The Polypill: A New Alternative in the Prevention and Treatment of Cardiovascular Disease.

Cardiovascular disease (CVD) is the primary cause of death and disability worldwide. Although age-standardized CVD mortality rates decreased globally by 14.5% between 2006 and 2016, the burden of CVD remains disproportionately higher in low- and middle-income countries compared to high-income countries. Even though proven, effective approaches based on multiple-drug intake aimed at the prevention and treatment of CVD are currently available, poor adherence, early discontinuation of treatment, and suboptimal daily execution of the prescribed therapeutic regimes give rise to shortfalls in drug exposure, leading to high variability in the responses to the prescribed medications. Wald and Law, in their landmark paper published in BMJ 2003, hypothesized that the use of a fixed-dose combination of statins, ß-blockers, angiotensin receptor blockers, angiotensin-converting enzyme inhibitors, and aspirin (classic Polypill composition) may increase adherence and decrease CVD by up to 80% when prescribed as primary prevention or in substitution of traditional protocols. Since then, many clinical trials have tested this hypothesis, with comparable results. This review aims to describe the available clinical trials performed to assess the impact of fixed-dose combinations on adherence, cost-effectiveness, and the risk factors critical to the onset of CVD.

Effects of empathy training on psychological concerns and empathy in caregivers of older people: A randomized, double-blind, crossover, clinical trial with follow-up.

OBJECTIVES: To investigate the effects of empathy training on psychological concerns and empathy in caregivers of older people. METHODS: A randomized, double-blind, crossover, clinical trial with follow-up was conducted online. Thirty paid and unpaid caregivers of older people from different regions of Brazil participated in an empathy training program. The caregivers answered a sociodemographic questionnaire and measures for the evaluation of empathy (affective and cognitive domains), burden, the impact of providing care as well as depressive symptoms and psychiatric symptoms before and immediately after training. Empathy and its domains were also assessed at three post-intervention follow-ups. RESULTS: Empathy training diminished levels of psychological concerns. Moreover, an increase was found in levels of cognitive empathy 15, 30 and 60 days after the intervention. CONCLUSIONS: Empathy training with a focus on cognitive empathy diminished psychological concerns in caregivers of older people and increased the levels of this ability over time. This intervention can be considered a coping strategy for negative impacts related to providing care. CLINICA LTRIAL REGISTRATION: RBR-8kjtfx3.

The remote intercessory prayer, during the clinical evolution of patients with COVID -19, randomized double-blind clinical trial.

The objective of this study was to evaluate the effect of intercessory prayer performed by a group of spiritual leaders on the health outcomes of hospitalized patients with Novel Coronavirus (COVID-19) infection, specifically focusing on mortality and hospitalization rates. DESIGN: This was a double-blinded, controlled, and randomized trial conducted at a private hospital in São Paulo, Brazil. INTERVENTIONS: Both groups continued to receive their usual medical care in accordance with HCor Hospital's institutional patient care protocol for COVID-19 patients. INTERVENTION: Both groups received their regular medical care according to HCor's institutional patient care protocol for COVID-19 patients. The intervention group, in addition to standard treatment, received intercessory prayers performed by a group of spiritual leaders. MAIN OUTCOME MEASURES: The primary endpoint was in-hospital mortality. Secondary endpoints included the need for mechanical ventilation during hospitalization, duration of mechanical ventilation, length of ICU stay, and length of hospital stay. RESULTS: A total of 199 participants were randomly assigned to the groups. The primary outcome, in-hospital mortality, occurred in 8 out of 100 (8.0 %) patients in the intercessory prayer group and 8 out of 99 (8.1 %) patients in the control group (HR 0.86 [0.32 to 2.31]; p = 0.76). Additionally, there were no significant differences between the groups in terms of secondary outcomes. CONCLUSION: The study found no evidence of an effect of intercessory prayer on the primary outcome of mortality or on the secondary outcomes of hospitalization time, ICU time, and mechanical ventilation time.

Generalizability of the Necrotizing Enterocolitis Surgery Trial to the Target Population of Eligible Infants.

OBJECTIVE: The objective of this study was to evaluate whether infants randomized in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network Necrotizing Enterocolitis Surgery Trial differed from eligible infants and whether differences affected the generalizability of trial results. STUDY DESIGN: Secondary analysis of infants enrolled in Necrotizing Enterocolitis Surgery Trial (born 2010-2017, with follow-up through 2019) at 20 US academic medical centers and an observational data set of eligible infants through 2013. Infants born ≤1000 g and diagnosed with necrotizing enterocolitis or spontaneous intestinal perforation requiring surgical intervention at ≤8 weeks were eligible. The target population included trial-eligible infants (randomized and nonrandomized) born during the first half of the study with available detailed preoperative data. Using model-based weighting methods, we estimated the effect of initial laparotomy vs peritoneal drain had the target population been randomized. RESULTS: The trial included 308 randomized infants. The target population included 382 (156 randomized and 226 eligible, non-randomized) infants. Compared with the target population, fewer randomized infants had necrotizing enterocolitis (31% vs 47%) or died before discharge (27% vs 41%). However, incidence of the primary composite outcome, death or neurodevelopmental impairment, was similar (69% vs 72%). Effect estimates for initial laparotomy vs drain weighted to the target population were largely unchanged from the original trial after accounting for preoperative diagnosis of necrotizing enterocolitis (adjusted relative risk [95% CI]: 0.85 [0.71-1.03] in target population vs 0.81 [0.64-1.04] in trial) or spontaneous intestinal perforation (1.02 [0.79-1.30] vs 1.11 [0.95-1.31]). CONCLUSION: Despite differences between randomized and eligible infants, estimated treatment effects in the trial and target population were similar, supporting the generalizability of trial results. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT01029353.

Use of calcium-containing bioactive desensitizers in dental bleaching: A systematic review and meta-analysis.

BACKGROUND: Topical application of calcium-containing bioactive desensitizers (CBs) has been used to minimize bleaching-induced tooth sensitivity (TS). This study answered the research question "Is the risk of TS lower when CBs are used with dental bleaching in adults compared with bleaching without desensitizers?" TYPES OF STUDIES REVIEWED: The authors included randomized clinical trials comparing topical CB application with a placebo or no intervention during bleaching. Searches for eligible articles were performed in MEDLINE via PubMed, Cochrane Library, Brazilian Library in Dentistry, Latin American and Caribbean Health Sciences Literature, Scopus, Web of Science, Embase, and gray literature without language and date restrictions and updated in September 2022. The risk of bias was evaluated using Risk of Bias Version 2.0. The authors conducted meta-analyses with the random-effects model. The authors assessed heterogeneity with the Cochrane Q test, I2 statistics, and prediction interval. The authors used the Grading of Recommendations Assessment, Development and Evaluation approach to assess the certainty of the evidence. RESULTS: After database screening, 22 studies remained, with most at high risk of bias. No difference in the risk of TS was detected (risk ratio, 0.95; 95% CI, 0.90 to 1.01; P = .08, low certainty). In a visual analog scale, the intensity of TS (mean difference, -0.98; 95% CI, -1.36 to -0.60; P < .0001, very low certainty) was lower for the CB group. The color change was unaffected (P > .08). PRACTICAL IMPLICATIONS: Although topical CB dental bleaching did not reduce the risk of TS and color change, these agents slightly reduced the TS intensity, but the certainty of the evidence is very low.

Influence of two caries detection strategies on the quality of life of preschool children: An analysis of secondary outcomes of a 2-Year randomized clinical trial.

OBJECTIVE: This randomized clinical trial aimed to evaluate the influence of two caries diagnosis strategies, and subsequent management, on oral health-related quality of life (OHRQoL) of preschoolers. Additionally, the association of the OHRQoL outcomes with the clinician-centred primary outcome used in the main study was also explored. MATERIALS AND METHODS: This study refers to the OHRQoL secondary outcomes analyses of the so-called RCT 'CARDEC-1'. Three- to 6-year-old children were randomly allocated in two caries detection strategies in primary molars: visual inspection (VIS) or visual + radiographic (RAD) assessment. Participants were diagnosed and treated according to the allocated group and followed up for 2 years. Caregivers answered the Early Childhood Oral Health Impact Scale (ECOHIS) at baseline and after 2 years. Intention-to-treat analysis was performed. ECOHIS scores at baseline and 2 years later were compared using the Mann-Whitney test. Effect sizes, change scores and the minimally important difference (MID) were also compared between groups. Additional analysis was performed to assess if OHRQoL variables could reflect the primary clinical outcome (number of new operative interventions during the follow-up), observing if these met the Prentice criteria. RESULTS: Two hundred and five children had the ECOHIS answered in both period times (18.7% attrition rate). There was a decrease in total ECOHIS scores, as well as for different domains for both trial groups, with effect sizes varying from 0.43 to 0.77. Comparisons between groups, however, did not show significant differences. In the additional analysis, the OHRQoL variables met the Prentice criteria and presented the same trends observed with the clinician-centred primary endpoint. CONCLUSION: Caries detection performed by visual inspection alone or associated with radiographic method does not influence the long-term impact on OHRQoL. Furthermore, OHRQoL variables reflect clinical outcomes in this type of clinical trial. CLINICALTRIALS: gov NCT02078453.

Diagnostic criteria and outcome measures in randomized clinical trials on carpal tunnel syndrome: a systematic review

ABSTRACT BACKGROUND: The diagnostic criteria for carpal tunnel syndrome (CTS) lack uniformity. Moreover, because CTS is a syndrome, there is no consensus as to which signs, symptoms, clinical and complementary tests are more reproducible and accurate for use in clinical research. This heterogeneity is reflected in clinical practice. Thus, establishing effective and comparable care protocols is difficult. OBJECTIVE: To identify the diagnostic criteria and outcome measures used in randomized clinical trials (RCTs) on CTS. DESING AND SETTING: Systematic review of randomized clinical trials carried out at the Federal University of São Paulo, São Paulo, Brazil. METHODS: We searched the Cochrane Library, PubMed, and Embase databases for RCTs with surgical intervention for CTS published between 2006 and 2019. Two investigators independently extracted relevant data on diagnosis and outcomes used in these studies. RESULTS: We identified 582 studies and 35 were systematically reviewed. The symptoms, paresthesia in the median nerve territory, nocturnal paresthesia, and special tests were the most widely used clinical diagnostic criteria. The most frequently assessed outcomes were symptoms of paresthesia in the median nerve territory and nocturnal paresthesia. CONCLUSION: The diagnostic criteria and outcome measures used in RCTs about CTS are heterogeneous, rendering comparison of studies difficult. Most studies use unstructured clinical criteria associated with ENMG for diagnosis. The Boston Questionnaire is the most frequently used main instrument to measure outcomes. REGISTRATION: PROSPERO (CRD42020150965- https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=150965).

Da imaginação à neuroimagem: uma análise antropológica sobre a racionalidade do efeito placebo em ensaios clínicos / From imagination to neuroimage: An anthropological analysis on the rationality of the placebo effect in clinical trials

Resumo O efeito placebo é um ponto de passagem obrigatório para a compreensão da racionalidade envolvida nos ensaios clínicos randomizados. A partir da antropologia da ciência e da tecnologia, este artigo analisa como a noção de efeito placebo tem sido utilizada pela ciência na produção de fronteiras biossociais. Assim, enfoca fenômenos que inicialmente eram atribuídos à imaginação e analisa as consequências de novas metodologias científicas que têm reconhecido outras potencialidades desse efeito, mas tendem a privilegiar marcadores biológicos. O argumento central é que a disputa epistemológica oculta a existência múltipla do efeito placebo que pode ser reconhecida em função das diferentes práticas às quais ele confere racionalidade.

Abstract The placebo effect is an obligatory passage point to understand rationality in randomized clinical trials. From the perspective of science and technology studies, this paper analyzes how the notion of the placebo effect has been used by science in the production of biosocial borders. Thus, it will pay attention to the phenomena considered caused by imagination, and we will analyze the consequences of new methodologies that have recognized other potentialities of this effect but tend to favor biological markers. The central argument is that the epistemological dispute hides the multiple existences of the placebo effect to be recognized due to the different scientific practices to which it confers rationality.

Terapia de reposição enzimática para doença de Anderson-Fabry: revisão sistemática de ensaios clínicos randomizados / Enzyme synthesis therapy for Anderson-Fabry disease: systematic reviewof randomized clinical trials

A doença de Anderson-Fabry, uma doença rara, é causada por uma deficiência da enzima alfa-galactosidase A. Isso leva ao acúmulo de um material gorduroso denominado globotriaosilceramida em várias células do corpo. Globotriaosilceramida é uma substância gordurosa, formada por três açúcares, comumente denominada ceramida e é encontrada na maioria das células do corpo. Indivíduos não tratados podem apresentar dor, complicações na pele, olhos, e problemas gastrointestinais. A doença de Fabry pode causar complicações potencialmente fatais, como danos aos rins, ataque cardíaco e acidente vascular cerebral. Um dos tipos disponíveis de tratamento é a terapia de reposição enzimática com agalsidase alfa ou beta, que substitui a deficiência enzimática. Avaliamos a eficácia e segurança da terapia de reposição enzimática com agalsidase alfa ou beta para doença de Anderson-Fabry. Para realizar essa revisão analisamos revisões sistemática de ensaios clínicos randomizados (ECRs). Não houve restrições de idiomas. Pesquisamos o registro de ensaios clínicos de erros inatos do metabolismo do grupo Cochrane de fibrose cística e desordens genéticas, e as seguintes bases de dados: MEDLINE, EMBASE, LILACS, e clinicaltrials.gov. Os revisores examinaram de forma independente os artigos elegíveis, extraíram dados e avaliaram o risco de viés. Essa revisão está registrada na Cochrane e foi realizada juntamente com o grupo de Fibrose Cística e Doenças Genéticas. Foram selecionados onze estudos randomizados controlados, os resultados apontam para uma diminuição nos depósitos de Gb3 plasmático para os pacientes que receberam agalsidase beta, nos domínios do rim (MD -1,70 (95% CI -2,09 a -1,31) e coração (MD -0,90 95% CI (-1,18 a -0,62) e uma influência positiva na qualidade de vida relacionada à dor, porém, os estudos apresentam baixa qualidade metodológica e não fornecem evidências robustas que indiquem se a TRE é mais efetiva e segura quando comparada a outras terapias ativas, placebo, ou nenhuma intervenção (AU)

Anderson-Fabry disease, a rare disease, is caused by a deficiency of the enzyme alpha-galactosidase A. This leads to the accumulation of a fatty material called globotriaosylceramide in various cells of the body. Globotriaosylceramide is a fatty substance, made up of three sugars, commonly called ceramide and is found in most cells in the body. Untreated individuals may experience pain, skin, eye, and gastrointestinal problems. Fabry disease can cause life-threatening complications, such as kidney damage, heart attack, and stroke. One of the available types of treatment is enzyme replacement therapy with agalsidase alpha or beta, which replaces the enzyme deficiency. We evaluated the efficacy and safety of enzyme replacement therapy with agalsidase alfa or beta for Anderson-Fabry disease. To perform this review, we analyzed systematic reviews of randomized controlled trials (RCTs). There were no language restrictions. We searched the clinical trial registry ofinborn errors of metabolism from the Cochrane group of cystic fibrosis and genetic disorders, and the following databases: MEDLINE, EMBASE, LILACS, and clinicaltrials.gov. Reviewers independently screened eligible articles, extracted data, and assessed risk of bias. This review is registered in Cochrane and was carried out jointly with the Cystic Fibrosis and Genetic Diseases group. Eleven randomized controlled trials were selected, the results point to a decrease in plasma Gb3 deposits for patients receiving agalsidase beta, in the kidney domains (MD -1.70 (95% CI -2.09to -1.31) and heart (MD -0.90 95% CI (-1.18 to -0.62) and a positive influence on pain-related quality of life, however, studies have low methodological quality and do not provide robust evidence to indicate whether ERT is more effective and safer when compared to other active therapies, placebo, or no intervention (AU)

Current Medical Treatment for Alcohol-Associated Liver Disease.

Alcohol-associated liver disease is one of the main causes of chronic liver disease. It comprises a clinical-histologic spectrum of presentations, from steatosis, steatohepatitis, to different degrees of fibrosis, including cirrhosis and severe necroinflammatory disease, called alcohol-associated hepatitis. In this focused update, we aim to present specific therapeutic interventions and strategies for the management of alcohol-associated liver disease. Current evidence for management in all spectra of manifestations is derived from general chronic liver disease recommendations, but with a higher emphasis on abstinence and nutritional support. Abstinence should comprise the treatment of alcohol use disorder as well as withdrawal syndrome. Nutritional assessment should also consider the presence of sarcopenia and its clinical manifestation, frailty. The degree of compensation of the disease should be evaluated, and complications, actively sought. The most severe acute form of this disease is alcohol-associated hepatitis, which has high mortality and morbidity. Current treatment is based on corticosteroids that act by reducing immune activation and blocking cytotoxicity and inflammation pathways. Other aspects of treatment include preventing and treating hepatorenal syndrome as well as preventing infections although there is no clear evidence as to the benefit of probiotics and antibiotics in prophylaxis. Novel therapies for alcohol-associated hepatitis include metadoxine, interleukin-22 analogs, and interleukin-1-beta antagonists. Finally, granulocyte colony-stimulating factor, microbiota transplantation, and gut-liver axis modulation have shown promising results. We also discuss palliative care in advanced alcohol-associated liver disease.

Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions.

Nutrition is an essential component when promoting human health. Without a doubt, improving the quality of one's diet can improve one's quality of life as a whole and help postpone the onset or control of many chronic diseases. The volume of publications in this field has increased in recent years, in line with increased awareness of the importance of nutrition in health; however, the quality of the evidence on which most nutritional guidelines are based remains low, due to errors in conducting nutritional interventions or because the information is primarily derived from observational studies. To enhance the evidence supporting clinical guidelines in nutrition, the quality of randomized clinical trials (RCT) based on nutritional interventions must be improved; nevertheless, due to their heterogeneous nature and a lack of specific guidelines for designing, performing, documenting, and reporting on this type of intervention, conducting a nutritional intervention is a real challenge. Following a review of the literature on the methodological and ethical standards, as well as four extensions of the CONSORT (Consolidated Standards of Reporting Trials) guidelines that should be considered when implementing a nutritional intervention, seven essential aspects were identified. The current narrative review includes definitions, examples, diagrams, and algorithms regarding aspects of the appropriate study design, the intervention of the control group, the randomization and blinding processes, the study population selection, as well as a description of the type of intervention and the personnel involved in carrying out the study in order to make the implementation of a nutritional intervention easier.

Thrombolysis Experience in Costa Rica Compared Against Individual Patient Data from two Randomized Controlled Trials.

OBJECTIVES: We sought to compare thrombolysis outcomes from the Costa Rican Stroke Registry Program (CRSRP) with published individual patient data from NINDS and CLOTBUST-ER trials using matching and outcome modeling from randomized clinical trials (RCTs). MATERIALS AND METHODS: A retrospective observational study matching subjects on baseline characteristics, from the CRSRP, the control arm of CLOTBUST-ER, and the interventional arm of NINDS trials. Day 7-10/discharge modified Rankin Score (mRS), and early mortality was compared between matched subjects. A mortality model derived from RCTs was developed, and outcomes were compared at similar baseline NIHSS scores. CRSRP symptomatic hemorrhage (SICH) rate was compared with an Ibero-American cohort (IAC). RESULTS: Of 540 CRSRP patients, 351 received rt-PA under 3 hours and were matched with NINDS subjects yielding 292 pairs; 161 CRSRP subjects treated within 4.5 hours were matched with CLOTBUST-ER subjects resulting in 151 pairs. The proportion of patients achieving excellent outcomes (mRS 0-1) did not differ between CRSRP and either NINDS or CLOTBUST-ER (CRSRP vs NINDS: 36.6% vs 32.9%, p=0.3; CRSRP vs CLOTBUST-ER: 26.5% vs 24.5%, p=0.8). Mortality was higher for CRSRP vs CLOTBUST-ER (7.3% vs 0.7%, p=0.006), but not vs NINDS (6.5% vs 4.5%, p=0.4). A pooled mortality model derived from 15 RCTs representing 4410 patients (R2=0.39) showed CRSRP and NINDS within expected mortality, while CLOTBUST-ER showed lower than expected mortality. CRSRP SICH rate equaled IAC (5.7% vs 5.7%; p=0.9). CONCLUSIONS: Functional outcomes and SICH of thrombolysed Costa Rican patients compared favorably with published datasets, with a potential increase in early mortality.

Psicoterapia para la regulación emocional desde un enfoque transdiagnóstico: revisión de ensayos clínicos aleatorizados / Psychotherapy for emotional regulation from transdiagnostic approach: a review of randomized clinical trials

Resumen Introducción: La regulación emocional (RE) refiere a los procesos por los cuales los individuos influyen en las emociones que tienen, cuando las tienen y cómo las experimentan y expresan (Gross, 1998). El uso de estrategias desadaptativas de RE se asocia con distintos cuadros psicopatológicos. La concepción de RE como proceso transdiagnóstico permite sortear el problema de la comorbilidad, y ha sido abordado desde distintos modelos e investigaciones. Objetivo: El presente estudio se propone realizar una revisión de ensayos clínicos aleatorizados de psico-terapia para la RE desde una perspectiva transdiagnóstica. Método: Para ello se realizó una búsqueda en las bases de datos PubMed, SciELO, Redalyc y ScienceDirect. Resultados: Se hallaron 11 artículos que cumplían los criterios de inclusión. Los resultados mostraron que las intervenciones transdiagnósticas obtuvieron mejores resultados que grupos control, que incluyeron otros tratamientos o listas de espera. Conclusión: Se señala la importancia de realizar más ensayos clínicos aleatorizados que comparen nuevas intervenciones con tratamientos de primera línea.

Abstract Introduction: Emotional regulation (ER) refers to the processes by which individuals influence the emotions they have, when they have them and how they experience and express them (Gross, 1998). The use of maladaptive ER strategies is associated with different psychopathological conditions. The conception of ER as a transdiagnostic process allows to overcome the problem of comorbidity, and has been approached from different models and investigations. Objective: The present study aims to conduct a review of randomized clinical trials of psychotherapy for ER from a transdiagnostic perspective. Method: For this, a search was carried out in the databases PubMed, SciELO, Redalyc and ScienceDirect. Results: Eleven articles were found that met the inclusion criteria. The results showed that the transdiagnostic interventions obtained better results than control groups, which included other treatments or waiting lists. Conclusion: The importance of conducting more randomized clinical trials comparing new interventions with first-line treatments is noted.

Cardiovascular toxicity following immune checkpoint inhibitors: A systematic review and meta-analysis.

BACKGROUND: Immune checkpoint inhibitors may be associated with multiple immune-related toxicities. Cardiovascular adverse effects are underreported in clinical trials. METHODS: We conducted a systematic review and meta-analysis to evaluate cardiovascular adverse effects incidence among patients with solid tumors receiving immune checkpoint inhibitors in randomized clinical trials and the relative risk of presenting these effects compared to placebo or best supportive care. The search was conducted through MEDLINE, Embase, and Scopus databases from January 1st, 2010 until July 1st, 2020. Outcomes were reported following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. RESULTS: 57 randomized clinical trials including 12,118 patients were included. All grade CV AEs incidence rate was 8.32% (95% CI = 6.35%-10.53%). When only grade 3-5 CV AEs were considered, ICIs were significantly associated with increased risk than placebo or BSC (RR = 1.36; 95% CI = 1.06-1.73; p = 0.01). CONCLUSION: This meta-analysis corroborates the hypothesis of increased CV risk related to immune checkpoint inhibitors.

Ensaios clínicos randomizados sobre unidade de terapia intensiva realizados por enfermeiros no Brasil / Ensayos clínicos aleatorizados sobre la unidad de cuidados intensivos realizados por enfermeras en Brasil / Randomized clinical trials on the intensive care unit conducted by nurses in Brazil

Objetivo: caracterizar os ensaios clínicos randomizados realizados em unidade de terapia intensiva desenvolvidos por enfermeiros no Brasil. Método : trata-se de um estudo descritivo, de natureza quantitativa, com coleta de dados realizada mediante o acesso ao website de Registro Brasileiro de Ensaios Clínicos, no qual foram incluídos os ensaios cadastrados por enfermeiros. A análise ocorreu de forma descritiva a partir do software R. Resultados: a amostra do estudo foi composta por 33 ensaios clínicos. Predominaram os ensaios referentes à especialidade da enfermagem em neonatologia, que representou 16 (48,5%) dos estudos analisados. A maioria das intervenções testadas foram procedimentos de enfermagem, encontradas em 17 (51,5%) estudos. Observou-se predominância do mascaramento aberto, em 19 (57,6%) estudos e a maioria dos autores encontrava-se na docência, em 26 (48,1%) dos estudos. Conclusão: sugere-se que sejam realizados outros estudos que abordem a caracterização de ensaios clínicos realizados por outras categorias profissionais no setor em questão(AU)

Objective: to characterize the randomized clinical trials carried out in an intensive care unit developed by nurses in Brazil. Method: this is a descriptive, quantitative study, with data collection performed by accessing the website of the Brazilian Registry of Clinical Trials, which included trials registered by nurses. The analysis detected descriptively using the R software. Results: the study sample consisted of 33 clinical trials. The trials referring to the specialty of nursing in neonatology predominated, representing 16 (48.5%) of the studies involved. Most of the interventions tested were nursing procedures, found in 17 (51.5%) studies. There was a predominance of open masking in 19 (57.6%) studies and most authors were in teaching, in 26 (48.1%) of the studies. Conclusion: it is necessary to carry out other studies that address the characterization of tests carried out by other professional categories in the sector in question(AU)

Objetivo: caracterizar los ensayos clínicos aleatorizados realizados en una unidad de cuidados intensivos desarrollados por enfermeras en Brasil. Método: se trata de un estudio descriptivo, cuantitativo, con recolección de datos mediante el acceso a la página web del Registro Brasileño de Ensayos Clínicos, que incluyó ensayos registrados por enfermeras. El análisis se detectó de forma descriptiva mediante el software R. Resultados: la muestra de estudio estuvo formada por 33 ensayos clínicos. Predominaron los ensayos referidos a la especialidad de enfermería en neonatología, representando 16 (48,5%) de los estudios involucrados. La mayoría de las intervenciones probadas fueron procedimientos de enfermería, encontrados en 17 (51,5%) estudios. Hubo predominio del enmascaramiento abierto en 19 (57,6%) estudios y la mayoría de los autores estaban en la docencia, en 26 (48,1%) de los estudios. Conclusión: es necesario realizar otros estudios que aborden la caracterización de pruebas realizadas por otras categorías profesionales del sector en cuestión(AU)

Association between industry support and the reporting of study outcomes in randomized clinical trials of dental implant research from the past 20 years.

BACKGROUND: Industry support is a significant funding source in implant dentistry research, not only to provide regulatory processes, but also to validate and promote products through randomized clinical trials (RCTs). However, industry funding should not affect scientific outcomes. PURPOSE: The aim of this study was to investigate whether there is an association between industry support for RCTs in implant dentistry and a greater chance of the reporting of positive outcomes, and whether there are other funding tendencies. MATERIALS AND METHODS: Randomized clinical trials from five implant dentistry journals were reviewed. Data were extracted, and descriptive and inferential statistical analyses (α = 0.05), including bivariate and multivariable logistic regression, and Spearman's correlation were performed. RESULTS: Two hundred eleven RCTs were included. Industry-funded and -unfunded studies presented similar outcomes, in terms of positive and negative results (p ≥ 0.05). North American and European countries received more industry funding, as did high-income countries, which showed well-established collaboration with each other. Clinical Oral Implants Research and Clinical Implant Dentistry and Related Research published 83.6% of industry-funded articles. Industry-funded studies from middle-income countries established more international collaborations with high-income countries than did unfunded studies. Citation numbers were similar for funded and unfunded studies. The chance of RCTs being industry-funded was higher for high-income (odds ratio [OR] = 3.00; 95% confidence interval [CI], 0.99-9.32; p = 0.05) and North American articles (OR = 3.40; 95% CI, 1.37-8.42; p = 0.008) than in lower-middle-income and other continents, respectively. Higher industry funding was associated with specific topics such as "surgical procedures," "prosthodontics topics," and "implant macrodesign" (OR = 4.7; 95% CI, 1.45-15.20; p = 0.010) and with the increase in numbers of institutions (OR = 1.52; 95% CI, 1.16-2.0; p = 0.002). CONCLUSION: The available evidence suggests no association between industry funding and greater chances of the reporting of positive outcomes in implant dentistry RCTs. A strong association was identified in industry trends concerning geographic origins, higher numbers of institutions, and specific research topics.

Efficacy of an iodoform-based filling material for pulpectomy of primary teeth: A 24-month non-inferiority randomized clinical trial.

AIM: The aim of this non-inferiority randomized clinical trial was to compare the efficacy of an iodoform-based paste (Guedes-Pinto -(GP)) as a filling material in pulpectomies of primary teeth, and a standard material composed by calcium hydroxide and iodoform (CaOH/Iodof paste; Vitapex® ). DESIGN: A total of 104 teeth from 61 children (3-8 years old) were randomly allocated to two groups according to filling materials. Children were followed up for 24 months. The primary endpoint was the treatment success rate evaluated through clinical and radiographic examinations at follow-up, and the secondary outcome was the analysis of the canal filling quality. Differences in the proportion of treatment success was calculated based on 95% confidence intervals (95% CI) and with the Miettinen and Nurminen method in the intention-to-treat population, considering a -20% of the non-inferiority limit. RESULTS: From 104 randomized teeth, 102 were followed up after 24 months (attrition rate of 1.9%). The success rate of teeth treated with the GP paste was 86.8% (95% CI: 69.9-94.9) and 78.4% (95% CI: 61.8-89.1) with the CaOH/Iodof paste. Consequently, a non-inferiority of the GP paste was observed when compared to the CaOH/Iodof paste (P < .001). CONCLUSION: The GP paste has a non-inferior success rate than the CaOH/Iodof paste used as filling material for pulpectomy in primary teeth.

Looking for Crumbs in the Obesity Forest: Anti-obesity Interventions and Obesity-Associated Cardiometabolic Traits in the Mexican Population. History and Systematic Review With Meta-Analyses.

Mexicans and Mexican Americans share culture, genetic background, and predisposition for chronic complications associated with obesity and diabetes making imperative efficacious treatments and prevention. Obesity has been treated for centuries focused-on weight loss while other treatments on associated conditions like gout, diabetes (T2D), and hypertriglyceridemia. To date, there is no systematic review that synthesizes the origin of obesity clinics in Mexico and the efforts to investigate treatments for obesity tested by randomized clinical trials (RCT). We conducted systematic searches in Pubmed, Scopus, and Web of Science to retrieve anti-obesity RCT through 2019 and without an inferior temporal limit. The systematic review included RCT of anti-obesity treatments in the Mexican adult population, covering alternative medicine, pharmacological, nutritional, behavioral, and surgical interventions reporting metabolism-associated traits such as BMI, weight, waist circumference, triglycerides, glucose, among others. Only the studies with at least 3 months of treatment were included in the meta-analyses in order to reduce placebo effects. We found 634 entries, after removal of duplicates and screening the studies based on eligibility criteria, we analyzed 43 national, and 2 multinational-collaborative studies. Most of the national studies had small sample sizes, and the implemented strategies do not have replications in the population. The nutrition/behavioral interventions were difficult to blind, and most studies have medium-to-high risk of bias. Nutritional/behavioral interventions and medications showed effects on BMI, waist circumference, and blood pressure. Simple measures like pure water instead of sweet beverages decrease triglycerides and systolic blood pressure. Dark chocolate showed the highest effect for BMI and high blood pressure, and treatment with insulin increased weight in those with T2D. The study of obesity in Mexico has been on-going for more than four decades, the interest on RCT just increased until this millennium, but with small sample sizes and lack of replication. The interventions affect different cardiometabolic associated traits, which should be analyzed in detail in the population living near the Mexico-U.S. border; therefore, bi-national collaboration is desirable to disentangle the cultural effects on this population's treatment response. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020221436, identifier: CRD42020221436.

COMPLIANCE OF RANDOMIZED CLINICAL TRIALS ON DENTAL CARIES PREVENTION METHODS WITH THE CONSORT STATEMENT: A SYSTEMATIC REVIEW.

OBJECTIVE: Reporting of randomized controlled trials (RCTs) in dentistry remains suboptimal. Considering the positive impact of the Consolidated Standards of Reporting Trials (CONSORT) guidelines on the quality of evidence in RCTs, the main objective of this systematic review was to determine whether RCTs on dental caries prevention conform to these guidelines. The secondary objective was to assess the association between CONSORT adherence and the year and impact factor of the journal in which the study was published. METHODS: A systematic search was conducted in different databases using appropriate terms to retrieve RCTs that assessed the caries-preventive effect of at least 2 of the following materials-fluoride varnish, resin-based fissure sealants, and ionomer-based fissure sealants-on the occlusal surfaces of permanent molars. Since the first CONSORT statement was published in 1996, a time frame from 1997 to 2020 was established for the identification of studies. Selected articles were assessed according to their adherence to the CONSORT statement, risk of bias (Cochrane risk of bias tool, RoB 2.0), and journal impact factor based on the InCites Journal Citation Reports. The year of publication and other relevant data were also recorded. SPSS (SPSS Statistics 25.0, IBM©) was used to perform the linear correlation analyses to determine the relationship between the article CONSORT score (previously determined) and the year of publication and journal impact factor. A significance level of 5% was established for all analyses. RESULTS: Of 3196 references retrieved, 30 articles were selected and evaluated. Using RoB 2.0, 8 studies were classified as having a high risk of bias, 16 as having some concerns about the risk of bias assessment, and 6 as having a low risk of bias. Concerning CONSORT adherence, 77% of the studies adequately reported the intervention domain, since the methodology for the application of fluoride varnish or sealant materials was thoroughly described. However, the participants' setting and location, random sequence generation, randomization, and the flowchart description of the losses/exclusions domains were poorly reported. Meanwhile, the allocation concealment process was not reported in 83% of the articles. Correlation analyses indicated a positive relationship between CONSORT adherence and the year of publication, as well as the journal impact factor. CONCLUSION: When assessing clinical trials on the prevention of occlusal caries, most RCTs examined followed the CONSORT statement. However, some methodological domains remain poorly reported, demonstrating the need to improve CONSORT compliance in these RCTs.