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.

An Ethical Framework for Disclosing the Training Status and Roles of Resident-Level Surgeons to Patients.

The concept of informed consent includes disclosure of all information that a reasonable patient would need to make a well-informed decision about whether to undergo a surgical procedure. This has traditionally been defined as including diagnosis, details about the procedure, prognosis, potential risks, and alternative treatments. The operating surgeon has final say and responsibility for the case, but the actual operation may be done (under supervision) by a surgeon in training. In this paper, we discuss the ethical dimensions of disclosing resident involvement, reviewing considerations such as established legal and professional standards, consequences for patients and for the surgical educators responsible for preparing future generations of surgeons, and patient rights. We conclude by offering a novel ethical framework intended to serve as a guide to disclosing resident involvement as part of the overall consent process.

Attitudes towards disclosure of familial genetic risk in a Mediterranean island population - A survey of the Maltese population.

Germline genetic testing has implications that extend beyond the individual patient to relatives, particularly for high-penetrance variants implicated in hereditary cancer or neurodegenerative syndromes. Many countries encourage patient-led communication to inform at-risk relatives, although the efficacy and uptake of this approach varies. Alternative scenarios envisage direct contact mediated by clinicians. The familial disclosure of sensitive genetic information is also determined by complex socio-ethnic factors. To date, no study has explored whether relatives would want to be informed of familial genetic risk and their preferences on different methods of communication in Malta. We thus used a published instrument that utilizes hypothetical scenario methodology to survey the attitudes of the Maltese population (n = 334) to receiving genetic information from family members. Two vignettes on Huntington's disease and colorectal cancer were presented. We also explored preferences towards the communication of genetic risk, confidentiality, and disclosure policies. Our preliminary results show that most respondents want to be informed of their increased risk by a family member or a clinician and would opt to receive confirmatory genetic testing. Most respondents preferred being informed of genetic risk by a close relative, but in the case of non-disclosure would want to be informed by a clinician. Most respondents expressed preference in favour of the introduction of registries, legislative change and sharing of contact details to address cases of nondisclosure. Our findings contribute further to evidence that supports, in selected hypothetical scenarios, an envisioned change in disclosure of genetic data policy by the public that is different from current practice to date.

Disclosure of Adverse Events and Medical Errors: A Framework for Anesthesiologists.

Ethical disclosure of adverse events (AE) presents opportunities and challenges for physicians and has unique ramifications for anesthesiologists. AE disclosure is supported by patients, regulatory organizations, and physicians. Disclosure is part of a physician's ethical duty toward patients, supports fully informed patient decision making, and is a critical component of root cause analysis. Barriers to AE disclosure include disruption of the doctor-patient relationship, fear of litigation, and inadequate training. Apology laws intended to support disclosure and mitigate concern for adverse legal consequences have not fulfilled that initial promise. Training and institutional communication programs support physicians in providing competent, ethical AE disclosure.

Conflict of Interest Disclosure in Oncology: Preliminary Insights From the Global ONCOTRUST-1 Cross-Sectional Study.

PURPOSE: Conflicts of interest (COIs) between oncologists and industry might considerably influence how the presentation of the research results is delivered, ultimately affecting clinical decisions and policy-making. Although there are many regulations on reporting COI in high-income countries (HICs), little is known about their reporting in low- and middle-income countries (LMICs). Oncology Transparency Under Scrutiny and Tracking (ONCOTRUST-1) is a pilot global survey to explore the knowledge and perceptions of oncologists regarding COI. MATERIALS AND METHODS: We designed an online 27-question-based survey in the English language to explore the perceptions and knowledge of oncologists regarding COI, with an emphasis on LMICs. Descriptive statistics and the Consensus-Based Checklist for Reporting of Survey Studies guidelines were used to report the findings. RESULTS: ONCOTRUST-1 surveyed 200 oncologists, 70.9% of them practicing in LMICs. Median age of the respondents was 36 (range, 26-84) years; 47.5% of them were women. Of the respondents, 40.5% reported weekly visits by pharmaceutical representatives to their institutions. Regarding oncologists' perceptions of COI that require disclosure, direct financial benefits, such as honoraria, ranked highest (58.5%), followed by gifts from pharmaceutical representatives (50%) and travel grants for attending conferences (44.5%). By contrast, personal or institutional research funding, sample drugs, consulting or advisory board, expert testimony, and food and beverage funded by pharmaceutical industry were less frequently considered as COI. Moreover, only 24% of surveyed oncologists could correctly categorize all situations representing a COI. CONCLUSION: These findings underscore the importance of clear guidelines, education, and transparency in reporting COI in oncology. This hypothesis-generating pilot survey provided the rationale for ONCOTRUST-2 study, which will compare perceptions of COI among oncologists in LMICs and HICs.

Lebanese medical students' attitudes towards patient safety and medical error disclosure: A cross-sectional study.

OBJECTIVE: To assess Lebanese medical students' attitudes towards patient safety and medical error disclosure. METHODS: This was a cross-sectional study involving medical students from seven different medical schools in Lebanon. The participants completed the Attitudes to Patient Safety Questionnaire (APSQ-III) online, which consists of 26 items across nine key patient safety domains. Items were scored from 1 (strongly disagree) to 5 (strongly agree). Demographic data were also collected. RESULTS: Of the 549 students enrolled in the study, 325 (59%) were female and 224 (41%) were male. More than half (287, 52%) were aged between 20 and 22 years and 95% were Lebanese. The overall attitude of students towards patient safety was positive (3.59 ± 0.85) with the most positive attitudes in the domains of 'Team functioning' followed by 'Working hours as an error cause'. More positive attitudes were perceived among male students in the domains of 'Professional incompetence as an error cause' and 'Disclosure responsibility' whereas more positive attitudes were seen in female students in the domain of 'Working hour as an error cause'. Older medical students had more positive attitudes in the domain of 'Team functioning' than younger students. CONCLUSION: Medical students in Lebanon had an overall positive attitude towards patient safety. These findings may be used to guide improvements in patient safety education and enhance patient-centred care in medical institutions in Lebanon.

Men with metastatic prostate cancer carrying a pathogenic germline variant in breast cancer genes: disclosure of genetic test results to relatives.

Some patients with metastatic prostate cancer carry a pathogenic germline variant (PV) in a gene, that is mainly associated with an increased risk of breast cancer in women. If they test positive for such a PV, prostate cancer patients are encouraged to disclose the genetic test result to relatives who are at risk in case the carrier status changes the relatives' medical care. Our study aimed to investigate how men who learned they carry a PV in BRCA1, BRCA2, PALB2, CHEK2 or ATM disclosed their carrier status to at-risk relatives and to assess the possible psychological burden for the carrier and their perception of the burden for relatives. In total, 23 men with metastatic prostate cancer carrying a PV completed the IRI questionnaire about family communication; 14 also participated in a semi-structured interview. Patients felt highly confident in discussing the genetic test result with relatives. The diagnosis of prostate cancer was experienced as a burden, whereas being informed about genetic testing results did in most cases not add to this burden. Two patients encountered negative experiences with family communication, as they considered the genetic test result to be more urgent than their relatives. This mixed-methods study shows that metastatic prostate cancer patients with a PV in genes mainly associated with increased risk of breast cancer feel well-equipped to communicate about this predisposition in their families. Carriers felt motivated to disclose their genetic test result to relatives. Most of them indicated that the disclosure was not experienced as a psychological burden.

How hereditary cancer risk disclosure to relatives is handled in practice - Patient perspectives from a Swedish cancer genetics clinic.

OBJECTIVES: Hereditary cancer risks can be effectively managed if at-risk relatives enroll in surveillance and preventive care. Family-mediated risk disclosure has internationally been shown to be incomplete, selective and leave over a third of eligible at-risk individuals without access to genetic counseling. We explored patients handling of cancer risk information in practice. METHODS: We conducted twelve semi-structured interviews with patients who had completed their genetic counseling and been asked to disclose risk information to relatives. Questions were designed to investigate lived experiences of communicating hereditary risk and focused on disclosure strategies, intrafamilial interactions and emotional responses. RESULTS: Qualitative content analysis yielded five categories. These span personal fears, shared responsibilities, feeling of empowerment, innovative solutions and unmet needs. Patients put high value on collaboration with their genetic healthcare professionals but also solicited better overview of the counseling process and more personalized, case-tailored information. CONCLUSIONS: Our results add novel insights about the practical strategies employed by genetic counselees and their motivations behind disclosing hereditary risk information to relatives. PRACTICE IMPLICATIONS: A patient-centered cancer genetics care would clarify roles and responsibilities around risk disclosure, inform counselees about the process upfront and tailor information to offer case-specific data with the family's inheritance pattern explained.

Informed consent in cancer clinical care: Perspectives of healthcare professionals on information disclosure at a tertiary institution in Uganda.

INTRODUCTION: While there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners' experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals' perspectives on information disclosure during the consenting process in cancer care. METHODS: A qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results. RESULTS: There were five key themes, and these included information disclosure to patients; assessment of patients' cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process. CONCLUSION: Overall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.

Hepatic Ablation Technology: Assessment of Conflicts of Interest in Recent Literature.

INTRODUCTION: Collaboration between the health care industry and surgeons is critical in modern medicine. Conflict of interest (COI) has the risk of introducing bias into research studies. We investigated the accuracy of self-disclosed COI for studies that researched the use of microwave ablation for liver metastasis. METHODS: A literature search identified studies that investigated the use of microwave ablation for liver cancer between 2016 and 2022. We utilized the Open Payments Database to query individual authors' financial contributions from the industry. The accuracy of the disclosure statement and financial contribution for each study and author was calculated. We compared the amount of financial contribution authors received based on the accuracy of their COI statement. RESULTS: Twenty-five studies of interest were identified. The mean number of authors was 8.24. A disclosure statement was present in 52% of studies. Of those, 28% had an incongruent disclosure statement. 9/25 (36%) of studies had a conflict of interest based on financial payments provided by industry. Overall, authors received an average of $440,483.41 (SD $1,889,375.34). We did not find a difference in the financial contribution's value based on the disclosure statement's accuracy (P = .55). CONCLUSIONS: Over a quarter of studies in our review of microwave ablation literature had discrepancies in the reporting of conflicts of interest, highlighting the need for improved reporting of potential conflicts of interest to protect the integrity of clinical research. Compared to other fields of surgery, we found a lower rate of undisclosed COI, suggesting that the scope of cancer-directed surgery may be more resistant to industry influence.

Timing of genetic testing in BRCA1/2 and PALB2-Associated breast cancer: Preoperative result disclosure increases uptake of risk-reducing mastectomy and reduces unnecessary exposure to radiotherapy.

INTRODUCTION: The impact of timing of genetic testing on uptake of risk reducing mastectomy (RRM) in affected female BRCA1/2 or PALB2 carriers remains an area of evolving interest, particularly with the introduction of mainstream genetic testing initiatives. METHODS: Women with stage I-III breast cancer and a confirmed germline pathogenic variant in BRCA1/2 or PALB2 between 2000 and 2023 were identified from an institutional genetics database. Uptake of RRM was evaluated according to disclosure of genetic testing results before or after index surgery for a first diagnosis of breast cancer. RESULTS: The cohort included 287 female BRCA1/2 or PALB2 carriers with a median age of 44 years (IQR, 36-52). Overall, 155 (54 %) carriers received genetic testing results before and 132 (46 %) after index breast surgery. Receipt of genetic testing results before surgery was associated with a higher rate of index bilateral mastectomy (58.7 % vs. 7.6 %, p < 0.001) and a commensurate decrease in adjuvant radiation (41.9 % vs. 74.2 %, p < 0.001). At a median follow up of 4.4 years after genetic testing, 219 (76.3 %) affected carriers had undergone bilateral RRM, including 83.9 % with preoperative knowledge and 67.4 % of patients with postoperative knowledge of their germline pathogenic variant (log rank, p < 0.001). On multivariate regression, disclosure of genetic testing results before index breast surgery was independently associated with long-term uptake of bilateral mastectomy (HR 1.69, 95 % CI 1.21-2.38). CONCLUSION: Genetic testing results delivered prior to index breast surgery increase uptake of bilateral RRM in affected BRCA1/2 and PALB2 carriers. Efforts to mainstream genetic testing would help optimize surgical decision-making.

ChatGPT for Automated Cross-Checking of Authors' Conflicts of Interest Against Industry Payments.

OBJECTIVE: The Centers for Medicare & Medicaid Services "OpenPayments" database tracks industry payments to US physicians to improve research conflicts of interest (COIs) transparency, but manual cross-checking of articles' authors against this database is labor-intensive. This study aims to assess the potential of large language models (LLMs) like ChatGPT to automate COI data analysis in medical publications. STUDY DESIGN: An observational study analyzing the accuracy of ChatGPT in automating the cross-checking of COI disclosures in medical research articles against the OpenPayments database. SETTING: Publications regarding Food and Drug Administration-approved biologics for chronic rhinosinusitis with nasal polyposis: omalizumab, mepolizumab, and dupilumab. METHODS: First, ChatGPT evaluated author affiliations from PubMed to identify those based in the United States. Second, for author names matching 1 or multiple payment recipients in OpenPayments, ChatGPT undertook a comparative analysis between author affiliation and OpenPayments recipient metadata. Third, ChatGPT scrutinized full article COI statements, producing an intricate matrix of disclosures for each author against each relevant company (Sanofi, Regeneron, Genentech, Novartis, and GlaxoSmithKline). A random subset of responses was manually checked for accuracy. RESULTS: In total, 78 relevant articles and 294 unique US authors were included, leading to 980 LLM queries. Manual verification showed accuracies of 100% (200/200; 95% confidence interval [CI]: 98.1%-100%) for country analysis, 97.4% (113/116; 95% CI: 92.7%-99.1%) for matching author affiliations with OpenPayments metadata, and 99.2% (1091/1100; 95% CI: 98.5%-99.6%) for COI statement data extraction. CONCLUSION: LLMs have robust potential to automate author-company-specific COI cross-checking against the OpenPayments database. Our findings pave the way for streamlined, efficient, and accurate COI assessment that could be widely employed across medical research.

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.

Transcriptome disclosure of hormones inducing stigma exsertion in Nicotiana tabacum by corolla shortening.

BACKGROUND: Stigma exsertion is an essential agricultural trait that can promote cross-pollination to improve hybrid seed production efficiency. However, the molecular mechanism controlling stigma exsertion remains unknown. RESULTS: In this study, the Nicotiana tabacum cv. K326 and its two homonuclear-heteroplasmic lines, MSK326 (male-sterile) and MSK326SE (male-sterile and stigma exserted), were used to investigate the mechanism of tobacco stigma exsertion. A comparison of the flowers between the three lines showed that the stigma exsertion of MSK326SE was mainly due to corolla shortening. Therefore, the corollas of the three lines were sampled and presented for RNA-seq analysis, which found 338 candidate genes that may cause corolla shortening. These genes were equally expressed in K326 and MSK326, but differentially expressed in MSK326SE. Among these 338 genes, 15 were involved in hormone synthesis or signal transduction pathways. Consistently, the content of auxin, dihydrozeatin, gibberellin, and jasmonic acid was significantly decreased in the MSK326SE corolla, whereas abscisic acid levels were significantly increased. Additionally, seven genes involved in cell division, cell cycle, or cell expansion were identified. Protein-protein interaction network analysis identified 45 nodes and 79 protein interactions, and the largest module contained 20 nodes and 52 protein interactions, mainly involved in the hormone signal transduction and pathogen defensive pathways. Furthermore, a putative hub gene coding a serine/threonine-protein kinase was identified for the network. CONCLUSIONS: Our results suggest that hormones may play a key role in regulating tobacco stigma exsertion induced by corolla shortening.

In-person versus electronic screening for social risks among carers of pediatric inpatients: A mixed methods randomized trial.

We aimed to compare disclosure of social risks according to self-report on an iPad versus face-to-face questions from a health professional and to explore carers' experiences of screening. This two-arm, parallel group, randomized trial was conducted from January 19, 2021, to December 17, 2021, in a public hospital pediatric ward serving a disadvantaged area of an Australian capital city. Carers of children aged ≤ 5 years admitted to the Children's Ward were eligible. The primary outcome was disclosure of social risks. The screener included nine items on food security, household utilities, transport, employment, personal and neighborhood safety, social support, housing and homelessness. Disclosure of social risks was similar between the self-completion (n = 193) and assisted-completion (n = 193) groups for all 9 items, ranging 4.1% higher for worrying about money for food (95% CI - 11.4, 3.1%) among the assisted-completion group, to 5.7% (-1.6, 13.0%) higher for unemployment among the self-completion group. In qualitative interviews, participants were positive about screening for social risks in the hospital ward setting and the majority indicated a preference for self-completion.  Conclusion: Differences in the disclosure of social risks according to self- versus assisted-completion were small, suggesting that either method could be used. Most carers expressed a preference for self- completion, which is therefore recommended as the ideal mode for such data collection for Australian pediatric inpatient settings.  Trial registration: Australia New Zealand Clinical Trial Registry ( www.anzctry.org.au ; #ACTRN12620001326987; date of registration 8 December 2020). What is Known: • Most evidence on screening of social risks in pediatric inpatient settings is from the USA. • Little is known about disclosure of social risks in countries with universal health care and social welfare. What is New: • Disclosure of social risks was similar for electronic compared with face-to-face screening. • Carers preferred electronic completion over face-to-face completion.

Factors associated with cancer disclosure in adolescent and young adult cancer survivors: An integrative review from the social-ecological model perspective.

PURPOSE: Young cancer survivors ("young survivors") may need to disclose their cancer experiences to reintegrate into society. In such cases, the recognition of social support through the disclosure of cancer experiences may prevent potential social disadvantages． This review aimed to describe the motivations, strategies and outcomes, and benefits and disadvantages of disclosure in young survivors based on the social-ecological model (SEM) to identify the support survivors need when disclosing their cancer experiences. METHODS: Using the integrated review methodology, we systematically searched six databases in English and Japanese as well as searched the reference lists of the selected studies. The themes identified via thematic analysis were categorized within the SEM levels. RESULTS: This review analyzed 14 studies and identified four themes, including "Motivation for Cancer Disclosure," "Barriers to Cancer Disclosure," "Consequences of Cancer Disclosure: Benefits," and "Consequences of Cancer Disclosure: Disadvantages." Motivations for young survivors to disclose their cancer involved post-cancer differences, perceptions, relationships, and social context. In navigating barriers, including self-stigma, peer exclusion, and discrimination, they employed strategies such as reassurance and information limitation. Tailored disclosure strategies at each SEM level offered social and psychological benefits, however, disadvantages, including stress, vulnerability, employment issues, and limited insurance coverage, were experienced by young survivors due to cancer disclosure. CONCLUSIONS: To optimize the benefits of cancer disclosure for young survivors, addressing psychological burdens, enhancing disclosure skills, offering familial psychological support, and fostering public awareness of cancer are essential.

Disclosure following a medical error: lessons learned from a national initiative of workshops with patients, healthcare teams, and executives.

BACKGROUND: Despite the increase in disclosures of medical errors, transparency remains a challenge. Recognized barriers include shame, fear of litigation, disciplinary actions, and loss of patient trust. In 2018, the Israeli Ministry of Health initiated a series of workshops about disclosure of medical errors. The workshops involved medical center executives, healthcare providers, patients, and family members of patients who had previously been harmed by a medical error. This study presents the lessons learned about perceived challenges in disclosure of errors in 15 such workshops. METHODS: Data collection included participant observations in 15 workshops, full audio recordings of all of the workshops, and documentation of detailed field notes. Analysis was performed under thematic analysis guidelines. RESULTS: We identified four main themes: "Providers agree on the value of disclosure of a medical error to the patient"; "Emotional challenges of disclosure of medical error to patients"; "The medico-legal discourse challenges transparency"; and "Providers and patients call for a change in the culture regarding disclosure of medical errors". Participant observations indicated that the presence of a patient who had experienced a tragedy in another hospital, and who was willing to share it created an intimate atmosphere that enabled an open conversation between parties. CONCLUSION: The study shows the moral, human, and educational values of open discourse in a protective setting after the occurrence of a medical error. We believe that workshops like these may help foster a culture of institutional disclosure following medical errors. We recommend that the Ministry of Health extend such workshops to all healthcare facilities, establish guidelines and mandate training for skills in disclosure for all providers.