The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial.

OBJECTIVES: To determine if portable video media (PVM) improves patient's knowledge and satisfaction acquired during the consent process for cystoscopy and insertion of a ureteric stent compared to standard verbal communication (SVC), as informed consent is a crucial component of patient care and PVM is an emerging technology that may help improve the consent process. PATIENTS AND METHODS: In this multi-centre randomised controlled crossover trial, patients requiring cystoscopy and stent insertion were recruited from two major teaching hospitals in Australia over a 15-month period (July 2014-December 2015). Patient information delivery was via PVM and SVC. The PVM consisted of an audio-visual presentation with cartoon animation presented on an iPad. Patient satisfaction was assessed using the validated Client Satisfaction Questionnaire 8 (CSQ-8; maximum score 32) and knowledge was tested using a true/false questionnaire (maximum score 28). Questionnaires were completed after first intervention and after crossover. Scores were analysed using the independent samples t-test and Wilcoxon signed-rank test for the crossover analysis. RESULTS: In all, 88 patients were recruited. A significant 3.1 point (15.5%) increase in understanding was demonstrable favouring the use of PVM (P < 0.001). There was no difference in patient satisfaction between the groups as judged by the CSQ-8. A significant 3.6 point (17.8%) increase in knowledge score was seen when the SVC group were crossed over to the PVM arm. A total of 80.7% of patients preferred PVM and 19.3% preferred SVC. Limitations include the lack of a validated questionnaire to test knowledge acquired from the interventions. CONCLUSIONS: This study demonstrates patients' preference towards PVM in the urological consent process of cystoscopy and ureteric stent insertion. PVM improves patient's understanding compared with SVC and is a more effective means of content delivery to patients in terms of overall preference and knowledge gained during the consent process.

Association between operational indexes and the utilization rate of a general surgery center.

This is a prospective study that focused on the dynamics of operating rooms using operational indexes that measure optimization, resistance, overload and utilization of the surgical unit, and also identified the factors most associated with these indexes. A total of 1,908 surgeries were analyzed over a period of two months in 2007. The average rates of utilization, optimization and resistance indexes were 80.41%, 65.35% and 34.65% respectively. The difference between the positive and negative overload index was low (5.42%). Operating room rescheduling and delays were the variables that contributed the most to the increase in these indexes. In the linear regression statistical model, the utilization rate was found to be the first common variable selected in the overload, resistance and optimization indexes. It is essential to work on these operational indexes with a view to obtain satisfactory results in the management of the surgical center, with well-defined work processes and teamwork.

Severe maternal morbidity (near miss) as a sentinel event of maternal death. An attempt to use routine data for surveillance.

BACKGROUND: To identify all the records within the Brazilian Hospital Information System (HIS) that contained information suggestive of severe maternal morbidity (near miss); to describe the diagnoses and procedures used; to identify variables associated with maternal death. METHODS: A descriptive population study with data from the HIS and Mortality Information System (MIS) files of records of women during pregnancy, delivery and in the postpartum period in all the capital cities of the Brazilian states in 2002. Initially, records of women between 10 and 49 years of age were selected; next, those records with at least one criterion suggestive of near miss were selected. For the linkage of HIS with MIS and HIS with itself, a blocking strategy consisting of three independent steps was established. In the data analysis, near miss ratios were calculated with corresponding 95% confidence interval and the diagnoses and procedures were described; a multiple logistic regression model was adjusted. Primary and secondary diagnoses and the requested and performed procedures during hospitalization were the main outcome measures. RESULTS: The overall maternal near miss ratio was 44.3/1,000 live births. Among the records indicating near miss, 154 maternal deaths were identified. The criteria of severity most frequently found were infection, preeclampsia and hemorrhage. Logistic regression analysis resulted in 12 variables, including four significant interactions. CONCLUSION: Although some limitations, the perspective of routinely using this information system for surveillance of near miss and implementing measures to avoid maternal death is promising.

Process for obtaining informed consent: women's opinions.

UNLABELLED: In Brazil, every study involving human beings is required to produce an informed consent form that must be signed by study participants: this is stated in Resolution 196/96.(1) Consent must be obtained through a specific structured process. OBJECTIVE: To present the opinions of women regarding how the process of obtaining informed consent should be conducted when women are invited to participate in studies on contraceptive methods. SUBJECTS AND METHODS: Eight focus groups were conducted, involving a total of 51 women living in the metropolitan region of Campinas. The women involved in the study were either participating in a clinical trial in the area of women's health or had participated in such a trial in the previous 12 months. A thematic guide was used to conduct the focus group discussions; the discussions were recorded, transcribed and a thematic analysis performed. RESULTS: In general, the person who invites a woman to participate in a study should be a member of the research team but not the principal investigator. Information relating to the study should be given orally and in writing, both individually and in the group setting. Study volunteers should be informed about, among other things, the risks, possible side effects and discomforts, including long-term effects. The use of audiovisual aids to provide information was suggested. CONCLUSION: The process for obtaining informed consent was seen as a means of establishing a relationship between the volunteers and the investigator/research team. The information that the study participants expected to be given coincides with the requirements established under Resolution 196/96. The use of audiovisual aids would improve understanding of the information provided.

[Probabilistic record linkage: an application to severe maternal morbidity (near miss) and maternal mortality]. / Relacionamento probabilístico de registros: uma aplicação na área de morbidade materna grave (near miss) e mortalidade materna.

This article presents an experience with record linkage from the Brazilian Hospital Information System (SIH) with the Mortality Information System (SIM), and the SIH with itself, applied to severe maternal morbidity (near miss) and maternal mortality. This was an empirical study using Brazilian data for the state capitals and Federal District in 2002. For the two linkages separately applied in each capital, a three simple step blocking strategy was established, plus related multiple steps and also two clerical review strategies. From the total number of true pairs found after the two linkages, simple steps failed to find fewer than 8%, while the multiple step strategy failed to find only 0.7%. This approach allowed exploring the issue of severe maternal morbidity and mortality in these databases. The number of pairs found and reviewed under the multiple steps strategy was lower than the sum of pairs obtained with the three simple steps, and fewer pairs were lost. However, for the record linkage of the SIH with itself, both strategies are suggested.

Women's responses to menses and nonbleeding intervals in the USA, Brazil and Germany.

BACKGROUND: Studies from several countries suggest women differ in their preferred length of nonbleeding intervals, yet studies to date have not explored the social determinants of such preferences. METHOD: We report results from a menstrual preference and social survey of 1207 healthy women in three age groups (18-20, 25-34 and 45-49 years) and two educational strata (high and low educational attainment), from Campinas (Brazil), Heidelberg (Germany) and Ann Arbor (USA) ( approximately 400 women from each country). RESULTS: Women's preferred length of nonbleeding intervals differed significantly between countries. In Ann Arbor, only 15.5% of women preferred to bleed monthly, vs. 30.2% in Heidelberg. In both Ann Arbor and Campinas, approximately one-third of women preferred to "never" have menses, compared to 8.2% in Heidelberg. Multivariate analyses indicated that country, church attendance, stress and menstrual pain were significant predictors of women's preferences. CONCLUSION: The most common preference among women was to bleed once every 3 months, but preferences varied substantially by country groups. Preferences for nonbleeding intervals were, in part, explained by personal experiences of stress or menstrual pain, but unexplained cultural differences persist between country groups.

Delivery of microbicides to the vagina: difficulties reported with the use of three devices, adherence to use and preferences.

PURPOSE: A crossover study was carried out in 405 couples to compare women's difficulties with three different devices that could be used to administer a microbicide and to evaluate adherence to use and preference for any one of the devices. METHODS: Couples used a single size diaphragm, a vaginal ring or disposable applicators for 1 month each in a randomly assigned order. RESULTS: Few women reported difficulty using the applicators or the ring; however, almost two-thirds reported difficulty using the diaphragm. Approximately 5%, 10% and 40% of the women and a similar but slightly lower percentage of their partners reported incorrect use of the applicator, vaginal ring and diaphragm, respectively. About half the women preferred the vaginal ring, while around half the men preferred the applicator. CONCLUSION: The release of microbicides from a vaginal ring is a lead worth pursuing. The diaphragm is the only one of the three devices that also offers mechanical protection, but it requires greater investment in patient education to ensure adherence to use.

[Gender vulnerability for parenthood among male adolescents]. / Vulnerabilidade de gênero para a paternidade em homens adolescentes.

OBJECTIVE: To analyze gender relations perceived by male adolescents and how they contribute to making them more vulnerable to pregnancy during adolescence. METHODS: Qualitative study carried out in Campo Grande, Midwestern Brazil, in 2003. Subjects were 13 male adolescents under 20 years of age, fathers of an only child aged up to 11 months whose mother was in the same age group as them. Semi-structured interviews were carried out, tape recorded and transcribed. Thematic content analysis was carried out. RESULTS: Gender stereotypes were identified in which the role of leader, provider, and sexually active was stressed and the role of caregiver was rejected. These roles seemed consolidated especially in the subjects' perspective regarding paid employment as a marker of their male condition as well as of a family provider. Adolescents' leadership prevailed in the relationship with the mother of their child especially in taking initiative in sexual intercourse and the use of contraceptives. They considered that pregnancy was unexpected and happened "by chance". However, fatherhood was experienced as a definite evidence of their status as adult men. CONCLUSIONS: Male adolescents showed to be vulnerable to fatherhood due to gender socialization following traditional patterns. This was evidenced by the inexistence of roles related to self care and care for others, and early playing roles of male sexual dominance, of father and family provider in order to grow up and become a man.

[Declared maternal death and the linkage between health information systems]. / Morte materna declarada e o relacionamento de sistemas de informações em saúde.

OBJECTIVE: To describe the characteristics of maternal mortality according to the Mortality Information System in relation to the data corresponding to these records that are in other systems. METHODS: This was a descriptive study using two information systems on vital data and another on the hospital system, for the 26 state capitals and the Federal District of Brazil, in 2002. Initially, the maternal mortality ratios were calculated and information on declared maternal deaths were obtained. From these data, the Mortality Information System was probabilistically linked with the Live Birth Information System and the Hospital Information System, using the "Reclink II" software, with a multiple-step blocking strategy. For paired records, the diagnoses and hospital procedures brought together by the best-known criteria for severe maternal morbidity were detailed. RESULTS: A total of 339 maternal deaths were recorded in 2002. The official and adjusted maternal mortality ratios were, respectively, 46.4 and 64.9 (deaths per 100,000 live births). By correlating with data from the live birth system, 46.5% of the maternal deaths could be located; and from the hospital information, 55.2%. The most frequent admission diagnosis was infection (13.9%) and the most frequent procedure was intensive care unit admission (39.0%). CONCLUSIONS: There were low percentage linkages between the records from the three sources studied. However, the possible failures and/or impossibilities in the linkages indicated may separately or jointly explain these low percentages.

[Adolescents as research subjects and free informed consent: knowledge and opinion of researchers and adolescents]. / Adolescentes como voluntários de pesquisa e consentimento livre e esclarecido: conhecimento e opinião de pesquisadores e jovens.

This article presents the results of a study that evaluated the knowledge and opinions of researchers and adolescents that served as their research subjects on the legal norms that regulate the participation of the latter as research subjects, the capacity of adolescents to make autonomous decisions regarding participation, and the adolescent experience after agreeing to take part in a study. This was a qualitative study with a convenience sample, the size of which was defined by the criteria of informational redundancy. Interviews were conducted with three researchers who had used adolescents as research subjects and nine of these subjects. This number of interviews was sufficient to reach informational redundancy. Data was collected through recorded semi-structured interviews, with open questions. All the researchers were familiar with some legal document related to the participation of adolescents as subjects of research. On the other hand, the adolescents were surprised because they were not aware of the existence of such documents. However, they considered them necessary for their own protection. In general, researchers and adolescents believe that adolescents have the capacity to decide autonomously to participate as research subjects. The adolescents affirmed that they had decided to volunteer conscientiously.

[Hysterosonography: evaluation of the uterine cavity in women with abnormal uterine bleeding]. / Histerossonografia: avaliação da cavidade uterina com sangramento anormal.

OBJECTIVE: To compare the diagnostic accuracy of sonohysterography with that of hysteroscopy and ultrasonography for the diagnosis of uterine alterations with abnormal uterine bleeding. METHODS: Fifty three patients scheduled for hysteroscopy at the Hysteroscopy Sector of the Women's Hospital (CAISM) at the "Universidade Estadual de Campinas" (Brazil) were included in the study. Sensitivity and specificity of the three propaedeutic methods were compared using histology as the gold standard. RESULTS: Sensitivity of sonohysterography and of hysteroscopy was 94% and that of ultrasonography 83%. The specificity of sonohysterography was 77%, of hysteroscopy 91% and of ultrasonography 69%. There were no significant differences between sensitivities of the three methods. However, a significant difference was found between the specificity of ultrasonography and hysteroscopy. Sonohysterography demonstrated a much greater capability than ultrasonography to identify endometrial polyps. CONCLUSION: Sonohysterography may be used to complement ultrasonography and to substitute hysteroscopy, for the diagnosis of alterations that result in abnormal uterine bleeding.

Menstruation and amenorrhea: opinion of Brazilian women.

Contemporary women experience more menstrual cycles than their predecessors, and their menstrual patterns are modified by contraceptives. Amenorrhea is one side effect that has recently been advocated as desirable. This qualitative study investigated Brazilian women's views regarding the suppression of menstruation using hormones. Data were collected through eight focus groups, following a semistructured guideline. Sixty-four women, 21-51 years old, all menstruating regularly and all of whom had already initiated sexual activity and had no perceived infertility participated. Discussions were recorded, transcribed and entered into the computer, using the Ethnograph V 5.0 software to aggregate similar patterns. Thematic content analysis revealed that menstruation and amenorrhea were both seen with ambiguity. Although regarded as a nuisance, menstruation was associated with femaleness, youth, fertility and health. Most women, although they would like to be free from menstruation, feared negative consequences of induced amenorrhea and even regarded the proposition as a male intrusion into what they consider a natural female condition.

Quality assurance in cervical smears: 100% rapid rescreening vs. 10% random rescreening.

OBJECTIVE: To compare 100% rapid rescreening of cervical smears with 10% random rescreening as a method of quality assurance. STUDY DESIGN: A total of 5215 smears, randomly selected from smears reported as negative by cytotechnologists during routine screening, underwent 100% rapid rescreening by senior cytotechnologists. Ten percent of these smears, selected at random, were rescreened by other senior cytotechnologists. The gold standard was defined by cytopathologists, who rescreened all 5215 smears. After excluding unsatisfactory smears detected by cytopathologists, 4271 were included in the analysis. RESULTS: The 100% rapid rescreening method identified 69.9%, 95.7% and 100%, respectively, of atypical squamous cells of undetermined significance, low grade squamous intraepithelial lesion and high grade squamous intraepithelial lesion cases reported by the cytopathologists. The 100% rapid rescreening method showed a sensitivity of 73.5% and specificity of 98.6%. The 10% rescreening method showed sensitivity of 40.9% and specificity of 98.8%. CONCLUSION: One hundred percent rapid rescreening is an efficient method of internal quality assurance in cervical smear diagnosis. It can reduce the false negative rate and therefore can provide greater certainty to women who have received negative results. Well-trained cytotechnologists are able to identify abnormal smears in 1-minute rapid rescreening.

Fine-needle aspiration biopsy for breast lesions: a comparison between two devices for obtaining cytological samples.

CONTEXT AND OBJECTIVE: Fine-needle aspiration biopsy has been accepted worldwide for breast lesions. However, some questions remain, including the appropriateness of the puncture method. The objective of this work was to compare aspirates obtained by the auto-vacuum device and by the syringe pistol holder. DESIGN AND SETTING: Randomized trial for validation of diagnostic method, at Hospital das Clínicas da Universidade Federal de Goiás and Hospital Araújo Jorge, Goiânia. METHODS: 351 patients presenting breast lumps underwent fine-needle aspiration biopsy, either with the auto-vacuum device or the syringe pistol holder. A single cytopathologist analyzed all of the cytology slides. The rates of insufficient material, cellularity, cell distortion and background hemorrhage were evaluated. RESULTS: The percentages of insufficient material were 16% and 22% (p = 0.18), for the auto-vacuum and pistol aspirates, respectively. Good cellularity was seen in 34% of auto-vacuum and 29% of pistol samples (p = 0.4). Cell distortion was seen in 31 and 26 cases, respectively (p = 0.7). Background hemorrhage occurred in 63 (35%) and 54 cases (31%) (p = 0.2), for auto-vacuum and pistol. The sensitivity was 88% and 86%; specificity 99% and 100%, positive predictive value 96% and 100%, negative predictive value 96% and 95% and total accuracy 76% and 75% for the auto-vacuum and pistol, respectively. CONCLUSION: The results obtained from the two fine-needle aspiration biopsy methods were equivalent. Therefore, the auto-vacuum device is a good option for obtaining aspirates for cytology.

Women's preferences for vaginal antimicrobial contraceptives. V: attitudes of Brazilian women to the insertion of vaginal products.

The rapid spread of HIV/AIDS in the female population increases the urgency of developing new formulations that offer protection from this disease as well as other sexually transmitted infections. In many cultures, women do not readily accept touching their genitals or inserting products into their vaginas. Information on this subject was collected during a study involving 635 women in Brazil to determine the preferred attributes of vaginal products. Seventy-six percent would use an idealized contraceptive method that offered dual protection even though it could only be inserted with a finger and 96% would use this method if it could only be placed with an applicator. Qualitative analyses of responses to open questions suggest that the majority of Brazilian women studied did not like to touch their vagina with their finger or to insert devices. Although the introduction of safe and effective vaginal microbicides into many cultural settings can be successful, it should be accompanied by significant efforts to educate women about their bodies.

Acceptability of emergency contraception in Brazil, Chile, and Mexico. 2 - Facilitating factors versus obstacles.

A multi-center study was performed in Brazil, Chile, and Mexico to identify factors that may facilitate or hinder the introduction of emergency contraception (EC) as well as perceptions concerning emergency contraceptive pills. Background information on the socio-cultural, political, and legal context and the characteristics of reproductive health services was collected. The opinions of potential users and providers were obtained through discussion groups, and those of authorities and policymakers through semi-structured interviews. Barriers to introduction included: perception of EC as an abortifacient, opposition by the Catholic Church, limited recognition of sexual and reproductive rights, limited sex education, and insensitivity to gender issues. Facilitating factors were: perception of EC as a method that would prevent abortion and pregnancy among adolescents and rape victims; interest in the method shown by potential users as well as by some providers and authorities. It appears possible to reduce barriers through support from segments of society committed to improving sexual and reproductive health and adequate training of health care providers.

Acceptability of emergency contraception in Brazil, Chile, and Mexico: 1 - Perceptions of emergency oral contraceptives.

This article presents the results of a study on the acceptability of emergency contraception (EC) in Brazil, Chile, and Mexico. Opinions of potential users and possible providers were obtained through discussion groups and those of authorities and policy-makers through semi-structured interviews. Most participants had a positive opinion of EC, based on the view that it can help reduce unplanned pregnancy, adolescent pregnancy, and unsafe abortion. Several interviewees felt that all women should be informed about EC, while others viewed it as a method for special situations such as rape and unprotected first sexual intercourse. Concern was expressed that its introduction might be associated with a decrease in condom use, increase in sexually transmitted diseases, and irresponsible or promiscuous sexual behavior among adolescents. The need for EC was clearly perceived by most participants, leading to the conclusion that health authorities have the responsibility of implementing programs for its introduction. Training of health care personnel should include the discussion of reproductive health problems that could be prevented by EC.

[Free informed consent: the experience of Brazilian researchers in the area of fertility regulation]. / Consentimento livre e esclarecido: experiência de pesquisadores brasileiros na área da regulação da fecundidade.

This study aimed to evaluate the experience of Brazilian researchers in relation to: assessment of the research protocol by a research ethics committee with the elaboration of a free informed term of consent (FITC) and the process of obtaining consent, as well as to verify whether the content and wording of the term of consent complies with Federal Ruling 196/96. Thirty-four researchers filled out a questionnaire and returned it by electronic mail. The vast majority of the respondents (91%) reported that the respective study protocol had been evaluated by a research ethics committee. More than half reported that they had received a previously prepared FITC; that consent from potential study subjects had been obtained by the researcher in charge; and that the subjects had received a copy of their signed FITC. Approximately one half of participants stated that the form of reimbursement of subjects was specified in the FITC, and 44% reported the same in relation to occasional damages resulting from the study. According to participants, in general the provisions of Ruling 196/96 had been met.

[Age at natural menopause among Brazilian women: results from a population-based survey]. / Idade de ocorrência da menopausa natural em mulheres brasileiras: resultados de um inquérito populacional domiciliar.

A descriptive, exploratory, cross-sectional, population-based study was conducted to identify age at menopause and its associated factors as well as socio-cultural, demographic, and economic characteristics of climacteric women in Campinas, São Paulo State. Subjects were 456 Brazilian women between 45 to 60 years of age, selected through area cluster sampling. Data were collected through home interviews using a structured, pre-tested questionnaire. This instrument was an adaptation, done by the authors, of questionnaires provided by the International Health Foundation/International Menopause Society and by the North American Menopause Society. Statistical analysis was performed through life table analysis and Cox logistic regression. Mean age at menopause was 51.2 years. There was no association between study factors and age at natural menopause.

[Characterization of hormone replacement therapy users in Campinas, São Paulo]. / Caracterização das usuárias de terapia de reposição hormonal do Município de Campinas, São Paulo.

This study employed a descriptive, cross-sectional, population-based design to characterize climacteric women from Campinas, São Paulo State, based on use of hormone replacement therapy (HRT). An area cluster sample was selected with 456 women 45 to 60 years of age, residing in Campinas, based on data from the Brazilian Institute of Statistics and Geography (IBGE). Women were selected by area cluster, and the reference unit was the census tract as defined by the IBGE. Data were collected through home interviews using a structured and pre-tested questionnaire provided by the International Health Foundation/International Menopause Society and by the North American Menopause Society and adapted by the authors. In order to characterize women according to current, past, or no use of HRT, a polytonic logistic regression model was used, with a backward selection process of variables. The authors conclude that the main characteristics of HRT users in the city of Campinas were perimenopausal status and higher literacy and socioeconomic class.