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Concept: Safety

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Hospitals and clinics are adapting to new technologies and implementing electronic health records, but the efforts need to be aligned explicitly with goals for patient safety. EHRs bring the risks of both technical failures and inappropriate use, but they can also help to monitor and improve patient safety.

Concepts: Personal health record, Computer physician order entry, Safety, Hospital, Electronic health record

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Patient safety measurement remains a global challenge. Patients are an important but neglected source of learning; however, little is known about what patients can add to our understanding of safety. We sought to understand the incidence and nature of patient-reported safety concerns in hospital.

Concepts: Safety, Seven gifts of the Holy Spirit, Learning, Physician, Understanding, Patient, Knowledge, Hospital

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BACKGROUND: The efficacy and safety of rigid pericardial endoscopy as the promising minimally invasive approach to the pericardial space was evaluated. Techniques for cell transplantation, epicardial pacemaker lead implantation, and epicardial ablation were developed. METHODS: Two swine and 5 canines were studied to evaluate the safety and efficacy of rigid pericardial endoscopy. After a double pericardiocentesis, a transurethral rigid endoscope was inserted into the pericardial space. The technique to obtain a clear visual field was examined, and acute complications such as hemodynamic changes and the effects on intra-pericardial pressure were evaluated. Using custom-made needles, pacemaker leads, and forceps, the applications for cell transplantation, epicardial pacemaker lead implantation, and epicardial ablation were also evaluated. RESULTS: The use of air, the detention of a stiff guide wire in the pericardial space, and the stretching of the pericardium with the rigid endoscope were all useful to obtain a clear visual field. A side-lying position also aided observation of the posterior side of the heart. As a cell transplantation methodology, we developed an ultrasonography-guided needle, which allows for the safe visualization of transplantation without major complications. Pacemaker leads were safely and properly implanted, which provides a better outcome for cardiac resynchronizing therapy. Furthermore, the success of clear visualization of the pulmonary veins enabled us to perform epicardial ablation. CONCLUSIONS: Rigid pericardial endoscopy holds promise as a safe method for minimally invasive cell transplantation, epicardial pacemaker lead implantation, and epicardial ablation by allowing clear visualization of the pericardial space.

Concepts: Optical fiber, Effectiveness, Safety, Pericardium, Minimally invasive, Artificial pacemaker, Endoscopy, Heart

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OBJECTIVE: /st>To study the psychometric properties of a translated version of the Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture (HSOPSC) in the Slovenian setting. DESIGN: /st>A cross-sectional psychometric study including principal component and confirmatory factor analysis. The percentage of positive responses for the 12 dimensions (42 items) of patient safety culture and differences at unit and hospital-level were calculated. SETTING: /st>Three acute general hospitals. PARTICIPANTS: /st>Census of clinical and non-clinical staff (n = 976). MAIN OUTCOME MEASURES: /st>Model fit, internal consistency and scale score correlations. RESULTS: /st>Principal component analysis showed a 9-factor model with 39 items would be appropriate for a Slovene sample, but a Satorra-Bentler scaled χ(2) difference test demonstrated that the 12-factor model fitted Slovene data significantly better. Internal consistency was found to be at an acceptable level. Most of the relationships between patient safety culture dimensions were strong to moderate. The relationship between all 12 dimensions and the patient safety grade was negative. The unit-level dimensions of patient safety were perceived better than the dimensions at the hospital-level. CONCLUSION: /st>The original 12-factor model for the HSOPSC was a good fit for a translated version of the instrument for use in the Slovene setting.

Concepts: Patient safety, Confirmatory factor analysis, Safety, Slovenia, Hospital, Principal component analysis, Psychometrics, Factor analysis

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Background Idarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran. Methods We performed a multicenter, prospective, open-label study to determine whether 5 g of intravenous idarucizumab would be able to reverse the anticoagulant effect of dabigatran in patients who had uncontrolled bleeding (group A) or were about to undergo an urgent procedure (group B). The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the diluted thrombin time or ecarin clotting time. Secondary end points included the restoration of hemostasis and safety measures. Results A total of 503 patients were enrolled: 301 in group A, and 202 in group B. The median maximum percentage reversal of dabigatran was 100% (95% confidence interval, 100 to 100), on the basis of either the diluted thrombin time or the ecarin clotting time. In group A, 137 patients (45.5%) presented with gastrointestinal bleeding and 98 (32.6%) presented with intracranial hemorrhage; among the patients who could be assessed, the median time to the cessation of bleeding was 2.5 hours. In group B, the median time to the initiation of the intended procedure was 1.6 hours; periprocedural hemostasis was assessed as normal in 93.4% of the patients, mildly abnormal in 5.1%, and moderately abnormal in 1.5%. At 90 days, thrombotic events had occurred in 6.3% of the patients in group A and in 7.4% in group B, and the mortality rate was 18.8% and 18.9%, respectively. There were no serious adverse safety signals. Conclusions In emergency situations, idarucizumab rapidly, durably, and safely reversed the anticoagulant effect of dabigatran. (Funded by Boehringer Ingelheim; RE-VERSE AD ClinicalTrials.gov number, NCT02104947 .).

Concepts: Blood, Boehringer Ingelheim, Anticoagulant, Bleeding, Safety, Warfarin, Hemostasis, Normal distribution

47

A culture of blame and fear of retribution are recognized barriers to reporting patient safety incidents. The extent of blame attribution in safety incident reports, which may reflect the underlying safety culture of health care systems, is unknown. This study set out to explore the nature of blame in family practice safety incident reports.

Concepts: Report, Health economics, Illness, Health care provider, Medicine, Safety, Health care

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There is a poorly understood relationship between Leadership WalkRounds (WR) and domains such as safety culture, employee engagement, burnout and work-life balance.

Concepts: Safety

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Advances in left ventricular assist device (LVAD) therapy have resulted in increasing numbers of adult LVAD recipients in the community. However, device failure, stroke, bleeding, LVAD thrombosis and systemic infection can be life-threatening emergencies. Currently, four LVAD systems are implanted in six UK transplant centres, each of which provides device-specific information to local emergency services. This has resulted in inconsistent availability and content of information with the risks of delayed or inappropriate decision-making. In order to improve patient safety, a consortium of UK healthcare professionals with expertise in LVADs developed universally applicable prehospital emergency algorithms. Guidance was framed as closely as possible on the standard ABCDE approach to the assessment of critically ill patients.

Concepts: Health care provider, Emergency, Safety, Hospital, Ambulance, Patient, Risk, Ventricular assist device

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Mobile health apps are health and wellness programs available on mobile devices such as smartphones or tablets. In three systematic assessments published in BMC Medicine, Huckvale and colleagues demonstrate that widely available health apps meant to help patients calculate their appropriate insulin dosage, educate themselves about asthma, or perform other important functions are methodologically weak. Insulin dose calculators lacked user input validation and made inappropriate dose recommendations, with a lack of documentation throughout. Since 2011, asthma apps have become more interactive, but have not improved in quality; peak flow calculators have the same issues as the insulin calculators. A review of the accredited National Health Service Health Apps Library found poor and inconsistent implementation of privacy and security, with 28 % of apps lacking a privacy policy and one even transmitting personally identifying data the policy claimed would be anonymous. Ensuring patient safety might require a new approach, whether that be a consumer education program at one extreme or government regulation at the other. App store owners could ensure transparency of algorithms (whiteboxing), data sharing, and data quality. While a proper balance must be struck between innovation and caution, patient safety must be paramount.Please see related articles: http://dx.doi.org/10.1186/s12916-015-0444-y , http://www.biomedcentral.com/1741-7015/13/106 and http://www.biomedcentral.com/1741-7015/13/58.

Concepts: Safety, Health, Health science, Health care, Health care provider, Policy, Illness, Medicine