeric flour on glycemic control. METHODS: This is a systematic review and meta-analysis following the PRISMA protocol. The following inclusion criteria were applied: (1) Case-control studies, cohort studies, and clinical trials, due to the improved statistical analysis and, in restrict cases, cross-sectional studies; (2) Articles published in any language. The databases used for the search were PubMed, Scopus, Web of Science, Cochrane, and LILACS. A bias analysis and a meta-analyses were undertaken using R Studio (version 3.3.1) using effect- size models. RESULTS: A total of 565 studies were identified from which 11 met the inclusion and exclusion criteria. Through isolated analysis, the effectiveness of turmeric flour on glycemic control was in the order of 0.73 CI (Confidence Interval) (from 0.68 to 0.79) and the effectiveness of passion fruit peel flour was 0.32 CI (0.23 to 0.45). The joint analysis resulted in 0.59 CI (0.52 to 0.68). The assessment of blood glucose was by glycated hemoglobin levels. All values were significant at a p < 0.05 level. CONCLUSION: Both interventions showed significant effects on glycemic control.

Effectiveness of the automated drug dispensing system: systematic review and meta-analysis / Eficacia del sistema de dispensación electrónica de medicamentos: revisión sistemática y metaanálisis / Efetividade do sistema de dispensação eletrônica de medicamentos: revisão sistemática e metanálise

ABSTRACT Objectives: to compare the effectiveness of the decentralized automated drug dispensing system with pockets. Methods: an effectiveness study based on a systematic review guided by the question: for patients admitted to hospital units, is the use of automated drug dispensing effective for reducing medication errors when compared to manual unit dose dispensing? The evidence was evaluated by the Grading of Recommendations Assessment, Development and Evaluation and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses instrument, used in the report. Results: the sample was composed of 15 studies and none of them directly compared both technologies; however, the meta-analysis showed that there is no difference in effectiveness between them [OR 1.03 95%CI (0,12 - 8,99)]. Conclusions: the conclusion is that the recommendation in favor of the automated dispensing system is weak.

RESUMEN Objetivos: comparar la eficacia del sistema automatizado de distribución descentralizada de medicamentos por armario. Métodos: se trata de un estudio de efectividad basado en una revisión sistemática guiada por el tema: Para los pacientes ingresados en los hospitales, ¿el uso del dispensario electrónico es eficaz para reducir errores de medicación en comparación con la dispensación manual por dosis unitaria? El conjunto de la evidencia se evaluó según los sistemas GRADE (evaluación de la calidad de la evidencia y graduación de la fuerza de las recomendaciones) y PRISMA (elementos de informes preferidos para los protocolos de revisión sistemática y metaanálisis) usado en el informe. Resultados: la muestra estaba compuesta de 15 estudios y ninguno comparó directamente las tecnologías; sin embargo, el metaanálisis mostró que no existe diferencia de la eficacia entre ellas [OR 1.03 IC 95% (0,12 - 8,99)]. Conclusiones: se ultima que la recomendación es débil a favor del dispensario electrónico.

RESUMO Objetivos: comparar a efetividade do sistema automatizado de distribuição descentralizada de medicamentos por armário. Métodos: trata-se de estudo de efetividade embasado por revisão sistemática, norteada pela questão: Para pacientes internados em unidades hospitalares, o uso de dispensário eletrônico é efetivo para a redução de erros de medicação comparado à dispensação manual por dose unitária? O conjunto da evidência foi avaliado pelo Grading of Recommendations Assessment, Development and Evaluation, sendo o instrumento Preferred Reporting Items for Systematic Reviews and Meta-Analyses usado no relatório. Resultados: a amostra foi composta por 15 estudos e nenhum deles comparou diretamente as tecnologias, contudo, a metanálise revelou que não existe diferença de efetividade entre elas [OR 1.03 IC 95% (0,12 - 8,99)]. Conclusões: conclui-se que a recomendação é fraca a favor do dispensário eletrônico.

Cost-effectiveness of Hepatitis A vaccination in a developed and developing country.

PURPOSE: Hepatitis A is a prevalent disease that is largely preventable by vaccine usage. The vaccine for this illness is highly underused in most regions. In an attempt to find the strategies that are most beneficial in regard to quality-adjusted life years (QALYs) and cost in current environments, the purpose of this paper is to conduct cost-effectiveness analyses to investigate vaccination strategies in a more economically developed country (MEDC), generally known as a "developed" area: the USA, and a less economically developed country (LEDC), generally known as a "developing" area: the state of Rio de Janeiro, Brazil. DESIGN/METHODOLOGY/APPROACH: This study used a dynamic transmission model for comparative effectiveness analyses. The model ran two different scenarios. The two regions studied have different policies and strategies for Hepatitis A vaccination currently, and also used different strategies in 2009. In the USA, a universal vaccination policy was modeled, along with a scenario in which it was removed. In Rio de Janeiro, a no vaccination policy was modeled, along with a scenario in which a universal vaccination policy was effected. FINDINGS: The comparison of resulting incremental cost-effectiveness ratio values to accepted threshold values showed universal vaccination to be cost-effective in both the USA and Rio de Janeiro as compared to no vaccination. When episode and vaccination costs and vaccination efficacy were varied, this still remained true. Universal vaccination was found to result in lower incidence of Hepatitis A in both the USA and Rio de Janeiro. Over the twenty-year time horizon, universal vaccination is projected to prevent 506,945 cases of symptomatic Hepatitis A in the USA and 42,318 cases of Hepatitis A in Rio de Janeiro. Other benefits include a projected increase in cumulative QALYs through the use of universal vaccination. ORIGINALITY/VALUE: This analysis showed universal vaccination to be cost-effective as compared to no vaccination, and portions of the study's approach had not previously been applied in tandem to investigate Hepatitis A interventions. The results may help foster higher compliance rates for Hepatitis A vaccination and even greater per-person economic benefits of universal vaccination, particularly in the USA. The purpose of this study is also to encourage elevated levels of surveillance on age of infection in developing regions and consistent reevaluation utilizing dynamic transmission models in both the USA and Brazil, as well as other rapidly developing regions, in order to prevent future epidemics and costs associated with the disease.

What do Cochrane systematic reviews say about interventions for insomnia?

ABSTRACT CONTEXT AND OBJECTIVE: Insomnia is a frequent complaint that generates more than five million visits to doctors per year in the United States. This study summarizes all Cochrane systematic reviews (SRs) that evaluated interventions to treat insomnia. DESIGN AND SETTING: Review of SRs, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: A sensitive search was carried out in the Cochrane Database of Systematic Reviews to identify Cochrane SRs that assessed the effects of any type of intervention for people with insomnia. The results, main characteristics of the SRs and the certainty of the evidence obtained from them were synthesized and discussed. RESULTS: Seven SRs were included. They addressed the benefits and harm of acupuncture (n = 1), behavioral interventions (n = 1), music (n = 1), pharmacotherapy (n = 2), phototherapy (n = 1) and physical exercise (n = 1). The certainty of the evidence ranged from moderate to very low. CONCLUSION: Acupuncture, music, physical exercise, paroxetine, doxepin, trimipramine and trazodone seem to present some benefit for patients with insomnia. However, the uncertainty around these results means that no robust and definitive recommendations for clinical practice can be made until the benefits and harms from each intervention for patients with insomnia have been confirmed through further studies.

Morphine vs Methadone Treatment for Infants with Neonatal Abstinence Syndrome.

OBJECTIVE: To estimate the relationship of initial pharmacotherapy with methadone or morphine and length of stay (LOS) in infants with neonatal abstinence syndrome (NAS) admitted to the neonatal intensive care unit (NICU). STUDY DESIGN: From the Pediatrix Clinical Data Warehouse database, we identified all infants born at ≥36 weeks of gestation between 2011 and 2015 who were diagnosed with NAS (International Classification of Diseases, Ninth Revision code 779.5) and treated with methadone or morphine in the first 7 days of life. We used multivariable Cox proportional hazards regression analysis to quantify the association between initial treatment and LOS after adjusting for maternal age, maternal race/ethnicity, maternal drug use, maternal smoking, gestational age, small for gestational age status, inborn status, and discharge year. RESULTS: We identified a total of 7667 eligible infants, including 1187 treated with methadone (15%) and 6480 treated with morphine (85%). Birth weight, gestational age, and sex were similar in the 2 groups. Methadone treatment was associated with a 22% shorter median LOS (18 days [IQR, 11-30 days] vs 23 days [IQR, 16-33]; P < .001) and a 19% shorter median NICU stay (17 days [IQR, 10-29 days] vs 21 days [IQR, 14-36 days]; P < .001). After adjustment, methadone was associated with a shorter LOS (hazard ratio for discharge, 1.24; 95% CI, 1.11-1.37; P < .001) CONCLUSION: Among infants born at ≥36 weeks of gestation with NAS, initial methadone treatment was associated with a shorter LOS compared with morphine treatment. Future prospective comparative effectiveness trials to treat infants with NAS are needed to verify this observation.

Effectiveness and safety of insulin glargine versus detemir analysis in patients with type 1 diabetes: systematic review and meta-analysis.

BACKGROUND: Diabetes mellitus type 1 (DM1) is an autoimmune disease characterized by metabolic destruction of pancreatic cells responsible for insulin production, with treatment based on replacing insulin. Long-acting insulin analogs are indicated for patients with DM1 who exhibit important oscillations of their daily glycemia, despite its higher cost. Our study objective was to evaluate the effectiveness and safety of two long-acting insulins, insulin glargine and detemir, in treating patients with DM1. METHODS: We undertook a systematic review with meta-analysis of observational studies (cohort and registry) available in the databases and the gray literature, and a complementary search in the Diabetes Care journal. Outcomes assessed were: glycated hemoglobin concentration; fasting plasma or capillary glucose; occurrence of episodes of severe hypoglycemia and occurrence of nocturnal hypoglycemia. The assessment of methodological quality was performed using the Newcastle score. The meta-analyses were performed on software Review Manager® 5.2. RESULTS: Out of 705 publications, 8 cohort studies were included. The quality of these studies was classified as high. In the meta-analysis, results regarding episodes of severe hypoglycemia (p = 0.02) and fasting glucose (p = 0.01) were in favor of detemir. The glycated hemoglobin (p = 0.49; I2 = 89) showed high heterogeneity and no statistically significant difference between the two. The meta-analysis of total insulin dose favored glargine (p = 0.006; I2 = 75). The rates of nocturnal hypoglycemia (NH) were evaluated only for one study and showed a significant reduction of NH after therapy with detemir, (p < 0.0001). CONCLUSION: Although some outcomes were favorable to detemir insulin analog, it has not been possible to identify important differences of effectiveness and safety between the two analogs. These results can help in the current debate on the inclusion of long-acting analogs on the list of reimbursed medicines in Brazil, especially with the recent introduction of an insulin glargine biosimilar at a considerably lower price.

Inconsistency prevents the valuable synergism of explanatory and pragmatic trails.

OBJECTIVE: To assess review articles on pragmatic trials in order to describe how authors define the aim of this type of study, how comprehensive methodological topics are covered, and which topics are most valued by authors. METHODS: Review articles were selected from Medline Database, based on the expression "pragmatic trial" in the titles. Five trained medical students evaluated the articles, based on a list of 15 self-explanatory methodological topics. Each article was evaluated regarding topics covered. Baseline statements on the aim of pragmatic trials were derived. RESULTS: Among 22 articles identified, there was general agreement that the aim of a pragmatic trial is to evaluate if the intervention works under real-world conditions. The mean number of methodological topics addressed by each article was 7.6 ± 3.1. Only one article covered all 15 topics, three articles (14%) responded to at least 75% of topics and 13 articles (59%) mentioned at least 50% of the topics. The relative frequency each of the 15 topics was cited by articles had a mean of 50% ± 25%. No topic was addressed by all articles, only three (20%) were addressed by more than 75% of articles. CONCLUSIONS: There is agreement on the different aims of explanatory and pragmatic trials. But there is a large variation on methodological topics used to define a pragmatic trial, which led to inconsistency in defining the typical methodology of a pragmatic trial.

Efficacy of Interventions to Improve Respiratory Function After Stroke.

BACKGROUND: The aim of this study was to systematically review all current interventions that have been utilized to improve respiratory function and activity after stroke. METHODS: Specific searches were conducted. The experimental intervention had to be planned, structured, repetitive, purposive, and delivered with the aim of improving respiratory function. Outcomes included respiratory strength (maximum inspiratory pressure [PImax], maximum expiratory pressure [PEmax]) and endurance, lung function (FVC, FEV1, and peak expiratory flow [PEF]), dyspnea, and activity. The quality of the randomized trials was assessed by the PEDro scale using scores from the Physiotherapy Evidence Database (www.pedro.org.au), and risk of bias was assessed in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. RESULTS: The 17 included trials had a mean PEDro score of 5.7 (range 4-8) and involved 616 participants. Meta-analyses showed that respiratory muscle training significantly improved all outcomes of interest: PImax (weighted mean difference 11 cm H2O, 95% CI 7-15, I2 = 0%), PEmax (8 cm H2O, 95% CI 2-15, I2 = 65%), FVC (0.25 L, 95% CI 0.12-0.37, I2 = 29%), FEV1 (0.24 L, 95% CI 0.17-0.30, I2 = 0%), PEF (0.51 L/s, 95% CI 0.10-0.92, I2 = 0%), dyspnea (standardized mean difference -1.6 points, 95% CI -2.2 to -0.9; I2 = 0%), and activity (standardized mean difference 0.78, 95% CI 0.22-1.35, I2 = 0%). Meta-analyses found no significant results for the effects of breathing exercises on lung function. For the remaining interventions (ie, aerobic and postural exercises) and the addition of electrical stimulation, meta-analyses could not be performed. CONCLUSIONS: This systematic review reports 5 possible interventions used to improve respiratory function after stroke. Respiratory muscle training proved to be effective for improving inspiratory and expiratory strength, lung function, and dyspnea, and benefits were carried over to activity. However, there is still no evidence to accept or refute the efficacy of aerobic, breathing, and postural exercises, or the addition of electrical stimulation in respiratory function.

A systematic review of serious games in medical education: quality of evidence and pedagogical strategy.

INTRODUCTION: The literature shows an optimistic landscape for the effectiveness of games in medical education. Nevertheless, games are not considered mainstream material in medical teaching. Two research questions that arise are the following: What pedagogical strategies do developers use when creating games for medical education? And what is the quality of the evidence on the effectiveness of games? METHODS: A systematic review was made by a multi-disciplinary team of researchers following the Cochrane Collaboration Guidelines. We included peer-reviewed journal articles which described or assessed the use of serious games or gamified apps in medical education. We used the Medical Education Research Study Quality Instrument (MERSQI) to assess the quality of evidence in the use of games. We also evaluated the pedagogical perspectives of such articles. RESULTS: Even though game developers claim that games are useful pedagogical tools, the evidence on their effectiveness is moderate, as assessed by the MERSQI score. Behaviourism and cognitivism continue to be the predominant pedagogical strategies, and games are complementary devices that do not replace traditional medical teaching tools. Medical educators prefer simulations and quizzes focused on knowledge retention and skill development through repetition and do not demand the use of sophisticated games in their classrooms. Moreover, public access to medical games is limited. DISCUSSION: Our aim was to put the pedagogical strategy into dialogue with the evidence on the effectiveness of the use of medical games. This makes sense since the practical use of games depends on the quality of the evidence about their effectiveness. Moreover, recognition of said pedagogical strategy would allow game developers to design more robust games which would greatly contribute to the learning process.

A SUVmax-based propensity matched analysis of stereotactic body radiotherapy versus surgery in stage I non-small cell lung cancer: unveiling the role of 18F-FDG PET/CT in clinical decision-making.

BACKGROUND: The value of maximum standard uptake value (SUVmax) was overlooked in current studies comparing stereotactic body radiotherapy (SBRT) versus surgery for stage I non-small cell lung cancer (NSCLC). Herein, we aimed to compare the 3-year outcomes based on patients for whom SUVmax were available, and to explore the role of SUVmax in clinical decision-making. METHODS: From January 2010 to June 2016, data of eligible patients were collected. Patient variables and clinical outcomes were compared in both unmatched and matched groups using propensity score matching (PSM). Multivariate analysis was performed for predictors of poor outcome. The relationship between treatment approach and survival outcome was also evaluated in subgroup patients stratified by SUVmax level. RESULTS: A total of 425 patients treated with either surgery (325) or SBRT (100) were included. Patients receiving SBRT were significantly older, had a higher level of SUVmax and were more likely to have tumor of centrally located. Multivariate analysis showed that SUVmax and tumor size were significant predictors for 3-year OS, LRC, and PFS, while better PFS was also related to peripheral tumor and surgery. The result of PSM analysis also showed that compared to SBRT, surgery could only achieve better PFS. Subgroup analysis indicated that surgery had added advantage of 3-year LRC and PFS for patients in high SUVmax group (SUVmax > 8), but not in low SUVmax group. CONCLUSIONS: The study found a superior PFS after surgery while OS and LRC did not differ between SBRT and surgery. Surgery should be recommended for tumor of high SUVmax.

Use of administrative data for comparative effectiveness research in the treatment of non-prostate genitourinary malignancies.

Comparative effectiveness research (CER) is imperative for objective and balanced assessment of treatment outcomes. CER that uses administrative databases (AD-CER) affords unique opportunities for large scale data analyses that potentially transcend limitations of small institutional datasets. Prostate cancer has received much attention from the AD-CER research community, whereas non-prostate genitourinary malignancies are less well-studied. The objective of this article is to review the currently available AD-CER that has been published in the non-prostate genitourinary malignancies space.

The clinical effectiveness of insulin glargine in patients with Type I diabetes in Brazil: findings and implications.

AIM: Published studies have challenged the cost-effectiveness of insulin glargine versus neutral protamine hagedorn (NPH) insulins in Brazil with limited evidence of increased effectiveness despite considerably higher acquisition costs. However, still a controversy. Consequently, there is a need to address this. MATERIALS & METHODS: Retrospective cohort study of Type I diabetes patients receiving insulin glargine in Brazil following NPH insulin who met the criteria. RESULTS: 580 patients were enrolled. HbA1c varied from 8.80 ± 1.98% in NPH insulin users to 8.54 ± 1.88% after insulin glargine for 6 months, which is not clinically significant. Frequency of glycemic control varied from 22.6% with NPH insulin to 26.2% with insulin glargine. No statistically significant difference was observed between controlled and still uncontrolled groups for all analyzed factors including type and frequency of insulin use and carbohydrate counting. CONCLUSION: Limited differences between NPH insulins and insulin analogs in routine clinical care do not justify an appreciable cost difference.

Reduction of glycated hemoglobin (HbA1c) and cost analysis of treatment with insulin analogues in the state of Paraná: a retrospective cohort study / Redução de hemoglobina glicada (HbA1c) e análise de custo do tratamento com análogas insulinas no estado do Paraná: estudo de coorte retrospectivo

Objective: Diabetes mellitus (DM) is a serious public health problem in Brazil. The goal of this study was to evaluate the effectiveness of long-acting insulin analogues in controlling glycemia in type 1 DM patients and to analyze the direct costs of the treatment. Methods: A retrospective cohort study was undertaken with data collected from the State Health Secretary's 2nd Regional Health Center from the State of Paraná. After randomization, socio-demographic data, the source of their drug prescriptions, and the pharmacotherapeutic profiles of the drugs were collected, along with clinical outcome information, such as glycated hemoglobin (HbA1c) and fasting plasma glucose levels. The direct costs of treatment with analogue insulin were evaluated based on the drugs and supplies acquisition data from the Center for Drugs, Paraná Cemepar. Results: One hundred and forty-eight type 1 diabetes mellitus patients, older than 18 years of age, were included in the cohort study. The HbA1c reduction after the insulin treatment was 0.36 ± 2.75, and the direct costs to reduce this parameter by 1% over a period of 24 months were U$ 1,806. The estimated costs to reduce HbA1c by 1% are U$ 5,016. Conclusions: In this study, we were able to estimate the public health system costs of using insulin analogues to reduce HbA1c by 1% in patients with type 1 DM. This information will assist clinicians in decision-making regarding insulin treatment.

Objetivo: Diabetes mellitus (DM) é um grave problema de saúde pública no Brasil. O objetivo deste estudo foi avaliar a redução da HbA1c em pacientes usuários de insulinas análogas de longa duração no controle glicêmico de pacientes com DM tipo 1 e avaliar custos diretos do tratamento com insulinas análogas. Métodos: O estudo é uma coorte retrospectiva e análise de custos para o tratamento de DM tipo 1, com pacientes pertencentes a 2a Regional de Saúde do estado do Paraná. Após randomização dos pacientes, foram coletados dados sociodemográficos, origem da prescrição e seu perfil farmacoterapêutico, além dos desfechos clínicos, como hemoglobina glicada (HbA1c) e glicemia em jejum. Foi realizada uma análise dos custos diretos do tratamento com insulinas análogas, e os valores foram obtidos por meio dos dados de compra dos medicamentos e insumos realizados pelo Centro de Medicamentos Básicos do Paraná (Cemepar). Resultados: Foram incluídos 148 pacientes maiores de 18 anos. A variável avaliada foi redução na HbA1c que, entre os pacientes, foi de 0,36 ± 2,75. Os resultados médios dos custos diretos totais do tratamento com DM tipo 1 durante 24 meses foram de R$ 7.224,00, para obter redução em 0,36% dos valores de HbA1c. O custo teórico para a redução em 1% de HbA1c é de R$ 20.064,00. Conclusões: Neste estudo foi possível estimar o custo para o sistema público de saúde, da redução de 1% da HbA1c em pacientes com DM tipo 1 usando insulinas análogas. Essa informação serve de subsídios para gestores e clínicos na tomada de decisão do tratamento com insulinas.

Neonatal Histamine-2 Receptor Antagonist and Proton Pump Inhibitor Treatment at United States Children's Hospitals.

OBJECTIVE: To determine treatment frequency and duration of histamine-2 receptor antagonist (H2RA)/proton pump inhibitor (PPI) use among infants hospitalized within US children's hospital neonatal intensive care units and evaluate diagnoses/demographic factors associated with use. STUDY DESIGN: We retrospectively analyzed a cohort of neonatal intensive care unit infants admitted to 43 US children's hospitals within the Pediatric Health Information System database between January 2006 and March 2013 to determine H2RA/PPI treatment frequency, timing/duration of treatment, factors associated with use, percent of infants remaining on treatment at discharge, and interhospital prescribing variation. We used a modified Poisson regression to calculate the adjusted probability of infants ever receiving H2RAs/PPIs in relation to diagnosis, gestation, and sex. RESULTS: Of the 122 002 infants evaluated, 23.8% (n = 28 989) ever received an H2RA or PPI; 19.0% received H2RAs (n = 23 187), and 10.5% (n = 12 823) received PPIs. Extremely preterm infants and term infants were the most likely to receive H2RA and PPI treatment. Infants with gastroesophageal reflux disease (relative risk [RR] = 3.13) and congenital heart disease (RR = 2.41) had the highest H2RA/PPI treatment probabilities followed by those with an ear, nose, and throat diagnosis (RR = 2.34; P < .05). The majority of treated infants remained treated at discharge. CONCLUSIONS: Despite limited evidence and increasing safety concerns, H2RAs/PPIs are frequently prescribed to extremely preterm neonates and those with congenital anomalies and continued through discharge. Our findings support the need for innovative studies to examine the comparative effectiveness and safety of H2RA/PPIs vs no treatment in these high-risk neonatal populations.