Practice Implications of Expanded Genetic Testing in Oncology.

Genetic test use in oncology is growing, yet providers' experiences with evolving testing norms and their implications for patient care remain under-explored. In interviews with oncologists and cancer genetics professionals, 22 key informants described the increasing importance of germline results for therapeutic decision-making, preference for ordering tests directly rather than referring, and rapid adoption of cancer gene panels for testing. Implications for informed consent, result interpretation, and patient management were identified. These results suggest concerns raised by the transition of genetic test delivery from cancer genetics professionals to oncologists that must be addressed in practice guidelines and provider training.

NCCN Guidelines Insights: Kidney Cancer, Version 2.2020.

The NCCN Guidelines for Kidney Cancer provide multidisciplinary recommendations for the clinical management of patients with clear cell and non-clear cell renal cell carcinoma, and are intended to assist with clinical decision-making. These NCCN Guidelines Insights summarize the NCCN Kidney Cancer Panel discussions for the 2020 update to the guidelines regarding initial management and first-line systemic therapy options for patients with advanced clear cell renal cell carcinoma.

The Function of Disclosing Medical Errors: New Cultural Challenges for Physicians.

A general consensus has been reached in health care organizations that the disclosure of medical errors can be a very powerful way to improve patients and physicians well-being and serves as a core component to high quality health care. This practice strongly encourages transparent communication with patients after medical errors or unanticipated outcomes. However, many countries, such as Brazil, do not have a culture of disclosing harmful errors to patients or standards emphasizing the importance of disclosing, taking responsibility, apologizing, and discussing the prevention of recurrences. Medical error is not discussed or approached during medical school. The stigma of error has a strong connection with value judgments, and emotional support for physicians does not exist. This paper suggests that open communication with the patient is essential. Guidance about error disclosure from health care organizations would be helpful for quality and patient safety and for health care professionals in countries like Brazil.

Twelve tips for teaching quality improvement in the clinical environment.

Medical educators are expected to teach quality improvement (QI) skills alongside traditional clinical skills such as physical examination and bedside manner. Educational resources for intensive training in QI have proliferated. However, many physicians lack the time or resources to undergo this training, and may struggle with teaching these skills to their learners. In response, we offer twelve tips to help physicians teach basic QI concepts in the clinical environment. By following these tips physicians will be able to engage their learners interest in QI and provide experiential learning that makes a lasting impact.

Kidney Cancer, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology.

The NCCN Guidelines for Kidney Cancer provide multidisciplinary recommendations for the clinical management of patients with clear cell and non-clear cell renal carcinoma. These guidelines are developed by a multidisciplinary panel of leading experts from NCCN Member Institutions consisting of medical oncologists, hematologists and hematologic oncologists, radiation oncologists, urologists, and pathologists. The NCCN Guidelines are in continuous evolution and are updated annually or sometimes more often, if new high-quality clinical data become available in the interim.

Evaluating the implementation of a national disclosure policy for large-scale adverse events in an integrated health care system: identification of gaps and successes.

BACKGROUND: Many healthcare organizations have developed disclosure policies for large-scale adverse events, including the Veterans Health Administration (VA). This study evaluated VA's national large-scale disclosure policy and identifies gaps and successes in its implementation. METHODS: Semi-structured qualitative interviews were conducted with leaders, hospital employees, and patients at nine sites to elicit their perceptions of recent large-scale adverse events notifications and the national disclosure policy. Data were coded using the constructs of the Consolidated Framework for Implementation Research (CFIR). RESULTS: We conducted 97 interviews. Insights included how to handle the communication of large-scale disclosures through multiple levels of a large healthcare organization and manage ongoing communications about the event with employees. Of the 5 CFIR constructs and 26 sub-constructs assessed, seven were prominent in interviews. Leaders and employees specifically mentioned key problem areas involving 1) networks and communications during disclosure, 2) organizational culture, 3) engagement of external change agents during disclosure, and 4) a need for reflecting on and evaluating the policy implementation and disclosure itself. Patients shared 5) preferences for personal outreach by phone in place of the current use of certified letters. All interviewees discussed 6) issues with execution and 7) costs of the disclosure. CONCLUSIONS: CFIR analysis reveals key problem areas that need to be addresses during disclosure, including: timely communication patterns throughout the organization, establishing a supportive culture prior to implementation, using patient-approved, effective communications strategies during disclosures; providing follow-up support for employees and patients, and sharing lessons learned.

Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey.

BACKGROUND: The U.S. Office for Human Research Protections has proposed that end points of randomized trials comparing the effectiveness of standard medical practices are risks of research that would require disclosure and written informed consent, but data are lacking on the views of potential participants. OBJECTIVE: To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices. DESIGN: Cross-sectional survey conducted in August 2014. SETTING: Web-based questionnaire. PATIENTS: 1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290). MEASUREMENTS: Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices. RESULTS: 97% of respondents agreed that health systems should evaluate standard treatments. Most wanted to be asked for permission to participate in each of 3 scenarios (range, 75.2% to 80.4%), even if it involved only medical record review, but most would accept nonwritten (oral) permission or general notification if obtaining written permission would make the research too difficult to conduct (range, 70.2% to 82.7%). Most perceived additional risk from each scenario (range, 64.0% to 81.6%). LIMITATION: Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population. CONCLUSION: Most respondents preferred to be asked for permission to participate in observational and randomized research evaluating usual medical practices, but they are willing to accept less elaborate approaches than written consent if research would otherwise be impracticable. These attitudes are not aligned with proposed regulatory guidance. PRIMARY FUNDING SOURCE: National Center for Advancing Translational Sciences at the National Institutes of Health.

Internists' attitudes about assessing and maintaining clinical competence.

BACKGROUND: Important changes are occurring in how the medical profession approaches assessing and maintaining competence. Physician support for such changes will be essential for their success. OBJECTIVE: To describe physician attitudes towards assessing and maintaining competence. DESIGN: Cross-sectional internet survey. PARTICIPANTS: Random sample of 1,000 American College of Physicians members who were eligible to participate in the American Board of Internal Medicine Maintenance of Certification program. MAIN MEASURES: Questions assessed physicians' attitudes and experiences regarding: 1) self-regulation, 2) feedback on knowledge and clinical care, 3) demonstrating knowledge and clinical competence, 4) frequency of use and effectiveness of methods to assess or improve clinical care, and 5) transparency. KEY RESULTS: Surveys were completed by 446 of 943 eligible respondents (47%). Eighty percent reported it was important (somewhat/very) to receive feedback on their knowledge, and 94% considered it important (somewhat/very) to get feedback on their quality of care. However, only 24% reported that they receive useful feedback on their knowledge most/all of the time, and 27% reported receiving useful feedback on their clinical care most/all of the time. Seventy-five percent agreed that participating in programs to assess their knowledge is important to staying up-to-date, yet only 52% reported participating in such programs within the last 3 years. The majority (58%) believed physicians should be required to demonstrate their knowledge via a secure examination every 9-10 years. Support was low for Specialty Certification Boards making information about physician competence publically available, with respondents expressing concern about patients misinterpreting information about their Board Certification activities. CONCLUSIONS: A gap exists between physicians' interest in feedback on their competence and existing programs' ability to provide such feedback. Educating physicians about the importance of regularly assessing their knowledge and quality of care, coupled with enhanced systems to provide such feedback, is needed to close this gap.

Providers' perceptions of communication breakdowns in cancer care.

BACKGROUND: Communication breakdowns in cancer care are common and represent a failure in patient-centered care. While multiple studies have elicited patients' perspectives on these breakdowns, little is known about cancer care providers' attitudes regarding the causes and potential solutions. OBJECTIVE: To examine providers' (1) perceptions of the nature and causes of communication breakdowns with patients in cancer care and (2) suggestions for managing and preventing breakdowns. DESIGN: Qualitative study of nine focus groups held at three sites (Massachusetts, Georgia and Washington). PARTICIPANTS: Fifty-nine providers: 33% primary care physicians, 14% oncologists, 36% nurses, and 17% nurse practitioners, physician assistants, and others. APPROACH: Directed content analysis of focus group transcripts. KEY RESULTS: Providers' perceptions of the causes of communication breakdowns fell into three categories: causes related to patients, providers, or healthcare systems. Providers perceived that patients sometimes struggle to understand cancer and health-related information, have unrealistic expectations, experience emotional and psychological distress that interferes with information exchange; and may be reticent to share their confusion or concerns. Providers described their own and colleagues' contributions to these breakdowns as sharing inaccurate, conflicting, or uncoordinated information. Providers also described the difficulty in balancing hope with reality in discussions of prognosis. System issues named by providers included insufficient time with patients, payment systems, and changing protocols that inhibit communication and coordination of care. Potential solutions included greater patient engagement, team coordination, and systems that promote patient feedback. CONCLUSIONS: Providers described multiple causes for communication breakdowns at the patient, provider, and system level. Multi-level interventions that coordinate care and encourage feedback may help to address or prevent communication breakdowns.

Improving healthcare systems' disclosures of large-scale adverse events: a Department of Veterans Affairs leadership, policymaker, research and stakeholder partnership.

BACKGROUND: The Department of Veterans Affairs (VA) mandates disclosure of large-scale adverse events to patients, even if risk of harm is not clearly present. Concerns about past disclosures warranted further examination of the impact of this policy. OBJECTIVE: Through a collaborative partnership between VA leaders, policymakers, researchers and stakeholders, the objective was to empirically identify critical aspects of disclosure processes as a first step towards improving future disclosures. DESIGN: Semi-structured interviews were conducted with participants at nine VA facilities where recent disclosures took place. PARTICIPANTS: Ninety-seven stakeholders participated in the interviews: 38 employees, 28 leaders (from facilities, regions and national offices), 27 Veteran patients and family members, and four congressional staff members. APPROACH: Facility and regional leaders were interviewed by telephone, followed by a two-day site visit where employees, patients and family members were interviewed face-to-face. National leaders and congressional staff also completed telephone interviews. Interviews were analyzed using rapid qualitative assessment processes. Themes were mapped to the stages of the Crisis and Emergency Risk Communication model: pre-crisis, initial event, maintenance, resolution and evaluation. KEY RESULTS: Many areas for improvement during disclosure were identified, such as preparing facilities better (pre-crisis), creating rapid communications, modifying disclosure language, addressing perceptions of harm, reducing complexity, and seeking assistance from others (initial event), managing communication with other stakeholders (maintenance), minimizing effects on staff and improving trust (resolution), and addressing facilities' needs (evaluation). CONCLUSIONS: Through the partnership, five recommendations to improve disclosures during each stage of communication have been widely disseminated throughout the VA using non-academic strategies. Some improvements have been made; other recommendations will be addressed through implementation of a large-scale adverse event disclosure toolkit. These toolkit strategies will enable leaders to provide timely and transparent information to patients and families, while reducing the burden on employees and the healthcare system during these events.

Disclosure of adverse events and errors in surgical care: challenges and strategies for improvement.

The disclosure of adverse events to patients, including those caused by medical errors, is a critical part of patient-centered healthcare and a fundamental component of patient safety and quality improvement. Disclosure benefits patients, providers, and healthcare institutions. However, the act of disclosure can be difficult for physicians. Surgeons struggle with disclosure in unique ways compared with other specialties, and disclosure in the surgical setting has specific challenges. The frequency of surgical adverse events along with a dysfunctional tort system, the team structure of surgical staff, and obstacles created inadvertently by existing surgical patient safety initiatives may contribute to an environment not conducive to disclosure. Fortunately, there are multiple strategies to address these barriers. Participation in communication and resolution programs, integration of Just Culture principles, surgical team disclosure planning, refinement of informed consent and morbidity and mortality processes, surgery-specific professional standards, and understanding the complexities of disclosing other clinicians' errors all have the potential to help surgeons provide patients with complete, satisfactory disclosures. Improvement in the regularity and quality of disclosures after surgical adverse events and errors will be key as the field of patient safety continues to advance.

Crowdsourced Feedback to Improve Resident Physician Error Disclosure Skills: A Randomized Clinical Trial.

Importance: Residents must prepare for effective communication with patients after medical errors. The video-based communication assessment (VCA) is software that plays video of a patient scenario, asks the physician to record what they would say, engages crowdsourced laypeople to rate audio recordings of physician responses, and presents feedback to physicians. Objective: To evaluate the effectiveness of VCA feedback in resident error disclosure skill training. Design, Setting, and Participants: This single-blinded, randomized clinical trial was conducted from July 2022 to May 2023 at 7 US internal medicine and family medicine residencies (10 total sites). Participants were second-year residents attending required teaching conferences. Data analysis was performed from July to December 2023. Intervention: Residents completed 2 VCA cases at time 1 and were randomized to the intervention, an individual feedback report provided in the VCA application after 2 weeks, or to control, in which feedback was not provided until after time 2. Residents completed 2 additional VCA cases after 4 weeks (time 2). Main Outcomes and Measures: Panels of crowdsourced laypeople rated recordings of residents disclosing simulated medical errors to create scores on a 5-point scale. Reports included learning points derived from layperson comments. Mean time 2 ratings were compared to test the hypothesis that residents who had access to feedback on their time 1 performance would score higher at time 2 than those without feedback access. Residents were surveyed about demographic characteristics, disclosure experience, and feedback use. The intervention's effect was examined using analysis of covariance. Results: A total of 146 residents (87 [60.0%] aged 25-29 years; 60 female [41.0%]) completed the time 1 VCA, and 103 (70.5%) completed the time 2 VCA (53 randomized to intervention and 50 randomized to control); of those, 28 (54.9%) reported reviewing their feedback. Analysis of covariance found a significant main effect of feedback between intervention and control groups at time 2 (mean [SD] score, 3.26 [0.45] vs 3.14 [0.39]; difference, 0.12; 95% CI, 0.08-0.48; P = .01). In post hoc comparisons restricted to residents without prior disclosure experience, intervention residents scored higher than those in the control group at time 2 (mean [SD] score, 3.33 [0.43] vs 3.09 [0.44]; difference, 0.24; 95% CI, 0.01-0.48; P = .007). Worse performance at time 1 was associated with increased likelihood of dropping out before time 2 (odds ratio, 2.89; 95% CI, 1.06-7.84; P = .04). Conclusions and Relevance: In this randomized clinical trial, self-directed review of crowdsourced feedback was associated with higher ratings of internal medicine and family medicine residents' error disclosure skill, particularly for those without real-life error disclosure experience, suggesting that such feedback may be an effective way for residency programs to address their requirement to prepare trainees for communicating with patients after medical harm. Trial Registration: ClinicalTrials.gov Identifier: NCT06234085.

Patients' and family members' views on patient-centered communication during cancer care.

OBJECTIVES: To explore patients' and family members' views on communication during cancer care and to identify those aspects of clinician-patient communication which were most important to patients and family members. METHODS: We conducted a secondary data analysis of qualitative data from 137 patients with cancer and family members of patients with cancer. We used a modified version of the constant comparative method and coding paradigm of grounded theory. RESULTS: Patients want sensitive, caring clinicians who provide information that they need, when they need it, in a way that they can understand; who listen and respond to questions and concerns, and who attempt to understand the patient's experience. Effective information exchange and a positive interpersonal relationship with the clinician were of fundamental importance to patients and family members. These were interrelated; for instance, failure to provide information a patient needed could damage the relationship, whereas excellent listening could foster the relationship. Information exchange and relationship were also integral to decision-making, managing uncertainty, responding to emotions, and self-management. Clinicians who were responsive to patients' needs beyond the immediate medical encounter were valued. CONCLUSIONS: The complexity of cancer care today suggests that efforts to improve communication must be multilevel, acknowledging and addressing patient, clinician, organizational and policy barriers, and facilitators. Measurement tools are needed to assess cancer patients' and family members' experiences with communication over the course of cancer care to provide meaningful, actionable feedback to those seeking to optimize their effectiveness in communicating with patients with cancer.

Disclosure of harmful medical errors in out-of-hospital care.

Safety experts and national guidelines recommend disclosing harmful medical errors to patients. Communicating with patients and families about errors respects their autonomy, supports informed decisionmaking, may decrease malpractice costs, and can enhance patient safety. Yet existing disclosure guidelines may not account for the difficulty in discussing out-of-hospital errors with patients. Emergency medical services (EMS) providers operate in unpredictable environments that require rapid interventions for patients with whom they have only brief relationships. EMS providers also have limited access to patient medical data and risk management resources, which can make conducting disclosure conversations even more difficult. In addition, out-of-hospital errors may be discovered only after the transition of care to the inpatient setting, further complicating the question of who should disclose the error. EMS organizations should support the disclosure of out-of-hospital errors by fostering a nonpunitive culture of error reporting and disclosure, as well as developing guidelines for use by EMS systems.

Patients' experiences with disclosure of a large-scale adverse event.

BACKGROUND: Hospitals face a disclosure dilemma when large-scale adverse events affect multiple patients and the chance of harm is extremely low. Understanding the perspectives of patients who have received disclosures following such events could help institutions develop communication plans that are commensurate with the perceived or real harm and scale of the event. METHODS: A mailed survey was conducted in 2008 of 266 University of Washington Medical Center (UWMC) patients who received written disclosure in 2004 about a large-scale, low-harm/low-risk adverse event involving an incomplete endoscope cleaning process. The survey measured patients' satisfaction with this disclosure, their concerns about healthcare outcomes, and their recommendations for future communication, given similar circumstances. RESULTS: Surveys were received from 127 of 266 (48 percent) of eligible respondents; 98 percent thought that UWMC was right to inform them about this event, and mean satisfaction with the disclosure was 7.7 on a 0 to 10 scale. Of the 127 respondents, 64 percent were somewhat or very concerned that the endoscope cleaning problem might cause them health problems; 60 percent reported their impressions of UWMC's honesty and integrity had increased; 31 percent said their perceptions of the quality of care had increased; 94 percent agreed that institutions should tell patients about any error in their care, even when the risk of harm was low, although 28 percent agreed that such notifications would make them anxious. Respondents who reported concern that the event could cause them health problems were less likely to be satisfied with the institution's disclosure. Patients cited their right to know information material to their own health and healthcare as an important reason for disclosure. CONCLUSION: Recipients of disclosure of a large-scale, low-harm/low-risk event overwhelmingly supported being told of the event and endorsed notification of patients for similar events in the future. Although informing patients may cause concern for some, institutions should ensure their disclosure policies and procedures reflect their patients' preferences.

Nurses' disclosure of error scenarios in nursing homes.

BACKGROUND: Little work has explored the disclosure of errors in nursing homes (NHs). PURPOSE: This paper reports how nurses would disclose hypothetical errors that occur in NH settings. METHOD: A cross-sectional survey was given to a randomly selected sample of registered nurses (RNs) and registered practical nurses (RPNs) working in Ontario, Canada NHs. RESULTS: Of 1,180 respondents, only half might provide full details and the cause of the error and provide steps in how the error would be prevented if they were in situations described by the hypothetical scenarios. Scenarios that were less serious had an almost 3 times higher likelihood of an explicit apology (OR 2.97; 95% CI 1.36-6.51; P = 0.007). Nurses who were RNs, had more education, had a prior history of disclosing a serious error, and agreed with full disclosure were more likely to respond to disclosing more information about the error. Nurses also reported numerous barriers to effective disclosure in their workplace. CONCLUSION: Improvements in NH safety culture are necessary to enhance the error disclosure process.