"Tirando o jaleco": notas etnográficas sobre as práticas obstétricas em um hospital de ensino / "Taking off the lab coat": ethnographic notes on obstetric practices in a university hospital

Resumo O estudo teve como objetivo descrever e analisar aspectos do cotidiano da assistência ao parto em um hospital universitário no Sul do Brasil. A expressão "tirando o jaleco" serve como uma metáfora para iluminar o processo de conversão da enfermeira obstetra em pesquisadora em um ambiente hospitalar. Trata-se de uma de pesquisa qualitativa que lançou mão da perspectiva socioantropológica como referencial teórico e metodológico. Os resultados mostraram uma recorrente ausência de informações sobre condutas e decisões médicas dadas as mulheres, desconsiderando-as como sujeitos de direitos, a despeito do que preconiza a política de humanização do parto, revelando nuances do parto e do nascimento pautadas no modelo tecnocrático de assistência. Esse modelo de assistência vigente nos hospitais de ensino requer importantes mudanças através da incorporação de práticas com fundamentos científicos, da inclusão de enfermeiras obstetras e do respeito à mulher como protagonista deste evento.

Abstract The study aimed to describe and analyze everyday aspects of childbirth care in a university hospital in southern Brazil. The expression "taking off the coat" serves as a metaphor to illuminate the process of converting the obstetrician nurse into a researcher in a hospital environment. This is a qualitative research work that made use of the perspective socio-anthropology as a theoretical and methodological framework. The results showed a recurrent lack of information about medical conduct and decisions given to women, disregarding them as subjects of rights, despite what the policy of humanization of childbirth, revealing nuances of childbirth and birth based on the model assistance technocracy. This current care model in teaching hospitals requires important changes through the incorporation of practices with scientific foundations, the inclusion of obstetric nurses and respect for women as the protagonists of this event.

Sharing ICU Patient Data Responsibly Under the Society of Critical Care Medicine/European Society of Intensive Care Medicine Joint Data Science Collaboration: The Amsterdam University Medical Centers Database (AmsterdamUMCdb) Example.

OBJECTIVES: Critical care medicine is a natural environment for machine learning approaches to improve outcomes for critically ill patients as admissions to ICUs generate vast amounts of data. However, technical, legal, ethical, and privacy concerns have so far limited the critical care medicine community from making these data readily available. The Society of Critical Care Medicine and the European Society of Intensive Care Medicine have identified ICU patient data sharing as one of the priorities under their Joint Data Science Collaboration. To encourage ICUs worldwide to share their patient data responsibly, we now describe the development and release of Amsterdam University Medical Centers Database (AmsterdamUMCdb), the first freely available critical care database in full compliance with privacy laws from both the United States and Europe, as an example of the feasibility of sharing complex critical care data. SETTING: University hospital ICU. SUBJECTS: Data from ICU patients admitted between 2003 and 2016. INTERVENTIONS: We used a risk-based deidentification strategy to maintain data utility while preserving privacy. In addition, we implemented contractual and governance processes, and a communication strategy. Patient organizations, supporting hospitals, and experts on ethics and privacy audited these processes and the database. MEASUREMENTS AND MAIN RESULTS: AmsterdamUMCdb contains approximately 1 billion clinical data points from 23,106 admissions of 20,109 patients. The privacy audit concluded that reidentification is not reasonably likely, and AmsterdamUMCdb can therefore be considered as anonymous information, both in the context of the U.S. Health Insurance Portability and Accountability Act and the European General Data Protection Regulation. The ethics audit concluded that responsible data sharing imposes minimal burden, whereas the potential benefit is tremendous. CONCLUSIONS: Technical, legal, ethical, and privacy challenges related to responsible data sharing can be addressed using a multidisciplinary approach. A risk-based deidentification strategy, that complies with both U.S. and European privacy regulations, should be the preferred approach to releasing ICU patient data. This supports the shared Society of Critical Care Medicine and European Society of Intensive Care Medicine vision to improve critical care outcomes through scientific inquiry of vast and combined ICU datasets.

Medical students' reflections on surgical educators' professionalism: Contextual nuances in the hidden curriculum.

INTRODUCTION: Surgical educators' professional behavior constitutes a hidden curriculum and impacts trainee's professional identity formation. This study explores the nuances of professional behaviors as observed in varying surgical settings. METHODS: 411 Transcripts originated from essays written by MS3 students during their surgical clerkship from 2010 to 2016 were collated. Employing a qualitative research methodology, we conducted a thematic analysis to uncover specific meaning emerging from medical student reflections' on surgical professionalism. RESULTS: In clinics, taking time and protecting patient privacy; in the OR, control over emotion during difficult situations and attention to learners; and in the inpatient setting, showing accountability above normal expected behavior were noted as professional. Similarly, unprofessional behaviors in these contexts paralleled lack of these attributes. CONCLUSIONS: Behaviors observed and the attributes of professionalism in the surgical learning environment have contextual nuances. These variations in professionalism can be utilized in deliberate development of professionalism in surgery.

Ghent University Hospital's protocol regarding the procedure concerning euthanasia and psychological suffering.

BACKGROUND: Notwithstanding fears of overly permissive approaches and related pleas to refuse euthanasia for psychological suffering, some Belgian hospitals have declared that such requests could be admissible. However, some of these hospitals have decided that such requests have to be managed and carried out outside their walls. MAIN TEXT: Ghent University Hospital has developed a written policy regarding requests for euthanasia for psychological suffering coming from patients from outside the hospital. The protocol stipulates several due care criteria that go beyond the requirements of the Belgian Euthanasia Law. For instance, the legally required first and second consulted physicians should all be psychiatrists and be affiliated with a psychiatry department of a Flemish university hospital. Moreover, euthanasia for psychological suffering can only be performed if the advices of these consulted physicians are positive. Importantly, preliminary reflection by the multidisciplinary Hospital Ethics Committee was introduced to discuss every request for euthanasia for psychological suffering coming from outside the hospital. CONCLUSION: In this way, the protocol supports psychiatrists faced with the complexities of assessing such requests, improves the quality of euthanasia practice by ensuring transparency and uniformity, and offers patients specialised support and guidance during their euthanasia procedure. Nevertheless, some concerns still remain (e.g. relating to possible unrealistic patient expectations and to the absence of aftercare for the bereaved or for patients whose requests have been refused).

Evaluation of the work of hospital districts' research ethics committees in Finland.

The main task of research ethics committees (RECs) is to assess research studies before their start. In this study, 24 RECs that evaluate medical research were sent questionnaires about their structure and functions. The RECs were divided into two separate groups: those working in university hospital districts (uRECs) and those in central hospital districts (non-uRECs). The two groups were different in many respects: the uRECs were bigger in size, covered a wider range of disciplines (both medical and non-medical), had better resources and more frequent and regular meetings. After the survey was performed and analysed, the Medical Research Act was amended so that only hospital districts with a medical faculty in their region had a duty to establish ethics committees. After the amendment, the number of RECs evaluating medical research in Finland decreased from 25 to 9. The ethics committees that remained had wider expertise and were better equipped already by the time of this survey. Only one non-uREC was continuing its work, and this was being done under the governance of a university hospital district. Simple measures were used for qualitative analysis of the work of RECs that evaluate medical research. These showed differences between RECs. This may be helpful in establishing an ethics committee network in a research field or administrational area.

Serious adverse events and compensation in registration trials: a review of data from a Japanese university hospital.

BACKGROUND: Clinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is now widely recognized. Attending to serious adverse events is an important duty of the CRC and investigators alike, and managing these complications and compensation constitutes a key responsibility. We retrospectively examined the frequency of serious adverse events and compensation events reported from 2007 through 2011 at Tokushima University Hospital, an academic hospital in rural Japan. We present herein the results of our analysis. RESULTS: Over the five-year period, 284 subjects participating in 106 registration trials experienced a total of 43 serious adverse events, and eight compensation events were documented. Among the serious adverse events, 35 (81.4%) were considered not related to the investigational drug, and 17 (39.5%) resulted in withdrawal of the study drug. Patients with malignant diseases experienced serious adverse events significantly more frequently compared to those with non-malignant diseases (28.3% versus 8.2%, respectively; P < 0.01). CONCLUSIONS: The CRC should be vigilant for serious adverse events in oncology clinical trials due to the generally higher frequency of these complications in subjects with malignancy. However, on an individual basis, the CRC may be seldom involved in the process for compensating serious adverse events. Therefore, the CRC's ability to share such experiences may serve as an opportunity for educating clinical trial support staff at the study site as well as those at other sites. However, further study is warranted to determine the role of the clinical trial support staff in optimizing methods for managing adverse events requiring compensation in registration trials.

Clinical ethics and patient advocacy: the power of communication in health care.

In recent years, the rights of patients have assumed a more pivotal role in international discussion. Stricter laws on the protection of patients place greater priority on the perspective and the status of patients. The purpose of this study is to emphasize ethical aspects in communication, the role of patient advocates as contacts for the concerns and suggestions of patients, and how many problems of ethics disappear when communication is highlighted. We reviewed 680 documented cases of consultation in a 10-year period of patient advocates' activity at a big German university hospital with 1,300 beds. On the basis of this extensive material, the article will focus on the intersection of the advocate's work with the problems of patients in hospitals. Deficits in the level of communication between health care professionals and patients were frequently uncovered. Patients primarily complain about the lack of dialogue and empathy. Middle-aged patients consulted the patients' advocate disproportionately more often. Measured against this baseline, the group of 65 and older complained less frequently. Besides complaints the advocate was asked in more than one-third of all cases for information about medical matters, hospital regulations or administrative problems. Patients obviously see the advocate as a well-connected and ideally unbiased contact person for uncertainties concerning their malady or a potential stay in hospital. Those seeking help often set hope in the information given by the voluntary patient representative. It should be highly recommended for every German hospital to establish the position of a patient advocate. Furthermore, patients can profit from regular exchange between the advocate and the Ethics Committee, also, to help ensure that their rights are taken into account and implemented in an ethically desirable context.

Grumblers in the time of Diagnosis-Related Groups: sand in the gear or lubricating oil?

OBJECTIVE: After the change from cost allowance to a German system of Diagnosis-Related Groups there has been much public discussion about how the new terms of employment within the health sector are increasingly in conflict with individuals'original motivations for their career choice. If such criticism remains unheard a further loss of employees might occur. METHODS: Two decades of professional experiences have been reviewed. The results were personally assessed and summarized in a field report. PARTICIPANTS: One senior physician, Department of Anesthesiology, University Hospital. RESULTS: In total, a deliberate contact approach by management to address employees' criticisms and grumbling about the terms of employment is essential for enterprise's success. CONCLUSIONS: While employees can introduce criticisms more constructively to contribute ideas that protect the enterprise'ssuccess, executives will have to position themselves in such a way as to be open to these perspectives. Constructive contact with "hospital troublemakers" should be implemented into the enterprise culture. Guidance is necessary to institute such changes.

Ethical issues faced by a department chairperson.

There are numerous ethical dilemmas faced routinely by department chairmen. Herein, we attempt to describe the responsibilities of a chairperson and then discuss some exemplary ethical issues that they are often required to handle, including. (1) How should a chair deal with the potential undermining of established doctor-patient relationships when a patient comes to the tertiary medical center? (2) What demands can a chair require of volunteer faculty to ensure the success of the department? (3) How should a chair deal with promotion issues and mentorship? (4) How should a chair deal with performance issues? We offer opinions and cite existing data, but we ask the reader to recognize that very few peer-reviewed publications are available on these topics. We hope that in the future these ethical conundrums will be addressed more frequently in medical journals.

[Challenges in the organization of investigator initiated trials: in transplantation medicine]. / Herausforderungen in der Organisation "investigator initiated trials": Am Beispiel der Transplantationsmedizin.

INTRODUCTION: Transplantation medicine offers multiple translational questions which should preferably be transferred to clinical evidence. The current gold standard for testing such questions and hypotheses is by prospective randomized controlled trials (RCT). The trials should be performed independently from the medical industry to avoid conflicts of interests and to guarantee a strict scientific approach. A good model is an investigator initiated trial (IIT) in which academic institutions function as the sponsor and in which normally a scientific idea stands before marketing interests of a certain medical product. METHODS: We present a model for an IIT which is sponsored and coordinated by Regensburg University Hospital at 45 sites in 13 nations (SiLVER study), highlight special pitfalls of this study and offer alternatives to this approach. RESULTS: Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) offers annual grants. The expansion of financial support through foundations is desirable. Infrastructure: sponsorship within the pharmaceutics act (Arzneimittelgesetz) demands excellent infrastructural conditions and a professional team to accomplish clinical, logistic, regulatory, legal and ethical challenges in a RCT. If a large trial has sufficient financial support certain tasks can be outsourced and delegated to contract research organizations, coordinating centers for clinical trials or partners in the medical industry. CONCLUSIONS: Clinical scientific advances to improve evidence are an enormous challenge when performed as an IIT. However, academic sponsors can perform (international) IITs when certain rules are followed and should be defined as the gold standard when scientific findings have to be established clinically.