Committed to Safety: Ten Case Studies on Reducing Harm to Patients

Presents case studies of healthcare organizations, clinical teams, and learning collaborations to illustrate successful innovations for improving patient safety nationwide. Includes actions taken, results achieved, lessons learned, and recommendations

Medical Errors and Information Quality: A Review and Research Agenda

The Information Systems (IS) discipline is active in researching the many aspects of the role of information systems inhealthcare and the application of Information Technology (IT) to healthcare delivery. The contributory role of poor qualityinformation to medical errors is one area that has received little direct attention by IS researchers. In this paper, we present abrief review of the literature on medical errors and examine a number of definitions that have been offered. We further lookat the relationship of complex systems and errors. We then briefly outline some research avenues in which the IS/ITcommunity could become more active. Lastly, we present the specific, but limited area, on which we are focusing ourresearch. We present an outline of our research strategy and short term objectives

Characterising the nature of primary care patient safety incident reports in the England and Wales National Reporting and Learning System: a mixed-methods agenda-setting study for general practice

Background There is an emerging interest in the inadvertent harm caused to patients by the provision of primary health-care services. To date (up to 2015), there has been limited research interest and few policy directives focused on patient safety in primary care. In 2003, a major investment was made in the National Reporting and Learning System to better understand patient safety incidents occurring in England and Wales. This is now the largest repository of patient safety incidents in the world. Over 40,000 safety incident reports have arisen from general practice. These have never been systematically analysed, and a key challenge to exploiting these data has been the largely unstructured, free-text data. Aims To characterise the nature and range of incidents reported from general practice in England and Wales (2005–13) in order to identify the most frequent and most harmful patient safety incidents, and relevant contributory issues, to inform recommendations for improving the safety of primary care provision in key strategic areas. Methods We undertook a cross-sectional mixed-methods evaluation of general practice patient safety incident reports. We developed our own classification (coding) system using an iterative approach to describe the incident, contributory factors and incident outcomes. Exploratory data analysis methods with subsequent thematic analysis was undertaken to identify the most harmful and most frequent incident types, and the underlying contributory themes. The study team discussed quantitative and qualitative analyses, and vignette examples, to propose recommendations for practice. Main findings We have identified considerable variation in reporting culture across England and Wales between organisations. Two-thirds of all reports did not describe explicit reasons about why an incident occurred. Diagnosis- and assessment-related incidents described the highest proportion of harm to patients; over three-quarters of these reports (79%) described a harmful outcome, and half of the total reports described serious harm or death (n = 366, 50%). Nine hundred and ninety-six reports described serious harm or death of a patient. Four main contributory themes underpinned serious harm- and death-related incidents: (1) communication errors in the referral and discharge of patients; (2) physician decision-making; (3) unfamiliar symptom presentation and inadequate administration delaying cancer diagnoses; and (4) delayed management or mismanagement following failures to recognise signs of clinical (medical, surgical and mental health) deterioration. Conclusions Although there are recognised limitations of safety-reporting system data, this study has generated hypotheses, through an inductive process, that now require development and testing through future research and improvement efforts in clinical practice. Cross-cutting priority recommendations include maximising opportunities to learn from patient safety incidents; building information technology infrastructure to enable details of all health-care encounters to be recorded in one system; developing and testing methods to identify and manage vulnerable patients at risk of deterioration, unscheduled hospital admission or readmission following discharge from hospital; and identifying ways patients, parents and carers can help prevent safety incidents. Further work must now involve a wider characterisation of reports contributed by the rest of the primary care disciplines (pharmacy, midwifery, health visiting, nursing and dentistry), include scoping reviews to identify interventions and improvement initiatives that address priority recommendations, and continue to advance the methods used to generate learning from safety reports

Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial

Background: Intraventricular haemorrhage is a subtype of intracerebral haemorrhage, with 50% mortality and serious disability for survivors. We aimed to test whether attempting to remove intraventricular haemorrhage with alteplase versus saline irrigation improved functional outcome. Methods: In this randomised, double-blinded, placebo-controlled, multiregional trial (CLEAR III), participants with a routinely placed extraventricular drain, in the intensive care unit with stable, non-traumatic intracerebral haemorrhage volume less than 30 mL, intraventricular haemorrhage obstructing the 3rd or 4th ventricles, and no underlying pathology were adaptively randomly assigned (1:1), via a web-based system to receive up to 12 doses, 8 h apart of 1 mg of alteplase or 0·9% saline via the extraventricular drain. The treating physician, clinical research staff, and participants were masked to treatment assignment. CT scans were obtained every 24 h throughout dosing. The primary efficacy outcome was good functional outcome, defined as a modified Rankin Scale score (mRS) of 3 or less at 180 days per central adjudication by blinded evaluators. This study is registered with ClinicalTrials.gov, NCT00784134. Findings: Between Sept 18, 2009, and Jan 13, 2015, 500 patients were randomised: 249 to the alteplase group and 251 to the saline group. 180-day follow-up data were available for analysis from 246 of 249 participants in the alteplase group and 245 of 251 participants in the placebo group. The primary efficacy outcome was similar in each group (good outcome in alteplase group 48% vs saline 45%; risk ratio [RR] 1·06 [95% CI 0·88–1·28; p=0·554]). A difference of 3·5% (RR 1·08 [95% CI 0·90–1·29], p=0·420) was found after adjustment for intraventricular haemorrhage size and thalamic intracerebral haemorrhage. At 180 days, the treatment group had lower case fatality (46 [18%] vs saline 73 [29%], hazard ratio 0·60 [95% CI 0·41–0·86], p=0·006), but a greater proportion with mRS 5 (42 [17%] vs 21 [9%]; RR 1·99 [95% CI 1·22–3·26], p=0·007). Ventriculitis (17 [7%] alteplase vs 31 [12%] saline; RR 0·55 [95% CI 0·31–0·97], p=0·048) and serious adverse events (114 [46%] alteplase vs 151 [60%] saline; RR 0·76 [95% CI 0·64–0·90], p=0·002) were less frequent with alteplase treatment. Symptomatic bleeding (six [2%] in the alteplase group vs five [2%] in the saline group; RR 1·21 [95% CI 0·37–3·91], p=0·771) was similar. Interpretation: In patients with intraventricular haemorrhage and a routine extraventricular drain, irrigation with alteplase did not substantially improve functional outcomes at the mRS 3 cutoff compared with irrigation with saline. Protocol-based use of alteplase with extraventricular drain seems safe. Future investigation is needed to determine whether a greater frequency of complete intraventricular haemorrhage removal via alteplase produces gains in functional status

The Influence of Perceived Safety Culture and Nurses\u27 Work Environment on Medication Error Occurrence and Reporting

Purpose: The purpose of this research study was to 1) compare differences in perceptions of the influence of organizational safety and 2) the nurses\u27 practice environment on medication error occurrence and barriers to reporting among nurses working in Magnet, Magnet-aspiring, and non-Magnet hospitals using an Internet survey method.;Background: Over the last several years, there have been many publications that cite organizational variables that are potentially important in addressing medical errors and patient safety. Unfortunately, it is unclear which specific organizational factors contribute to errors and safety in health care organizations. Empiric support of the effects of the nurses\u27 work environment and perceived safety culture within an organization on reasons nurses make medication errors and the barriers to report those errors would provide nursing leaders with data that would be useful in prioritizing interventions to improve patient safety.;Design and method: This descriptive correlational study used a cross sectional design. Additionally, for several of the research questions, a between-participants design was used to evaluate differences among acute care nurses in Magnet, Magnet-aspiring, and non-Magnet hospitals in perceptions of medication error occurrence and reporting, work environment, and safety culture. The study population included 447 nurses working in acute care Magnet, Magnet-aspiring, and non-Magnet designated hospitals. Data were collected online using Qualtrics web-based software. An advertisement for participation was placed on professional organizations\u27 websites. Participants clicked on the link if interested in learning more about the study. A cover letter explaining the research was available to the potential participants.;Instruments: All of the instruments used in this study had validity and reliability demonstrated in prior studies. The Medication Administration Error (MAE) Reporting Survey contains 45 questions in 2 general content areas; (a) reasons why medication errors occur (29 items) and (b) reasons why medication errors are not reported (16 items) The instrument has five subscales for why MAEs occur and four subscales for why MAEs are not reported. Internal consistency of each subscale was acceptable, with Cronbach\u27s alpha ranging from .74--.97. Safety culture was measured using the Hospital Survey on Patient Safety Culture (HSPSC). The survey consists of 79 items measuring 12 dimensions: 2 outcome dimensions and 10 safety culture dimensions with Cronbach\u27s alpha ranging from .72--.91. Nurses\u27 work environment was measured using the Practice Environment Scale of the Nursing Work Index (PES-NWI) instrument. The PES-NWI consists of 31 items in five subscales that characterized professional practice in the original Magnet hospitals with Cronbach\u27s alpha ranging from .88--.92.;Results: Differences were found among nurses working in Magnet, Magnet-aspiring, and non-Magnet hospitals regarding reasons why medication errors occur and reasons why medication errors are not reported. Safety culture variables (hospital handoffs, nonpunitive response, staffing and resources, collegial nurse-physician relations) and type of work unit were predictors of reasons medication errors occur. Safety culture variables (nonpunitive response and hospital management) and years as a nurse were predictors of reasons medication errors are not reported. Work environment variables (nursing foundation for quality of care, staffing and resources, and nurse manager ability) were predictors of reasons medication errors are not reported. The relationships between the perceived work environment and reasons medication errors are not reported and the perceived safety culture and perceived work environment were as theorized but not in the anticipated direction, most likely due to participant fatigue causing participants to not notice that the response scale options were in the opposite direction as the rest of the questionnaires.;Conclusions: This study revealed there are a number of person and system attributes that influence the reasons why medication errors occur and the reasons why medication errors are not reported, confirming the complexity of hospital systems and the influence of organizational variables on medication error occurrence and reporting and providing support for the Conceptual Model of Medication Safety. This study also revealed that reasons medication errors occur and nurses\u27 willingness to report those errors are influenced by the key environmental attributes of Magnet hospital settings

How Perioperative Define, Attribute Causes of, and React to Intraoperative Nursing Errors

Errors in nursing practice are a growing concern in healthcare posing a threat to patient safety. Practitioners have been hesitant to come forward and report errors because of negative ramifications in the workplace. Few studies have approached error management through the eyes of the clinician or have studied how nurses cope or change their practice after committing an error. Studies on nursing errors have traditionally used floor/unit nurses as the sample population. This study used an often unseen and highly specialized group known as perioperative or operating room registered nurses. This study was a descriptive, correlational design using a survey to obtain information. Perioperative registered nurses (N=272) who were members of the Association of periOperative Registered Nurses (AORN) participated in the study. From this sample, 158 participants admitted to committing an intraoperative nursing error. The conceptual framework that guided this study was Lazarus and Folkman\u27s (1984) cognitive theory of psychological stress and coping. Results showed that nurses who used accepting responsibility as a coping strategy after committing an error tended to experience high levels of emotional distress (r = .55, p = .000). Relationships were shown between the strategy of planful problem solving with constructive changes in practice (r = .34, p = .000), and the strategy of escape-avoidance with defensive changes in practice (r = .52, p = .000). Using multiple regression analysis, the strategies of accepting responsibility (Β = .34, p \u3c .001) and using self-control (Β = .17, p \u3c .05) were found to be significant predictors of emotional distress. Seeking social support (Β = .20, p \u3c .05) and planful problem solving (Β = .29, p \u3c .001) emerged as significant predictors of constructive changes in practice. The most predictive of defensive changes was the strategy of escape-avoidance (Β = .35, p \u3c .001). Outcomes that are identified from the process of error management should include measures intended to promote learning from the error and interventions designed to prevent future errors. This study provided evidence that perioperative nurses experienced a variety of emotions after committing an error which led to alterations in the way they practiced

A workshop on developing risk assessment methods for medical use of radioactive material. Volume 1: Summary

A workshop was held at the Idaho National Engineering Laboratory, August 16--18, 1994 on the topic of risk assessment on medical devices that use radioactive isotopes. Its purpose was to review past efforts to develop a risk assessment methodology to evaluate these devices, and to develop a program plan and a scoping document for future methodology development. This report contains a summary of that workshop. Participants included experts in the fields of radiation oncology, medical physics, risk assessment, human-error analysis, and human factors. Staff from the US Nuclear Regulatory Commission (NRC) associated with the regulation of medical uses of radioactive materials and with research into risk-assessment methods participated in the workshop. The workshop participants concurred in NRC`s intended use of risk assessment as an important technology in the development of regulations for the medical use of radioactive material and encouraged the NRC to proceed rapidly with a pilot study. Specific recommendations are included in the executive summary and the body of this report. An appendix contains the 8 papers presented at the conference: NRC proposed policy statement on the use of probabilistic risk assessment methods in nuclear regulatory activities; NRC proposed agency-wide implementation plan for probabilistic risk assessment; Risk evaluation of high dose rate remote afterloading brachytherapy at a large research/teaching institution; The pros and cons of using human reliability analysis techniques to analyze misadministration events; Review of medical misadministration event summaries and comparison of human error modeling; Preliminary examples of the development of error influences and effects diagrams to analyze medical misadministration events; Brachytherapy risk assessment program plan; and Principles of brachytherapy quality assurance

INTEGRATION OF BIOMEDICAL IMAGING AND TRANSLATIONAL APPROACHES FOR MANAGEMENT OF HEAD AND NECK CANCER

The aim of the clinical component of this work was to determine whether the currently available clinical imaging tools can be integrated with radiotherapy (RT) platforms for monitoring and adaptation of radiation dose, prediction of tumor response and disease outcomes, and characterization of patterns of failure and normal tissue toxicity in head and neck cancer (HNC) patients with potentially curable tumors. In Aim 1, we showed that the currently available clinical imaging modalities can be successfully used to adapt RT dose based-on dynamic tumor response, predict oncologic disease outcomes, characterize RT-induced toxicity, and identify the patterns of disease failure. We used anatomical MRIs for the RT dose adaptation purpose. Our findings showed that after proper standardization of the immobilization and image acquisition techniques, we can achieve high geometric accuracy. These images can then be used to monitor the shrinkage of tumors during RT and optimize the clinical target volumes accordingly. Our results also showed that this MR-guided dose adaptation technique has a dosimetric advantage over the standard of care and was associated with a reduction in normal tissue doses that translated into a reduction of the odds of long-term RT-induced toxicity. In the second aim, we used quantitative MRIs to determine its benefit for prediction of oncologic outcomes and characterization of RT-induced normal tissue toxicity. Our findings showed that delta changes of apparent diffusion coefficient parameters derived from diffusion-weighted images at mid-RT can be used to predict local recurrence and recurrence free-survival. We also showed that Ktrans and Ve vascular parameters derived from dynamic contrast-enhanced MRIs can characterize the mandibular areas of osteoradionecrosis. In the final clinical aim, we used CT images of recurrence and baseline CT planning images to develop a methodology and workflow that involves the application of deformable image registration software as a tool to standardize image co-registration in addition to granular combined geometric- and dosimetric-based failure characterization to correctly attribute sites and causes of locoregional failure. We then successfully applied this methodology to identify the patterns of failure following postoperative and definitive IMRT in HNC patients. Using this methodology, we showed that most recurrences occurred in the central high dose regions for patients treated with definitive IMRT compared with mainly non-central high dose recurrences after postoperative IMRT. We also correlated recurrences with pretreatment FDG-PET and identified that most of the central high dose recurrences originated in an area that would be covered by a 10-mm margin on the volume of 50% of the maximum FDG uptake. In the translational component of this work, we integrated radiomic features derived from pre-RT CT images with whole-genome measurements using TCGA and TCIA data. Our results demonstrated a statistically significant associations between radiomic features characterizing different tumor phenotypes and different genomic features. These findings represent a promising potential towards non-invasively tract genomic changes in the tumor during treatment and use this information to adapt treatment accordingly. In the final project of this dissertation, we developed a high-throughput approach to identify effective systemic agents against aggressive head and neck tumors with poor prognosis like anaplastic thyroid cancer. We successfully identified three candidate drugs and performed extensive in vitro and in vivo validation using orthotopic and PDX models. Among these drugs, HDAC inhibitor and LBH-589 showed the most effective tumor growth inhibition that can be used in future clinical trials

Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists

Medical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high‐profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk‐based analysis of security concerns that supports ongoing discussions with patients about their medical devices.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/138357/1/pace13102_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/138357/2/pace13102.pd