[Ethical issues in the clinical records of a group of terminal patients admitted into a third level hospital. Lacks and improvements.] / Cuestiones éticas en los registros clínicos de un grupo de pacientes terminales ingresados en un hospital de tercer nivel. Carencias y mejoras.

OBJECTIVE: Terminal patients and their relatives must know their real situation, and be treated according to the principle of autonomy, to establish therapeutic objectives adapted each one, according to their needs and decisions. The objective of this study is to identify the sufficient existence of records in the Medical Histories of terminal patients, which indicate their situation, such as the information given to the patients, or the LET, No-RCP or Z.51.5 codes, and the statistical relation they have with the sociodemographic and clinical variables. METHODS: Cross-sectional study in a third-level hospital, with patients admitted between January and December 2017, who died with terminal illness criteria. Data were collected from the medical records, and, fundamentally, from the nursing clinical notes. The statistical analysis was performed with the SPSS program, version 22. RESULTS: Participants were 140 people, 54.3% men, of 78.51 (SD=13.5) of middle age. People up to 70 years of age received less information (Odds ratio (OR): 0.077, 95% Confidence interval (CI): 0.015-0.390) and lower sedation (OR: 0.366, 95% CI: 0.149-0.899). Proceeding from city reduced the probability of receiving information (OR: 0.202; IC95%: 0.058-0.705). Presenting dyspnea reduced LTE (OR: 0.44, 95% CI: 0.20-093), No CPR (0.29, 95% CI: 0.12-0.68) and sedation (OR: 0.27; 95% CI: 0.12-060). Fatigue increased the probability of being Non-CPR (OR: 2.77, 95% CI: 1.166-6.627) and of receiving sedation (OR: 2.6, 95% CI: 1.065-6.331). CONCLUSIONS: Efforts to empower the patient in the decision of their process and the management of the information of their diagnosis and prognosis are still lacking. A greater and better clinical records facilitates knowing how actions are developed, allowing to identify and implement ethical and responsible interventions.

OBJETIVO: Los/las pacientes en estado terminal y sus familiares deben conocer su situación y ser tratados según el principio de autonomía, para establecer así objetivos terapéuticos adaptados a cada uno/a de acuerdo a sus necesidades y decisiones. El objetivo de este estudio fue identificar la existencia de registros en las historias clínicas de pacientes terminales que señalen su situación, como la información ofrecida, los códigos de limitación del esfuerzo terapéutico (LET), la no reanimación cardiopulmonar (No-RCP) o Z.51.5, y la relación con las variables sociodemográficas y clínicas. METODOS: Se realizó un estudio descriptivo transversal en un hospital de tercer nivel, con pacientes ingresados entre enero y diciembre de 2017, que fallecieron con criterios de enfermedad terminal. Se recogieron los datos de las historias clínicas y, fundamentalmente, de las notas clínicas de enfermería. El análisis estadístico se realizó con el programa SPSS, versión 22. RESULTADOS: Participaron 140 personas, 54,3% de hombres, de 78,51 años (Desviación estándar -DS-=13,5) de edad media. Las personas menores de 70 años recibieron menos información (Odds Ratio -OR-: 0,077; Intervalo de Confianza -IC- 95%: 0,015-0,390) y menor sedación (OR: 0,366; IC 95%: 0,149-0,899). Proceder de ciudad redujo la probabilidad de recibir información (OR: 0,202; IC 95%: 0,058-0,705). Presentar disnea redujo la LET (OR: 0,44; IC 95%: 0,20-093), el No RCP (0,29; IC 95%: 0,12-0,68) y la sedación (OR:0,27; IC 95%: 0,12-060). La fatiga aumentó la probabilidad de ser No RCP (OR: 2,77; IC 95%: 1,163-6,627) y de recibir sedación (OR:2,6; IC 95%: 1,065-6,331). CONCLUSIONES: Los esfuerzos por empoderar al paciente en la toma de decisiones son todavía escasos. Un mayor y mejor registro facilita conocer cómo se desarrollan las actuaciones, permitiendo identificar y poner en marcha intervenciones éticas y responsables.

Reports of site monitoring visits by institutional ethics committees in an Indian tertiary care hospital: A retrospective analysis.

The monitoring of clinical trials is an integral function of the institutional ethics committee (IEC)to ensure the ethical conduct of research. The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, of the Indian Council of Medical Research, underline a strong need for active monitoring of clinical trials. A previous study by the authors, of research studies initiated between 2008 and 2010, had found many lapses after site monitoring. In the present study, 12 clinical studies-both sponsored and investigator initiated-were monitored by members of the King Edward Memorial Hospital (Mumbai) IEC between 2011 and 2017. The most common violations seen were related to informed consent (8/12 sites). The other violation themes were lack of investigator understanding of protocol (6/12), deviation from the investigational plan (5/12), non-reporting of the study's progress to the IEC (4/12), and patient recruitment prior to IEC approval (2/12). The IEC took various corrective actions, such as ordering retaking of consent and good clinical practice (GCP) re-training and requiring interim reports, explanations for deviations, upgradation of facilities, and payment of pending compensation. The IEC even froze review of protocols from a frequently defaulting Principal Investigator's (PI) site and put study recruitment on hold for the same PI. This study demonstrates that active site monitoring by IECs is a must for ensuring the ethical conduct of studies.

Segunda opinión, uso compasivo y ensayo clínico / Second opinion, compasive use and clinical trial

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Knowledge, awareness and practice of ethics among doctors in tertiary care hospital.

INTRODUCTION: With the advancement of healthcare and medical research, doctors need to be aware of the basic ethical principles. This cross-sectional study is an attempt to assess the knowledge, awareness, and practice of health-care ethics among health-care professionals. MATERIALS AND METHODS: After taking written informed consent, a standard questionnaire was administered to 117 doctors. No personal information was recorded on the questionnaire so as to ensure the confidentiality and anonymity of participants. Data analysis was done using SPSS version 21 (IBM Corp., Armonk, NY, USA). RESULTS: Statistically significant difference observed between the opinions of consultant and senior resident (SRs) on issues like, adherence to confidentiality; paternalistic attitude of doctors (doctors should do their best for the patient irrespective of patient's opinion); doctor's decision should be final in case of disagreement and interest in learning ethics (P < 0.05). However, no difference reported among them with respect to patient wishes, informing patient regarding wrongdoing, informing close relatives, seeking consent for children and patients' consent for procedures. Furthermore, no significant difference observed between the two with respect to the practice of health-care ethics. Surprisingly, the response of clinical and nonclinical faculty did not differ as far as awareness and practice of ethics were concerned. CONCLUSION: The significant difference is observed in the knowledge, awareness, and practice of ethics among consultants and SRs. Conferences, symposium, and workshops, on health-care ethics, may act as a means of sensitizing doctors and thus will help to bridge this gap and protect the well-being and confidentiality of the patients. Such an effort may bring about harmonious change in the doctor-patient relationship.

Nurses' knowledge in ethics and their perceptions regarding continuing ethics education: a cross-sectional survey among nurses at three referral hospitals in Uganda.

BACKGROUND: High disease burden and scarcity of healthcare resources present complex ethical dilemmas for nurses working in developing countries. We assessed nurses' knowledge in ethics and their perceptions about Continuous Nurses' Ethics Education (CNEE) for in-service nurses. METHODS: Using an anonymous, pre-tested self-administered questionnaire, we assessed nurses' knowledge in basic ethics concepts at three regional hospitals in Uganda. Adequate knowledge was measured by a score ≥50% in the knowledge assessment test. Nurses' perceptions on CNEE were assessed using a six-point Likert scale. RESULTS: Of 114 nurses, 91% were female; with mean age 44.7 (SD 10) years. Half were diploma, 47 (41%) certificates, 6 (5%) bachelors' degrees and one masters' level training. Overall, 18 (16%) scored ≥50% in the ethics knowledge test. Nurses with diploma or higher level of nursing training were less likely to fail the ethics knowledge than certificate-level nurses (OR 0.14, 95% CI: 0.02-0.7). Only 45% had ever attended at least one CNEE session and up to 93% agreed that CNEE is required to improve nurses' ethics knowledge and practice. CONCLUSIONS: Nurses exhibited low knowledge in ethics and positive attitudes towards CNEE. We recommend structured CNEE programs to address basic concepts in nursing ethics and their application in clinical practice.

Ethics policy review: a case study in quality improvement.

Policy work is often cited as one of the primary functions of Hospital Ethics Committees (HECs), along with consultation and education. Hospital policies can have far reaching effects on a wide array of stakeholders including, care providers, patients, families, the culture of the organisation and the community at large. In comparison with the wealth of information available about the emerging practice of ethics consultation, relatively little attention has been paid to the policy work of HECs. In this paper, we hope to advance the development of best practices in HEC policy work by describing the quality improvement process that we undertook at Hamilton Health Sciences, Hamilton, Ontario, Canada. In the first section of the paper we describe the context of our HEC policy work, and the shortcomings of our historical review process. In subsequent sections, we detail the quality improvement project we undertook in 2010, the results of the project and the specific tools we developed to enhance the quality of HEC policy work. Our goal in sharing this organisational case study is to prompt other HECs to publish qualitative descriptions of their policy work, in order to generate a body of knowledge that can inform the development of best practices for ethics policy review.