PurposeThis study aims to describe the adverse events following immunization of SARS-CoV-2 vaccination in cancer patients/survivors associated with their psychological distress.MethodsA cross-sectional study was conducted to assess AEFIs after the receipt of SARS-CoV-2 vaccines in cancer patients/survivors attending a university hospital in Malaysia. Psychological distress was measured using the Hospital Anxiety and Depression Scale before and after the first and second doses of COVID-19 vaccine.ResultsA total of 217 complete responses were received. Compared with before vaccination, both HADS Anxiety and (...) HADS Depression scores were significantly reduced after the first and second dose of the SARS-CoV-2 vaccine. Most of the participants had mild-or-moderate systemic and local AEFIs, with the most common being pain at the injection site, tiredness, and headache for both the first and second doses of the vaccine. Positive correlations between the total AEFI score and HADS-A and HADS-D scores were observed after the first dose of the SARS-CoV-2 vaccine. Similarly, positive associations were observed between the total AEFI score and HADS-A and HADS-D scores after the second dose of the SARS-CoV-2 vaccine.ConclusionMild-to-moderate AEFIs found in this study help address vaccine hesitancy in cancer patients/survivors. Receiving the SARS-CoV-2 vaccine had a positive effect on decreasing psychological distress in cancer patients/survivors. High severity of an AEFI was associated with higher anxiety and depressive symptoms. (shrink)

A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health. Description: The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to (...) standardize and integrate data relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term ‘adverse event’ denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data. (shrink)

Patient safety has assumed a prominent role on the policy agenda since the Institute of Medicine report To Err Is Human was released in November 1999. The report maintained that medical error is the predominant mechanism by which patients in the United States and around the world are injured. This finding, along with the report’s recommendation for a “systems” approach to reducing medical error, provided an extremely important insight into the operation of our medical delivery system. Clearly, while advances in (...) medical technology, diagnostic techniques, and knowledge provide the foundation for saving lives, medical error has resulted in their loss. However, recognition that medical error is a primary cause of these avoidable patient injuries and deaths is a key one and may result in improvements within our system of health-care delivery as well as minimization of the emotional and financial toll that iatrogenic injury causes. (shrink)

Patient safety has assumed a prominent role on the policy agenda since the Institute of Medicine report To Err Is Human was released in November 1999. The report maintained that medical error is the predominant mechanism by which patients in the United States and around the world are injured. This finding, along with the report’s recommendation for a “systems” approach to reducing medical error, provided an extremely important insight into the operation of our medical delivery system. Clearly, while advances in (...) medical technology, diagnostic techniques, and knowledge provide the foundation for saving lives, medical error has resulted in their loss. However, recognition that medical error is a primary cause of these avoidable patient injuries and deaths is a key one and may result in improvements within our system of health-care delivery as well as minimization of the emotional and financial toll that iatrogenic injury causes. (shrink)

Adverse health care events are a global public health issue despite major efforts, and they have been acknowledged as a complex concern. The aim of this study was to explore the construction of unsafe care using accounts of adverse events concerning the patient, as reported by patients, relatives, and health care professionals. Twenty‐nine adverse events reported in an acute care setting in a Swedish university hospital were analyzed through discourse analysis, where the construction of what was considered (...) to be real and true in the descriptions of unsafe care was analyzed. In the written reports about unsafe events, the patient was spoken of in three different ways: (a) the patient as a presentation of physical signs, (b) the patient as suffering and vulnerable, and (c) the patient as unpredictable. When the patient's voice was subordinate to physical signs, this was described as being something that conflicted with patient safety. The conclusion was that the patient's voice might be the only sign available in the early stages of adverse events. Therefore, it is crucial for health care professionals to give importance to the patient's voice to prevent patients from harm and not unilaterally act only upon abnormal physical signs. (shrink)

Health Care Centres are institutions which, because of their specificity and character, are particularly exposed to various kinds of risk. One of the most important and most frequently used methods of risk management is the black spots method. The research material collected for the study comes from one of the hospitals in Wrocław. All hospital stays of the C22 (Face and Jaw Surgery Ward) and H05 (Injury and Orthopaedics Surgery Ward) settlement groups (DRG) were analysed - a total of 178 (...) hospitalisations. The black spots method was used in the study, which consisted of risk identification, the ordering of threats and proposals for remedial actions. Using the black spots method, it was possible to identify adverse events that occurred during the hospitalisation of patients with H05 and C22 DRGs in the Injury and Orthopaedics Surgery Ward and Facial and Jaw Surgery Ward. In both cases, the treatment costs for patients with complications were higher than for the stays without complications. (shrink)

SummaryThe aim of the study was to assess the relationship between adverse life events, a tendency to respond with a high level of anxiety, and height and adiposity of adolescents. The sample included 575 persons aged 10–15 from the Wielkopolska region of Poland. The influence of adverse events during the 6 months before the examination and anxiety trait, as assessed with a STAIC questionnaire, on body height and BMI was analysed. Also sex, age, chronic diseases and socioeconomic status (...) indicators were assessed. One-way and two-way ANOVA was used for assessment of relationships. Adverse events had no influence on body height and BMI. Subjects with a high level of anxiety trait were shorter than subjects with a normal level of anxiety trait. The association of anxiety trait and body height was significant after adjustment for sex, age, chronic diseases and history of adverse life events. The analysis showed no statistically significant influence of adverse life events on height and BMI and a significant relationship between the general tendency to respond with anxiety and body height of adolescents. This suggests that psychological characteristics associated with the cognitive tendency to interpret events as threatening, and consequently, to respond with stress, may be involved in the variability of biological traits regardless of the objective harmfulness of the situation. (shrink)

Many major medical institutions have now embraced the idea that it is best to be honest with patients and families when an error causes harm that could have been avoided. This kind of disclosure improves patient safety and quality of care; enhances satisfaction for patients, families, and providers; and reduces malpractice litigation costs. The University of Michigan has perhaps the best‐known program. Since 2001, that institution has seen more than a 55 percent drop in the number of new malpractice claims (...) filed, a comparable reduction in lawsuits, and a dramatic drop in both defense costs and malpractice payouts—money then redirected toward quality improvement. A few states have also embraced this approach, sometimes known as “Candor” (for “communication and optimal resolution”). Yet all of these efforts face a major challenge. Although many physicians would like very much to achieve insight, reconciliation, and quality improvement in just this way, many fear that money paid to resolve an incident in which they were involved can result in a lifelong black mark in the National Practitioner Data Bank. (shrink)

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of (...) the adverse events they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity. (shrink)

One way to detect, monitor and prevent adverse events with the help of Information Technology is by using ontologies capable of representing three levels of reality: what is the case, what is believed about reality, and what is represented. We report on how Basic Formal Ontology and Referent Tracking exhibit this capability and how they are used to develop an adverse event ontology and related data annotation scheme for the European ReMINE project.

One way to detect, monitor and prevent adverse events with the help of Information Technology is by using ontologies capable of representing three levels of reality: what is the case, what is believed about reality, and what is represented. We report on how Basic Formal Ontology and Referent Tracking exhibit this capability and how they are used to develop an adverse event ontology and related data annotation scheme for the European ReMINE project.

BackgroundInternational guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned.MethodsIt was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National (...) Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety.ResultsIn total, 106 clinical trial protocols were identified from 2173 protocols seen in the archive and 104 included for review. Seventy six trials did not include the surveillance of adverse events as part of their objective. A total of 91 protocols did not budget for adverse event surveillance, 76 did not have a data safety management board, 11 included insurance for participants, 47 did not include a case definition for serious adverse events, 33 described procedures to detect adverse events, 33 described procedure for reporting and 22 described procedure for investigating adverse events.DiscussionsMost clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols.ConclusionClinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee. (shrink)

BackgroundHospitals 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.MethodsA 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.ResultsSurveys 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.ConclusionRecipients 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. (shrink)

A 78-year-old Chinese woman joined a clinical trial sponsored by a Pharmaceutical companies. Unfortunately a serious Serious Adverse Event occurred. The sponsor paid for the cost of the medical care arising from the SAE, but refused the family’s request for compensation. The family then sued the company and the hospital in Beijing. Although the SAE was related to a complication of lower extremity angiography and not the drug itself, it was a direct consequence of participating in the trial. (...) According Good Clinical Practice, a set of regulations promulgated under Chinese law, “the sponsor should provide Insurance to those human subjects who participate in clinical trials, cover the cost of Treatment and the corresponding economic compensation for the occurrence of the harm or death associated with the trial”. The court ordered the trial sponsor to provide a translation of the company’s insurance policy, so that the court could understand the amount of compensation available to the Patient under the policy, but the sponsor never surrendered either the documentation or a translation. Consensus was never reached about the amount of compensation due to the patient through negotiation with the hospital, the company and the family. The Litigation ended after nine hearings and five long years. This chapter provides an ethical analysis of the case relative to at least three areas of Risks of Exploitation when a major, international Pharmaceutical companies sponsors clinical research in a country with an immature legal system and where Research participants have limited resources. (shrink)

Various kinds of alcohol and drug testing, such as preemployment, routine, and for-cause testing, are commonly performed by employers. While healthcare organizations usually require preemployment drug testing, they vary on whether personnel will be subjected to further testing. Recently, a call has gone out for postincident testing among physicians who are involved in serious, preventable events, especially ones leading to a patient's death. This article will offer a number of counterarguments to that proposal and discuss an alternate approach: that health (...) institutions can better improve patient safety and employees’ well-being by implementing an organizational policy of “speaking up” when system operators notice work behaviors or environmental factors that threaten harm or peril. The article will conclude with a description of various strategies that facilitate speaking up, and why the practice constitutes a superior alternative to mandatory alcohol and drug testing in the wake of serious, harm-causing m.. (shrink)

Introduction: Children affected by parental HIV are more likely than unaffected peers to experience trauma and are at-risk for negative psychological and social outcomes. This study aimed to examine the relationship between adverse childhood events and psychosocial functioning among children affected by parental HIV.Methods: A total of 790 children ages 6–17 from Henan, China were enrolled in a longitudinal, randomized controlled trial of a resilience-based psychosocial intervention. At baseline, children reported on numerous psychosocial factors, including trauma exposure, symptoms of (...) anxiety and depression, and peer social functioning. We used linear regression analysis to test the direct effect of trauma exposure on peer social functioning. We then tested whether depression and anxiety symptoms served as two potential parallel mediators in the association between trauma exposure and peer social functioning.Results: Trauma exposure was significantly associated with poor peer social functioning when controlling for key covariates. When depression and anxiety symptoms were added to the model, the association between trauma exposure and peer social functioning became nonsignificant. Instead, there were significant indirect effects from trauma exposure to peer social functioning via depression and anxiety.Conclusion: This study is among the first to link trauma exposure to peer social functioning deficits for children affected by parental HIV and demonstrates that symptoms of anxiety and depression mediate this relationship. Findings underscore the need for comprehensive psychosocial support for children affected by HIV, including screening for trauma exposure and mental health disorders. (shrink)

ObjectivesThis study examined the association between childhood adversity and cognitive impairment in later life and explored the potential moderation effect of gender and race.MethodsThe study sample included 15,133 participants of the Health and Retirement Study who had complete data on key study measures and were more than 50. The outcome variable is a dichotomous indicator of cognitive impairment as assessed by the Telephone Interview for Cognitive Status for self-respondents and the 16-item Informant Questionnaire on Cognitive Decline in the Elderly for (...) proxies. A total of six childhood adversity indicators included grade retention, parental substance abuse, physical abuse, trouble with the police, moving due to financial hardship, and receipt of help due to financial hardship in early life. The estimation of the association between childhood adversity and cognitive impairment involved Cox proportional hazards regression. Results: Grade retention had the largest effect on incident cognitive impairment, followed by physical abuse by a parent. The impact of grade retention was more detrimental to women than men. Parental substance abuse was associated with a lower risk of incident cognitive impairment for most racial groups, but this association was reversed in “non-Hispanic other” race, consisting mainly of Asians.DiscussionSome aspects of childhood adversity continue to harm cognitive functioning in later life, while some events may have the opposite effect, with evidence of heterogeneity across gender and race. (shrink)

BackgroundDreams can be affected by recent life events and long-term life experiences. Previous evidence has shown that childhood adverse experiences are associated with sleep quality and dream experiences.ObjectiveThe aim of this study was to explore the relationship between childhood adverse experiences and dream content in adults.Participants and SettingA total of 163 participants without current or past physical or mental disorders aged between 18 and 35 were screened in the hospital. Among them, 120 subjects who completed a dream content (...) record at home and whose anxiety and depression levels and sleep quality were within the normal range were included in the data analysis.MethodsA cross-sectional survey was conducted from June 2017 to December 2019. Dream content for 10 consecutive days was recorded by the participants and coded by the Hall and Van de Castle coding system. Childhood adversity was assessed by the Childhood Trauma Questionnaire. In the end, 719 dreams out of 626 nights for 120 participants were included in the data analysis, gender differences between groups were analyzed using t-tests or U tests, and Spearman’s partial correlation and multiple linear regression were used to investigate the relationship between childhood trauma and dream content.ResultsChildhood adversity was associated with characters, friendly interactions, and objects in dream content. Regression models of childhood adversity predicting characters and objects in dream content were constructed. There were no gender differences in general demographic data, sleep quality, emotional state, childhood adversity, dream recall frequency, or dream content.ConclusionChildhood adversity is associated with adult dream content. (shrink)

Truth Eternal and the Adversity of Diversity Law sheds new light on the problem of truth, and its power to create, sustain, and account for all things. It also seeks to convey some new insights into how truth inconspicuously pervades every element of creation. Silent and unseen, it grounds time and the flow of events within it.

A wide body of research in the field of happiness economics shows that individuals adapt to both prosperity and to adversity and return to their usual levels of happiness. In this paper we used novel methods and data to assess the effects of the deep economic crisis of 2008-2009 on well-being in the United States. We found, as expected, that the crisis had profound effects on happiness levels, as well as on individuals' assessments of their standards of living and of (...) their future. These attitudes varied significantly depending on respondents' socioeconomic cohort, the industry that they were employed in, and their pre-existing states of mental and physical health. Our most notable finding, though, is a clear, U-shaped trend in reported happiness, with levels falling sharply with the onset of the crisis in mid-08 and trending downward until late March 2009 — around the time that stock markets stopped their free fall. From that point on, happiness levels increased, eventually surpassing the levels that they were in the pre-crisis period of early 2008. This general pattern supports our previous research suggesting that although people react negatively to unpleasant events, they adapt to unpleasant certainty better than they do to uncertainty. (shrink)

Loneliness has been described as endemic among young people. Such feelings of social isolation ‘even in a crowd’ are likely linked to adverse early life experiences that serve to diminish perceptions of social support and intensify negative social interactions. It was suggested in the present series of survey studies that childhood abuse, which compromises a child’s sense of safety in relationships, may affect social processes that contribute to loneliness in young adulthood. Study 1 assessed different adverse childhood and (...) adult experiences in relation to loneliness among young adults. Linear regression analyses indicated that childhood abuse was uniquely associated with greater loneliness, and this relationship was partially mediated by the perceived availability of social support. Study 2 assessed different forms of childhood abuse and demonstrated that early life emotional abuse was a unique predictor of loneliness, and this relationship was fully mediated by lower perceived support or value in social connections and more frequent unsupportive interactions with friends. Study 3 evaluated the implications of the age of occurrence of abuse. Both emotional and sexual abuse predicted young adult loneliness regardless of age; abuse that was recalled to have occurred at very early ages was not predictive of loneliness over and above consideration of events that happened in older childhood. These relationships were at least partially mediated by perceived social support, social connectedness, and in the case of emotional abuse, unsupportive interactions with friends. Our results add to mounting evidence pointing to the prevalence of loneliness among young adults and the links to adverse early life experiences that may serve to shape appraisals of safety, value, and personal worth in social relationships. (shrink)

The pandemic outbreak in March 2020 and its associated sanitary regulations and restrictions triggered an abrupt and significant change for society in general and for families’ organization in particular. In Chile, the Santiago Metropolitan District was under a strict lockdown that involved the closure of the entire educational system. From a systemic-family stress perspective, the impact of these changes might have consequences not only for each individual family member, but for the parental dynamic and, consequently, for children’s well-being. This paper (...) presents the results of a follow-up study showing changes in self-reported parental depression and the perceived home organization of mothers and fathers assessed at three different moments: before the pandemic, at the initial outbreak, and after 1 month of strict lockdown. Relevant moderators were explored using linear mixed models to understand the within-subject changes in mothers’ and fathers’ self-reports across the different assessment times. Financial strain, personality traits of self-criticism and dependency, previous parent–child quality interaction, recent major stressful events, and number of children are highlighted as relevant factors that moderate changes in home chaos and parental mental health perception. Significant risks and protective factors are described for fathers and mothers. The use of pre-pandemic measures as baseline levels enabled the identification of personal and family characteristics that were related to better outcomes. The results help increase our understanding of the sanitary regulations’ impacts on the family system and identify vulnerability indicators that should be considered. (shrink)

Despite the antecedents of unethical sales behavior (USB) have been well studied, these literatures primarily focus on the work domain and neglect the spillover effects of the home domain. Drawing on ego depletion theory as an overarching theoretical framework, this research investigates why and how salespersons’ work-family conflict (WFC) at home triggers next day’s USB at work. This study used daily diary data collected from 99 salespeople in two weeks to test the proposed hypotheses. The multilevel path analysis indicates that (...) evening’s WFC positively affects next afternoon’s USB via increased next morning’s ego depletion (ED). Furthermore, service climate was found to moderate this indirect relationship, such that the indirect relationship becomes weaker under high service climate. To the best of my knowledge, this study is one of the first to reveal that salespersons’ daily WFC may serve as a role conflict event and lead to next day’s USB at work, which provides a fine-grained understanding of spillover effects of daily WFC through a daily diary study. (shrink)

Adverse events that harm patients can also have a harmful impact on health care workers. A few health care organizations have begun to provide psychological support to these Second Victims, but there is uncertainty over whether these discussions are admissible as evidence in malpractice litigation or disciplinary proceedings. We examined the laws governing the admissibility of these communications in 5 states, and address how the laws might affect participation in programs designed to support health care workers involved in (...) class='Hi'>adverse events. We found that privilege is uneven from stateto- state, and also unclear. Ambiguity alone could have a chilling effect on Second Victim programs. We propose legislation to protect volunteer and health care worker communications provided by peer counselors, or failing this, updating of statutory provisions to explicitly include these communications within the ambit of existing protections. Enhancing protections could help to foster an environment of healing for both patients and caregivers. (shrink)

It is widely claimed that climate change has increased the magnitude and the frequency of natural phenomena such as storms, droughts, and floods with the concomitant costs in terms of damages and victims. This paper using weekly data from global stock market indices in a Fama–French model, examines how and to what extent market agents and investors react to such events. As a yardstick for comparison purposes, the possible market impact of industrial accidents is also incorporated and examined in the (...) empirical investigation. The study uses in a comparative approach the STOXX Global ESG Environmental Leaders index and the STOXX Global index diversified across 1800 top companies. Results reported herein seem to indicate that natural and anthropogenic adversity have no immediate impact on the stock indices, while wildfires have an immediate reduction impact on market risk in the case of the ESG Environmental Leaders index. Moreover, wildfires and industrial accidents appear to cause a significant reduction of systematic risk over the next week following the incident. However, the magnitude of the effect is higher in the case of the ESG Environmental Leaders stock index. Finally, the effect on systematic risk by industrial accidents is temporarily without any lasting imprint. (shrink)

The COVID-19 pandemic is a global health issue which has severely disrupted and deferred several landmark international sporting competitions. Like the general population, athletes have faced direct psychological consequences from COVID-19 in addition to cancelation of events, loss of support, lack of training, loss of earnings, hypervigilance, and anxiety among others. The aim of the present research was to identify the adversity experiences of athletes caused by COVID-19 and explore the process of resilience used by competitive elite athletes for positive (...) adaptation. Research has indicated psychological resilience to be a protective factor against similar adversities in the sporting context. The study uses an across-cases qualitative design comparing the real-time lived experiences of athletes during COVID-19 using narrative analysis. Data were collected from 10 competitive elite athletes from various countries, as part of a larger doctoral dissertation study during the lockdown period, using in-depth experiential interviews. Study 1 presents detailed narratives on the loss and incongruence, which were the two major adversities experienced. Study 2 outlines the process of resilience as narrated by the participants through the emergent and minimal-impact resilience trajectories. We discuss recommendations for interventions and the role of sports psychologists, coaches, and sporting organizations in ensuring athletes’ mental health and their rehabilitation into post-COVID sports life. (shrink)

The harmful impact of an adverse event ripples beyond injured patients and their families to affect physicians, nurses, and other health care staff that are involved. These “Second Victims” may experience intense feelings of anxiety, guilt, and fear. They may doubt their clinical competence or ability to continue working at all. Some go on to suffer post-traumatic stress disorder and depression.Medical institutions long ignored this problem, preferring to believe that adverse events, or “errors,” occur due to incompetence (...) — the unfortunate work of a few “bad” practitioners who deserve, if anything, a reprimand for their negligence. Study after study has rejected this attribution and shown that adverse events in health care stem primarily from systemic flaws, not “bad apples.” Devastating errors, in other words, can, do, and always will happen in the care of competent, well-trained, and caring practitioners. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.2 (2001) 165-168 [Access article in PDF] UPMC Presbyterian Policy and Procedure Manual Guidelines for Disclosure and Discussion of Conditions and Events with Patients, Families and Guardians* I. Introduction and Background In the course of hospital care, an extensive amount of clinical information is generated. It includes diagnostic findings, treatment options, responses to interventions, and professional opinions. The information can be positive or negative. (...) Clinical events may or may not be caused by clinicians and consequently may be iatrogenic (caused by medical treatment), nosocomial (occurring in the hospital) or natural events.In accordance with the informed consent policy (#4011), Patients' Bill of Rights (# 0154, Section II H), and the Guidelines on Forgoing Life Sustaining Treatment (#4007), patients have the right to information regarding their condition and care. Physicians and other caregivers are obligated to provide accurate information as expeditiously as possible. While it is usually easy to provide positive information, negative information is more difficult to disclose, especially when the cause is iatrogenic."Therapeutic privilege" has been invoked to explain why certain negative information might be withheld. By invoking therapeutic privilege, the physician refrains from full disclosure to protect the patient from the effects of receiving the information itself. The use of therapeutic privilege is increasingly being called into question because it decreases patient autonomy and reduces trust.The following recommendations are provided to clinicians to help guide delivery of sensitive information, positive and negative. Specific recommendations [End Page 165] are provided for situations where the information is about an unfavorable or adverse event, or where the information might best be characterized as "bad news." II. Definitions Unfavorable event or unfavorable condition. For the purposes of these guidelines, an unfavorable condition is an occurrence or diagnosis that results in or is likely to result in a significant negative outcome, and/or a significant alteration in the care plan.An unfavorable event in this context is not the same as a sentinel event, which in policy #4025 is defined as, "a serious, unexpected, adverse patient event which has resulted in, or if repeated would have a significant probability of resulting in, loss of life or serious physical or psychological injury, that is judged to be a warning of an underlying problem involving hospital facilities, policies, procedures, systems or personnel."Adverse Event. An unfavorable event for the purposes of these guidelines is also distinguished from the FDA definition of the term "adverse event", which is a reportable negative effect of a drug or device potentially resulting in death, hospitalization, or medical or surgical intervention. (See policy #4022 Safe Medical Device Act.)Examples of unfavorable events or conditions for the purpose of these guidelines include a new diagnosis of cancer, a perioperative myocardial infarction, or unintended delivery of an incorrect medication that results in clinical change.Examples of events not covered by these guidelines are intravenous saline infiltration and medication dosing errors that have no clinical impact on care.Iatrogenic. Event caused by the treatment of a healthcare provider. III. Guidelines and Principles It is appropriate that UPMC Presbyterian support basic principles for patient and family notification regarding all clinical events and conditions, including unfavorable ones. Physicians must be honest because that is a cornerstone of the patient-physician relationship, and because it fosters patient autonomy.UPMC Presbyterian supports the following AMA position regarding patient information: [End Page 166] It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and to be free of any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician's mistake or judgement. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care. Ethical responsibility includes informing patients of changes in their diagnoses... (shrink)