Clinical risk management and the ethics of open disclosure: Part I. Benefits and risks to patient safety

Patient safety experts and other authorities have strongly postulated the open disclosure of errors and adverse events to patients as an essential component of effective clinical risk management in health care. Commentators also contend that ‘when things go wrong’, openly disclosing such events to the patient and his or her nominated support person is simply ‘the right thing to do’. Despite the obvious importance of the issue of open disclosure and its possible implications for the nursing profession, it has not been comprehensively addressed in the nursing literature. A key aim of this article (the first of a two-part discussion) is to contribute to the positive project of redressing this oversight by providing a brief overview of what open disclosure is and what its intended purpose, aims, and rationale are. Consideration is also given to the risks and benefits of open disclosure as a public policy and whether it will succeed in achieving the anticipated outcomes envisaged. In a second article (to be presented as Part II), the ethics of open disclosure and its possible implications for the nursing profession are explored.     

医护人员主动告知患者及其家属医疗安全不良事件的调查研究

目的 了解医护人员对主动告知患者及其家属医疗安全不良事件的经历和态度。方法 采用自编问卷对武汉市2所三级甲等医院的564名医护人员进行调查。结果 告知经历：71.0%医生和50.4%护士有主动告知医疗安全不良事件的经历;68.3%的医生和57.1%的护士对告知结果感到满意;3.3%的医生和2.6%的护士表示主动告知对医患、护患关系有消极影响;55.2%的医生和59.3%的护士表示主动告知得到了领导支持;86.3%的医生和56.6%的护士赞成将主动告知作为一项规定。培训经历：74.3%的护士和86.3%的医生没有相关培训经历;64.5%的医生和87.1%的护士表示将来愿意参加相关培训。告知态度：对Ⅰ级事件（警告事件）、Ⅱ级事件（不良后果事件）、Ⅲ级事件（未造成后果事件）、Ⅳ级事件（隐患事件）,医护人员支持主动告知的人数和比例分别为378名（67.0%）、348名（61.7%）、327名（58.0%）、219名（38.8%）。告知程度：医护人员对Ⅰ~Ⅳ级事件选择部分告知的比例和人数分别为359名（63.7%）、384名（68.1%）、330名（58.5%）、237名（42.0%）。结论 部分医护人员有过主动告知的经历且结果较好,医护人员对主动告知持支持态度,但仍有较多的医护人员有所顾虑。医院管理者应加强对医护人员进行关于主动告知医疗安全不良事件的培训。     

Advocacy care on HIV disclosure to children

Children with HIV are dependent on taking continuous medication and care, and family preparation is required when disclosing HIV. This study aimed to unveil families’ experiences with HIV disclosure to children under 13 years old. Eight family members who have disclosed HIV to seropositive children were interviewed in‐depth and individually. The fieldwork took place at a public paediatric outpatient hospital in Rio de Janeiro. The results showed that the family members’ discourse highlighted two ways of knowing their own condition and disclosing the condition of the children with HIV. First, they needed to address the communication of bad news and discover their own HIV status through their children's disease. Second, the disclosure was a process constituted by four stages: preparing for disclosure, identifying the time, deciding how and where to tell, and instilling silence after disclosure. They also recognized that nurses had a role in the process as part of an interprofessional team. Nurses can develop advocacy care and empower family members in the preparation of safe HIV disclosure. By systematizing and institutionalizing the care advocacy process, nurses may enable caretakers and children to participate in their therapeutic management, improving adherence to the treatment and self‐care with autonomy.     

Medical errors: an introduction to concepts

The prevalence of medical errors in health care systems has generated immense interest in recent years. The research on adverse events in hospitalized populations has consistently revealed high rates of adverse events. Some of these adverse events result from medical errors and a majority of these errors may be preventable. These errors can occur anywhere and at anytime in health care processes. The consequences of these errors may vary from little or no harm to being ultimately fatal to the patients. It is important to recognize that a degree of error is inevitable in any human task and human fallibility in health care should be accepted. The underlying precursors for many of these human errors may primarily be attributed to latent systemic factors inherent in today's increasingly complex health care system. The focus of adverse event analyses on individual shortcomings without appropriate attention to system issues leads to ineffective solutions. The cognitive influence on medical decision-making and error generation is also significant and should not be discounted.     

Medical error,disclosure and patient safety: A global view of quality care

Medical errors are a prominent issue in health care. Numerous studies point at the high prevalence of adverse events, many of which are preventable. Although there is a range of severity in errors, they all cause harm, to the patient, to the system, or both. While errors have many causes, including human interactions and system inadequacies, the focus on individuals rather than the system has led to an unsuitable culture for improving patient safety. Important areas of focus are diagnostic procedures and clinical laboratories because their results play a major role in guiding clinical decisions in patient management. Proper disclosure of medical errors and adverse events is also a key area for improvement. Globally, system improvements are beginning to take place, however, in Canada, policies on disclosure, error reporting and protection for physicians remain non-uniform. Achieving a national standard with mandatory reporting, in addition to a non-punitive system is recommended to move forward.     

The Critical Care Safety Study: The incidence and nature of adverse events and serious medical errors in intensive care

OBJECTIVE: Critically ill patients require high-intensity care and may be at especially high risk of iatrogenic injury because they are severely ill. We sought to study the incidence and nature of adverse events and serious errors in the critical care setting. DESIGN: We conducted a prospective 1-year observational study. Incidents were collected with use of a multifaceted approach including direct continuous observation. Two physicians independently assessed incident type, severity, and preventability as well as systems-related and individual performance failures. SETTING: Academic, tertiary-care urban hospital. PATIENTS: Medical intensive care unit and coronary care unit patients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary outcomes of interest were the incidence and rates of adverse events and serious errors per 1000 patient-days. A total of 391 patients with 420 unit admissions were studied during 1490 patient-days. We found 120 adverse events in 79 patients (20.2%), including 66 (55%) nonpreventable and 54 (45%) preventable adverse events as well as 223 serious errors. The rates per 1000 patient-days for all adverse events, preventable adverse events, and serious errors were 80.5, 36.2, and 149.7, respectively. Among adverse events, 13% (16/120) were life-threatening or fatal; and among serious errors, 11% (24/223) were potentially life-threatening. Most serious medical errors occurred during the ordering or execution of treatments, especially medications (61%; 170/277). Performance level failures were most commonly slips and lapses (53%; 148/277), rather than rule-based or knowledge-based mistakes. CONCLUSIONS: Adverse events and serious errors involving critically ill patients were common and often potentially life-threatening. Although many types of errors were identified, failure to carry out intended treatment correctly was the leading category.     

Rationing in the intensive care unit: to disclose or disguise?

INTRODUCTION: Growing pressures to ration intensive care unit beds and services pose novel challenges to clinicians. Whereas the question of how to allocate scarce intensive care unit resources has received much attention, the question of whether to disclose these decisions to patients and surrogates has not been explored. KEY CONSIDERATIONS: We explore how considerations of professionalism, dual agency, patients' and surrogates' preferences, beneficence, and healthcare efficiency and efficacy influence the propriety of disclosing rationing decisions in the intensive care unit. CONCLUSIONS: There are compelling conceptual reasons to support a policy of routine disclosure. Systematic disclosure of prevailing intensive care unit norms for making allocation decisions, and of at least the most consequential specific decisions, can promote transparent, professional, and effective healthcare delivery. However, many empiric questions about how best to structure and implement disclosure processes remain to be answered. Specifically, research is needed to determine how best to operationalize disclosure processes so as to maximize prospective benefits to patients and surrogates and minimize burdens on clinicians and intensive care units.     

Physicians' attitudes to and problems with truth-telling to cancer patients

 Disclosure of a diagnosis of cancer to patients is a major problem among physicians in Italy. The aim of the study was to assess physicians' attitudes to and opinions about disclosure. A convenience sample of 675 physicians in Udine (North Italy) completed a ten-item questionnaire. About 45% indicated that, in principle, patients should always be informed of the diagnosis, but only 25% reported that they always disclosed the diagnosis in practice. Physicians with a surgical specialization employed in general hospitals endorsed disclosure of the diagnosis more frequently than GPs and older physicians. One third of the responding physicians persist in the belief that the patients never want to know the truth. Hospital doctors considered the hospital, rather than the patient's home, was the most appropriate place to inform the patients. The opposite result was found among GPs. Almost all the physicians endorsed the involvement of family members when disclosing the diagnosis, but, at the same time they also indicated that families usually prefer their ill relative not to be informed. Ninety-five per cent of physicians believed that the GP should always be involved in the processes of diagnosis and communication, and 48% indicated that the GP should communicate the diagnosis to the patient (as opposed to the physician who made the diagnosis). Having guidelines for breaking bad news to patients was indicated as an important need by 86% of the responding physicians. Despite changes in medical education, improvement of communication skills in dealing with cancer patients and their families represents an important need in healthcare settings. Published online: 22 July 1999     

Opioids,Iatrogenic Harm and Disclosure of Medical Error

The safety of patients in U.S. hospitals is a serious problem, with adverse events because of medical error affecting a significant proportion of hospitalized patients. Patients at the end of life are particularly vulnerable and are at risk of potential adverse events. This article presents a case in which opioids were rapidly titrated to neurotoxic doses in a patient who was terminally extubated. The patient was profoundly sedated and was noted to have Cheyne-Stokes breathing. The possibility of opioid-related iatrogenic harm is raised, and a discussion of what counts as medical error in these circumstances is explored. Palliative care specialists have a unique responsibility to provide guidance and establish a standard of care that clinicians should adhere to. Prevention of harm in dying patients should be a priority in the hospital setting.     

Nurses’ perspectives regarding the disclosure of errors to patients: A qualitative study

BackgroundThere is often a mismatch between patients’ desire to be informed about errors and clinical reality. In closing the “disclosure gap” an understanding of the views of all members of the healthcare team regarding errors and their disclosure to patients is needed. However, international research on nurses’ views regarding this issue is currently limited.ObjectivesExplore nurses’ attitudes and experiences concerning disclosing errors to patients and perceived barriers to disclosure.DesignInductive, exploratory study employing semi-structured interviews with participants, followed by conventional content analysis in which investigators read and discussed transcribed data to identify important themes.SettingsNursing departments from hospitals in two German-speaking cantons in Switzerland.ParticipantsPurposive sample of 18 nurses from a range of fields, positions in organisational hierarchy, work experience, hospitals, and religious perspectives.MethodsData were collected via individual, face-to-face interviews using a researcher–developed semi-structured interview guide. Interviews were transcribed in German and analysed using the qualitative data analysis software package Atlas-Ti (Berlin) and conventional content analysis. The most illustrative quotes were translated into English.ResultsNurses generally thought that patients should be informed about every error, but only a very few nurses actually reported disclosing errors in practice. Indeed, many nurses reported that most errors are not disclosed to the patient. Nurses identified a number of barriers to error disclosure that have already been reported in the literature among all clinicians, such as legal consequences and the fear of losing patients’ trust. However, nurses in this study more frequently reported personal characteristics and a lack of guidance from the organisation as barriers to disclosure. Both issues suggest the need for a systematic institutional approach to error disclosure in which the decision to inform the patient stems from within the organisation and is not shouldered by individual nurses alone.ConclusionsOur study suggests that hospitals need to do more to support and train nurses in relation to error disclosure. Such measures as hospitals establishing a disclosure support system, providing background disclosure education, ensuring that disclosure coaching is available at all times, and providing emotional support for all parties involved, would likely go a long way to address the barriers identified by nurses.     

Disclosing HIV status to HIV positive children before adolescence

This literature review aims to explore the importance of disclosing HIV status to HIV positive children before they reach adolescence. Since the use of paediatric highly active antiretroviral therapy, many HIV positive children are now surviving into adulthood. This faces parents and healthcare workers with the difficult process of disclosing HIV status to children. A review of the literature has revealed discussions of the following themes: barriers to HIV disclosure before adolescence; disclosure as a process, rather than a one-off event; and the benefits of and need for HIV disclosure before adolescence. Parental beliefs and anxieties were found to be the main barrier to HIV disclosure and this needs to be addressed through education and governmental policies (Department of Health (DH), 2007). HIV disclosure before adolescence is vital, as a lack of communication about HIV creates confusion and mistrust, harms psychosocial development, compromises the child's right to autonomy and increases the risk of uknowingly transmitting the disease.     

Interventions for anxiety in the critically ill: a guide for nurses and families

Anxiety is a common feeling for patients and families during the critical care experience. As anxiety for critically ill patients presents increased risks for morbidity and mortality, it is imperative that nurses strive to identify unrelieved anxiety early to prevent adverse events. Alleviating anxiety experienced by families as a result of the critical care experience involves providing assurance, allowing them to remain near the patient, providing accurate and current information, providing for their comfort, and projecting a supportive attitude. As constant care providers, nurses can have the greatest impact on creating an environment that is safe, healing, and humane for critically ill patients and their families.     

Medical Errors—What and When: What Do Patients Want to Know?

OBJECTIVES: 1) To determine how and when emergency department (ED) patients and their families wish to learn of health care errors. 2) To assess the error threshold this population believes should trigger reporting to government agencies, state medical boards, and hospital patient safety committees. 3) To evaluate the role patients and families believe medical educators should play in this process. METHODS: A 12-item survey was administered to a convenience sample of ED patients and families during evaluation in a tertiary care academic ED. Results were tabulated and data were reported as percentages. Statistical significance was analyzed using the chi-square test. RESULTS: 258 surveys were returned (80%). A majority of respondents wished to be informed immediately of any medical error (76%) and to have full disclosure of the error's extent (88%). An overwhelming majority of respondents endorse reporting of errors to government agencies (92%), state medical boards (97%), and hospital committees (99%). Most respondents believe medical educators should focus on teaching students to be honest and compassionate (38%) or on how to tell patients about mistakes (25%). The frequency of hospital admission or physician visits per year had no impact on any response pattern (ns with chi(2) test). CONCLUSIONS: Regardless of health care utilization, a majority of respondents want full disclosure of medical error and wish to be informed of error immediately upon its detection. Respondents support reporting of errors to government agencies, the state medical board, and hospital committees focused on patient safety. Teaching physicians error disclosure techniques, honesty, and compassion were endorsed as a priority for educators who teach error management.     

Harm caused by adverse events in primary care: a clinical observational study

Rationale, aims and objectives  Patient safety in primary care is important, but not well studied. The aim of our study was to determine the actual and potential harm caused by adverse events in primary care.
Method  Observational study in two general practices, including the patients of five doctors. Two methods were used to identify adverse events; (1) a prospective registration of adverse events by the general practitioner and (2) a retrospective audit of medical records. Actual harm was registered and a clinical analysis was made to estimate potential harm.
Results  A total of 31 adverse events were collected and analysed. The adverse events were spread over different adverse event categories. About half of the events did not have health consequences, but a third led to worsening of symptoms and a few resulted in unplanned hospital admission. Potential negative health consequences were likely in three-quarters of the events.
Conclusions  The identified adverse events had some impact on health outcomes, but a risk for harm existed in a majority of the events. Patient safety programmes in primary care should focus on adverse events and not just on harm.     

Understanding how medications contribute to clinical deterioration and are used in rapid response systems: A comprehensive scoping review

BackgroundIn hospitals, rapid response systems (RRSs) identify patients who deteriorate and provide critical care at their bedsides to stabilise and escalate care. Medications, including oral and parenteral pharmaceutical preparations, are the most common intervention for hospitalised patients and the most common cause of harm. This connection between clinical deterioration and medication safety is poorly understood.ObjectivesTo inform improvements in prevention and management of clinical deterioration, this review aimed to examine how medications contributed to clinical deterioration and how medications were used in RRSs.Review methodsA scoping review was undertaken of medication data reported in studies of clinical deterioration or RRSs in diverse hospital settings between 2005 and 2017. Bibliographic database searches used permutations of “rapid response system,” “medical emergency team,” and keyword searching with medication-related terms. Independent selection, quality assessment, and data extraction informed mapping against four medication themes: causes of deterioration, predictors of deterioration, RRS use, and management.ResultsThirty articles were reviewed. Quality was low: limited by small samples, observational, single-centre designs and few primary medication-related outcomes. Adverse drug reactions and potentially preventable medication errors, involving sedatives, analgesics, and cardiovascular agents, contributed to clinical deterioration. While sparsely reported, outcomes included death and escalation of care. In children, administration of antibiotics or nebulised medications appeared to predict subsequent deterioration. Cardiovascular medications, sedatives, and analgesics commonly were used to manage deterioration but further detail was lacking. Despite reported potential for patient harm, evaluation of medication management systems was limited.ConclusionsMedications contributed to potentially preventable clinical deterioration, with considerable harm, and were common interventions for its management. When assessing deteriorating patients or caring for patients who require escalation to critical care, clinicians should consider medication errors and adverse reactions. Studies with more specific medication-related, patient-centred end points could reduce medication-related deterioration and refine RRS medication use and management.     

Medical errors,incidents, accidents and violations

Atul Gawande: 'The real problem isn't how to stop bad doctors from harming, even killing their patients. It's how to prevent good doctors from doing so.'A. Gawande: When doctors make mistakes. The New Yorker, 1st February 1999; 40-55.Errors are an integral part of human behaviour and performance, and in this respect, medical/ surgical practice is no exception. Undoubtedly medical errors account for substantial patient morbidity and mortality. The subject is complicated due to complex and at times confusing taxonomy and the lack of agreed definitions and classification of medical/ surgical errors. It is not possible to eliminate errors from clinical practice but we can improve the quality of medical care by adopting error-tolerant operating medical systems (E-TOMS) based on progress in cognitive psychology, human factors, and human reliability assessment made during the past 30 years. E-TOMS should enable detection, reporting and targeted reduction of errors, and together with effective team dynamics, good clinical governance incorporating root-cause analysis of adverse events during the delivery of health care should improve the quality of care that we can provide for our patients.     

The second victim of adverse health care events

Nurses and other professionals drawn to health care by their desire to help others may be traumatized because they are involved in situations that bring harm rather than healing to patients. Health systems should develop early warning systems to alert unit or team leaders when health workers are at risk of harm from adverse events. This article focuses on health professionals who become second victims of adverse events that occur to patients.     

When is public disclosure of HIV seropositivity acceptable?

HIV/AIDS is a major public health problem in Africa. Stigmatization, discrimination and lack of appropriate health care are among the commonest challenges that HIV infected persons and their families face. It has been suggested that among the tools available in the fight against stigmatization and discrimination is public disclosure of a person's HIV seropositive status. While public disclosure of HIV status has a place in the fight against HIV and AIDS, especially by resulting in behavioural change among people who know of an HIV infected person, we argue that such disclosure also has potential attendant harms. The posthumous disclosure of HIV status is particularly problematic. Public disclosure should be accompanied by appropriate individual counselling and preparation of the community to deal with the situation, and should have regard for cultural sensitivity after consideration of the risks and benefits to individuals, families and the community. Health practitioners should keep in mind that their main duty is to the best interest of the patient, the family and the community, in that order.     

Do medical inpatients who report poor service quality experience more adverse events and medical errors?

PURPOSE: Service quality deficiencies are common in health care. However, little is known about the relationship between service quality and the occurrence of adverse events and medical errors. We hypothesized that patients who reported poor service quality were at increased risk of experiencing adverse events and medical errors. SUBJECTS AND METHODS: Patients were interviewed during and after their admissions regarding problems experienced during the hospitalizations. We used this information to identify service quality deficiencies. We then performed a blinded, retrospective chart review to independently identify adverse events and errors. We used multivariable methods to analyze whether patients who reported service quality deficiencies (obtained by patient report) experienced any adverse event, close call, or low risk error (ascertained by chart review). RESULTS: The 228 participants (mean age 63 years, 37% male) reported 183 service quality deficiencies. Of the 52 incidents identified on chart review, patients experienced 34 adverse events, 11 close calls, and 7 low risk errors. The presence of any service quality deficiency more than doubled the odds of any adverse event, close call, or low risk error (adjusted odds ratio = 2.5; 95% confidence interval = 1.2-5.4). Service quality deficiencies involving poor coordination of care (adjusted odds ratio = 4.4; 95% confidence interval = 1.4-14.0) were associated with the occurrence of adverse events and medical errors. CONCLUSIONS: Patient-reported service quality deficiencies were associated with adverse events and medical errors. Patients who report service quality incidents may help to identify patient safety hazards.