Coronavirus disease (COVID-19) pandemic: an overview of systematic reviews.

BACKGROUND: Navigating the rapidly growing body of scientific literature on the SARS-CoV-2 pandemic is challenging, and ongoing critical appraisal of this output is essential. We aimed to summarize and critically appraise systematic reviews of coronavirus disease (COVID-19) in humans that were available at the beginning of the pandemic. METHODS: Nine databases (Medline, EMBASE, Cochrane Library, CINAHL, Web of Sciences, PDQ-Evidence, WHO's Global Research, LILACS, and Epistemonikos) were searched from December 1, 2019, to March 24, 2020. Systematic reviews analyzing primary studies of COVID-19 were included. Two authors independently undertook screening, selection, extraction (data on clinical symptoms, prevalence, pharmacological and non-pharmacological interventions, diagnostic test assessment, laboratory, and radiological findings), and quality assessment (AMSTAR 2). A meta-analysis was performed of the prevalence of clinical outcomes. RESULTS: Eighteen systematic reviews were included; one was empty (did not identify any relevant study). Using AMSTAR 2, confidence in the results of all 18 reviews was rated as "critically low". Identified symptoms of COVID-19 were (range values of point estimates): fever (82-95%), cough with or without sputum (58-72%), dyspnea (26-59%), myalgia or muscle fatigue (29-51%), sore throat (10-13%), headache (8-12%) and gastrointestinal complaints (5-9%). Severe symptoms were more common in men. Elevated C-reactive protein and lactate dehydrogenase, and slightly elevated aspartate and alanine aminotransferase, were commonly described. Thrombocytopenia and elevated levels of procalcitonin and cardiac troponin I were associated with severe disease. A frequent finding on chest imaging was uni- or bilateral multilobar ground-glass opacity. A single review investigated the impact of medication (chloroquine) but found no verifiable clinical data. All-cause mortality ranged from 0.3 to 13.9%. CONCLUSIONS: In this overview of systematic reviews, we analyzed evidence from the first 18 systematic reviews that were published after the emergence of COVID-19. However, confidence in the results of all reviews was "critically low". Thus, systematic reviews that were published early on in the pandemic were of questionable usefulness. Even during public health emergencies, studies and systematic reviews should adhere to established methodological standards.

Insufficient evidence for vitamin D use in COVID-19: A rapid systematic review.

BACKGROUND: Vitamin D deficiency has been linked to the increased severity of numerous viral infections. OBJECTIVE: To assess whether vitamin D supplementation is safe and effective for the treatment of COVID-19. METHODS: We searched MEDLINE, EMBASE, CENTRAL, LILACS and LOVE for randomised controlled trials (RCTs) published up to 2 March evaluating the effects of vitamin D for the treatment of coronavirus disease (COVID-19). Two authors selected the studies and analysed the data evidence following Cochrane Recommendations. RESULTS: We included three RCTs with a total of 385 participants. We found low certainty evidence indicating that hospitalised patients under calcifediol plus standard care (SC) treatment seem to present a significantly lower risk of being admitted to ICU but no difference in mortality. We found low to very low certainty evidence that the improvement in fibrinogen levels is slightly greater in mildly symptomatic or asymptomatic patients with COVID-19 that used cholecalciferol plus SC than in those treated with placebo plus SC (mean difference), and the patients who used cholecalciferol plus SC achieved more SARS-CoV-2 negativity, but not on d-dimer, c-reactive protein (CRP) or procalcitonin compared with the patients in the placebo plus SC group. We also found low to moderate certainty evidence that a single high dose of vitamin D does not seem to be effective for reducing mortality, length of hospital stay, ICU admissions and d-dimer or CRP levels when used in patients with moderate to severe COVID-19. CONCLUSIONS: As a practical implication, the use of vitamin D associated with SC seems to provide some benefit to patients with COVID-19. However, the evidence is currently insufficient to support the routine use of vitamin D for the management of COVID-19, as its effectiveness seems to depend on the dosage, on the baseline vitamin D levels, and on the degree of COVID-19 severity.

lilacs search strategy for systematic reviews of diagnostic test accuracy studies.

BACKGROUND: There are few publications on search strategies to identify diagnostic test accuracy (DTA) studies in lilacs. OBJECTIVE: To translate and customise medline search strategies for use in lilacs and assess their retrieval of studies in Cochrane DTA systematic reviews. METHOD: We developed a six-step process to translate and customise medline search strategies for use in lilacs (iAHx interface). We identified medline search strategies of published Cochrane DTA reviews, translated/customised them for use in lilacs, ran searches in lilacs and compared the retrieval results of our translated search strategy versus the one used in the published reviews. RESULTS: Our lilacs search strategies translated/customised from the medline strategies retrieved studies in 70 Cochrane DTA reviews. Only 29 of these reviews stated that they had searched the lilacs database and 21 published their lilacs search strategies. Few had used the lilacs database search tools, none exploded the subject headings, and 86% used only English terms. CONCLUSION: Translating and tailoring a medline search strategy for the lilacs database resulted in the retrieval of DTA studies that would have been missed otherwise.

Design and rationale for the WARFA trial: a randomized controlled cross-over trial testing the therapeutic equivalence of branded and generic warfarin in atrial fibrillation patients in Brazil.

BACKGROUND: Warfarin is a commonly used anticoagulant. Whether a given dose of the different formulations of Brazilian warfarin will result in the same effect on the international normalized ratio (INR) is uncertain. The aim of the WARFA trial is to determine whether the branded and two generic warfarins available in Brazil differ in their effect on the INR. METHODS: WARFA is a cross-over RCT comparing three warfarins. The formulations tested are the branded Marevan® (Uniao Quimica/Farmoquimica) and two generic warfarin (manufactured respectively by Uniao Quimica Farmaceutica Nacional and Laboratorio Teuto Brasileiro). All of them were manufactured in Brazil, are available in all settings of the Brazilian healthcare system and were purchased from retail drugstores. Eligible participants had atrial fibrillation or flutter, had been using warfarin for at least 2 months with a therapeutic range of 2.0-3.0 and had low variability in INR results during the 1st period of the trial. Our primary outcome, for which we have an equality hypothesis, is the difference between warfarins in the mean absolute difference between two INR results, obtained after three and 4 weeks with each drug. Our secondary outcomes, that will be tested for inequality (except for the mean INR, which will be tested for equality), include the difference in the warfarin dose, and time in therapeutic range. Clinical events and adherence were also recorded and will be reported. DISCUSSION: To our knowledge, WARFA will be the first comparison of the more readily applicable INR results between branded and generic warfarins in Brazil. WARFA is important because warfarins are commonly switched between in the course of a chronic treatment in Brazil. Final results of WARFA are expected in May 2017. TRIAL REGISTRATION: ClinicalTrials.gov NCT02017197 . Registered 11 December 2013.

Characterization of cardiac arrest in the emergency department of a Brazilian University Reference Hospital: A prospective study.

BACKGROUND & OBJECTIVES: Sudden cardiac arrest (CA) represents one of the greatest challenges for medicine due to the vast number of cases and its social and economic impact. Despite advances in cardiopulmonary resuscitation (CPR) techniques, mortality rates have not significantly decreased over decades. This study was undertaken to characterize patients that have suffered CA and to identify factors related to mortality. METHODS: This prospective study was conducted at Emergency Department of São Paulo Hospital, Brazil. Two hundred and eighty five patients were followed for one year after treatment for CA. The mean age was 66.3±17.2 yr, and they were predominantly male (55.8%) and Caucasian (71.9%). Mortality rate and factors associated with mortality were the primary and secondary outcome measures. Data were collected using an in-hospital Utstein-style report. A logistic regression analysis was used to determine which variables were related to mortality. RESULTS: Regarding the characteristics of CPR, 76.5 per cent occurred in hospital, respiratory failure was the most common presumed immediate cause of CA (30.8%) and pulseless electrical activity was the most frequent initial rhythm (58.7%). All attempts at CPR utilized chest compressions and ventilation and the most utilized interventions were epinephrine (97.2%) and intubation (68.5%). Of all patients treated, 95.4 per cent died. Patients with pulseless electrical activity had a higher risk of death than those patients with ventricular fibrillation. INTERPRETATION & CONCLUSIONS: The findings of the study highlighted that the mortality rate among CA patients was high. The variable that best explained mortality was the initial CA rhythm.

Dermoscopy of black skin: A cross-sectional study of clinical and dermoscopic features of melanocytic lesions in individuals with type V/VI skin compared to those with type I/II skin.

BACKGROUND: The identification of "normal" dermoscopic patterns of acquired melanocytic nevi provides better diagnostic accuracy for melanoma in people with black skin. OBJECTIVE: We sought to describe melanocytic lesions (numbers and anatomic distributions) in skin types V and VI compared with skin types I and II, according to the Fitzpatrick classification. We sought to identify differences in dermoscopic findings in acquired melanocytic nevi (global pattern, pigment and color distribution) between the groups. METHODS: We conducted cross-sectional, prospective, and consecutive data collection in 2 dermatologic outpatient clinics, between October 8, 2010, and March 20, 2013. From the 501 volunteers, 480 participants fulfilled the eligibility criteria. A total of 460 acquired melanocytic nevi were selected for dermoscopic analysis. RESULTS: Individuals with skin type V/VI had fewer melanocytic lesions than those with skin type I/II (15.08 vs 7.90; P = .032), and the anatomic distribution in the first group was predominantly on the face and acral sites (P < .001). The acquired melanocytic nevi in the skin type V/VI group were associated with the reticular pattern (P < .0001), with a tendency toward central hyperpigmentation (P = .0025). LIMITATIONS: The choice of a single representative nevus per patient is a limitation. CONCLUSIONS: Acquired melanocytic nevi in individuals with skin type V/VI have a distinct dermoscopic pattern from those with skin type I/II.

[Advantages of a cohort study on cardiac arrest conducted by nurses]. / Vantagens do estudo de coorte realizado por enfermeiros em parada cardiorrespiratória.

OBJECTIVE: Identifying factors associated to survival after cardiac arrest. METHOD: An experience report of a cohort study conducted in a university hospital, with a consecutive sample comprised of 285 patients. Data were collected for a year by trained nurses. The training strategy was conducted through an expository dialogue lecture. Collection monitoring was carried out by nurses via telephone calls, visits to the emergency room and by medical record searches. The neurological status of survivors was evaluated at discharge, after six months and one year. RESULTS: Of the 285 patients, 16 survived until hospital discharge, and 13 remained alive after one year, making possible to identify factors associated with survival. There were no losses in the process. CONCLUSION: Cohort studies help identify risks and disease outcomes. Considering cardiac arrest, they can subsidize public policies, encourage future studies and training programs for CPR, thereby improving the prognosis of patients.

Effectiveness of sensorimotor training in patients with rheumatoid arthritis: a randomized controlled trial.

The objective of this study was to evaluate the effectiveness of a sensorimotor training in patients with rheumatoid arthritis on the improvement of functional skills and quality of life, a double-blinded, prospective, randomized controlled trial. One hundred two participants with rheumatoid arthritis were selected. After the baseline evaluation, the participants were randomized to two different groups: sensorimotor group (2 sessions per week, 30-50 min each session, besides continuing taking the same drugs as the control group) and control group (control group was only submitted to the clinical drug treatment with Methotrexate, Leflunomide and/or Prednisone (5 mg), being then evaluated 4 months later). Functional capacity [Health Assessment Questionnaire (HAQ) and Timed Up & Go Test (TU>)], Balance and Gait (Berg Balance Scale (BBS) and Tinetti Test) and Quality of Life (Short Form Health Survey-SF-36). The study had been concluded with ninety-one participants, and a statistically significant improvement was found in all variables assessed: HAQ (P < .01), TU> (P < .01), BBS (P < .01), Tinetti Test (P < .01) and improvement in the subscales of SF-36 (P < .01) in the sensorimotor group in comparison with the baseline evaluation and control group. No significant difference was found related to the pre- and post-evaluation in the control group. Therefore, the sensorimotor training is effective in the improvement of the functional capacity and quality of life of patients with rheumatoid arthritis.

Mandibular manipulation for the treatment of temporomandibular disorder.

The aim of this study was to conduct a systematic review to identify the randomized clinical studies that had investigated the following research question: Is the mandibular manipulation technique an effective and safe technique for the treatment of the temporomandibular joint disk displacement without reduction? The systematic search was conducted in the electronic databases: PubMed (Medical Publications), LILACS (Latin American and Caribbean Literature in Health Sciences), EMBASE (Excerpta Medica Database), PEDro (Physiotherapy Evidence Database), BBO (Brazilian Library of Odontology), CENTRAL (Library Cochrane), and SciELO (Scientific Electronic Library Online). The abstracts of presentations in physical therapy meetings were manually selected, and the articles of the ones that meet the requirements were investigated. No language restrictions were considered. Only randomized and controlled clinical studies were included. Two studies of medium quality fulfilled all the inclusion criteria. There is no sufficient evidence to support the effectiveness of the mandibular manipulation therapy, and therefore its use remains questionable. Being minimally invasive, this therapy is attractive as an initial approach, especially considering the cost of the alternative approaches. The analysis of the results suggests that additional high-quality randomized clinical trials are necessary on the topic, and they should focus on methods for data randomization and allocation, on clearly defined outcomes, on a priori calculated sample size, and on an adequate follow-up strategy.

Intravenous zoledronate for postmenopausal women with osteopenia and osteoporosis: a systematic review and metanalysis.

BACKGROUND: Osteoporosis compromises bone strength and increases the risk of fractures. Zoledronate prevents loss of bone mass and reduces the risk of fractures. OBJECTIVES: To determine the efficacy and safety of zoledronate in postmenopausal women with osteopenia and osteoporosis. DESIGN AND SETTINGS: A systematic review and meta-analysis was conducted within the evidence-based health program at the Universidade Federal de São Paulo. METHODS: An electronic search of the CENTRAL, MEDLINE, Embase, and LILACS databases was performed until February 2022. Randomized controlled trials comparing zoledronate with placebo or other bisphosphonates were included. Standard methodological procedures were performed according to the Cochrane Handbook and the certainty of evidence for the Grading of Recommendations Assessment, Development, and Evaluation Working Group. Two authors assessed the risk of bias and extracted data on fractures, adverse events, bone turnover markers (BTM), and bone mineral density (BMD). RESULTS: Twelve trials from 6,652 records were included: nine compared zoledronate with placebo, two trials compared zoledronate with alendronate, and one trial compared zoledronate with ibandronate. Zoledronate reduced the incidence of fractures in osteoporotic [three years: morphometric vertebral fractures (relative risk, RR = 0.30 (95% confidence interval, CI: 0.24-0.38))] and osteopenic women [six years: morphometric vertebral fractures (RR = 0.39 (95%CI: 0.25-0.61))], increased incidence of post-dose symptoms [RR = 2.56 (95%CI: 1.80-3.65)], but not serious adverse events [RR = 0.97 (95%CI: 0.91-1.04)]. Zoledronate reduced BTM and increased BMD in osteoporotic and osteopenic women. CONCLUSION: This review supports the efficacy and safety of zoledronate in postmenopausal women with osteopenia for six years and osteoporosis for three years. PROSPERO REGISTRATION NUMBER: CRD42022309708, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=309708.

Brazilian health technology assessment bulletin: editorial process, dissemination strategies, critical appraisal, and initial impact.

OBJECTIVES: This study reports on the Brazilian experience of developing a specialized bulletin, the Brazilian Health Technology Assessment Bulletin (BRATS), on health technology assessments (HTA). METHODS: The editorial process, format, and dissemination strategy of the publication are presented. A critical appraisal of the available issues was made using the checklist for HTA reports of the International Network of Agencies for Health Technology Assessment. The initial impact was estimated based on a retrospective observational measurement of the types of publications that cite the bulletin as a source of information. The publications citing BRATS were identified using Google Scholar. RESULTS: Since June 2008, fourteen issues of the bulletin have been produced. BRATS has not presented any significant limitation that would compromise generalizations of its results within the Brazilian context. The initial impact of the bulletin, however, has been small, which may be due to its exclusively electronic dissemination format and technical language. We found nine publications citing BRATS in Google Scholar. CONCLUSIONS: It is hoped that the bulletin will promote the continuity of HTA actions among health-sector managers and professionals in Brazil.

A randomized clinical trial on inhaled ciclesonide for managing acute asthma in the emergency room.

BACKGROUND: Use of inhaled corticosteroids for managing acute asthma exacerbations has been tested since the 1990s. OBJECTIVE: To compare high doses of inhaled ciclesonide with systemic hydrocortisone for managing acute asthma exacerbations in the emergency department. DESIGN AND SETTING: Double-blind, randomized clinical trial in the public healthcare system of the city of São Paulo. METHODS: Fifty-eight patients with moderate or severe asthma with peak flow < 50% of predicted were randomized into two groups. Over the course of four hours, one group received 1440 mcg of inhaled ciclesonide plus hydrocortisone-identical placebo (ciclesonide + placebo), while the other received 500 mg of intravenous hydrocortisone plus ciclesonide-identical placebo (hydrocortisone + placebo). Both groups received short-acting bronchodilators (fenoterol hydrobromide and ipratropium bromide). The research protocol included spirometry, clinical evaluation, vital signs and electrocardiogram monitoring. Data were obtained at 30 (baseline), 60, 90, 120, 180, and 240 minutes. We compared data from baseline to hour 4, between and within groups. RESULTS: Overall, 31 patients received ciclesonide + placebo and 27 received hydrocortisone + placebo. Inhaled ciclesonide was as effective as intravenous hydrocortisone for improving clinical parameters (Borg-scored dyspnea, P = 0.95; sternocleidomastoid muscle use, P = 0.55; wheezing, P = 0.55; respiratory effort, P = 0.95); and spirometric parameters (forced vital capacity, P = 0.50; forced expiratory volume in the first second, P = 0.83; peak expiratory flow, P = 0.51). CONCLUSIONS: Inhaled ciclesonide was not inferior to systemic hydrocortisone for managing acute asthma exacerbations, and it improved both clinical and spirometric parameters. TRIAL REGISTRATION: RBR-6XWC26 - Registro Brasileiro de Ensaios Clínicos (http://www.ensaiosclinicos.gov.br/rg/RBR-6xwc26/).

Assessment of the strength of recommendation and quality of evidence: GRADE checklist. A descriptive study.

BACKGROUND: Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a tool for assessing evidence produced in synthesis reports. OBJECTIVES: To present the translation into Portuguese of the GRADE checklist, whose original version is in English, and to describe and explain each topic, in order to provide examples to researchers and professionals who will use the tool. DESIGN AND SETTING: Descriptive study developed at Centro Universitário Tiradentes, Maceió, Alagoas, Brazil. METHODS: This was a translation of the GRADE checklist, with the addition of the Risk Of Bias In Systematic Reviews (ROBIS) tool in the checklist, with examples of its use. RESULTS: Situations of practical use of the tool were presented in order to facilitate and expand the use of assessment of the quality and strength of evidence among Portuguese speakers. CONCLUSIONS: The GRADE checklist is valuable in helping to assess the strength and quality of evidence for synthesis reports for healthcare decision-making.

Effectiveness and safety of tocilizumab for COVID-19: a systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: Tocilizumab is an anti-human interleukin 6 receptor monoclonal antibody that has been used to treat coronavirus disease 2019 (COVID-19). However, there is no consensus on its efficacy for the treatment of COVID-19. OBJECTIVE: To evaluate the effectiveness and safety of tocilizumab for treating COVID-19. DESIGN AND SETTING: Systematic Review of randomized controlled trials (RCTs), Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil. METHODS: We searched MEDLINE via PubMed, EMBASE, CENTRAL, and IBECS for RCTs published up to March 2021. Two authors selected studies and assessed the risk of bias and the certainty of the evidence following Cochrane Recommendations. RESULTS: Eight RCTs with 6,139 participants were included. We were not able to find differences between using tocilizumab compared to standard care on mortality in hospitalized patients with COVID-19 (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.84 to 1.13; 8 trials; 5,950 participants; low-certainty evidence). However, hospitalized patients under tocilizumab plus standard care treatment seemed to present a significantly lower risk of needing mechanical ventilation (risk ratio = 0.78; 95% CI 0.64-0.94 moderate-certainty of evidence). CONCLUSIONS: To date, the best evidence available shows no difference between using tocilizumab plus standard care compared to standard care alone for reducing mortality in patients with COVID-19. However, as a finding with a practical implication, the use of tocilizumab in association to standard care probably reduces the risk of progressing to mechanical ventilation in those patients. REGISTRATION: osf.io/qe4fs.

Indications for accurate and appropriate use of personal protective equipment for healthcare professionals. A systematic review.

BACKGROUND: The speed of the spread of coronavirus disease 2019 (COVID-19) has put enormous pressure on hospitals and other healthcare facilities. This, together with blockages in several countries, has hindered the availability and accessibility of the necessary personal protective equipment (PPE). OBJECTIVE: To identify, systematically evaluate and summarize the available scientific evidence on the efficacy, safety, safe use and reuse of PPE for healthcare professionals, for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. DESIGN AND SETTING: Systematic review of studies analyzing products for disinfecting and enabling reuse of PPE for coronavirus within the evidence-based health program of a federal university in São Paulo (SP), Brazil. METHODS: A systematic search of the relevant literature was conducted in the PubMed, EMBASE, Cochrane Library, CINAHL, SCOPUS, Web of Science and LILACS databases, for articles published up to November 30, 2020. RESULTS: Ten studies were selected. These analyzed the use of N95, surgical and cotton masks, face shields, flexible enclosures with plastic covers or polycarbonate intubation boxes and plastic curtains; and also PPE disinfection using several substances. CONCLUSION: Combined use of a face shield with a N95 mask proved to be superior to other associations for protecting healthcare workers. Some products are useful for disinfecting PPE, such as 70% ethanol, 0.1% sodium hypochlorite and a mixture of quaternary ammonium and H2O2, and hydrogen peroxide. Ultraviolet light and dry heat at 70 °C can be used to decontaminate N95 masks. REGISTRATION NUMBER: DOI: 10.17605/OSF.IO/4V5FD at the OPENSCIENCE Framework.

Homeopathic Plumbum metallicum for lead poisoning: a randomized clinical trial.

INTRODUCTION: Poisoning due to lead and its compounds has short and long-term effects primarily on the nervous, hematopoietic, gastrointestinal, cardiovascular, musculoskeletal, renal and reproductive systems. It can manifest in acute or chronic symptoms. Measuring serum concentration is the primary method for diagnosing and monitoring exposed workers. Presently, elevated lead levels are treated by drugs whose effectiveness is contested on various fronts. Experimental studies suggest that homeopathic preparations may be in controlling blood lead levels in laboratory animals, creating the need for controlled studies to evaluate the effectiveness and safety of these preparations in humans. OBJECTIVE: To evaluate the effectiveness of the homeopathic preparation Plumbum metallicum in reducing the blood lead level of workers exposed to this metal. DESIGN: Double-blind randomized trial. SETTING: Workers' clinic in the Ajax battery plant, which employs 900 workers with varying degrees of lead exposure in Bauru, São Paulo State, Brazil. SUBJECTS: 131 workers exposed to lead. INTERVENTION: Plumbum metallicum 15 cH or placebo, orally for 35 days. RESULTS: The percentage of workers who demonstrated a reduction in lead counts by a percentage greater than or equal to 25% following treatment was the same for both groups: 20.3% in the homeopathic groups versus 21% in the control group [Relative Risk (RR) = 0.95, confidential interval (CI) 95%: 0.47-1.92)]. Analysis by intention-to-treat also did not show any difference between the groups: 18.2% in the treated group versus 20% in the placebo group (RR = 0.91, CI 95%: 0.45-1.84). CONCLUSION: The homeopathic preparation Plumbum metallicum had no effect, in this study, in terms of reducing serum lead in workers exposed to lead.

Analysis on mental-insanity and cessation-of-dangerousness examinations in three Brazilian custodial institutions: a retrospective cross-sectional study.

BACKGROUND: In Brazil, the right to healthcare and the incorporation of best scientific evidence in public health are universally guaranteed by law. However, the treatment offered to patients with mental disorders in custodial hospitals in this country has not been rigorously evaluated. OBJECTIVES: To analyze the psychiatric diagnoses and treatments implemented in three Brazilian custodial institutions. DESIGN AND SETTING: This was a retrospective, cross-sectional and descriptive study on patients held in custody in three Brazilian institutions, as judicially-determined safety measures due to their mental disorders, and the tools used in diagnoses and treatments. These institutions are in Rio de Janeiro and the Federal District. METHODS: The data from medical and judicial records that were made available were assessed regarding the diagnoses that were made and the instruments that were used. RESULTS: None of these inpatients were evaluated using validated tools, and only a few medical records presented clear descriptions of the cases. No patient with substance involvement had undergone laboratory toxicological assays. It was not possible to verify the adequacy of treatments because the procedures were inadequately described in the records. CONCLUSIONS: No standardized protocols or instruments for diagnosing mental health disorders or assessing use of psychoactive substances had been applied among the inpatients at these custodial institutions in Rio de Janeiro and the Federal District. The treatments that were prescribed to these inpatients consisted mainly of drugs.

Examining therapeutic equivalence between branded and generic warfarin in Brazil: The WARFA crossover randomized controlled trial.

OBJECTIVES: To determine whether the generic and branded warfarins used as anticoagulants in Brazil are therapeutic equivalents based on their international normalized ratio (INR) results. METHODS: This crossover randomized controlled trial had four periods. We used the branded Marevan and two generic versions of warfarin sodium tablets, manufactured by União Química and Teuto laboratories, all purchased from retail drugstores. Eligible participants were outpatients from an anticoagulation clinic at a university hospital in São Paulo, Brazil. They had atrial fibrillation or flutter and had been using warfarin for at least 2 months with an INR therapeutic range of 2.0-3.0. Randomization was by numbered, opaque, sealed envelopes. Healthcare personnel and outcome assessors were blinded to treatments, but patients were not. The primary outcome was the variability in the INR (ΔINR) and secondary outcomes included mean INR. We accepted formulations as equivalent if the 95% confidence interval (CI) of the comparison of ΔINR between branded and generic formulations was within the limit of ±0.49. RESULTS: One hundred patients were recruited and randomized to six sequences of treatment (four sequences with n = 17 and two sequences with n = 16). União Química generic warfarin had equivalent variability in the INR to Marevan (ΔINR +0.09 [95% CI -0.29 to +0.46], n = 84). Comparison between Teuto generic warfarin and Marevan was inconclusive (ΔINR +0.29 [95% CI -0.09 to +0.68], n = 84). CONCLUSIONS: Marevan and União Química warfarin had equivalent therapeutic effectiveness and both could be confidently used for anticoagulation. The comparison between Marevan and TW was inconclusive and does not warrant a statement of equivalence. Our methods are especially important for comparing generic and branded drugs that raise concerns and may be subject of future investigations by regulatory agents. TRIAL REGISTRATION: ClinicalTrials.gov NCT02017197.

Use of color Doppler ultrasonography for the prediction of malignancy in follicular thyroid neoplasms: systematic review and meta-analysis.

OBJECTIVE: The purpose of this systematic review was to obtain summary estimates of the diagnostic accuracy of color Doppler ultrasonography (CDU) in predicting malignancy in thyroid follicular neoplasms (FNs). METHODS: We searched Medical Subject Headings together with the search terms "follicular," "thyroid," and "Doppler" in the MEDLINE, Web of Science, and Excerpta Medica databases as well as the Latin American and Caribbean Health Sciences Literature database, after which we performed manual searches of the reference lists to locate additional studies. There were no language restrictions. We included studies that assessed the diagnostic accuracy of CDU in identifying malignancy in thyroid FNs. The assessments of the quality and extraction of data were performed by 3 independent reviewers. RESULTS: We included 4 studies, which collectively evaluated 457 thyroid FNs, 67 of which had been classified as malignant based on the evaluation of surgical biopsy samples. Moderate, rich, predominant, or exclusive internal flow on CDU of thyroid FNs was considered indicative of malignancy. The overall sensitivity of CDU was 85% (95% confidence interval [CI], 74%-93%), with an overall specificity of 86% (95% CI, 82%-89%). The overall prevalence was 14.7%, and the positive and negative predictive values were 51% and 97%, respectively. The positive likelihood ratio was 6.07, and the negative likelihood ratio was 0.18. CONCLUSIONS: Predominant internal flow seen on CDU is associated with malignancy of thyroid FNs. Absence of internal flow or predominantly peripheral flow indicates a low probability of thyroid FN malignancy.

Detecting the extent of control over selection bias relating to oral health and otorhinolaryngology: cross-sectional study.

BACKGROUND: The authors of randomized controlled trials will usually claim that they have met the randomization process criterion. However, sequence generation schemes differ and some schemes that are claimed to be randomized are not genuinely randomized. Even less well understood, and often more difficult to ascertain, is whether the allocation was really concealed. OBJECTIVE: To detect the extent of control over selection bias, in a comparison between two Cochrane groups: oral health and otorhinolaryngology; and to describe the methods used to control for this bias. DESIGN AND SETTING: Cross-sectional study conducted in a public university in São Paulo, Brazil. METHODS: The risk of selection bias in 1,714 records indexed in Medline database up to 2018 was assessed, independent of language and access. Two dimensions implicated in the allocation were considered: generation of the allocation sequence; and allocation concealment. RESULTS: We included 420 randomized controlled trials and all of them were evaluated to detect selection bias. In the sample studied, only 28 properly controlled the selection bias. Lack of control over selection bias was present in 80% of the studies evaluated in both groups. CONCLUSION: The two groups were similar regarding control over selection bias. They are also similar to the methods used. The dimension of allocation concealment appears to be a limiting factor with regard to production of randomized controlled trials with low risk of selection bias. The quality of reporting in studies on oral health and otorhinolaryngology is suboptimal and needs to be improved, in line with other fields of healthcare.