Estimating the Effect of Disclosure of Patient Safety Incidents in Diagnosis-Related Patient Safety Incidents: A Cross-sectional Study Using Hypothetical Cases.

BACKGROUND: Disclosure of patient safety incidents (DPSIs) is a strategic measure to reduce the problems of patient safety incidents (PSIs). However, there are currently limited studies on the effects of DPSIs on resolving diagnosis-related PSIs. Therefore, this study aimed to estimate the effects of DPSIs using hypothetical cases, particularly in diagnosis-related PSIs. METHODS: A survey using 2 hypothetical cases of diagnosis-related PSIs was conducted in 5 districts of Ulsan Metropolitan City, Korea, from March 18 to 21, 2021. The survey used a multistage stratified quota sampling method to recruit participants. Multiple logistic regression and linear regression analyses were performed to determine the effectiveness of DPSIs in hypothetical cases. The outcomes were the judgment of a situation as a medical error, willingness to revisit and recommend the hypothetical physician, intention to file a medical lawsuit and commence criminal proceedings against the physicians, trust score of the involved physicians, and expected amount of compensation. RESULTS: In total, 620 respondents, recruited based on age, sex, and region, completed the survey. The mean age was 47.6 (standard deviation, ±15.1) years. Multiple logistic regression showed that DPSIs significantly decreased the judgment of a situation as a medical error (odds ratio [OR], 0.44; 95% confidence interval [CI], 0.24-0.79), intention to file a lawsuit (OR, 0.53; 95% CI, 0.42-0.66), and commence criminal proceedings (OR, 0.43; 95% CI, 0.34-0.55). It also increased the willingness to revisit (OR, 3.28; 95% CI, 2.37-4.55) and recommend the physician (OR, 8.21; 95% CI, 4.05-16.66). Meanwhile, the multiple linear regression demonstrated that DPSIs had a significantly positive association with the trust score of the physician (unstandardized coefficient, 1.22; 95% CI, 1.03-1.41) and a significantly negative association with the expected amount of compensation (unstandardized coefficient, -0.18; 95% CI, -0.29 to -0.06). CONCLUSIONS: DPSIs reduces the possibility of judging the hypothetical case as a medical error, increases the willingness to revisit and recommend the physician involved in the case, and decreases the intent to file a lawsuit and commence a criminal proceeding. Although this study implemented hypothetical cases, the results are expected to serve as empirical evidence to apply DPSIs extensively in the clinical field.

Clinician perspectives on policy approaches to genetic risk disclosure in families.

Genomic sequencing has emerged as a powerful tool with significant implications for patients and their relatives, however, empirical evidence suggests that effective dissemination of risk information within families remains a challenge. Policy responses to address this issue vary across countries, with Belgium notably lacking specific regulations governing nondisclosure of genetic risk. In this study, we conducted semi-structured interviews with clinicians from Belgian clinical genetics centers to gain insight into their perspectives on policy approaches to the disclosure of genetic risk within families. Using real-world examples of legislation and court rulings from France, Australia, and the UK, we explored clinician viewpoints on the roles and responsibilities of both patients and clinicians in the family communication process. Clinicians expressed confusion regarding what was legally permissible regarding contacting at-risk relatives. While there was a consensus among participants that patients have a responsibility to inform their at-risk relatives, participants were hesitant to support the legal enforcement of this duty. Clinicians mostly recognized some responsibility to at-risk relatives, but the extent of this responsibility was a subject of division. Our findings highlight the need for a comprehensive policy that clarifies the roles and responsibilities of clinicians and patients to inform at-risk relatives. Furthermore, the study underscores the practical challenges clinicians face in supporting patients through the complex process of family communication, suggesting a need for additional resources and the exploration of alternative approaches to communication.

The right to be forgotten versus the right to disclosure of gamete donors' id: ethical and legal considerations / El derecho al olvido frente al derecho a revelar la identificación de los donantes de gametos: consideraciones éticas y jurídicas / O direito ao esquecimento versus o direito à divulgação da identificação de dadores de gâmetas: considerações éticas e legais

Abstract: 15. The anonymity of gamete donors in the context of medically-assisted reproduction techniques (ART) and the right of the offspring to know their genetic or biological parents' identity is a controversial and widely debated topic in the scientific literature. The positions on the issue in each country are different. Sometimes they are in opposition to each other even in countries with strong similarities, such as those in the European Union (EU), in the framework of shared ethical values. Although some countries still enshrine the rule of anonymity, there is an undeniable tendency to guarantee the right to know one's origins by creating relevant exceptions or abolishing donor anonymity status altogether. 16. This article offers ethical and legal considerations of whether the so-called 'right to be forgotten' (RTBF) could be extended to include gamete donors' right to remain anonymous. This perspective goes against the general trend, certainly in Europe, of recognizing that offspring born from donor gametes have a right to access information relating to their genetic progenitors. The novel addition is to question whether the General Data Protection Regulation (GDPR) might provide fertile ground for questioning this approach, and effectively support those jurisdictions where anonymity is still possible.

Resumen: 20. El anonimato de los donantes de gametos en el contexto de las técnicas de reproducción médicamente asistida (RM) y el derecho de la descendencia a conocer su identidad genética o biológica es un tema controvertido y ampliamente debatido en la literatura científica. Las posiciones sobre el tema en cada país son diferentes. A veces se oponen entre sí, incluso en países con fuertes similitudes, como los de la Unión Europea (UE), en el marco de valores éticos compartidos. Aunque algunos países siguen consagrando la norma del anonimato, es innegable la tendencia a garantizar el derecho a conocer el propio origen creando las excepciones pertinentes o suprimiendo por completo el estatus de anonimato del donante. 21. Este artículo ofrece consideraciones éticas y jurídicas sobre si el llamado "derecho al olvido" podría ampliarse para incluir el derecho de los donantes de gametos a permanecer en el anonimato. Esta opinión es contraria a la tendencia general, ciertamente en Europa, de reconocer que los hijos nacidos de gametos donados tienen derecho a acceder a la información relativa a sus padres genéticos. La nueva adición consiste en debatir si el Reglamento general de protección de datos (RGPD) podría proporcionar un terreno fértil para cuestionar este enfoque y apoyar efectivamente a las jurisdicciones en las que el anonimato sigue siendo posible.

Resumo 25. O anonimato dos dadores de gâmetas no contexto das técnicas de reprodução medicamente assistida (RMA) e o direito da descendência a conhecer a sua identidade genética ou biológica é um tema controverso e amplamente debatido na literatura científica. As posições sobre a questão em cada país são diferentes. Por vezes estão em oposição umas às outras, mesmo em países com fortes semelhanças, como os da União Europeia (UE), no quadro de valores éticos partilhados. Embora alguns países ainda consagrem a regra do anonimato, existe uma tendência inegável para garantir o direito de conhecer as suas origens, criando exceções relevantes ou abolindo completamente o estatuto de anonimato dos dadores. 26. Este artigo oferece considerações éticas e legais sobre se o chamado "direito ao esquecimento" poderia ser alargado para incluir o direito dos dadores de gâmetas a permanecerem anónimos. Esta perspetiva vai contra a tendência geral, certamente na Europa, de reconhecer que os descendentes nascidos de gâmetas doadas têm o direito de aceder à informação relacionada com os seus progenitores genéticos. O novo aditamento é debater se o Regulamento Geral de Proteção de Dados (RGPD) poderá fornecer um terreno fértil para questionar esta abordagem, e apoiar efetivamente as jurisdições onde o anonimato ainda é possível.

Policies and practice in the disclosure of medical error: Insights from leading countries to address the issue in Italy.

The relationship between physician and patient has undergone profound changes in recent years. Patients increasingly insist on being thoroughly informed with detailed information about treatments and procedures suggested for their best care. This is also due to the growing suspicion towards doctors and the health-care system in general. Therefore, it is no longer possible to hide a medical error. To satisfy the request for honesty and safety of patients and society, it is necessary to enhance the skills and tools that physicians can use when disclosing and explaining an error to the patient. All modern codes of medical conduct acknowledge the importance of strengthening communication between physician and patient, which is the only way to save a relationship under constant threat of rupture and to improve the quality and safety of the treatment. The disclosure and explanation of the error has become not only an ethical duty but also a prudent way of avoiding negligence lawsuits. In this context, in 2013, Germany approved a law known as Patientenrechtegesetz, which we consider a good compromise between patient expectations and the need for doctors to work without the constant fear of being sued for malpractice. This work seeks to provide an overview of the most important issues pertaining to disclosure of medical error and of practice in other countries, with the aim of offering a contribution to the debate on this subject in Italy.

Incidental Findings in the Trauma Population: Interdisciplinary Approach and Electronic Medical Record Reminder Association with Pre-Discharge Reporting and Medicolegal Risk.

BACKGROUND: Incidental findings (IFs) are reported in 20% or more of trauma CT scans. In addition to the importance of patient disclosure, there is considerable legal pressure to avoid missed diagnoses. We reported previously that 63.5% of IFs were disclosed before discharge and with 20% were nondisclosed. We initiated a multidisciplinary systemic plan to effect predischarge disclosure by synoptic CT reports with American College of Radiology recommended follow-up, electronic medical records discharge prompts, and provider education. STUDY DESIGN: Prospective observational series patients from November 2019 to February 2020 were included. Statistical analysis was performed with SPSS, version 21 (IBM Corp). RESULTS: Eight hundred and seventy-seven patients underwent 1 or more CT scans for the evaluation of trauma (507 were male and 370 were female). Mean age of the patients was 57 years (range 14 to 99 years) and 96% had blunt injury. In 315 patients, there were 523 IFs (1.7 per patient); the most common were lung (17.5%), kidney (13%), and liver (11%). Radiology report compliance rate was 84% (210 of 249 patients). There were 66 studies from outside facilities. Sixteen IFs were suspicious for malignancy. A total of 151 patients needed no follow-up and 148 patients needed future follow-up evaluation. Predischarge IF disclosure compliance rate was 90.1% (286 patients); 25 were post discharge. Four patients remained undisclosed. Compared with our previous report, clearer reporting and electronic medical records prompts increased predischarge disclosure from 63.5% to 90.1% (p < 0.01, chi-square test) and decreased days to notification from 29.5 (range 0 to 277) to 5.2 (range 0 to 59) (p < 0.01, Mann-Whitney U test). CONCLUSIONS: Timely, complete disclosure of IFs improves patient outcomes and reduces medicolegal risk. Collaboration among trauma, radiology, and information technology promotes improved disclosure in trauma populations.

Analysis of Radon Awareness and Disclosure Policy in Kentucky: Applying Kingdon's Multiple Streams Framework.

The purpose of this article is to analyze radon awareness and disclosure policy proposed during the 2018 Kentucky General Assembly using Kingdon's Multiple Stream Framework. Radon gas is the second leading cause of lung cancer. Exposure to radon occurs largely in the home. The proportion of homeowners who have completed radon testing remains low, and home radon testing is voluntary in most states. The Environmental Law Institute recommends states enact policies to promote radon awareness and testing. The most common radon awareness policy mandates radon disclosure during a real estate transaction. A bill to mandate radon disclosure during a real estate transaction was proposed during the 2018 Kentucky General Assembly but was met with opposition and was not filed. As a policy alternative, an administrative regulation to amend the Form for Seller's Disclosure of Conditions was proposed to the Kentucky Real Estate Commission. Administrative regulations set forth by government regulatory agencies are equally enforceable and may be a more politically feasible alternative to enacting public policy. Nurses are positioned to promote the health of patients and populations. Nurses advocating for radon control legislation and/or administrative regulations may push radon control policy higher on the governmental decision agenda leading to policy change to decrease the development of lung cancer.

Evaluating people's concern about their health information privacy based on power-responsibility equilibrium model: A case of Taiwan.

To address the issue of rising expenditure of healthcare service and to fulfill the skyrocketing demand for quality healthcare, the electronic medical records (EMR) exchange has become a vital and indispensable solution for healthcare facilities in terms of being able to share medical information among healthcare providers. Hence, EMR exchange was expected to improve the quality of healthcare and reduce the cost of repetitive medical check-ups and unnecessary treatments. However, recent reports affirming EMR data leaks and compromises have ignited major worldwide privacy concerns over the security of the EMR systems. How to effectively diminish patients' concern for EMR privacy has thus become an important issue that healthcare institution managers/stakeholders have to address urgently. This study leverages the power-responsibility equilibrium perspective to investigate the antecedents and consequences of concerns for the EMR exchange. A survey using 391 responses collected from medical centers, regional and district hospitals in Taiwan was used to conduct this study. The results show that government regulations have a positive effect on hospital privacy policies. Furthermore, both government regulations and hospital privacy policy are negatively associated with concern for EMR information privacy. Additional reports gathered from this study also showed that concern for EMR information privacy could result in patients' protective responses including refusal to provide personal health information (PHI), removal of PHI, negative word of mouth, complaining directly to the hospital, or complaining indirectly to third-party organizations. These findings demonstrate the need for healthcare facilities to formulate robust privacy policies in order to alleviate patients' concern for EMR information privacy based on governmental regulations. This regulation is top-priority as the incapability of reducing patients' concern for EMR information privacy may lead to the collapse of the campaign for the full-adoption of EMR or possibly jeopardize the promotion and application of EMR among healthcare facilities.

Navigating the Intersection between Genomic Research and Clinical Practice.

The Risk Assessment Program (RAP) at Fox Chase Cancer Center (Philadelphia, PA) is a multi-generational prospective cohort, enhanced for personal and family history of cancer, consisting of over 10,000 individuals for whom data on personal and family history of cancer, risk factors, genetic and genomic data, health behaviors, and biospecimens are available. The RAP has a broad research agenda including the characterization of genes with known or potential relevance to cancer, gene-gene and gene-environment interactions, and their contribution to clinically useful risk assessment and risk reduction strategies. Increasingly, this body of research is identifying genetic changes which may have clinical significance for RAP research participants, leading us to confront the issue of whether to return genetic results emerging from research laboratories. This review will describe some of the important fundamental points that must be debated as we develop a paradigm for return of research results. The key issues to address as the scientific community moves toward adopting a policy of return of research results include the best criteria for determining which results to offer, the consent document components necessary to ensure that the participant makes a truly informed decision about receiving their results, and associated logistical and cost challenges.See all articles in this Special Collection Honoring Paul F. Engstrom, MD, Champion of Cancer Prevention.

Analysis of Open Payments Receipts Among Surgical Faculty at a Large Academic Institution.

BACKGROUND: Section 6002 of the Affordable Care Act, commonly referred to as "The Sunshine Act," is legislation designed to provide transparency to the relationship between physicians and industry. Since 2013, medical product and pharmaceutical manufacturers were required to report any payments made to physicians to the Centers for Medicare and Medicaid Services (CMS). We predicted that most clinical faculty at our institution would be found on the Open Payments website. We elected to investigate payments in relationship to divisions within the department of surgery and the level of professorship. METHODS: All clinical faculty (n = 86) within the department of surgery at our institution were searched within the database: https://openpaymentsdata.cms.gov/. The total amount of payments, number of payments, and the nature of payments (food and beverage, travel and lodging, consulting, education, speaking, entertainment, gifts and honoraria) were recorded for 2017. Comparison by unpaired t-test (or ANOVA) where applicable, significance defined as P < 0.05. RESULTS: Of the 86 faculty studied, 75% were found within the CMS Open Payments database in 2017. The mean amount of payment was $4024 (range $13-152,215). Median amount of payment was $434.90 (range $12.75-152,214.70). Faculty receiving outside compensation varied significantly by division and academic rank (P < 0.05). Plastic surgery had the highest percentage of people receiving any form of payment ($143-$1912) and GI surgery had the largest payments associated with device management ($0-$152,215). The variation seen by rank was driven by a small number of faculty with receipt of large payments at the associate professor level. The median amount of payment was $428.53 (range $13.97-2306.05) for assistant professors, $5328.03 (range $28.30-152,214.70) for Associate Professors, and $753.82 (range $12.75-17,708.65) for full professors. CONCLUSIONS: Reporting of open payments to CMS provides transparency between physicians and industry. The significant relationship of division and rank with open payments database is driven by relatively few faculty. The majority (94%) received either no payments or less than $10,000.

Familial disclosure by genetic healthcare professionals: a useful but sparingly used legal provision in France.

Familial disclosure of genetic information is an important, long-standing ethical issue that still gives rise to much debate. In France, recent legislation has created an innovative and unprecedented procedure that allows healthcare professionals (HCPs), under certain conditions, to disclose relevant information to relatives of a person carrying a deleterious genetic mutation. This article will analyse how HCPs in two medical genetics clinics have reacted to these new legal provisions and show how their reticence to inform the patients' relatives on their behalf leads them to use this option sparingly.

Hii Chii Kok v (1) Ooi Peng Jin London Lucien; (2) National Cancer Centre: Modifying Montgomery.

In Hii Chii Kok v (1) Ooi Peng Jin London Lucien; (2) National Cancer Centre, the Singapore Court of Appeal followed the approach of other Commonwealth jurisdictions by rejecting the application of Bolam as the standard of disclosure in claims concerning informed consent to medical treatment. Instead, the court employed a modified version of the standard of disclosure adopted in Montgomery v Lanarkshire Health Board. While broadly welcomed, Montgomery has been criticised for its lack of clarity on the application of some elements of its disclosure standard. In particular, questions remain as to: what factors should be taken into account within the reasonable and particular patient limbs of the test of materiality; how will the 'reasonableness' of alternative treatments be determined; and what is the scope of the therapeutic exception. This case commentary explores how Hii's analysis of the modified standard offers insights into how those elements of Montgomery could be interpreted in the future.

Knee and Hip TEP Surgery: The Surgeons' Obligation to Give Information. / Die Selbstbestimmungsaufklärung bei Operationen in der Hüft- und Knieendoprothetik.

The German Civil Code (BGB) establishes in § 630e BGB formal and content-related requirements to provide the patient with a solid fundament of information. This is necessary for a valid informed consent. Without it, the physician is liable for the violation of the patients' physical integrity and his right to self-determination. According to German jurisprudence, this shall even apply when the treatment was conducted duly and without any complications. Therefore, it is astonishing that the correct way of giving information is neither taught in medical school nor in the residency. In practice, supervisors expect that young assistant doctors will be familiar with the correct procedure. As a result, many mistakes are made, even though these are easy to avoid. In this article, we point out all relevant information and the correct way of presenting this, using the example of hip/knee TEP operations.

Cooperation in confidential withholding of HIV status from partners of sexually-active patients: a role for organisational moral agency.

An increasingly blurred understanding of the conditions under which clinicians may withhold HIV seropositive status from partners of patients who are sexually active and who do not intend to disclose suggests a critical need to revisit the relationship between the principle of confidentiality, the moral and legal duties to warn at-risk third parties, and the organisational ethics surrounding licit cooperation with wrongdoing in the effort to uphold professional moral responsibility. This essay grounds its argument in two, straightforward premises: (i) the ethical principle of cooperation is an indispensable measure of the moral licitness of instances of complicity with wrongdoing; (ii) some instances of material organisational complicity vis-à-vis confidential withholdings of HIV seropositive status from partners of sexually active patients both meet and successfully employ the standards of the ethical principle of cooperation. Drawing from this syllogism, the essay argues that, in Type II cases, healthcare organisations may (initially and on certain conditions) materially cooperate in withholding the HIV seropositive status of patients from partners with whom patients are sexually active, and to whom patients do not intend to disclose HIV seropositive status, in the effort to honour professional obligations of privacy, confidentiality, and fidelity in a manner that is both legally licit and morally justifiable.

Keep Them From Harm and Injustice?

Fear remains a major barrier to transparency of hospital errors.

The impact of legislation mandating breast density notification - Review of the evidence.

Breast density (BD) is an independent risk factor for breast cancer and reduces the sensitivity of mammography. The enactment of BD legislation in a majority of states in the USA mandating notification of risks associated with BD directly to women undergoing mammography has catapulted interest in BD among women, physicians, and policymakers. We therefore report a descriptive review of the evidence on the impact of enactment of BD legislation. Based on 22 eligible studies, we identified four broad themes of research: studies of the impact on screening rates, most showing increased utilisation of supplemental screening; studies exploring the effect on women, radiologists, or primary physicians (reporting heterogeneous effects on knowledge, awareness, perceptions, attitudes and behaviour; and changes in practice); few studies assessing the population impact (effect on screening outcomes or breast cancer stage); and studies of costs highlighting the economic burden from supplemental screening. Given that many of the studies were retrospective single institution studies (comparing pre- and post-legislation) or small surveys with a paucity of population-level studies, we highlight areas meriting additional research. The information described in this review can inform research priorities where BD legislation has been introduced and can be used to guide world-wide policy or practice decisions where BD legislation may be under debate or contemplation.