Feasibility and Colonoscopy Yield Using the Fecal Immunochemical Test (FIT)-Based Colorectal Cancer Screening in a Latin America Country.

BACKGROUND & AIMS: Organized colorectal cancer (CRC) screening is not widely practiced in Latin America and the results of regional studies may help overcome barriers for implementation of national screening programs. We aimed to describe the implementation and findings of a fecal immunochemical test (FIT)-based program in Brazil. METHODS: In a prospective population-based study, asymptomatic individuals (50-75 years old) from Sao Paulo city were invited to undergo FIT for CRC screening. Participants with positive FIT (≥10 µg Hb/g feces) were referred for colonoscopy. Subjects were classified into groups according to the presence of CRC, precursor lesions, and other benign findings, possibly related to bleeding. RESULTS: Of a total of 9881 subjects, 7.8% had positive FIT and colonoscopy compliance was 68.9% (n = 535). Boston scale was considered adequate in 99% and cecal intubation rate was 99.4%. CRC was diagnosed in 5.9% of the cases, adenoma in 63.2%, advanced adenoma in 31.4%, and advanced neoplasia in 33.0%. Age was positively associated with CRC (P = .03). Higher FIT concentrations were associated with increased detection of CRC (P < .008), advanced adenoma (P < .001), and advanced neoplasia (P < .001). CONCLUSIONS: Implementation of a FIT-based CRC screening program was feasible in a low-resource setting, and there was a high yield for neoplasia in individuals with a positive FIT. This approach could be used as a model to plan and disseminate organized CRC screening more broadly in Brazil and Latin America.

Attendance for diagnostic colposcopy among high-risk human papillomavirus positive women in a Brazilian feasibility study.

OBJECTIVE: To investigate factors associated with colposcopy attendance in HPV-positive women in São Paulo, Brazil. METHODS: We analyzed data from a prospective cohort of women positive for high-risk HPV (hr-HPV) undergoing cervical cancer screening in primary care services in São Paulo, Brazil. Non-pregnant women attending routine screening between December 2014 and March 2016 were offered an hr-HPV test, and those testing positive and aged 25 years or older were invited for colposcopy. Sociodemographic information was recorded at study enrollment. We compared variables between women who did and did not attend colposcopy within a logistic regression framework. RESULTS: Of 1537 hr-HPV-positive women, 1235 (80.4%) attended for colposcopy, with a median time from primary test to colposcopy of 132 days. Younger age (P<0.001) and concurrent negative cytology results (P=0.025) were associated with lower attendance. Women registered at units providing both the primary test and colposcopy were more likely to attend than those at units making external referrals (788/862 [91.4%] versus 447/675 [66.2%], P<0.001). CONCLUSION: Non-attendance for colposcopy may limit the success of future screening programs based on hr-HPV testing in Brazil. Transfer of colposcopy services to primary care is a simple and effective facilitator of attendance.

A Bispecific Molecule Targeting CD40 and Tumor Antigen Mesothelin Enhances Tumor-Specific Immunity.

Agonistic CD40 monoclonal antibodies (mAb) have demonstrated some clinical activity, but with dose-limiting toxicity. To reduce systemic toxicity, we developed a bispecific molecule that was maximally active in the presence of a tumor antigen and had limited activity in the absence of the tumor antigen. LB-1 is a bispecific molecule containing single-chain Fv domains targeting mouse CD40 and the tumor antigen mesothelin. LB-1 exhibited enhanced activity upon binding to cell-surface mesothelin but was less potent in the absence of mesothelin binding. In a mouse model implanted with syngeneic 4T1 tumors expressing cell-surface mesothelin, LB-1 demonstrated comparable antitumor activity as an agonistic CD40 mAb but did not cause elevation of serum cytokines and liver enzymes, as was observed in anti-CD40-treated mice. The results from our study of LB-1 were used to develop a human cross-reactive bispecific molecule (ABBV-428) that targeted human CD40 and mesothelin. ABBV-428 demonstrated enhanced activation of antigen-presenting cells and T cells upon binding to cell-surface mesothelin, and inhibition of cultured or implanted PC3 tumor cell growth after immune activation. Although expression of cell-surface mesothelin is necessary, the bispecific molecules induced immune-mediated antitumor activity against both mesothelin+ and mesothelin- tumor cells. ABBV-428 represents a class of bispecific molecules with conditional activity dependent on the binding of a tumor-specific antigen, and such activity could potentially maximize antitumor potency while limiting systemic toxicity in clinical studies.

High-Risk HPV Testing in Primary Screening for Cervical Cancer in the Public Health System, São Paulo, Brazil.

Every year there are approximately 16,000 new cases of cervical cancer in Brazil. Novel screening technologies may reduce this number by expanding the population coverage but also by improving the detection rate of precursor lesions. We aimed to evaluate human papillomaviruses (HPV)-DNA testing in the context of routine cervical cancer screening in the public health system of the city of São Paulo, Brazil. Women participating in the primary screening program were invited to enroll. Liquid-based cytology samples were collected and cytology and Hr-HPV DNA testing were performed in parallel. Cytologists were blind to HPV results. Women older than 24 years with a positive high-risk HPV test and/or cytology class ≥ ASC-US were referred to colposcopy. From December 2014 to December 2016, 16,102 women joined the study. High-risk human papillomavirus (HR HPV) DNA prevalence was 14.9%, whereas cytologic abnormalities were found in 7.2% of the women. Per protocol, 1,592 Hr-HPV+ women, in addition to 72 patients with cytologic classification > low-grade squamous intraepithelial lesion (LSIL) were referred. A total of 80 cervical intraepithelial neoplasia (CIN2+) cases were diagnosed, 79 were Hr-HPV DNA+ and 18 had normal cytology. Hr-HPV DNA detected a significant number of patients with premalignant lesions missed by cytology and all 16 CIN3+ cases were Hr-HPV DNA+ HPV genotyping may be useful in the management of Hr-HPV+ women, reducing the burden of colposcopic referral for those harboring genotypes with a weaker association to CIN3+ Use of HPV-DNA testing was shown to be feasible and advantageous over current cytologic screening in the public health system.

Influence of Prior Knowledge of Human Papillomavirus Status on the Performance of Cytology Screening.

OBJECTIVES: This study aimed to evaluate the influence of prior knowledge of human papillomavirus (HPV) status in cervical cytopathology readings. METHODS: Participants comprised 2,376 women who underwent parallel cytology and HPV-DNA testing. Smears were read twice by the same team, first with previous knowledge of HPV-DNA status. RESULTS: Overall, 239 (10.2%) smears had their cytology classification altered by the HPV-informed review. Cytology readings with prior knowledge of the HPV status revealed 10.5% of abnormal smears (atypical squamous cells of undetermined significance or higher), while without prior knowledge, this rate dropped to 7.6%. When HPV status was informed, a significant increase in all categories of altered smears was observed. Cytology with prior knowledge of HPV status detected more cervical intraepithelial neoplasia grade 2 or higher (CIN 2+) compared with blinded: 86.7% vs 60.0%. CONCLUSIONS: Our data indicate that cytology interpreted with prior knowledge of the HPV status provides higher sensitivity for CIN 2+ lesions while marginally reducing the overall specificity compared with HPV status blinded cytology.

Critical Analyses of the Introduction of Liquid-Based Cytology in a Public Health Service of the State of São Paulo, Brazil.

OBJECTIVE: The aim of this study was to compare the performance of the current conventional Pap smear with liquid-based cytology (LBC) preparations. STUDY DESIGN: Women routinely undergoing their cytopathological and histopathological examinations at Fundação Oncocentro de São Paulo (FOSP) were recruited for LBC. Conventional smears were analyzed from women from other areas of the State of São Paulo with similar sociodemographic characteristics. RESULTS: A total of 218,594 cases were analyzed, consisting of 206,999 conventional smears and 11,595 LBC. Among the conventional smears, 3.0% were of unsatisfactory preparation; conversely, unsatisfactory LBC preparations accounted for 0.3%. The ASC-H (atypical squamous cells - cannot exclude high-grade squamous intraepithelial lesion) frequency did not demonstrate any differences between the two methods. In contrast, the incidence of ASC-US (atypical squamous cells of undetermined significance) was almost twice as frequent between LBC and conventional smears, at 2.9 versus 1.6%, respectively. An equal percentage of high-grade squamous intraepithelial lesions were observed for the two methods, but not for low-grade squamous intraepithelial lesions, which were more significantly observed in LBC preparations than in conventional smears (2.2 vs. 0.7%). The index of positivity was importantly enhanced from 3.0% (conventional smears) to 5.7% (LBC). CONCLUSIONS: LBC performed better than conventional smears, and we are truly confident that LBC can improve public health strategies aimed at reducing cervical lesions through prevention programs.

Penetração da perspectiva de gênero e análise crítica do desenvolvimento do conceito na produção científica da Saúde Coletiva / Penetration of the gender perspective and critical analysis on the development of this concept within scientific production on public health / La penetración de la perspectiva de género y análisis crítico de la evolución del concepto en la producción científica en Salud Pública

Estudou-se a produção científica brasileira baseada em gênero na Saúde Coletiva, entre 1990-2008. Um total de 1.343 resumos de trabalhos de congressos e 251 artigos publicados foi examinado segundo: distribuição temporal, autoria, abordagem metodológica, áreas de conhecimento e temáticas abordadas. Os artigos foram também analisados quanto à coerência epistemológica entre a intenção e o uso efetivo de gênero ao longo do estudo e quanto à consistência metodológica de aplicação do conceito em termos do sentido completo ou parcial dado a gênero de acordo com sua construção teórica. Resultados mostraram que, embora com penetração crescente, 25,1 por cento dos estudos reduzem gênero a sexo, uso considerado não coerente; 37,8 por cento possuem uso coerente de gênero, mas lhe atribuíram um sentido parcial, e apenas 37,1 por cento deram-lhe o sentido completo. Conclui-se que gênero tem importante presença no campo, mas é trabalhado de modo pouco preciso metodologicamente e inferior a seu potencial analítico.

Gender-based scientific production within public health from 1990 to 2008 was studied. A total of 1343 congress abstracts and 251 published articles was examined regarding their distribution in time, authorship, methodological approach, fields of knowledge and topics covered. The articles were also analyzed regarding epistemological coherence between the intention to use gender and actually doing so over the study, and regarding methodological consistency in applying the concept in terms of complete or partial meaning given to gender in accordance with its theoretical construction. The results showed that, despite its increasing penetration, 25.1 percent of the studies reduced gender to sex, what was considered to be non-coherent use; 37.8 percent had coherent gender use but gave it partial meaning; and only 37.1 percent gave it the complete meaning. In conclusion, gender has an important presence within the field, but is worked up in a methodologically imprecise manner that is lower than its analytical potential.

Se estudia la producción científica brasileña basada en género en Salud Colectiva entre 1990-2008. Un total de 1.343 resúmenes de conferencias y 251 artículos publicados fueron examinados según distribución temporal, autoría, enfoque metodológico, áreas de conocimiento y temas planteados. Los artículos fueron también analizados por la coherencia epistemológica entre la intención y el uso real de género en el estudio de la coherencia y la aplicación metodológica del concepto en términos de sentido total o parcial dado a género por su construcción teórica. Los resultados muestran que, aun que com la penetración cada vez mayor, 25,1 por ciento de los estudios de género se reducen a sexo, un uso considerado no coherente, 37,8 por ciento tienen uso coherente de género, pero con sentido parcial, y sólo 37,1 por ciento ledierón sentido completo. Se concluye que el género tiene una presencia significativa enel campo, pero su utilización es poco precisa metodológicamente y abajo de su potencial analítico.

eLearning to enhance physician patient communication: a pilot test of "doc.com" and "WebEncounter" in teaching bad news delivery.

BACKGROUND: Physician-patient communication skills help determine the nature and quality of diagnostic information elicited from patients, the quality of the physician's counseling, and the patient's adherence to treatment. In spite of their importance, surveys have demonstrated a wide variability and deficiencies in the teaching of these skills. AIM: Describe two specific methodologies for teaching physician-patient communication skills developed at our institution and pilot test them for effectiveness. METHODS: Between 2004 and 2009 we developed "doc.com," a series of 41 media-rich online modules on all aspects of healthcare communication jointly with the American Academy on Communication in Healthcare. Starting in 2006, we expanded our pre-existing experience with the videoconferencing system "WebOSCE" into the online application "WebEncounter." This new methodology combines practice of communication skills on standardized patients with structured assessment and constructive feedback. We had three randomized groups: controls who did only the assessment parts of a WebOSCE on two occasions, a doc.com group who had doc.com in between the assessment occasions, and a combined group that had both doc.com and a WebEncounter between assessments. RESULTS/CONCLUSION: We found significant improvement in skills as components were added, and the training program was well received.

The impact of the changing health care environment on the health and well-being of faculty at four medical schools.

PURPOSE: Increased pressure for clinical and research productivity and decreased control over the work environment have been reported to have adverse impacts on academic faculty in limited studies. The authors examined whether work-related stressors in academic medicine negatively affected the physical and mental health, as well as life and job satisfaction, of academic medical school faculty. METHOD: A 136-item self-administered anonymous questionnaire modified from a small 1984 study was distributed to 3,519 academic faculty at four U.S. medical schools following institutional review board approval at each school. Validated scales measuring depression, anxiety, work strain, and job and life satisfaction; a checklist of common physical and mental health symptoms; and questions about the impact of institutional financial stability, colleague attrition, and other work-related perceptions were used. Responses were analyzed by sex, academic rank, age, marital status, faculty discipline, and medical school. RESULTS: Responses were received from 1,951 full-time academic physicians and basic science faculty, a 54.3% response rate. Twenty percent of faculty, almost equal by sex, had significant levels of depressive symptoms, with higher levels in younger faculty. Perception of financial instability was associated with greater levels of work strain, depression, and anxiety. Significant numbers of faculty acknowledged that work-related strain negatively affected their mental health and job satisfaction, but not life satisfaction or physical health. Specialties were differentially affected. CONCLUSIONS: High levels of depression, anxiety, and job dissatisfaction-especially in younger faculty-raise concerns about the well-being of academic faculty and its impact on trainees and patient care. Increased awareness of these stressors should guide faculty support and development programs to ensure productive, stable faculty.

A survey of residents' attitudes and practices in screening for, managing, and documenting domestic violence.

OBJECTIVE: We conducted this study to identify residents' limitations in screening for, documenting, and managing domestic violence (DV) and to focus future educational interventions. METHODS: We administered a detailed survey to 103 internal medicine residents from 4 university-affiliated programs to ascertain their attitudes about and practices in screening for, documenting, and managing DV. RESULTS: Most residents agreed that DV is a significant health care problem (87%) and one in which physicians can intervene effectively (77%), yet 37% reported not screening for DV. Residents who said they do not screen reported a variety of mitigating factors, from uncertainty about how to screen for and manage DV, to fear of insulting or angering the patient. Eighty-two percent stated that they would document DV in the chart, but 51% had reasons for not documenting DV, ranging from fear that the patient's partner might harm the patient or the physician to concern that the patient may not be telling the truth. Fifty-seven percent of residents said they would ask about DV more often if state law mandated it. When asked to choose which management interventions were helpful or unhelpful, many residents made incorrect, potentially injurious choices. CONCLUSION: Many residents reported beliefs and practices that could inhibit optimal care of DV victims. Educational interventions should be directed at remedying residents' gaps in knowledge and attitudes to improve screening for, documenting, and managing DV.

Evaluating surgeons' informed decision making skills: pilot test using a videoconferenced standardised patient.

BACKGROUND: Standardised patients (SPs) are effective in evaluating communication skills, but not every training site may have the resources to develop and maintain SP programmes. OBJECTIVES: To test whether videoconferencing technology (VT) could enable an interaction between an SP and an orthopaedic surgeon that would allow the SP to accurately evaluate the surgeon's informed decision making (IDM) skills. We also assessed whether this sort of interaction was acceptable to orthopaedic surgeons as a means of learning IDM skills. METHODS: We trained an SP to represent a 75-year-old woman considering hip replacement surgery. Orthopaedic surgeons in Chicago individually consulted with the SP in Philadelphia; each participant could see and hear the other on large television screens. The SP evaluated the surgeons' advice using a 23-item checklist of IDM elements, and gave each surgeon verbal and written feedback on his IDM skills. The surgeons then gave their evaluations of the exercise. RESULTS: Twenty-two surgeons completed the project. The SP was > or = 80% accurate in classifying 20 of the 23 IDM skills when compared to a clinician rater. Although 12 (55%) of the orthopaedic surgeons felt that some aspects of the technology were distracting, most were pleased with it, and 19 of 22 (86%) would recommend the videoconferenced SP interaction to their colleagues as a means of learning IDM skills. CONCLUSIONS: These results suggest that VT allows accurate evaluation of IDM skills in a format that is acceptable to orthopaedic surgeons. Videoconferencing technology may be useful in long-distance SP communication assessment for a variety of learners.

A pilot test of WebOSCE: a system for assessing trainees' clinical skills via teleconference.

WebOSCE is a computer-based system that allows a student at an affiliate site to participate in a 10-station standardized patient-based exam using a videoconference interface, while nine other students take the exam on-site. We pilot-tested this system during a required year-end objective structured clinical exam. We compared performance data between the 26 distance students taking the exam via WebOSCE with 221 on-site students. We also compared both student groups' responses on a post-exam questionnaire, and conducted a post-exam structured interview to elicit the Pittsburgh students' perspectives on the WebOSCE experience. Students taking the exam via WebOSCE scored significantly lower in most categories except for physical exam and information-giving skills, on which the groups did not differ. There were no differences between groups in students' overall evaluation of the exam experiences. In general, Pittsburgh students rated WebOSCE highly and offered many helpful comments to improve the technology and the experience.

An assessment of residents' abilities to detect and manage domestic violence.

Despite increased awareness of domestic violence (DV), little is known about residents' preparedness to diagnose and respond appropriately to abuse victims. We designed a pilot study to examine this. Seventy-one internal medicine residents participated in a 10-station standardized patient-based Clinical Skills Assessment. Forty (56%) were male and 31 (44%) were female; 46 (65%) were PGY I; 63 (89%) were trained internationally. One station presented a woman with headaches, whose underlying issue was DV. Forty (56%) residents correctly diagnosed DV. Thirty referred the patient for DV counseling. Eighteen addressed immediate safety concerns, and 23 asked about child abuse. Forty-eight (68%) made 1 or more incorrect recommendations. Thirty-six (51%) ordered unnecessary tests. Residents who did not diagnose DV spent nearly twice as much per patient on work-up (mean, $942.00), compared to those who diagnosed DV (mean, $421.00). Use of certain interviewing skills appeared to promote elicitation of DV. Assessment-driven educational interventions could help trainees improve their recognition of DV and make appropriate and cost-effective management choices.

Metodologia de avaliaçäo do trabalho na atençäo primária à saúde / Methodology for assessment of activities in primary health care

Realiza-se um estudo de caso, no qual se analisa o processo de avaliaçäo de açöes assistenciais em uma unidade básica de saúde, no sentido de contribuir para o desenvolvimento de metodologias de avaliaçäo do trabalho assistencial e de proposiçäo de categorias orientadoras desses processos de avaliaçäo, tendo como base o processo de trabalho. Foi desenvolvido no Centro de Saúde Escola da Faculdade de Medicina da Universidade de Säo Paulo, tomando como seu material empírico as avaliaçöes das açöes assistenciais dirigidas ao pronto-atendimento e ao atendimento programático de pacientes crônicos (hipertensos e diabéticos). A análise dessas avaliaçöes, que apreenderam diferentes momentos constituintes do processo de trabalho (objetos do trabalho, atuaçäo dos agentes, análise dos meios de trabalho, produto do trabalho), sugerem a necessidade da elaboraçäo de categorias analíticas que operacionalizem a apreensäo desse processo, articulando cada momento à sua totalidade. As categorias analíticas propostas säo: 1) operacionalidade, como medida da efetivaçäo das açöes propostas; 2) efetividade estratégica, como medida do alcance dos resultados apreensíveis nos usuários e/ou na populaçäo, atribuuíveis às açöes realizadas.

Avaliaçäo do processo de atendimento a pacientes portadores de doença crônico-degenerativa em uma unidade básica de saúde / Evaluation of management of patients with chronic degenerative diseases in a primary health clinic

Avalia o desempenho de açöes de saúde desenvolvidas em uma unidade básica de saúde, relativas ao controle da hipertensäo arterial sistêmica (HAS) enquanto estratégia de reduçäo de morbi-mortalidade por doença cardiovascular baseada no enfoque de risco. Estas açöes estruturam-se a partir da detecçäo da hipertensäo arterial na populaçäo adulta atendida no serviço e do controle dos níveis pressóricos nos indivíduos portadores de HAS, incluindo outros fatores de risco conhecidos, bem como tratamento de eventuais complicaçöes. Analisa 3.793 usuários que compareceram pelo menos uma vez à consulta médica no serviço de Assistência ao Adulto de um Centro de Saúde-Escola, do Município de Säo Paulo (Brasil), no período de 1§ de junho de 1990 a 31 de maio de 1991. Para cada um dos usuários foram considerados os diagnósticos realizados, bem como a concentraçäo de cada modalidade de consulta realizada (pronto-atendimento e consulta agendada). Destes, 839 eram portadores de hipertensäo arterial e/ou diabete e foram agrupados em quatro categorias: os exclusivamente hipertensos, os hipertensos com outra doença crônica associada (exceto diabete), os diabéticos e os diabéticos com hipertensäo arterial. Os resultados deste estudo mostraram: 1) baixa cobertura de indivíduos hipertensos e diabéticos em atendimento no serviço, quando se considera a populaçäo atendida pelo Centro de Saúde; 2) a existência de pacientes diagnosticados como hipertensos em consultas de pronto-atendimento, que näo retornaram ao Centro de Saúde para seguimento médico programático, apontando para dificuldades na captaçäo efetiva destes indivíduos. Esta "perda" deveu-se tanto a faltas dos pacientes às consultas agendadas para seu seguimento quanto ao näo agendamento de consultas de seguimento por parte do serviço; 3) para os pacientes que aderiram ao seguimento, a concentraçäo de consultas médicas e a concentraçäo de faltas apresentaram números compatíveis com a proposta de agendamento trimestral; 4) a categoria dos exclusivamente hipertensos apresentou, quando comparada com as demais, menor concentraçäo de consultas e maior proporçäo de faltas por consulta agendada. Discute os limites das açöes baseadas no "enfoque de risco" para controle de doenças crônico-degenerativas em populaçäo

Avaliaçäo do atendimento ambulatorial / Assessment of an ambulatory care

Trabalho realizado no Centro de Saúde-Escola do Butantan, Säo Paulo, SP, objetivando: caracterizar a demanda que se utiliza de consultas eventuais no setor de atendimento ao adulto do Centro de Saúde-Escola no Butantan (CSEB); apreender a articulaçäo/integraçäo desta modalidade de atendimento com o atendimento programático; caracterizar aspectos do trabalho médico aí realizado