#consented - A semantic consent code to facilitate consistent documentation and implementation of consent in collaborative medical research.

INTRODUCTION: In German and international research networks different approaches concerning patient consent are applied. So far it is time-consuming to find out to what extent data from these networks can be used for a specific research project. To make the contents of the consents queryable, we aimed for a permission-based approach (Opt-In) that can map both the permission and the withdrawal of consent contents as well as make it queryable beyond project boundaries. MATERIALS AND METHODS: The current state of research was analysed in terms of approach and reusability. Selected process models for defining consent policies were abstracted in a next step. On this basis, a standardised semantic terminology for the description of consent policies was developed and initially agreed with experts. In a final step, the resulting code was evaluated with regards to different aspects of applicability. RESULTS: A first and extendable version for a Semantic Consent Code (SCC) based on 3-axis (CLASS, ACTION, PURPOSE) was developed, consolidated und published. The added value achieved by the SCC was illustrated using the example of real consents from large national research associations (Medical Informatics Initiative and NUM NAPKON/NUKLEUS). The applicability of the SCC was successfully evaluated in terms of the manual semantic mapping of consents by briefly trained personnel and the automated interpretability of consent policies according to the SCC (and vice versa). In addition, a concept for the use of the SCC to simplify consent queries in heterogeneous research scenarios was presented. CONCLUSIONS: The Semantic Consent Code has already successfully undergone initial evaluations. As the published 3-axis code SCC is an essential preliminary work to standardising initially diverse consent texts and contents and can iteratively be extended in multiple ways in terms of content and technical additions. It should be extended in cooperation with the potential user community.

The specifics of the interpretation of non-performance or improper performance by medical or pharmaceutical employees of their professional duties, taking into account the practice of the ECHR.

OBJECTIVE: Aim: To find out the specifics of the interpretation of non-performance or improper performance by medical or pharmaceutical employees of their professional duties, taking into account the practice of the ECHR. PATIENTS AND METHODS: Materials and Methods: This article is based on the analysis of the international legal acts, the practice of the ECHR, national judicial practice, court statistics, criminal and medical law legal doctrine, official statistics of the Office of the Prosecutor General of Ukraine, analytical data based on the results of cooperation with the "Main Bureau of Forensic Medical Examination of the Ministry of Health of Ukraine". Dialectical, comparative, analytical, synthetic and system analysis research, hermeneutic methods were used. RESULTS: Results: In each specific case it is necessary to establish whether there is non-performance or improper performance of professional duties by medical or pharmaceutical employees, the result of which is the failure to fulfil his direct professional duties, provided for by regulatory and legal acts, job instructions, qualification requirements and standards of treatment. The patient's right to health care is not ensured by the guarantees provided for by national legislation, so patients file complaints with the ECHR. CONCLUSION: Conclusions: A single approach to the interpretation of such terms as "non-performance or improper performance by a medical or pharmaceutical employee his professional duties" is a guarantee of the uniformity of their enforcement and the formation of stable judicial practice in this category of criminal cases.

Dignity in the Pediatric Population: A Systematic Review.

CONTEXT: Children are a uniquely vulnerable patient population with restricted abilities for self-advocacy and autonomy, risking infringement upon their dignity. Yet the concept of dignity in pediatrics remains underexplored relative to the adult literature and other outcome measures. OBJECTIVES: To characterize how dignity is defined, evaluated, and/or measured in pediatrics. METHODS: We conducted a systematic review following PRISMA guidelines across the following databases: MEDLINE, Embase, Cumulative Index of Nursing and Allied Health, PsycINFO, Global Health, Social Science Premium Collection, and Dissertation and Theses. We included publications from database inception through April 2023, in English, involving children aged 0-18 years, and prioritizing dignity as a central theme with a focus on defining, evaluating, or measuring dignity. Study descriptions and pertinent characteristics were extracted and synthesized using a predefined form. RESULTS: Forty-four articles met inclusion criteria; fewer than half comprised original research (20/44, 45%). Most studies (38/44, 86%) included description of the meaning of dignity, with emergence of salient themes around respect, communication, agency/autonomy, and privacy. Less than half (19/44, 43%) included a measurement or evaluation of dignity; approximately one-third described dignity therapy. More than one-third of publications focused on dignity at end of life (17/44, 39%) and included discussions of palliative care and hospice (15/44, 34%). CONCLUSION: Relatively few published studies describe dignity in pediatrics. Opportunities exist to broaden scholarship on this topic in partnership with patients, families, and clinicians, with the goal of assessing and strengthening dignity-centered care across the illness course and at the end of life.

Psychometric evaluation of the Vietnamese version of nurses' ethical behaviors for protecting patient rights scale (V-NEBPPRS): a methodological study.

BACKGROUND: Recognizing patients' rights as fundamental human rights, the global healthcare community, including the World Health Organization and various nursing organizations, has emphasized the critical role of nurses in upholding these rights through ethical practice and patient-centered care. However, in the complex landscape of healthcare, nurses in Vietnam face various ethical issues and challenges that may impede their ability to protect patient rights effectively, necessitating tools for better ethical decision-making and practice. PURPOSE: This study aims to translate the Nurses' Ethical Behaviours for Protecting Patient Rights Scale (NEBPPR) into Vietnamese and evaluate the validity and reliability of the V-NEBPPRS. METHODS: The original scale underwent a cross-cultural translation process to be adapted into Vietnamese. Construct validity was assessed using confirmatory factor analysis (CFA). The convergent validity, discriminant validity, and reliability of the V-NEBPPRS were evaluated. RESULTS: After removing four items with factor loading below 0.5, the V-NEBPPRS comprises 24 items divided into five factors. CFA demonstrated a good model fit (χ2/df = 2.86; GFI = 0.87; IFI = 0.85; CFI = 0.84; RMSEA = 0.07). Convergent and discriminant validity were confirmed with extracted mean variance ranging from 0.54 to 0.67, 0.54 to 0.67, and composite reliability from 0.73 to 0.81. Cronbach's α coefficient was 0.85 for the total scale and ranged from 0.70 to 0.79 for five subscales. CONCLUSION: The V-NEBPPRS is a reliable tool, providing nursing leaders and researchers with the means to utilize the V-NEBPPRS for assessing and promoting nurses' awareness and behaviour in safeguarding patients' rights, thereby contributing to improved overall health outcomes.

Diagnóstico humanizado: El paciente en el centro - la comunicación que cura / Diagnóstico humanizado: O paciente no centro - comunicação que cura / Humanized Diagnosis: The pacient at the center - communication that Heals

Este texto plantea la importancia de confeccionar protocolos de diagnóstico humanizado que permitan a los profesionales de la salud brindar información sobre patologías y/o discapacidades de manera clara y veraz, humana y delicadamente, facilitando su recepción por parte del paciente y su familia. El diagnóstico humanizado no forma parte únicamente de un protocolo de "urbanidad" en el vínculo médico ­ paciente: es parte integrante y relevante del procedimiento o tratamiento. Este abordaje exige una mirada interdisciplinar. En esta temática hay elementos que se vinculan a lo médico ­ científico; lo jurídico ­ legislativo ­ jurisprudencial y lo político.

Ao longo deste texto, discute-se a importância da elaboração de protocolos diagnósticos humanizados que permitam aos profissionais de saúde fornecerem informações sobre patologias e/ou incapacidades de forma clara e verdadeira, ao mesmo tempo em que humanizada e delicada, facilitando seu acolhimento pelo paciente e sua família. O diagnóstico humanizado não é apenas parte de um protocolo de "civilidade" na relação médico-paciente, mas parte integrante e relevante do procedimento para realizar o tratamento de uma doença ou deficiência. Essa abordagem requer uma abordagem interdisciplinar. Nessa disciplina há elementos que se vinculam ao médico-científico; as esferas jurídica, legislativa e política.

Throughout this text, the importance of creating humanized diagnostic protocols is discussed. These should allow healthcare professionals to provide clear and truthful information about pathologies and/or disabilities in a humane and delicate manner, facilitating their understanding by the patient and their family. Humanized diagnosis is not just part of a "politeness" protocol in the doctor-patient relationship, but an integral and relevant part of the procedure for treating a disease or disability. This approach requires an interdisciplinary perspective, as there are elements that are linked to the strictly medical-scientific, legal-legislative-jurisprudential, and political aspects of this topic.

Assessing nourishment problems at a hospital: what can we learn from them?

INTRODUCTION: Patient safety is a high priority in the Danish health care system, including that hospital patients get the proper nutrition during their stay. A Nutrition Committee at Odense University Hospital is responsible for policy regarding nourishment at the hospital. If patients experience suboptimal treatment, i.e. improper nourishment, in the Danish health care system, they have the right to file a complaint. These complaints enable the improvement potentials based on the patients' first hand experiences. Therefore, our aim was to examine the nutrition complaint pattern and to get a deeper understanding of the context surrounding nutrition problems, allowing the extraction of learning potentials. METHODS: We analysed complaints submitted to Odense University Hospital between 2018 and 2022 using the Healthcare Complaint Analysis Tool. The complaints were categorised into categories, levels of severity and overall patient harm. The complaints containing a high-severity nutrition problem were read through and thematised into aspects not defined in the Healthcare Complaint Analysis Tool. RESULTS: Between 2018 and 2022, 60 complaint cases containing 89 nutrition problems were filed to Odense University Hospital. Most (58.3%) of these were filed by the patients' relatives. The nutrition problems were mostly of low severity (56.2%), while 23.6% were severe, and 20.2% were very severe. The reading of 18 very severe nutrition complaints revealed a cascade of problems triggered by the nutrition problem in six cases. Moreover, we saw that two high-severity nutrition problems led to catastrophic harm. DISCUSSION: A low proportion of nutrition problems may express an underestimation regarding nourishment at the hospital. A patient's threshold may not be exceeded by suboptimal nutrition and therefore does not file a complaint. However, complaints contain important insights contributing to wider learning, given that improvements at the hospital so far are based on clinicians' reporting, overlooking the patient perspective.

Clinical Teaching and Consent: An Analysis of New Zealand's Legal Requirements for Obtaining Consent to Clinical Teaching Involving Consumers of Health and Disability Services.

Student involvement in patient care without consent has attracted recent attention in New Zealand. New Zealand's Code of Health and Disability Services Consumers' Rights (Code) gives patients the right to give or refuse consent to participate in clinical teaching, but its practical application to clinical teaching, particularly postgraduate, is unclear. This article explores the history and precedent of the Code and ethical considerations, to inform where amendment to the Code is desirable in the interests of clarity, pragmatism, and to reflect better the legislature's intent.

The Publishing Dilemmas of Authors Who Have Lived Experience With Mental Illness.

This column details some of the ways in which psychiatric survivors or those writing about their lived experience with mental illness are disadvantaged and devalued in mainstream academic publishing. This devaluation stems from structural issues involving various organizations, persons, and practices. Breaking the constraints of this structure is extremely difficult, but the author proposes some ways of doing so.

Values-Based Medicine Is an Ethical Concept for Implementing the Ethical Principles in Daily Practice.

Values-based medicine (VsBM) is an ethical concept, and bioethical framework has been developed to ensure that medical ethics and values are implemented, pervasive, and powerful parameters influencing decisions about health, clinical practice, teaching, medical industry, career development, malpractice, and research. Neurosurgeons tend to adopt ethics according to their own values and to what they see and learn from teachers. Neurosurgeons, in general, are aware about ethical codes and the patient's rights. However, the philosophy, concept, and principles of medical ethics are rarely included in the training programs or in training courses. The impact of implementing, observing the medical ethics and the patients' value and culture on the course, and outcome of patients' management should not underestimate. The main principles of medical ethics are autonomy, beneficence, nonmaleficence, justice, dignity, and honesty, which should be strictly observed in every step of medical practice, research, teaching, and publication. Evidence-based medicine has been popularized in the last 40-50 years in order to raise up the standard of medical practice. Medical ethics and values have been associated with the medical practice for thousands of years since patients felt a need for treatment. There is no conflict between evidence-based medicine and values-based medicine, as a medical practice should always be performed within a frame of ethics and respect for patients' values. Observing the principles of values-based medicine became very relevant as multicultural societies are dominant in some countries and hospitals in different corners of the world.

[After cancer: after-eff ects, return to work and the right to forget]. / Après un cancer : séquelles, retour à l'emploi et droit à l'oubli.

AFTER CANCER: AFTER-EFFECTS. RETURN TO WORK AND THE RIGHT TO FORGET. The ten-year strategy 2021-2030 against cancers makes staying at work or returning to work after cancer a major priority. A growing number of patients are on the job market at the time of their cancer diagnosis, with a potentially long career future. The after-effects of the disease, and the gap between them and the professional world, present them with numerous difficulties. French national cancer institute (INCa) has launched several initiatives to help people stay in work and return to work, in particular to complement the measures developed by the League against Cancer. INCa has set up the «Cancer and Employment¼ Business Club, a forum for the exchange of best practices and experiences between employers and researchers in the human and social sciences. The «Cancer aide info réseau entrepreneur¼ (CAIRE) scheme supports self-employed patients in their professional careers, and gives them a voice in their professional ecosystem. Research initiatives are also undertaken. The social repercussions of the disease also include its impact on borrowing capacity, for both personal and business loans. The "right to be forgotten" for cancer sufferers applies 5 years after the end of the therapeutic protocol. A grid completes the system, and in certain cases enables insurances for a loan can be obtained on standard or similar terms, even before this period has elapsed. It also includes other pathologies such as HIV, hepatitis C and cystic fibrosis. Last but not least, health questionnaires have been abolished for loans under €200,000. The role of the health professional is paramount, providing advice and facilitating the completion of documents requested by insurers.

APRÈS UN CANCER : SÉQUELLES, RETOUR À L'EMPLOI ET DROIT À L'OUBLI. La stratégie décennale de lutte contre les cancers 2021-2030 fait du maintien et/ou retour au travail ou en activité après un cancer une de ses priorités. Un nombre croissant de malades sont sur le marché du travail au moment de la survenue du cancer, avec un horizon de carrière potentiel assez long. Ces malades doivent faire face à de nombreuses difficultés du fait des séquelles de la maladie mais souvent également du décalage qui s'installe entre eux et le monde professionnel. Les entreprises se sentent fréquemment démunies. L'Institut national de cancer (INCa) a lancé plusieurs actions pour favoriser le maintien et le retour à l'emploi, notamment en complément de dispositifs développés par la Ligue contre le cancer ; l'INCa a ainsi créé un club d'entreprises « Cancer et emploi ¼, espace d'échanges de bonnes pratiques et d'expériences entre employeurs et chercheurs en sciences humaines et sociales. Le dispositif « Cancer Aide Info Réseau Entrepreneur ¼ (CAIRE) accompagne les travailleurs indépendants malades dans leur parcours professionnel et porte leur voix auprès des acteurs de leur écosystème professionnel. Des actions de recherche sont également entreprises. Le retentissement social de la maladie concerne aussi la capacité d'emprunt, pour des prêts à caractère personnel ou professionnel. Le droit à l'oubli pour les personnes atteintes de cancer s'applique cinq ans après la fin du protocole thérapeutique. Une grille vient compléter ce dispositif et permet dans certains cas, avant même la survenue de ce délai, l'obtention d'une assurance pour un prêt aux conditions standard ou s'en rapprochant. Cette grille inclut également d'autres pathologies, comme le VIH, l'hépatite C ou la mucoviscidose. Enfin, les questionnaires de santé sont supprimés pour les assurances de prêts inférieurs à 200 000 €. La place du professionnel de santé est prépondérante, en apportant des conseils et en facilitant la complétion des documents demandés par les assureurs.

Hospital Care for Cancer Patients-Education and Respect for Patient Rights.

This study aims to examine cancer patients' opinions of safety, the observance of patient's rights, and the quality of healthcare. Such an analysis will allow for the identification of areas for improvement in quality, safety, and communication between medical staff and patients. Cancer patients are a special kind of patients with chronic and complex diseases, so we need to observe the type of communication they use, which is a critical issue in a hospital ward but also has a significant impact on how the patient follows recommendations at home. Observing a patient's rights impacts the safety and quality of medical care. This information allows for the identification of areas requiring deeper analysis and improvement. This study was based on a survey conducted at an oncology hospital. The survey contained questions divided into seven sections related to the study areas. Our study emphasizes the importance of knowledge and understanding regarding patient rights among medical staff and patients, underscoring their role in ensuring quality and safety in healthcare settings. We found a strong correlation between the politeness of medical receptionists and staff and patient perceptions of the clarity and exhaustiveness of the information provided.

Public involvement in Australian clinical trials: A systematic review.

BACKGROUND: Public involvement enhances the relevance, quality, and impact of research. There is some evidence that public involvement in Australian research lags other countries, such as the United Kingdom. The purpose of the systematic review was to establish the rates and describe the characteristics of public involvement in Australian clinical trials. METHODS: We reviewed evidence of public involvement in all Australian randomised controlled trials published in the first 6 months of 2021. To determine the quality of public involvement, we used the five-item short-form version of the Guidance of Reporting Involvement Patients and the Public, version 2. RESULTS: In total, 325 randomised controlled trials were included, of which 17 (5%) reported any public involvement. Six trials reported public involvement in setting the research aim and seven in developing study methods. The authors of one study reflected on the overall role and influence of public involvement in the research. CONCLUSION: Rate of public involvement in Australian clinical trials is seemingly substantially lower than those reported in countries with similar advanced public health care systems, notably the United Kingdom. Our observations may be explained by a lack of researcher skills in how to involve the public and the failure by major funding agencies in Australia to mandate public involvement when deciding on how to award grant funding.

Literacy-related factors and knowledge of patient rights charter: evidence from nurses in selected hospitals in Ghana.

BACKGROUND: Systems of across the world have developed and implemented patient rights policies to protect and improve the provider-patient relationship. The Patient Charter of Ghana was developed in 2002 to improve service quality and protect patients' rights. However, it is not yet known whether those at the frontline of healthcare delivery can read and understand the contents of the charter. While studies have explored the socioeconomic and institutional level factors related to awareness and knowledge of the Patient Rights Charter, there is a lack of literature on its readability and comprehensibility among nurses. This study assesses nurses' knowledge of the Patient Rights Charter and associated literacy-related factors. METHOD: An exploratory cross-sectional design and quantitative methods were used to collect data on knowledge, comprehension, and readability of the Patient Rights Charter. 205 nurses from four district hospitals in the Central Region were recruited using proportional and total enumeration sampling. Data were collected using structured questionnaires and were processed using SPSS (version 26) and an online text readability consensus calculator (version 2.0). Descriptive and inferential statistical analyses were performed, and data were presented using simple frequencies, readability statistics, and regression output. RESULTS: The results show the charter is written at a higher reading grade level; Flesch-Kincaid Grade Level (13.36), Simple Measure of Gobbledygook (11.57), and Coleman-Liau Readability Index (14.2). The average reading grade level score was 14. The Gunning Fox Index (15.40) and the Flesch Reading Ease Score (34%) show the patient charter is difficult to read and will require at least 14 years of education to be able to read. 87.3% of nurses were able to read and comprehend the charter. Very few (8.3%) read at frustration level. Nurses' actual comprehension of the charter was the only significant predictor of knowledge of the charter. CONCLUSION: Comprehension of the patient charter is an important predictor of its knowledge. The results emphasize the need to enhance the readability and comprehensibility of the charter for providers. Hospitals can stimulate nurses' knowledge of the charter by simplifying the charter's language and deliberately educating nurses on its content.

Knowledge Gaps and Bridges: The Relationship between the Awareness of General Patient Rights and the Awareness of Minors' Patient Rights in the Netherlands.

The major focus of this research is the level of awareness among Dutch parents of general patient rights in relation to minors' patient rights. Moreover, this study is intended to highlight the most effective strategies to increase the awareness of general and minor patient rights in the Netherlands. A survey was conducted among 1010 Dutch parents aged between 35 and 55 years who had at least one child. In this study, we described the relationship between the knowledge among parents of general patient rights and their understanding of the patient rights of minors. A significant connection was found between the knowledge levels of general patient rights and the knowledge levels of the patient rights of minors (p < 0.05 [95% CI: 0.019-0.183]). While age and sex (male/female) did not appear to be significant confounders in this association, the educational background of the participants may have played a role. This study provides comprehensive insights into the association between the knowledge of general patient rights and the patient rights of minors among Dutch parents. Furthermore, this study points out that there is a need for focused educational interventions to address specific areas of misunderstanding or uncertainty.

Xenograft recipients and the right to withdraw from a clinical trial.

Preclinical xenotransplantation research using genetically engineered pigs has begun to show some promising results and could one day offer a scalable means of addressing organ shortage. While it is a fundamental tenet of ethical human subject research that participants have a right to withdraw from research once enrolled, several scholars have argued that the right to withdraw from xenotransplant research should be suspended because of the public health risks posed by xenozoonotic transmission. Here, we present a comprehensive critical evaluation of the claim that xenotransplant recipients should be required to waive their right to withdraw from lifelong biosurveillance. We conclude that if xenotransplantation requires participants to waive their right to withdraw, then clinical trials may not be justifiable, given the ethical and legal obstacles involved with doing so. Consequently, if clinical trials are permitted with a right to withdraw, then they may pose a significant public health risk.

Patterns in the provision of government-subsidised hormonal postpartum contraception in Queensland, Australia between 2012 and 2018: a population-based cohort study.

BACKGROUND: Short birth intervals and unintended pregnancy are associated with poorer maternal and infant outcomes. There is a risk of pregnancy during the immediate postpartum period unless contraception is initiated. This retrospective cohort study aimed to capture the current patterns of hormonal contraceptive provision within 12 months postpartum in a high-income country. METHODS: We used a linked administrative dataset comprising all women who gave birth in Queensland, Australia between 1 July 2012 and 30 June 2018 (n=339 265 pregnancies). We described our cohort by whether they were provided with government-subsidised hormonal contraception within 12 months postpartum. The associations between hormonal postpartum contraceptive provision and demographic and clinical characteristics were examined using univariate and multivariate logistic regression and presented in terms of crude and adjusted odds ratios with 95% confidence intervals. RESULTS: A majority of women (60.2%) were not provided with government-subsidised hormonal postpartum contraception within 12 months postpartum. Women who were younger (<25 years), were overweight or obese, smoked, were born in Australia, were non-Indigenous, gave birth in a public hospital, or were in the lowest socioeconomic status group were more likely to be provided with postpartum contraception after adjusting for other covariates, compared with their counterparts. CONCLUSIONS: Strategies to increase the provision and uptake of contraception in the immediate postpartum period are needed to prevent short birth intervals and unintended pregnancy and ensure women's fertility intentions are enacted. Ongoing research is needed to examine the factors influencing women's access to contraceptive services and, further, the types of contraception provided.

An Evaluation on the Attitude Toward Using Patient Rights and Satisfaction Levels in Emergency Department Patients.

INTRODUCTION: In emergency health care services, patient satisfaction is one of the fundamental indicators of quality emergency care, making it essential to identify factors that can impact this component of care. This study aimed to determine emergency service patients' attitudes toward using patient rights, their satisfaction levels with emergency service, and related factors. METHODS: The cross-sectional study was conducted with 382 patients who presented to the emergency department between November 2022 and March 2023. Data were collected using the Patient Description Form, the Emergency Department Patient Satisfaction Scale, and the Scale of Patient Rights Using Attitude. The study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist for reporting. RESULTS: The mean score of the Emergency Department Patient Satisfaction Scale was 53.88 ± 6.88 (minimum score, 30; maximum score, 68), and the mean score of the Scale of Patient Rights Using Attitude was 108.89 ± 11.90 (minimum score, 73; maximum score, 135). As a result of the regression analysis, it was found that the Scale of Patient Rights Using Attitude scores and frequency of ED visits significantly contributed to the Emergency Department Patient Satisfaction Scale scores. Younger patients who had higher educational status presented to the emergency department more frequently and had chronic diseases were associated with positive attitudes about using patient rights and had higher levels of ED patient satisfaction (P < .001). DISCUSSION: The study has provided valuable information for assessing the attitudes of ED patients toward exercising their patient rights and their satisfaction levels. Respect for patient rights and their effective utilization by patients can enhance the quality of ED services and increase patient satisfaction.