MOACYR ROBERTO CUCE NOBRE
Projetos de Pesquisa
Unidades Organizacionais
Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina
LIM/38 - Laboratório de Epidemiologia e Imunobiologia, Hospital das Clínicas, Faculdade de Medicina
LIM/38 - Laboratório de Epidemiologia e Imunobiologia, Hospital das Clínicas, Faculdade de Medicina
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- Predictors of the risk of falls among elderly with chronic atrial fibrillation(2012) SANTOS, Angela Cristina Silva dos; NOBRE, Moacyr Roberto Cuce; NUSSBACHER, Amit; RODRIGUES, Giselle Helena de Paula; GEBARA, Otavio Celso Eluf; AZUL, Joao Batista Carvalho Serro; WAJNGARTEN, MauricioOBJECTIVES: Though elderly persons with chronic atrial fibrillation have more comorbidities that could limit indications for the chronic use of anticoagulants, few studies have focused on the risk of falls within this particular group. To evaluate the predictors of the risk of falls among elderly with chronic atrial fibrillation, a cross-sectional, observational study was performed. METHODS: From 295 consecutive patients aged 60 years or older with a history of atrial fibrillation who were enrolled within the last 2 years in the cardiogeriatrics outpatient clinic of the Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, 107 took part in this study. Their age was 77.9 +/- 6.4 years, and 62 were female. They were divided into two groups: a) no history of falls in the previous year and b) a history of one or more falls in the previous year. Data regarding the history of falls and social, demographic, anthropometric, and clinical information were collected. Multidimensional assessment instruments and questionnaires were applied. RESULTS: At least one fall was reported in 55 patients (51.4%). Among them, 27 (49.1%) presented recurrent falls, with body lesions in 90.4% and fractures in 9.1% of the cases. Multivariate logistic regression showed that self-reported difficulty maintaining balance, use of amiodarone, and diabetes were independent variables associated with the risk of falls, with a sensitivity of 92.9% and a specificity of 44.9%. CONCLUSION: In a group of elderly patients with chronic atrial fibrillation who were relatively independent and able to attend an outpatient clinic, the occurrence of falls with recurrence and clinical consequences was high. Difficulty maintaining balance, the use of amiodarone and a diagnosis of diabetes mellitus were independent predictors of the risk for falls. Thus, simple clinical data predicted falls better than objective functional tests.
- The effect of Sao Paulo's smoke-free legislation on carbon monoxide concentration in hospitality venues and their workers(2011) ISSA, Jaqueline S.; ABE, Tania M. O.; PEREIRA, Alexandre C.; MEGID, Maria Cristina; SHIMABUKURO, Cristina E.; VALENTIN, Luis Sergio O.; FERREIRA, Marizete M. da C.; NOBRE, Moacyr R. C.; LANCAROTTE, Ines; BARRETTO, Antonio Carlos PereiraBackground Studies have shown that there is no safe level of secondhand smoke (SHS) exposure and there is a close link between SHS and the risk of coronary heart disease and stroke. Carbon monoxide (CO) is one of the most important components present in SHS. Objective To evaluate the impact of the smoking ban law in the city of Sao Paulo, Brazil, on the CO concentration in restaurants, bars, night clubs and similar venues and in their workers. Methods In the present study we measured CO concentration in 585 hospitality venues. CO concentration was measured in different environments (indoor, semi-open and open areas) from visited venues, as well as, in the exhaled air from approximately 627 workers of such venues. Measurements were performed twice, before and 12 weeks after the law implementation. In addition, the quality of the air in the city during the same period of our study was verified. Results The CO concentration pre-ban and pot-ban in hospitality venues was indoor area 4.57 (3.70) ppm vs 1.35 (1.66) ppm (p<0.0001); semi-open 3.79 (2.49) ppm vs 1.16 (1.14) ppm (p<0.0001); open area 3.31 (2.2) ppm vs 1.31 (1.39) ppm (p<0.0001); smoking employees 15.78 (9.76) ppm vs 11.50 (7.53) ppm (p<0.0001) and non-smoking employees 6.88 (5.32) ppm vs 3.50 (2.21) ppm (p<0.0001). The average CO concentration measured in the city was lower than 1 ppm during both pre-ban and post-ban periods. Conclusion Sao Paulos smoking-free legislation reduced significantly the CO concentration in hospitality venues and in their workers, whether they smoke or not.
- Clinical guidelines and patient related outcomes: summary of evidence and recommendations(2019) VASCONCELOS, Luciana Pereira de; RODRIGUES, Luiza de Oliveira; NOBRE, Moacyr Roberto CucePurpose Good medical practice, evidence-based medicine (EBM) and clinical practice guidelines (CPG) have been recurring subjects in the scientific literature. EBM advocates argue that good medical practice should be guided by evidence-based CPG. On the other hand, critical authors of EBM methodology argue that various interests undermine the quality of evidence and reliability of CPG recommendations. The purpose of this paper is to evaluate patient related outcomes of CPG implementation, in light of EBM critics. Design/methodology/approach The authors opted for a rapid literature review. Findings There are few studies evaluating the effectiveness of CPG in patient-related outcomes. The systematic reviews found are not conclusive, although they suggest a positive impact of CPGs in relevant outcomes. Originality/value The paper is the first of its kind to discuss, based on the published literature, next steps toward better health practice, while acknowledging the caveats of this process.
- New lung cancer treatments in Brazil, inequalities in patient access between the private and public health systems and differences in market access compared with the USA(2020) RIBEIRO, Tatiane Bomfim; MELO, Daniela Oliveira de; KELLES, Silvana Marcia Bruschi; NOBRE, Moacyr Roberto CuceObjective: To assess the differences in market access in Brazil and the USA for lung cancer treatment other than chemotherapy, and to assess Brazilian patient access to these drugs comparing the public health care system and private setting. Method: New lung cancer drugs other than chemotherapy, and approved since 2006, were assessed in the US Food and Drug Administration (FDA) online database. For approvals prior to 2006 we consulted cross-references. We assessed the corresponding Brazilian Health Surveillance Agency (ANVISA) approval dates and indications until 2018. In order to assess patient access, we consulted the online lists in the official organization responsible for the incorporation of new drugs in the Brazilian public health care system and private setting. Results: The FDA approved 19 lung cancer drugs, 14 of which were registered in Brazil until 2018. The market access for new lung cancer drugs diverged between Brazil and USA in 23 months however, in the past years probably due to Brazilian changes in law for faster drug approval, it decreased to 12 months or less. The label indications were similar between the FDA and ANVISA in almost 80 % of cases. The ANVISA online database, unlike the FDA database, has scarce information about drug approvals. Around 80 % (11 in 14) of lung cancer drugs approved in Brazil were available in Brazilian private setting and 14 % (2 in 14) in the public health system, divergence might be explained by divergences in regulatory standards for health technology assessment. Conclusion: Time to market access for lung cancer drugs varied between the FDA and ANVISA but its difference decreased in the past years. Patient access for cancer drugs can vary among patients attending in the same country and it depends on regulatory standards for health technology assessment.
- Comparison of application times for ice packs used to relieve perineal pain after normal birth: a randomised clinical trial(2012) OLIVEIRA, Sonia M. J. V.; SILVA, Flora M. B.; RIESCO, Maria L. G.; LATORRE, Maria do Rosario Do; NOBRE, Moacyr R. C.Aims and objectives. To compare the effect of an ice pack applied for 10, 15 and 20 minutes to relieve perineal pain after birth. Background. Perineal pain after vaginal birth, with or without vaginal trauma, is one of the most common morbidities reported for postnatal women. Cryotherapy has been used in postpartum period to relieve perineal pain and investigated in several studies. However, cryotherapy treatment protocols in perineal care vary widely regarding temperature, frequency and duration of the application. Design. A controlled trial, randomised for two groups and with a third group as a historical control. Method. The intervention was carried out in a maternity hospital in Sao Paulo, Brazil. The study population consisted of three groups of 38 women who used an ice pack on the perineum, in a single application: group A-10 minutes; group B-15 minutes; group C-20 minutes (historical control from another clinical trial). Participants perineal pain magnitude was evaluated through a numerical scale (010), at four different points: before the cryotherapy; immediately after and at 20 and 40 minutes after cryotherapy. Results. After application of the ice pack, there was no statistical difference when comparing the perineal pain among groups in the second, third and fourth evaluations. Most of the postnatal women reported pain relief, with 72.8% reporting a decrease in pain >50%; 21.9% reported a decrease between 3050%. All postnatal women subjected to cryotherapy were favourable to the procedure. Conclusion. There is no difference in pain scores following ice pack application in three different times (10, 15 and 20 minutes) in women who report moderate or intense perineal pain after normal delivery. Relevance for clinical practice. Ice treatment is safe, and application times of 10 or 15 minutes are as beneficial as an application time of 20 minutes to relieve perineal pain.
- Risk factors for adverse events of colorectal endoscopic submucosal dissection: a systematic review and meta-analysis(2021) SANTOS, Juliana B.; NOBRE, Moacyr R. C.; OLIVEIRA, Cleyton Z.; SAFATLE-RIBEIRO, Adriana V.; KAWAGUTI, Fabio; MARTINS, Bruno; NAHAS, Sergio C.; RIBEIRO JR., Ulysses; ZHANG, Lanjing; MALUF-FILHO, FauzeColorectal endoscopic submucosal dissection (ESD) is already an established treatment for superficial colorectal tumors. However, its technical difficulty and high adverse events rates, compared to endoscopic piecemeal mucosal resection, are a concern to some specialists and have probably contributed to discouragement in its widespread adoption. The debate mentioned above stimulated us to perform a systematic review aiming to identify risk factors for colorectal ESD-related adverse events. We conducted this study following the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement and registered in the PROSPERO (University of York) international database (CRD42016042625). We searched MEDLINE, EMBASE, Cochrane Library and LILACS for the publications focused on risk factors for colorectal ESD-related adverse events from inception until April 2020. We included a total of 22 qualified studies in this analysis. We found that fibrosis had an odds ratio (OR) for perforation of 2.90 [95% confidence interval, (1.83-4.59)], right colon location of 2.35 (1.58-3.50), colonic location of 2.20 (1.44-3.35) and larger size of 2.17 (1.47-3.21), as well as one protective factor, the endoscopist experience OR = 0.62 (0.45-0.86). For bleeding, we considered rectal location a risk factor [OR = 3.55 (2.066.12)]. Through the several meta-analyses that we performed in this article, we could summarize the main risk factors for perforation and bleeding on colorectal ESD. Therefore, we provide insightful information for clinical judgment on regions where colorectal ESD is already widespread and help in the learning process of this challenging technique.
- US Food and Drug Administration anticancer drug approval trends from 2016 to 2018 for lung, colorectal, breast, and prostate cancer(2020) RIBEIRO, Tatiane Bomfim; RIBEIRO, Adalton; RODRIGUES, Luiza de Oliveira; HARADA, Guilherme; NOBRE, Moacyr Roberto CuceObjective This paper aims to describe the clinical and regulatory aspects of new drugs and indications that were approved for lung, breast, prostate, and colorectal cancer, from 2016 to 2018, in order to provide health technology assessment trends in oncology. Methods Data were collected from the US Food and Drug Administration (FDA) online database for new medications and indications approved for the above-mentioned types of cancer. Data regarding clinical study characteristics and regulatory information were collected. Results From 2016 to 2018, 53 percent of the FDA approvals of new drugs and indications for the most incident cancers were for oral protein kinase inhibitor monotherapy for advanced lung cancer. Since 2018, four drugs were approved as tumor-agnostic therapies. A biomarker was included in 72 percent of indications, and 58 percent of approvals were for targeted therapies, potentially heralding an end to research into conventional cytotoxic agents. A special designation for faster approval was granted in 78 percent of new approvals. The majority of the studies were open label randomized controlled trials (RCTs) (44 percent), followed by blind RCTs, single-arm clinical trials, and cohort studies. Only 14 percent of studies used overall survival as the primary end point; the vast majority used surrogate end points, and did not use patient-important outcomes. Three biosimilars were approved in the period. Conclusion Advanced lung cancer therapy, mainly targeted drugs, accounted for 53 percent of approvals. Special designations for faster approval were used in 78 percent of FDA approvals, and four drugs were approved for tumor-agnostic treatment-a new form of approval.
- Ice pack induced perineal analgesia after spontaneous vaginal birth: Randomized controlled trial(2018) FRANCISCO, Adriana Amorim; OLIVEIRA, Sonia Maria Junqueira Vasconcellos De; STEEN, Mary; NOBRE, Moacyr Roberto Cuce; SOUZA, Eder Viana DeBackground: Ice-pack is widely used for alleviating postpartum perineal pain sustained after birth related perineal trauma. However, it lacks robust evidence on timing and frequency of applications, to ensure the effective and safe use of this therapy. Aims: To evaluate if a 10 min ice-pack application relieved postpartum perineal pain and if the analgesic effect was maintained for up to 2 h. Methods: A randomised controlled trial conducted from December 2012 to February 2013 with 69 primiparous women >= 18 years old, 6-24 h postpartum, with perineal pain >= 3, who had not received anti-inflammatory medication or analgesics after childbirth, who were randomised to a single ice-pack application on the perineum for 10 min or standard care. The primary and secondary outcomes were a reduction >= 30% in perineal pain intensity, immediately after the application and the maintenance of the analgesic effect for up to 2 h, respectively. Findings: Immediately post-intervention, the proportion of women whose perineal pain decreased >= 30% was significantly higher in the experimental group. Within 2 h, there was no significant difference in the pain levels in both groups. Within 2 h, for 61.9% and 89.3% of women in the experimental and control group, respectively, the perineal pain levels remained unchanged. For the remaining participants, perineal pain was increasing after an average time of 1 h 45 min and 1 h 56 min for the experimental and control groups, respectively. Conclusion: By applying an ice-pack for 10 min to the perineum, effective pain relief is achieved, that is maintained for between 1 h 45 min and 2 h.
conferenceObject - Factors associated with maternal intrapartum transfers from a freestanding birth centre in Sao Paulo, Brazil: A case control study(2012) SILVA, Flora Maria Barbosa da; OLIVEIRA, Sonia Maria Junqueira Vasconcellos de; BICK, Debra; OSAVA, Ruth Hitomi; NOBRE, Moacyr Roberto Cuce; SCHNECK, Camilla AlexsandraObjectives: to identify factors associated with maternal intrapartum transfer from a freestanding birth centre to hospital. Design: case-control study with retrospective data collection. Participants and settings: cases included all 111 women transferred from a freestanding birth centre in Sao Paulo to the referral hospital, from March 2002 to December 2009. The controls were 456 women who gave birth in the birth centre during the same period who were not transferred, randomly selected with four controls for each case. Methods: data were obtained from maternal records. Factors associated with maternal intrapartum transfers were initially analysed using a chi(2) test of association. Variables with p < 0.20 were then included in multivariate analyses. A multiple logistic regression model was built using stepwise forward selection; variables which reached statistical significance at p < 0.05 were considered to be independently associated with maternal transfer. Findings: during the study data collection period, 111(4%) of 2,736 women admitted to the centre were transferred intrapartum. Variables identified as independently associated factors for intrapartum transfer included nulliparity (OR 5.1, 95% CI 2.7-9.8), maternal age >= 35 years (OR 5.4, 95% CI 2.1-13.4), not having a partner (OR 2.8, 95% CI 1.5-5.3), cervical dilation <= 3 cm on admission to the birth centre (OR 1.9, 95% CI 1.1-3.2) and between 5 and 12 antenatal appointments at the birth centre (OR 3.8, 95% CI 1.9-7.5). In contrast, a low correlation between fundal height and pregnancy gestation (OR 0.3, 95% CI 0.2-0.6) appeared to be protective against transfer. Conclusions and implications for practice: identifying factors associated with maternal intrapartum transfer could support decision making by women considering options for place of birth, and support the content of appropriate information about criteria for admission to a birth centre. Findings add to the evidence base to support identification of women in early labour who may experience later complications and could support timely implementation of appropriate interventions associated with reducing transfer rates.