Universidade Federal De São Paulo Research Articles

What is an "ongoing" clinical trial? An analysis of different sources revealed heterogeneous definitions of when a clinical trial starts and ends: a meta-research study.

Although the concept of an "ongoing study" seems self-explanatory, it is difficult to determine whether a trial is underway. To analyze the definitions of "ongoing clinical trial" across different clinical trial registries, methodological guidelines, and other sources. This meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil. We performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials. We identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still "ongoing" during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study. The concept of "ongoing clinical trials" lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial.

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

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. To evaluate the effectiveness and safety of tocilizumab for treating COVID-19. Systematic Review of randomized controlled trials (RCTs), Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil. 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. 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). 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. osf.io/qe4fs.

Is sleep a barrier to physical activity practice?

Is sleep a barrier to physical activity practice?

A onda pró-ciência em tempos de negacionismo: percepção da sociedade brasileira sobre ciência, cientistas e universidades na pandemia da COVID-19

Abstract This article presents the results of our study on the public perception of science during the COVID-19 pandemic in Brazil, carried out at the Centro de Estudos SoU_Ciência, from Universidade Federal de São Paulo (UNIFESP). To answer the question: “Has the COVID-19 pandemic changed the perception of Brazilian society about science, scientists, and universities?”, quantitative and qualitative studies were conducted between August 2021 and July 2022. In national quantitative public opinion surveys, we collected exclusive data from a historical series of polls on the subject in Brazil, and in focus groups, we deepened studies on the perception and political position of different social segments. Amid the growth of scientific denialism; political and social setbacks; and the dismantling of public policies, specifically scientific and technological, resulting from the impeachment of 2016 and the election of Bolsonaro in 2018, research indicates, apparently contrary to an obscurantist political tendency, a significant expansion of public interest in science during the pandemic in the country. This paper analyzes the emergence of a “pro-science wave” in public opinion in Brazil, the factors that led to its emergence during the pandemic, and its current prospects.

Use of artificial intelligence in ophthalmology: a narrative review

Artificial intelligence (AI) deals with development of algorithms that seek to perceive one's environment and perform actions that maximize one's chance of successfully reaching one's predetermined goals. To provide an overview of the basic principles of AI and its main studies in the fields of glaucoma, retinopathy of prematurity, age-related macular degeneration and diabetic retinopathy. From this perspective, the limitations and potential challenges that have accompanied the implementation and development of this new technology within ophthalmology are presented. Narrative review developed by a research group at the Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil. We searched the literature on the main applications of AI within ophthalmology, using the keywords "artificial intelligence", "diabetic retinopathy", "macular degeneration age-related", "glaucoma" and "retinopathy of prematurity," covering the period from January 1, 2007, to May 3, 2021. We used the MEDLINE database (via PubMed) and the LILACS database (via Virtual Health Library) to identify relevant articles. We retrieved 457 references, of which 47 were considered eligible for intensive review and critical analysis. Use of technology, as embodied in AI algorithms, is a way of providing an increasingly accurate service and enhancing scientific research. This forms a source of complement and innovation in relation to the daily skills of ophthalmologists. Thus, AI adds technology to human expertise.

Cross-sectional Imaging of the Duodenum: Spectrum of Disease.

Cross-sectional Imaging of the Duodenum: Spectrum of Disease.

IDF21-0585 Prevention and Diagnosis of Feet Complications in Diabetes Mellitus Detection Campaigns

Background: The “Campanha Nacional Gratuita em Diabetes de Prevenção das Complicações, Detecção, Orientação e Educação” is an initiative carried out by the Associação Nacional de Atenção ao Diabetes (ANAD), a philanthropic institution accredited by the International Diabetes Federation (IDF) as a center of excellence and education in diabetes. Extension undergraduate at the Escola Paulista de Enfermagem da Universidade Federal de São Paulo (UNIFESP), through the ‘‘Projeto de Extensão Cuidar-te’’, have participated in the aforementioned campaign for over 20 years, working to integrate such tracking and education actions in diabetes.

The impact of the COVID-19 pandemic on the diagnosis and treatment of ocular cancer.

To evaluate the impact of social isolation due to the COVID-19 pandemic on the number of new cases and therapeutic approaches at the Ocular Oncology division from the Universidade Federal de São Paulo (UNIFESP). A retrospective study was conducted by medical records review of new patients treated before the pandemic from March 2019 to September 2019 (pre-pandemic group) and during the pandemic from March 2020 to September 2020 (pandemic group). Data regarding age, sex, ethnicity, place of origin, clinical diagnosis, time since referral, and proposed therapy were analyzed. We analyzed 186 new cases, 122 from the pre-pandemic group and 64 from the pandemic group, representing a decrease of 47.54% in new cases. There was no statistically significant change in sex, race, state of origin, history of cancer, age, or time with suspected cancer (p>0.05). A higher frequency of malignancies was observed in the pandemic group (68%) when compared to the pre-pandemic group (48.48%). Benign tumors were the most common diagnosis in the pre-pandemic group (41.80%), while conjunctival squamous cell carcinoma was the modal diagnosis in the pandemic group (31.25%). There was a decreasing trend (p=0.097) in the number of surgeries (-7.63%) and an increase in topical treatment (+10.68%). There was also a tendency to perform fewer surgeries in benign tumors and decreased follow-up visits. Our findings showed a significant decrease in the number of new cases referred to the Ocular Oncology service. Moreover, the pandemic led to a switch in the therapeutic approach with preference to non-invasive treatments that would demand operating rooms. A drastic increase of cases perhaps in advanced stages might be expected because of the decrease observed in the first six months of quarantine.

WALANT versus intravenous regional anesthesia for carpal tunnel syndrome: a randomized clinical trial.

There are several anesthetic techniques for surgical treatment of carpal tunnel syndrome (CTS). Results from this surgery using the "wide awake local anesthesia no tourniquet" (WALANT) technique have been described. However, there is no conclusive evidence regarding the effectiveness of the WALANT technique, compared with the usual techniques. To evaluate the effectiveness of the WALANT technique, compared with intravenous regional anesthesia (IVRA; Bier's block), for surgical treatment of CTS. Randomized clinical trial, conducted at Hospital Alvorada Moema and the Discipline of Hand Surgery, Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil. Seventy-eight patients were included. The primary outcome was measurement of perioperative pain through a visual analogue scale (VAS). The secondary outcomes were the Boston Questionnaire score, Hospital Anxiety and Depression Scale (HADS) score, need for use of analgesics, operating room times, remission of paresthesia, failures and complications. The WALANT technique (n = 40) proved to be superior to IVRA (n = 38), especially for controlling intraoperative pain (0.11 versus 3.7 cm; P < 0.001) and postoperative pain (0.6 versus 3.9 cm; P < 0.001). Patients spent more time in the operating room in the IVRA group (59.5 versus 46 minutes; P < 0.01) and needed to use more analgesics (10.8 versus 5.7 dipyrone tablets; P = 0.02). Five IVRA procedures failed (5 versus 0; P = 0.06). The WALANT technique is more effective than IVRA for CTS surgery.

Traditional weight loss and dukan diets as to nutritional and laboratory results

Traditional weight loss and dukan diets as to nutritional and laboratory results

COVID 19 repercussions in ophthalmology: a narrative review.

The new coronavirus of 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread globally and has repercussions within ophthalmological care. It has caused ocular manifestations in some patients, which can spread through eye secretions. The purpose of this review was to summarize the currently available evidence on COVID-19 with regard to its implications for ophthalmology. Narrative review developed by a research group at Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil, and at Ludwig-Maximilians-Universität, Munich, Germany. We searched the literature on the repercussions of COVID-19 within ophthalmological care, using the MEDLINE and LILACS databases, with the keywords "COVID-19", "ophthalmology" and "coronavirus", from January 1, 2020, to March 27, 2021. Clinical trials, meta-analysis, randomized controlled trials, reviews and systematic reviews were identified. We retrieved 884 references, of which 42 were considered eligible for intensive review and critical analysis. Most of the studies selected reported the evidence regarding COVID-19 and its implications for ophthalmology. Knowledge of eye symptoms and ocular transmission of the virus remains incomplete. New clinical trials with larger numbers of patients may answer these questions in the future. Moreover, positively, implementation of innovative changes in medicine such as telemedicine and artificial intelligence may assist in diagnosing eye diseases and in training and education for students.

Validation of the Brazilian Portuguese version of the narcolepsy severity scale

IntroductionNarcolepsy type 1 is a sleep disorder and the most common cause of hypersonia of central origin. It is characterized by sleep attacks, cataplexy, sleep-related hallucinations, sleep paralysis and sleep fragmentation in a pleomorphic presentation. The Narcolepsy Severity Scale (NSS), questionnaire which assesses the frequency and impact of the main symptoms of narcolepsy was developed in order to determine its clinical severity, needing translation, cultural adaptation and validation in many languages. The objective is to validate the Brazilian Portuguese version of the NSS. MethodsThe Brazilian version of the NSS was translated to Brazilian Portuguese and applied to patients with a diagnosis of narcolepsy type 1 at the Daytime Excessive Sleepiness Service, at Psychobiology Department of the Universidade Federal de São Paulo (UNIFESP) between February 2018 and July 2019. ResultsA total of 52 patients completed the questionnaire. Cultural adaptations were made to better comprehension of patients. The Brazilian version of the NSS showed high internal consistency, demonstrated by the Cronbach's alpha coefficient of 0.82. It showed good reproducibility capacity, verified through the test-retest, whose intraclass correlation was 0.98. The average severity of Brazilian patients was 33.94 (±11.24), higher than the values found in other population, which also underwent validation of this scale. There was a correlation between sleep latency in diagnostic polysomnography and the NSS. ConclusionsThe Brazilian Portuguese version of NSS showed to be valid and reproducible tool for assessing the severity of patients with type 1 narcolepsy and have potential impact on clinical practice.

Preoperative Fasting Abbreviation and its Effects on Postoperative Nausea and Vomiting Incidence in Gynecological Surgery Patients.

To investigate the effects of preoperative fasting abbreviation with a carbohydrate and protein-enriched solution, on postoperative nausea and vomiting (PONV) incidence in gynecological surgery patients, a population naturally at risk for such unpleasant episodes. The present prospective double-blind randomized study was performed at The Hospital Municipal e Maternidade Dr. Odelmo Leão Carneiro (HMMOLC, in the Portuguese acronym), in Uberlândia, state of Minas Gerais, Brazil, in partnership with the Gynecology Department of the Universidade Federal de São Paulo (UNIFESP), approved by the Human Research Ethics Committee of UNIFESP and the board of HMMOLC, and included in the Brazil Platform and in the Brazilian Clinical Trial Registry. After signing the consent form, 80 women, who were submitted to gynecological surgery in the period from January to June 2016, were randomized into 2 groups: control group (n = 42) and juice group (n = 38). They received, respectively, 200 mL of inert solution or liquid enriched with carbohydrate and protein 4 hours presurgery. The incidence, frequency and intensity of PONV were studied using the Visual Analogue Scale (VAS), with statistical analysis performed by the software IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, NY, USA). The incidence of nausea and vomiting was lower than in the literature, to this population, with 18.9% (14/74) for the control group and 10.8% (8/74) for the juice group, respectively, with no statistically significant difference between the groups. The incidence of nausea and vomiting was lower than in the literature, but it cannot be said that this is due to the abbreviation of fasting. It can provide greater comfort, with the possibility of PONV prevention in patients at risk for these episodes.

Alterações no estado nutricional segundo IMC e perda de peso, em pacientes com câncer de cabeça e pescoço em uso de terapia nutricional enteral, em ambulatório de oncologia clínica em São Paulo

Introduction: Head and neck cancer (HNC) patients constitute a recognized risk group for malnutrition due to several factors, and may require enteral nutritional therapy (ENT). This study evaluated alterations in nutritional status and weight loss in patients with HNC using ENT followed at the Universidade Federal de São Paulo (UNIFESP) oncology outpatient clinic. Methods: This was a retrospective study conducted through database analysis, collected from January to December of 2018 at an UNIFESP oncology outpatient clinic. We selected all patients with HNC in use of ENT at some moment of the treatment during 2018. Weight and height were considered to calculate body mass index (BMI) and to classify nutritional status and the classification of weight loss for evaluation. Results: The sample consisted of 24 patients, 71% were elderly and 29% adults and 75% were men. At the first consultation in 2018, 6 (25%) patients were at normal weight and 15 (63%) had some degree of malnutrition (underweight). A total of 11 (46%) patients reported previous weight loss. After the analysis it was found that 54% of patients had weight loss in the period, however, only 1 patient had severe weight loss. Changes in BMI were observed in all patients, but in 88% of the cases there was no change in BMI classification. Conclusion: Although patients were on ENT, many had weight loss, which may be a result of decreased food intake, metabolic abnormalities caused by tumor activity, or a consequence of treatment-related symptoms. Most of the weight losses were not significant, and most patients had increased body weight, which may have been result of ENT use, which is responsible for delayed weight loss in cancer patients.

Benign breast tumors: epidemiological profile and therapeutic conduct at the escola paulista de medicina

Introduction: Breasts represent an important site for the development of diseases. It is known that 80% of the palpable masses of the breast are of benign origin. Benign breast diseases range from inflammatory to neoplastic processes. Objectives: to evaluate the clinical and epidemiological characteristics of patients diagnosed with benign breast tumor at the Mastology outpatient clinic of the Universidade Federal de São Paulo (UNIFESP). Methods: 1,532 medical records, available on the electronic platform PEP-HUHSP through the ICD D24 (benign breast cancer) and N63 (unspecified breast nodule), of patients referred to the service between July 2008 and July 2017 were reviewed. After applying exclusion criteria, 403 medical records were submitted to data collection and tabulation in Excel, followed by statistical analysis using the IBM SPSS Statistics 23 software. The study in question was approved by the Research Ethics Committee of UNIFESP (CEP UNIFESP), in the Teaching and Research Coordination of Hospital São Paulo – Hospital Universitário/UNIFESP (CoEP of HSP-HU/UNIFESP) and exempted from the application of the Informed Consent by the same organs. Results: In the 9-year period, the following results were obtained: mean age was 39.3 years. Comorbidities: smoking (16.4%), SAH (16.8%) and dyslipidemia (6.3%). Family history of breast and/or ovarian cancer accounted for 16.6%. Mean age of menarche and menopause, respectively, were 12.7 and 42.5 years. Causes of referral: "alteration in image examination" (38.3%), "lump in the breast" (33.3%), "follow-up due to previous nodules" (16.5%). Anatomopathological report: fibroadenoma (41%), breast cysts (16%), phylloid tumors (3%), and papilloma (1%). Mean number of consultations per patient until discharge or abandonment of follow-up: three. Choice behavior: expectant (85.2%). Conclusion: The epidemiological profile of patients referred to the UNIFESP tertiary mastology service was mainly composed of women of childbearing age and nulliparous women, whose main comorbidities were smoking and SAH, in the great majority with no family history of breast cancer. Regarding the consultation, the main reason for referral is the findings on imaging exams, and, specially, patients would bring their breast USG along, which surpassed mammography by 34.1%. The choice for biopsy was restricted, present in approximately 1/3 of the cases, but pointed out that the most prevalent nodule is fibroadenoma, followed by phylloid and papilloma tumors. Nevertheless, there was a predilection for expectant conduct. On average, there were regular follow-ups for 1.5 years, followed by a significant dropout rate.

What do Cochrane systematic reviews say about interventions for age-related macular degeneration?

Age-related macular degeneration (AMD) is the third largest cause of blindness worldwide, accounting for 8.7% of all cases. A considerable number of preventive or therapeutic interventions have been used for AMD. This study presents a critical view of the interventions that have been assessed through Cochrane systematic reviews. Review of systematic reviews, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). Review of Cochrane systematic reviews about interventions for AMD. The 18 systematic reviews included assessed the effects of surgical techniques, laser/photo/radiotherapy, intravitreal injections, systemic drugs and phytotherapy/vitamins/supplements. The Cochrane systematic reviews found evidence that use of bevacizumab, ranibizumab, pegaptanib, laser photocoagulation, photodynamic therapy and multivitamin compounds may present some benefits for treating AMD. There was insufficient evidence for supporting the use of macular translocation, submacular surgery, steroid implantation, radiotherapy, intravitreal aflibercept, interferon alfa, statins or omega-3 fatty acids for treating AMD; or the use of multivitamin antioxidant vitamins or mineral supplementation for preventing AMD. Future randomized controlled trials are imperative to reduce the uncertainty in several clinical questions regarding AMD.

What do Cochrane systematic reviews say about the management of irritable bowel syndrome?

Irritable bowel syndrome (IBS) is a clinical disorder associated with high socioeconomic burden. Despite its importance, management of IBS remains difficult and several interventions have been hypothesized as beneficial for this condition. This study identified and summarized all Cochrane systematic reviews (SRs) about the effects of interventions for managing IBS patients. Review of systematic reviews, carried out in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). Review of Cochrane SRs addressing interventions for IBS. We included six SRs assessing acupuncture, bulking agents, antispasmodics, antidepressants, herbal medicines, homeopathy, hypnotherapy and psychological therapy for IBS. The certainty of evidence ranged from unknown to moderate, mainly due to imprecision in the estimates and high risk of bias from the primary studies included. There was moderate certainty of evidence that acupuncture had no important benefit regarding improvement of symptoms and quality of life, compared with sham acupuncture. There was also very low certainty of evidence that homeopathic asafoetida, used alone or in association with nux, was better than placebo regarding self-reported overall improvement. There was moderate certainty of evidence that acupuncture had no important benefit regarding improvement of symptoms and quality of life. Further well-designed and well-conducted randomized clinical trials are needed in order to reduce the uncertainties regarding the most commonly used interventions for patients with IBS.

A política de reestruturação das universidades federais e a instituição de modelos formativos inovadores

No ano de 2007 foi instituído no Brasil, por meio do Decreto nº 6.096, o Programa de Apoio aos Planos de Reestruturação e Expansão das Universidades Federais brasileiras, conhecido como REUNI. Entre seus principais objetivos estavam os de expandir o número de vagas no ensino superior público, elevar as taxas de conclusão e diminuir a evasão dos cursos. Um pouco antes do REUNI, a Universidade Federal de São Paulo (Unifesp) já tinha dado início a um processo de expansão e posteriormente aderiu ao programa, ampliando ainda mais o número de cursos, vagas e campi.Paralelamente aos cursos que tradicionalmente oferecia, a universidade implantou novos e com distintos modelos formativos, dentre eles, os chamados bacharelados interdisciplinares (BI). Tendo em vista esse panorama, este artigo analisa os diferentes modelos formativos da Unifesp a fim de compreender em que medida favorecem a permanência e a conclusão de seus estudantes. Para tanto, foram analisados dados referentes à matrícula, coeficiente de rendimento, taxa de evasão e taxa de sucesso acadêmico nos diferentes modelos formativos. A análise mostra que modelos alternativos por si sós não ampliam a permanência e a conclusão e não melhoram os rendimentos acadêmicos dos estudantes, inclusive nos BI. Ao fim, recomenda-se conhecer melhor o perfil e atender de forma mais adequada às necessidades básicas dos novos estudantes.

Combining RNA-seq and ddRAD-seq to SNP discovery of a highly migratory and apex predator

Combining RNA-seq and ddRAD-seq to SNP discovery of a highly migratory and apex predator

What do Cochrane systematic reviews say about interventions for insomnia?

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. Review of SRs, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). 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. 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. 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.