Consent for Teaching-The Experience of Pediatrics and Psychiatry.

Informed consent protects patients' right of autonomy, as they may refuse to participate in clinical teaching. In Pediatrics, young people aged 16 or over, and with the necessary judgment, may consent; in Psychiatry, consent is also essential due to the personal nature of the subjects addressed. This study aimed mainly to assess the practical application of informed consent in medical education. An observational cross-sectional study was developed, and an interview-like questionnaire was applied to participants waiting for a scheduled consultation for themselves or the person they represented, in Pediatrics and Psychiatry. Only 54% of Pediatrics participants and 75% of Psychiatry participants stated that the physician asked them if they minded the students' presence and an even smaller percentage from both departments affirmed that students introduced themselves as medical students and requested their consent to examine them. Patients feel satisfied to contribute to the students' training, although a considerable percentage of them had experiences without being informed or asked for consent, which represents an evident disrespect for their autonomy. There is a need to intervene and provide an adequate education of ethical values in clinical practice to students.

Medical Education: Patients' Perspectives on Clinical Training and Informed Consent.

There are complex ethical dilemmas inherent to medicine teaching, particularly in clinical practice involving actual patients. Questions must be raised on fulfilling medical students' training needs while still respecting patients' fundamental rights to autonomy and privacy. We aimed to assess patients' perspectives regarding medical students' involvement in their medical care. An observational, cross-sectional study was developed, and a questionnaire was applied randomly to patients waiting for a consultation/admitted to three distinct departments: General Surgery, Obstetrics/Gynaecology, and Infectious Diseases. Of the 77% interviewed patients who reported previous experiences with medical students, only 59% stated that they were asked for consent for their participation, and 28% stated that students had adequately introduced themselves. Patients from Gynaecology/Obstetrics were the ones who reported lower rates of these practices and were also the ones who were most bothered by students' presence, stating that they would be more comfortable without the presence of medical students. Male patients received more explanations than female patients regarding the same matters. Thirty-five percent of patients stated that they would feel more comfortable without the medical students' presence. The study shows a need to pay closer attention to fulfilling patients' fundamental rights.

Health expectancies in the European Union: same concept, different methods, different results.

BACKGROUND: Healthy life expectancy (HLE) is a population health measure that combines mortality and morbidity, which can be calculated using different methods. In this study, we aimed to assess the correlation, reliability and (dis)agreement between two estimates monitored in the European Union (EU), that is, the European Commission's HLE based on self-perceived health (SPH-HLE) and the Institute for Health Metrics and Evaluation's HLE based on disability weight (DW-HLE), by sex, and comparing these results with LE and proportion of life spent in good health (%GH). METHODS: We performed a retrospective study in the EU28 countries, between 2010 and 2017. The HLE methods differ in definition, measurement and valuation of health states. While SPH-HLE relies directly on one question, DW-HLE relies on epidemiological data adjusted for DW. Spearman's r, intraclass correlation coefficient, information-based measure of disagreement and Bland-Altman plots were used to assess reliability, correlation and disagreement in HLE resulting from both methods and in LE or %GH measured by both institutions. RESULTS: Correlation and reliability between SPH-HLE and DW-HLE were good (better for males), with low disagreement, and were even better for LE between both institutions. The HLE Bland-Altman plots suggest a variability range of approximately 6 years for both sexes, higher for females. There was also an increasing HLE difference between methods with higher average HLE for both sexes. CONCLUSION: We showed wide variations between both methods with a clear and different high impact on female and male HLE, showing a tendency for countries with higher health expectancies to yield larger gaps between SPH-HLE and DW-HLE.

Adverse drug reactions in adolescents: a review of reporting to a national pharmacovigilance system.

OBJECTIVE: Adverse drug reactions (ADR) cause significant morbidity, mortality and health costs and have an important prevalence in all ages. Few studies focus on ADR in adolescents. The goal of this study was to characterize a case series of ADR reported to the Portuguese Pharmacovigilance System (PPS) of the National Authority of Medicines and Health Products (INFARMED, I.P.) during an eleven-year period (from 2006 to 2016) concerning this specific population. METHODS: Retrospective analysis of reports concerning patients from 10 to 18 years received by the PPS between 2006 and 2016. The authors evaluated patients' demographics (age and sex). The characteristics and seriousness of the reactions, the type of reaction reported, and the drugs involved were assessed. RESULTS: The authors found 782 reports (59% females). Most reports came from physicians (61%). Overall 80% of the reports described serious ADR. A greater proportion of serious events was found among males. Most reactions referred to general disorders and administration site conditions (38%), followed by skin and subcutaneous tissue reactions (33%). In 3rd and 4th were gastrointestinal disorders (24%) and the nervous system disorders (23%), the former more frequent among females. Vaccines were the most represented group (42%) followed by antibacterials for systemic use (19%). CONCLUSION: Major findings considering drugs involved and the reported reactions varied according to age and sex.

On the prediction of foetal acidaemia: A spectral analysis-based approach.

A computational analysis of physiological systems has been used to support the understanding of how these systems work, and in the case of foetal heart rate, many different approaches have been developed in the last decades. Our objective was to apply a new method of classification, which is based on spectral analysis, in foetal heart rate (FHR) traces to predict foetal acidosis diagnosed with umbilical arterial blood pH ≤ 7.05. Fast Fourier transform was applied to a real database for the classification approach. To evaluate the models, sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve were used. Sensitivity equal to 1, specificity equal to 0.85 and an area under the ROC curve of 0.94 were found. In addition, when the definition of metabolic acidosis of umbilical arterial blood pH ≤ 7.05 and base excess ≤ -10 mmol/L was used, the proposed methodology obtained sensitivity = 1, specificity = 0.97 and area under the ROC curve = 0.98. The proposed methodology relies exclusively on the spectral frequency decomposition of the FHR signal. After further successful validation in more datasets, this approach can be incorporated easily in clinical practice due to its simple implementation. Likewise, the incorporation of this novel technique in an intrapartum monitoring station should be straightforward, thus enabling the assistance of labour professionals in the anticipated detection of acidaemia.

Promoting adverse drug reaction reporting: comparison of different approaches.

OBJECTIVE: To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS: We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal) to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS: All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each), followed by first educational approach (265 reports, 20.31 €/report) and by the hyperlink approach (136 reports, 15.59 €/report). Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs). Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report), followed by first educational approach (38.79 €/report). CONCLUSIONS: We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.

School failure in students who are normal-hearing or deaf: with or without cochlear implants.

To evaluate the impact of cochlear implants on the school failure of deaf who attend mainstream classes by comparing them to their normal-hearing peers as well as deaf without cochlear implants. This case-control study included participants aged 8-18 years. The number of school years failed was obtained from school records. The greatest differences in achievement levels were found between hearing students and those who were deaf without cochlear implants. Cochlear implants provide educational opportunities for hearing-impaired students, yet those without cochlear implants remain at a great disadvantage. These findings suggest that measures promoting greater equity and quality for all deaf students allow achievement levels closer to those of the not impaired.

Promoting adverse drug reaction reporting: comparison of different approaches / Promoção da notificação de reações adversas a medicamentos: comparação de estratégias

ABSTRACT OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal) to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each), followed by first educational approach (265 reports, 20.31 €/report) and by the hyperlink approach (136 reports, 15.59 €/report). Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs). Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report), followed by first educational approach (38.79 €/report). CONCLUSIONS We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.

RESUMO OBJETIVO Descrever diferentes abordagens de promoção da notificação de reações adversas a medicamentos entre os profissionais de saúde, determinando o seu custo-eficácia. MÉTODOS Foram analisadas e comparadas estratégias adotadas pela Unidade de Farmacovigilância do Norte (Portugal) para promoção da notificação de reações adversas a medicamentos. As estratégias foram comparadas quanto ao número e relevância das notificações de reações adversas a medicamentos obtidas e quanto aos custos envolvidos. Os custos por notificação foram calculados somando os custos iniciais e os custos de manutenção de cada estratégia. Esses custos foram então divididos pelo número de notificações obtidas em cada intervenção, para avaliar o seu custo-eficácia. RESULTADOS Todas as abordagens aumentaram o número de notificações de reações adversas a medicamentos. O maior aumento foi observado com os protocolos (321 notificações de reações adversas a medicamentos ganhas, custando 1,96 € cada), seguidos pela primeira abordagem educacional (265 notificações, 20,31 € cada) e pela colocação de hyperlinks (136 notificações, 15,59 € cada). Com relação à gravidade das reações adversas a medicamentos, os protocolos foram a estratégia mais eficiente, custando 2,29 € cada notificação, seguida da colocação de hyperlinks (30,28 € cada, sem custos de manutenção). Quanto às reações adversas a medicamentos inesperadas, o melhor resultado pertenceu aos protocolos (5,12 € cada notificação), seguido por uma primeira abordagem educativa (38,79 € cada notificação). CONCLUSÕES Os autores recomendam a implementação de protocolos em outros centros de farmacovigilância. De fato, estes parecem ser a intervenção mais eficaz, permitindo receber notificações de RAM com custos mais baixos, aplicando-se este aumento tanto ao número total de notificações de reações adversas a medicamentos, como à gravidade, imprevisibilidade e alto grau de causalidade atribuído a elas. Ainda assim, a colocação de hyperlinks apresenta a vantagem de não envolver custos de manutenção, por isso tem o segundo melhor desempenho no indicador custo por notificação de reações adversas a medicamentos.

Ethics, equity, and human dignity in access to health services: the case of cochlear implants in children and adolescents.

Compare the number of implants performed in the last 12 years for children and adolescents up to 18 years in different regions of mainland Portugal. Study the trend of total implants over the years as well as the percentage held in early ages. Verify to what extent this practice is in line with the values of fairness and justice that underpin European health systems. A retrospective study of cochlear implantation was conducted using a hospital database containing all the episodes with cochlear implant procedures in public hospitals that occurred in Portugal between 2000 and 2012. An analysis by age, year, and region of the implants were performed. The Northern and Central regions, the nearest big center specializing in cochlear implants in Portugal, are those with the largest number of implants: 2.0 and 2.4 per 10,000 children, respectively. The regions of Alentejo and Algarve, which are more rural and remote regions of the center, record the smallest number of implants, 1.1 and 1.5 per 10,000 children, respectively. Over the years, there seems to be an increase of implants implemented in children under 18, most notably from a significant reduction in 2011 and 2012. However, an increase in children implanted before 24 months has been observed from the same zero children at this age in the early years studied to 0.46 per 10,000 inhabitants in 2012. The right to adequate health care must be in accordance with the full respect of fundamental human rights. Economic, social, and educational conditions must also be guaranteed in this process of auditory rehabilitation. Societies must develop a system of ethical health priorities, so that even in situations of financial crisis, the most disadvantaged sectors are not the most penalized ones by the inevitable economic constraints that are implemented.

Health-related quality of life in children and adolescents with cochlear implants: self and proxy reports.

CONCLUSIONS: Cochlear implantation appears to favour the perception of improved quality of life (QoL) among children and adolescents. Similar trends were observed among the responses of deaf children and their parents. However, parents of deaf children perceive fewer feelings of provocation than children and adolescents. OBJECTIVE: This study aimed to assess health-related QoL (HRQoL) among prelingual profoundly deaf children and adolescents with cochlear implants and to compare the responses of these children to those of their parents. METHODS: Our sample consisted of deaf children and adolescents with cochlear implants and two control groups: hearing children and adolescents and deaf children and adolescents. The ages of the participants ranged between 8 and 18 years. Parents and children/adolescents were surveyed using the Kidscreen-52, which is a generic instrument for assessing the HRQoL of children and adolescents. Structured interviews were conducted with parents to collect information and clinical histories, and the Graffar scale was used to assess socioeconomic status. RESULTS: The hearing participants exhibited significantly higher QoL than the deaf participants without implants in nearly all domains. In contrast, although hearing participants exhibited a slightly higher QoL than implanted deaf children, these differences were smaller and failed to reach statistical significance.

Skin adhesive versus subcuticular suture for perineal skin repair after episiotomy--a randomized controlled trial.

OBJECTIVE: Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort, interfering with the normal activities of the puerperium. The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture, regarding the incidence of pain and wound complications. STUDY DESIGN: Randomized clinical trial. SETTING: Tertiary care university hospital. MATERIAL AND METHODS: One hundred women having mediolateral episiotomy at vaginal delivery were enrolled. They were randomized to receive skin adhesive (n = 53) or subcuticular suture (n = 47) for closure of perineal skin. The main outcome measure was self-evaluated pain in the 30 days following delivery. Secondary outcome measures were technical difficulties reported with the procedure, duration of surgical repair, wound complications observed at 42-68 hours post-partum and re-initiation of sexual activity by 30 days post-partum. RESULTS: No significant differences were observed between the two groups in incidence of technical difficulties and failed procedures, pain during the procedure, wound complications at hospital discharge, self-evaluated measures of pain at 7 and 30 days or re-initiation of sexual activity by 30 days post-partum. The skin adhesive group had a significantly shorter mean duration of the procedure (four minutes less). CONCLUSION: Perineal skin closure using adhesive glue is faster than subcuticular suture, and associated with a similar incidence of complications and pain in the first 30 days.

Mortalidade e o tempo de internação em uma unidade de terapia intensiva cirúrgica / Mortality and length of stay in a surgical intensive care unit

JUSTIFICATIVA E OBJETIVOS: Em cuidados intensivos os resultados podem ser relacionados aos índices de mortalidade ou morbidade. Quando avaliada de forma isolada, a mortalidade é uma medida insuficiente do resultado na Unidade de Terapia Intensiva (UTI); o tempo de internação pode ser uma medida indireta do resultado relacionado com a morbidade. O objetivo do presente estudo foi avaliar a incidência e os fatores preditivos para mortalidade e tempo de internação dos pacientes admitidos numa UTI cirúrgica. MÉTODO: Participaram deste estudo prospectivo, realizado, entre abril e julho de 2004, todos os 185 pacientes submetidos a procedimentos programados ou de emergência, admitidos numa UTI cirúrgica. Foram registrados os seguintes parâmetros: idade, sexo, altura e peso, temperatura central estado físico segundo a ASA, tipo de intervenção cirúrgica, porte cirúrgico, técnica anestésica, quantidade e qualidade de fluídos administrados durante a anestesia, monitorização da temperatura ou de técnica de aquecimento corporal peri-operatório, duração da anestesia, tempo de permanência na UTI e no hospital e escore SAPS II. RESULTADOS: O tempo médio de internação na UTI foi de 4,09 ± 10,23 dias. Fatores de risco significativos para permanências mais prolongadas na UTI foram o valor do escore SAPS II, estado físico ASA, quantidade administrada, durante a intervenção cirúrgica, de colóides, unidades de plasma fresco e unidades de concentrados de hemáceas. Quatorze pacientes (7,60 por cento) morreram durante a internação na UTI e 29 (15,70 por cento) morreram durante a internação hospitalar. Fatores de risco independentes de mortalidade com diferença estatística significativa foram intervenções cirúrgicas de emergência, de grande porte, escores altos SAPS II, permanência prolongada na UTI e no hospital. Fatores protetores com diferença estatística significativa para risco de morte hospitalar foram baixo peso corporal e baixo índice de massa corporal (IMC). CONCLUSÕES: As internações prolongadas em UTI são mais freqüentes nos pacientes mais graves à admissão e estão associadas às maiores mortalidades hospitalares. A mortalidade hospitalar é também mais freqüente em pacientes submetidos a intervenções cirúrgicas de emergência ou de grande porte.

[Mortality and length of stay in a surgical intensive care unit.]. / Mortalidade e o tempo de internação em uma unidade de terapia intensiva cirúrgica.

BACKGROUND AND OBJECTIVES: Outcome in intensive care can be categorized as mortality related or morbidity related. Mortality is an insufficient measure of ICU outcome when measured alone and length of stay may be seen as an indirect measure of morbidity related outcome. The aim of the present study was to estimate the incidence and predictive factors for intrahospitalar outcome measured by mortality and LOS in patients admitted to a surgical ICU. METHODS: In this prospective study all 185 patients, who underwent scheduled or emergency surgery admitted to a surgical ICU in a large tertiary university medical center performed during April and July 2004, were eligible to the study. The following variables were recorded: age, sex, body weight and height, core temperature (Tc), ASA physical status, emergency or scheduled surgery, magnitude of surgical procedure, anesthesia technique, amount of fluids during anesthesia, use of temperature monitoring and warming techniques, duration of the anesthesia, length of stay in ICU and in the hospital and SAPS II score. RESULTS: The mean length of stay in the ICU was 4.09 +/- 10.23 days. Significant risk factors for staying longer in ICU were SAPS II, ASA physical status, amount of colloids, fresh frozen plasma units and packed erythrocytes units used during surgery. Fourteen (7.60%) patients died in ICU and 29 (15.70%) died during their hospitalization. Statistically significant independent risk factors for mortality were emergency surgery, major surgery, high SAPS II scores, longer stay in ICU and in the hospital. Statistically significant protective factors against the probability of dying in the hospital were low body weight and low BMI. CONCLUSIONS: In conclusion, prolonged ICU stay is more frequent in more severely ill patients at admission and it is associated with higher hospital mortality. Hospital mortality is also more frequent in patients submitted to emergent and major surgery.