The Safety of Inpatient Health Care.

BACKGROUND: Adverse events during hospitalization are a major cause of patient harm, as documented in the 1991 Harvard Medical Practice Study. Patient safety has changed substantially in the decades since that study was conducted, and a more current assessment of harm during hospitalization is warranted. METHODS: We conducted a retrospective cohort study to assess the frequency, preventability, and severity of patient harm in a random sample of admissions from 11 Massachusetts hospitals during the 2018 calendar year. The occurrence of adverse events was assessed with the use of a trigger method (identification of information in a medical record that was previously shown to be associated with adverse events) and from review of medical records. Trained nurses reviewed records and identified admissions with possible adverse events that were then adjudicated by physicians, who confirmed the presence and characteristics of the adverse events. RESULTS: In a random sample of 2809 admissions, we identified at least one adverse event in 23.6%. Among 978 adverse events, 222 (22.7%) were judged to be preventable and 316 (32.3%) had a severity level of serious (i.e., caused harm that resulted in substantial intervention or prolonged recovery) or higher. A preventable adverse event occurred in 191 (6.8%) of all admissions, and a preventable adverse event with a severity level of serious or higher occurred in 29 (1.0%). There were seven deaths, one of which was deemed to be preventable. Adverse drug events were the most common adverse events (accounting for 39.0% of all events), followed by surgical or other procedural events (30.4%), patient-care events (which were defined as events associated with nursing care, including falls and pressure ulcers) (15.0%), and health care-associated infections (11.9%). CONCLUSIONS: Adverse events were identified in nearly one in four admissions, and approximately one fourth of the events were preventable. These findings underscore the importance of patient safety and the need for continuing improvement. (Funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.).

Factors influencing in-hospital prescribing errors: A systematic review.

AIM: In-hospital prescribing errors (PEs) may result in patient harm, prolonged hospitalization and hospital (re)admission. These events are associated with pressure on healthcare services and significant healthcare costs. To develop targeted interventions to prevent or reduce in-hospital PEs, identification and understanding of facilitating and protective factors influencing in-hospital PEs in current daily practice is necessary, adopting a Safety-II perspective. The aim of this systematic review was to create an overview of all factors reported in the literature, both protective and facilitating, as influencing in-hospital PEs. METHODS: PubMed, EMBASE.com and the Cochrane Library (via Wiley) were searched, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement, for studies that identified factors influencing in-hospital PEs. Both qualitative and quantitative study designs were included. RESULTS: Overall, 19 articles (6 qualitative and 13 quantitative studies) were included and 40 unique factors influencing in-hospital PEs were identified. These factors were categorized into five domains according to the Eindhoven classification ('organization-related', 'prescriber-related', 'prescription-related', 'technology-related' and 'unclassified') and visualized in an Ishikawa (Fishbone) diagram. Most of the identified factors (87.5%; n = 40) facilitated in-hospital PEs. The most frequently identified facilitating factor (39.6%; n = 19) was 'insufficient (drug) knowledge, prescribing skills and/or experience of prescribers'. CONCLUSION: The findings of this review could be used to identify points of engagement for future intervention studies and help hospitals determine how to optimize prescribing. A multifaceted intervention, targeting multiple factors might help to circumvent the complex challenge of in-hospital PEs.

The (commercialised) experience of operating: Embodied preferences, ambiguous variations and explaining widespread patient harm.

This article provides a detailed account of how surgeons perceived and used a device-procedure that caused widespread patient harm: transvaginal mesh for the treatment of pelvic floor disorders in women. Drawing from interviews with 27 surgeons in Canada, the UK, the United States and France and observations of major international medical conferences in North America and Europe between 2015 and 2018, we describe the commercially driven array of operative variations in the use of transvaginal mesh and show that surgeons' understanding of their hands-on, sensory experience with these variations is central to explaining patient harm. Surgeons often developed preferences for how to manage actual and anticipated dangers of transvaginal mesh procedures through embodied operative adjustments, but collectively the meaning of these preferences was fragmented, contested and deferred. We critically reflect on surgeons' understandings of their operative experience, including the view that such experience is not evidence. The harm in this case poses a challenge to some ways of thinking about uncertainty and errors in medical sociology, and calls for attention to a specific feature of surgical work: the extent and persistence of operative practices that elude classification as right or wrong but are still most certainly better and worse.

Development of the Harm Prevention Partners Clinical Model: An Academic-Practice Partnership for Prevention of Patient Harm Events.

This innovative academic-practice partnership applied user-centered design, resulting in a new clinical model, the "Harm Prevention Partners Program." The model engaged students working as teams with faculty to intervene on nurse-sensitive indicators by documenting care on a novel smartphone tool and generating an intervention dashboard to visualize impact. Faculty utilized the dashboard to guide postclinical debriefing and highlight students' impact on patient outcomes.

Patient Harm and Institutional Avoidability of Out-of-Hours Discharge From Intensive Care: An Analysis Using Mixed Methods.

OBJECTIVES: Out-of-hours discharge from ICU to the ward is associated with increased in-hospital mortality and ICU readmission. Little is known about why this occurs. We map the discharge process and describe the consequences of out-of-hours discharge to inform practice changes to reduce the impact of discharge at night. DESIGN: This study was part of the REcovery FoLlowing intensive CarE Treatment mixed methods study. We defined out-of-hours discharge as 16:00 to 07:59 hours. We undertook 20 in-depth case record reviews where in-hospital death after ICU discharge had been judged "probably avoidable" in previous retrospective structured judgment reviews, and 20 where patients survived. We conducted semistructured interviews with 55 patients, family members, and staff with experience of ICU discharge processes. These, along with a stakeholder focus group, informed ICU discharge process mapping using the human factors-based functional analysis resonance method. SETTING: Three U.K. National Health Service hospitals, chosen to represent different hospital settings. SUBJECTS: Patients discharged from ICU, their families, and staff involved in their care. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Out-of-hours discharge was common. Patients and staff described out-of-hours discharge as unsafe due to a reduction in staffing and skill mix at night. Patients discharged out-of-hours were commonly discharged prematurely, had inadequate handover, were physiologically unstable, and did not have deterioration recognized or escalated appropriately. We identified five interdependent function keys to facilitating timely ICU discharge: multidisciplinary team decision for discharge, patient prepared for discharge, bed meeting, bed manager allocation of beds, and ward bed made available. CONCLUSIONS: We identified significant limitations in out-of-hours care provision following overnight discharge from ICU. Transfer to the ward before 16:00 should be facilitated where possible. Our work highlights changes to help make day time discharge more likely. Where discharge after 16:00 is unavoidable, support systems should be implemented to ensure the safety of patients discharged from ICU at night.

Patient Harm Due to Diagnostic Error of Neuro-Ophthalmologic Conditions.

PURPOSE: To prospectively examine diagnostic error of neuro-ophthalmic conditions and resultant harm at multiple sites. DESIGN: Prospective, cross-sectional study. PARTICIPANTS: A total of 496 consecutive adult new patients seen at 3 university-based neuro-ophthalmology clinics in the United States in 2019 to 2020. METHODS: Collected data regarding demographics, prior care, referral diagnosis, final diagnosis, diagnostic testing, treatment, patient disposition, and impact of the neuro-ophthalmologic encounter. For misdiagnosed patients, we identified the cause of error using the Diagnosis Error Evaluation and Research (DEER) taxonomy tool and whether the patient experienced harm due to the misdiagnosis. MAIN OUTCOME MEASURES: The primary outcome was whether patients who were misdiagnosed before neuro-ophthalmology referral experienced harm as a result of the misdiagnosis. Secondary outcomes included appropriateness of referrals, misdiagnosis rate, interventions undergone before referral, and the primary type of diagnostic error. RESULTS: Referral diagnosis was incorrect in 49% of cases. A total of 26% of misdiagnosed patients experienced harm, which could have been prevented by earlier referral to neuro-ophthalmology in 97%. Patients experienced inappropriate laboratory testing, diagnostic imaging, or treatment before referral in 23%, with higher rates for patients misdiagnosed before referral (34% of patients vs. 13% with a correct referral diagnosis, P < 0.0001). Seventy-six percent of inappropriate referrals were misdiagnosed, compared with 45% of appropriate referrals (P < 0.0001). The most common reasons for referral were optic neuritis or optic neuropathy (21%), papilledema (18%), diplopia or cranial nerve palsies (16%), and unspecified vision loss (11%). The most common sources of diagnostic error were the physical examination (36%), generation of a complete differential diagnosis (24%), history taking (24%), and use or interpretation of diagnostic testing (13%). In 489 of 496 patients (99%), neuro-ophthalmology consultation (NOC) affected patient care. In 2% of cases, neuro-ophthalmology directly saved the patient's life or vision; in an additional 10%, harmful treatment was avoided or appropriate urgent referral was provided; and in an additional 48%, neuro-ophthalmology provided a diagnosis and direction to the patient's care. CONCLUSIONS: Misdiagnosis of neuro-ophthalmic conditions, mismanagement before referral, and preventable harm are common. Early appropriate referral to neuro-ophthalmology may prevent patient harm.

Core Competency Self-Assessment Enhances Critical Review of Complications and Entrustable Activities.

BACKGROUND: The Accreditation Council for Graduate Medical Education has defined six core competencies (CCs) that every successful physician should possess. However, the assessment of CC achievement among trainees is difficult. This project was designed to prospectively evaluate the impact of resident identification of CC as a component of morbidity review on error identification and standard of care (SOC) assessments. The platform was assessed for its reliability as a measure of resident critical analysis of complication causality across postgraduate year (PGY). MATERIALS AND METHODS: A total of 1945 general surgery cases with complications were assessed for error identification and SOC management between January 1, 2016, and December 31, 2018. CC identification was additionally assessed between January 1, 2019, and December 31, 2019, and included 708 general surgery cases. Data were evaluated for error assessments and overall SOC management. PGY4 and 5 residents were compared for number of cases and complications reviewed, severity, error causation, and CC relevance. RESULTS: Study groups were equivalent by Clavien-Dindo scores. Error identification significantly increased in all categories: diagnostic (P < 0.001), technical (P < 0.05), judgment (P < 0.001), system (P < 0.001), and communication (P < 0.001). Overall SOC assessments validated by a supervising surgical quality officer were unchanged. An increased exposure to cases with severe complications, error causation, and CC relevance was noted across PGY. CONCLUSIONS: The addition of CC assessment into morbidity review appears to improve the critical thinking of evaluating residents by increasing the identification of management errors. Used as an element of prospective self-assessment, teaching residents to identify CC principles in cases with complications may assist in learner progression toward clinical competence and critical thinking.

Cost-Effectiveness of Hepatocellular Carcinoma Surveillance: An Assessment of Benefits and Harms.

INTRODUCTION: The value of hepatocellular carcinoma (HCC) surveillance is defined by the balance of benefits, i.e., early tumor detection, and potential harms, related to false positive and indeterminate results. Although physical harms can be observed in 15%-20% of patients with cirrhosis undergoing HCC surveillance, previous cost-effectiveness analyses have not incorporated costs of harms. We aimed to evaluate the cost-effectiveness of HCC surveillance including both benefits and harms. DESIGN: We constructed a Markov model to compare surveillance strategies of ultrasound (US) alone, US and alpha fetoprotein (AFP), and no surveillance in 1 million simulated patients with compensated cirrhosis. Harms included imaging and biopsy in patients undergoing surveillance for HCC. Model inputs were based on literature review, and costs were derived from the Medicare fee schedule, with all costs inflated to 2018 dollars. The primary outcome was the incremental cost-effectiveness ratio per incremental quality-adjusted life-year. RESULTS: In the base case analysis, US with AFP was the dominant strategy over both US alone and no surveillance. In a probabilistic sensitivity analysis, US with AFP was the most cost-effective strategy in 80.1% of simulations at a willingness-to-pay threshold of $100,000 per quality-adjusted life-year. In our threshold analyses, an HCC incidence >0.4% per year and surveillance adherence >19.5% biannually were necessary for US with AFP to be cost-effective compared with no surveillance. DISCUSSION: Accounting for both surveillance-related benefits and harms, US and AFP is more cost-effective for HCC surveillance than US alone or no surveillance in patients with compensated cirrhosis.

The Emergency Department Trigger Tool: A Novel Approach to Screening for Quality and Safety Events.

STUDY OBJECTIVE: Trigger tools improve surveillance for harm by focusing reviews on records with "triggers" whose presence increases the likelihood of an adverse event. We refine and automate a previously developed emergency department (ED) trigger tool and present record selection strategies to further optimize yield. METHODS: We specified 97 triggers for extraction from our electronic medical record, identifying 76,894 ED visits with greater than or equal to 1 trigger. We reviewed 1,726 records with greater than or equal to 1 trigger, following a standard trigger tool review process. We validated query performance against manual review and evaluated individual triggers, retaining only those associated with adverse events in the ED. We explored 2 approaches to enhance record selection: on number of triggers present and using trigger weights derived with least absolute shrinkage and selection operator logistic regression. RESULTS: The automated query performed well compared with manual review (sensitivity >70% for 80 triggers; specificity >92% for all). Review yielded 374 adverse events (21.6 adverse events per 100 records). Thirty triggers were associated with risk of harm in the ED. An estimated 10.3% of records with greater than 1 of these triggers would include an adverse event in the ED. Selecting only records with greater than or equal to 4 or greater than or equal to 9 triggers improves yield to 17% and 34.8%, respectively, whereas use of least absolute shrinkage and selection operator trigger weighting enhances the yield to as high as 52%. CONCLUSION: The ED trigger tool is a promising approach to improve yield, scope, and efficiency of review for all-cause harm in emergency medicine. Beginning with a broad set of candidate triggers, we validated a computerized query that eliminates the need for manual screening for triggers and identified a refined set of triggers associated with adverse events in the ED. Review efficiency can be further enhanced with enhanced record selection.

Medicine's collision with false hope: The False Hope Harms (FHH) argument.

The goal of this paper is to introduce the false hope harms (FHH) argument, as a new concept in healthcare. The FHH argument embodies a conglomerate of specific harms that have not convinced providers to stop endorsing false hope. In this paper, it is submitted that the healthcare profession has an obligation to avoid collaborating or participating in, propagating or augmenting false hope in medicine. Although hope serves important functions-it can be 'therapeutic' and important for patients' 'self-identity as active agents'- the presentation of false hope along the hope continuum entails a misconstrued balancing act. By not speaking up against unrealistic patient and family requests-including some requests for rights to try, resuscitative efforts in terminally ill patients, or other demands for non-beneficial treatments-healthcare providers precipitate harms, i.e., the FHH. These harms arise on both individual and communal levels and cannot be ignored. The goal of this paper is not to offer a definition of false hope, because the phenomenon of false hope is too complex for any simple definition. Instead, this paper seeks to make four points while outlining the FHH argument: consumer medicine and false hope are connected; providers and patients are very vulnerable in the system of consumer medicine; providers have a responsibility to stand up against false hope; and how the FHH argument could perhaps offer a footing to resist giving in to false hope.

Patient-related factors associated with an increased risk of being a reported case of preventable harm in first-line health care: a case-control study.

BACKGROUND: Patient safety issues in primary health care and in emergency departments have not been as thoroughly explored as patient safety issues in the hospital setting. Knowledge is particularly sparse regarding which patients have a higher risk of harm in these settings. The objective was to evaluate which patient-related factors were associated with risk of harm in patients with reports of safety incidents. METHODS: A case-control study performed in primary health care and emergency departments in Sweden. In total, 4536 patients (cases) and 44,949 controls were included in this study. Cases included patients with reported preventable harm in primary health care and emergency departments from January 1st, 2011 until December 31st, 2016. RESULTS: Psychiatric disease, including all psychiatric diagnoses regardless of severity, nearly doubled the risk of being a reported case of preventable harm (odds ratio, 1.96; p < 0.001). Adjusted for income and education there was still an increased risk (odds ratio, 1.69; p < 0.001). The preventable harm in this group was to 46% diagnostic errors of somatic disease. CONCLUSION: Patients with psychiatric illness are at higher risk of preventable harm in primary care and the emergency department. Therefore, this group needs extra attention to prevent harm.

Testing a Model of Speaking up in Nursing.

BACKGROUND: Speaking up is using one's voice to alert those in authority of concerns. Failure to speak up leads to moral distress; speaking up leads to moral courage. OBJECTIVE: The purpose of this study was to explore the influences of organizational culture, personal culture, and workforce generation on speaking-up behaviors among RNs. METHODS: We distributed a cross-sectional electronic survey to several thousand RNs, resulting in 303 usable surveys. RESULTS: Organizational culture was a strong predictor of speaking-up behaviors; speaking up partially mediated the relationship between organizational culture and moral distress but was not a mediator between organizational culture and moral courage. Workforce generation did not explain speaking up. CONCLUSIONS: The role of organizational culture supports efforts toward healthy work environments. Because not speaking up is related to moral distress, efforts must be escalated to empower nurses to use their voices.

Variation in Physicians' Electronic Health Record Documentation and Potential Patient Harm from That Variation.

BACKGROUND: Physician-to-physician variation in electronic health record (EHR) documentation not driven by patients' clinical status could be harmful. OBJECTIVE: Measure variation in completion of common clinical documentation domains. Identify perceived causes and effects of variation and strategies to mitigate negative effects. DESIGN: Sequential, explanatory, mixed methods using log data from a commercial EHR vendor and semi-structured interviews with outpatient primary care practices. PARTICIPANTS: Quantitative: 170,332 encounters led by 809 physicians in 237 practices. Qualitative: 40 interviewees in 10 practices. MAIN MEASURES: Interquartile range (IQR) of the proportion of encounters in which a physician completed documentation, for each documentation category. Multilevel linear regression measured the proportion of variation at the physician level. KEY RESULTS: Five clinical documentation categories had substantial and statistically significant (p < 0.001) variation at the physician level after accounting for state, organization, and practice levels: (1) discussing results (IQR = 50.8%, proportion of variation explained by physician level = 78.1%); (2) assessment and diagnosis (IQR = 60.4%, physician-level variation = 76.0%); (3) problem list (IQR = 73.1%, physician-level variation = 70.1%); (4) review of systems (IQR = 62.3%, physician-level variation = 67.7%); and (5) social history (IQR = 53.3%, physician-level variation = 62.2%). Drivers of variation from interviews included user preferences and EHR designs with multiple places to record similar information. Variation was perceived to create documentation inefficiencies and risk patient harm due to missed or misinterpreted information. Mitigation strategies included targeted user training during EHR implementation and practice meetings focused on documentation standardization. CONCLUSIONS: Physician-to-physician variation in EHR documentation impedes effective and safe use of EHRs, but there are potential strategies to mitigate negative consequences.

Potential patient harms from misinterpretation of publically reported surgical outcomes.

OBJECTIVE: To determine how the general public interprets surgical complication rates presented from a publicly available online surgical-rating website. SUBJECTS AND METHODS: An in-person electronic survey was administered at the local State Fair to a convenience sample. Participants were presented with a representative output from an online surgeon-rating website and were asked to choose from three statistically equivalent surgeons for a hypothetical medical decision. We then suggested that their insurance company would only cover one surgeon and probed their willingness to pay to switch surgeons for a small chance of lowering the risk of a complication (0.7%, 95% confidence interval [CI] -8.1% to 9.5%, P = 0.9). We quantified the characteristics of those willing to switch, the degree of misinterpretation, and the subsequent potential patient harms. RESULTS: There were 343 completed responses. When presented with a hypothetical healthcare decision, most participants (n = 209, 61%) said they were willing to pay out-of-pocket expenses to switch to a statistically equivalent surgeon. Those who were willing to pay to switch surgeons were more likely to be older (odds ratio [OR] 1.02, 95% CI 1.01-1.03), poorer (OR 1.81, 95% CI 1.07-3.11), previously had cancer (OR 5.9, 95% CI 1.9-25), and misinterpreted the data (OR 3.03, 95% CI 1.87-4.96). Those who were willing to pay out-of-pocket expenses were more inaccurate in their estimation of surgeon complication rates (mean estimate 34.0% vs 8.9%, P < 0.001, correct rate = 3.6%), and on average were willing to pay $6 494 (95% CI 4 108-8 880). CONCLUSION: Understanding of a publicly reported surgical-complication website is often prone to misinterpretation by the general population and may lead to patient harm from a financial aspect.

Citing Harms, Momentum Grows to Remove Race From Clinical Algorithms.

This Medical News article discusses efforts to evaluate the inclusion of race as a factor in widely used clinical decision-making algorithms.

Analysis of Medication Errors and near Misses Made by Nursing Students.

Despite extensive research and technological advancements, errors related to medication administration continue to rise annually. The body of evidence surrounding medication errors has focused largely on licensed practicing nurses. Nursing students can offer a unique perspective regarding medication administration as their foundation for professional psychomotor skills and cognitive abilities are developed. The purpose of this study was to explore the variables related to medication errors made by pre-licensure nursing students. Data were collected from 2013-2015 in a pre-licensure program. Students completed a post-error survey available in Google Forms. One hundred thirteen responses to the error report were completed. By exploring the factors related to medication errors among nursing students, teaching and learning strategies forming the foundations of medication administration can improve professional nursing practice and improve safety and quality of care.

Family history-based colorectal cancer screening in Australia: A modelling study of the costs, benefits, and harms of different participation scenarios.

BACKGROUND: The Australian National Bowel Cancer Screening Programme (NBCSP) was introduced in 2006. When fully implemented, the programme will invite people aged 50 to 74 to complete an immunochemical faecal occult blood test (iFOBT) every 2 years. METHODS AND FINDINGS: To investigate colorectal cancer (CRC) screening occurring outside of the NBCSP, we classified participants (n = 2,480) in the Australasian Colorectal Cancer Family Registry (ACCFR) into 3 risk categories (average, moderately increased, and potentially high) based on CRC family history and assessed their screening practices according to national guidelines. We developed a microsimulation to compare hypothetical screening scenarios (70% and 100% uptake) to current participation levels (baseline) and evaluated clinical outcomes and cost for each risk category. The 2 main limitations of this study are as follows: first, the fact that our cost-effectiveness analysis was performed from a third-party payer perspective, which does not include indirect costs and results in overestimated cost-effectiveness ratios, and second, that our natural history model of CRC does not include polyp sojourn time, which determines the rate of cancerous transformation. Screening uptake was low across all family history risk categories (64%-56% reported no screening). For participants at average risk, 18% reported overscreening, while 37% of those in the highest risk categories screened according to guidelines. Higher screening levels would substantially reduce CRC mortality across all risk categories (95 to 305 fewer deaths per 100,000 persons in the 70% scenario versus baseline). For those at average risk, a fully implemented NBCSP represented the most cost-effective approach to prevent CRC deaths (AUS$13,000-16,000 per quality-adjusted life year [QALY]). For those at moderately increased risk, higher adherence to recommended screening was also highly cost-effective (AUS$19,000-24,000 per QALY). CONCLUSION: Investing in public health strategies to increase adherence to appropriate CRC screening will save lives and deliver high value for money.

Patient Harm in Cataract Surgery: A Series of Adverse Events in Massachusetts.

Massachusetts state agencies received reports of 37 adverse events (AEs) involving cataract surgery from 2011 to 2015. Fifteen were anesthesia related, including 5 wrong eye blocks, 3 cases of hemodynamic instability, 2 retrobulbar hematoma/hemorrhages, and 5 globe perforations resulting in permanent loss of vision. While Massachusetts' reported AEs likely underrepresent the true number of AEs that occur during cataract surgery, they do offer useful signal data to indicate the types of patient harm occurring during these procedures.