122 results match your criteria: "Clinical Risk Management[Affiliation]"

Therapeutic effect of RA223 in the management of breast cancer bone metastases.

Clin Ter

April 2019

Internal Medicine, Biomedical Department of Internal and Specialist Medicine, University of Palermo, Italy.

Radium 223 dichloride (Ra223) is the only targeted alpha therapy able to extend survival in patients with bone metastases from prostate cancer. Mechanism of action and data currently available focused mainly on osteoblastic metastases from prostate cancer. Phase 1 and 2 trials documented a clinical efficacy also in breast cancer patients with predominately bone disease, highlighting a reduction in alkaline phosphatase and other bone biomarkers.

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Effective quality risk management is fundamental to ensuring the protection of human subjects and reliability of clinical trial results during the conduct of clinical trials. Quality risk management supports effective delivery of clinical development programs and ultimately delivery of treatments to patients. Thus, risk management is a core element of an effective quality management system (QMS) as described in the TransCelerate Clinical Quality Management System (CQMS) conceptual framework.

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Background Procalcitonin (PCT)-guided antibiotic stewardship (ABS) has been shown to reduce antibiotics (ABxs), with lower side-effects and an improvement in clinical outcomes. The aim of this experts workshop was to derive a PCT algorithm ABS for easier implementation into clinical routine across different clinical settings. Methods Clinical evidence and practical experience with PCT-guided ABS was analyzed and discussed, with a focus on optimal PCT use in the clinical context and increased adherence to PCT protocols.

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Purpose: To evaluate vascular changes in patients with intermediate uveitis with or without retinal vasculitis using swept-source wide-field optical coherence tomography angiography (OCTA).

Methods: This is a prospective cross-sectional study. Consecutive patients with intermediate uveitis were evaluated using wide-field OCTA.

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Purpose: In diabetic patients presenting with macular edema (ME) shortly after cataract surgery, identifying the underlying pathology can be challenging and influence management. Our aim was to develop a simple clinical classifier able to confirm a diabetic etiology using few spectral domain optical coherence tomography parameters.

Methods: We analyzed spectral domain optical coherence tomography data of 153 patients with either pseudophakic cystoid ME (n = 57), diabetic ME (n = 86), or "mixed" (n = 10).

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Purpose: In the evolution of the minimally invasive treatment of vertebral compression fractures, vertebral body stenting (VBS) was developed to reduce intraoperative and secondary loss of vertebral height. Particularly in combination with the usage of biodegradable cement, the influence of VBS on the rate of intraoperative complications and long-term outcome is unclear. The purpose of this study was to investigate the differences between balloon kyphoplasty (BKP) and VBS regarding their long-term clinical and radiological outcome in combination with calcium phosphate (CaP) application instead of polymethyl methacrylate (PMMA).

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Does the site of primary colorectal cancer influence the outcome after resection of isolated liver metastases?

Dig Liver Dis

October 2018

Department of General and Visceral Surgery, Center for Surgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany. Electronic address:

Introduction: In unresectable patients with metastatic colorectal cancer (CRC), the site of the primary is a strong prognostic factor warranting major adjustments in palliative medical treatment. Initial results suggested that the site of CRC influences prognosis after curative resection of colorectal liver metastases (CLM). In this study, we evaluated outcome after resection of isolated CLM with regard to the location of the primary.

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Healthcare delivery is a highly complex, deeply personal and costly endeavour that involves multiple specialties and services. There is an imbalance in knowledge between the healthcare provider and consumer that may contribute to doubts and uncertainty over treatment and outcomes. It is unsurprising that conflict and dispute can develop between healthcare providers and patients and their next-of-kin.

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Introduction: The error in medicine is always the subject of debate in the scientific debates. The purpose of this study is to evaluate the degree knowledge, attitudes and behaviors of health workers towards the error in the health sector.

Methods: A survey was carried out involving 435 health profes- sionals working in health facilities of the Lazio region, of which 312 females (71%) and 123 males (28%) with an age between 21 and 68 years.

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Background: Psychoeducational family intervention (PFI) has been proven to be effective in improving the levels of family burden and patients' personal functioning in schizophrenia and bipolar disorders (BDs). Less is known about the impact of PFI on relatives' coping strategies in BD.

Methods: A multicenter, controlled, outpatient trial funded by the Italian Ministry of Health and coordinated by the Department of Psychiatry of the University of Campania "Luigi Vanvitelli" has been conducted in patients with bipolar I disorder (BD-I) and their key relatives consecutively recruited in 11 randomly selected Italian community mental health centers.

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Introduction: The error in medicine has long been discussed in scientific debates. The purpose of this study is to evaluate the degree knowledge, attitude and behavior of students in Nursing for the failure in the health sector.

Methods: It was administered to 231 students of Nursing of the Sapienza University of Rome (171 females and 60 males), aged between 21 and 45 years, a structured questionnaire in three questions that explore the experiences and opinions about the errors found in medical practice, the causes underlying them and the mistakes that should never be committed.

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To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis.

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Background: Delirium is a frequent in-hospital complication in elderly patients, and is associated with poor clinical outcome. Its clinical impact, however, has not yet been fully addressed in the setting of the cardiac intensive care unit (CICU). The present study is a prospective, two-centre registry aimed at assessing the incidence, prevalence and significance of delirium in elderly patients with acute cardiac diseases.

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Anxiety, Depression, and Health-Related QOL in Patients Diagnosed with PAH or CTEPH.

Lung

December 2017

Department of Internal Medicine, Academic Teaching Hospital of the Julius Maximilian University of Würzburg, Medical Mission Hospital, Salvatorstrasse 7, 97074, Würzburg, Germany.

Background: Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are life-threatening diseases with a high burden of symptoms. Although depression, anxiety, and reduced health related quality of life (HRQOL) have also been reported, a comparative analysis which explores these traits and their underlying factors was lacking.

Methods: A retrospective analysis of depression, anxiety, and health related QOL was conducted using a Hospital anxiety and depression scale (HADS) as well as the SF-36 HRQOL questionnaire.

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[Full article available at http://rimed.org/rimedicaljournal-2017-10.asp].

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Health and social care ergonomics: patient safety in practice.

Ergonomics

January 2018

c Clinical Practice and Human Factors, Department of Anesthesia and Perioperative Medicine , Medical University of South Carolina, USA.

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Maternal and neonatal mortality and morbidity associated with childbirth is a problem of the highest priority. This research has been aimed at testing a modified version of the WHO Safe Childbirth Checklist in one Italian hospital and to evaluate the tool in terms of its impact on clinical practice and safety. Results show that the presence of correctly compiled partogram tool is strongly and significantly associated with the checklist implementation (OR = 14.

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The aim of this study was to obtain baseline data on doctors' and nurses' work activities and rates of interruptions and multitasking to improve work organisation and processes. Data were collected in six surgical units with the WOMBAT (Work Observation Method by Activity Timing) tool. Results show that doctors and nurses received approximately 13 interruptions per hour, or one interruption every 4.

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The objective of the study is to analyze the variation of adverse events (AEs) according to the different structure of hospitals. The study is a multicenter, retrospective study. It involves 4 teaching hospitals (THs) and 32 community hospitals, distributed in 12 local trusts (LTs), of the Tuscany Regional Healthcare Service (RHS).

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Reducing the use of restrictive interventions by changing staff attitudes.

Nurs Manag (Harrow)

May 2017

Clinical risk management and personal safety, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, England.

The use of restraint in health and social care services has had a high profile in recent years. The goal for these organisations is to reduce it, and use effective preventive interventions instead. Changing staff attitudes to restraint, as part of a comprehensive training programme, is important in reducing the use of restrictive interventions.

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Article Synopsis
  • The study analyzed incident reporting trends over 6 years at a large Italian academic hospital, focusing on how different professions report incidents and their attitudes toward self-reporting.
  • Doctors' reporting rates significantly increased from 2010 to 2015, reaching 0.67, compared to nurses who had a stable rate of 0.40, despite nurses being more likely to self-report severe incidents.
  • The overall decrease in patient complaints and work accidents suggests a potential correlation with better reporting practices, highlighting the importance of monitoring incident reporting as a measure of patient safety.
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Adverse events in cardiac surgery, a mixed methods retrospective study in an Italian teaching hospital.

J Eval Clin Pract

August 2017

Osservatorio per la qualità e l'equità, Agenzia Regionale di Sanita della Toscana, Florence, Italy.

Rationale, Aims, And Objectives: Adverse events (AEs) are a major concern in surgery, but the evidence in cardiac surgery is limited, especially on the contributory factors. According to the data of the National Outcomes Program, a unit was selected to conduct a mixed methods investigation into the incidence, type, and cause of AE, given its mortality rate that was double the national average on coronary artery bypass grafting, valve reparation, and replacement.

Methods: A retrospective investigation on the performance of a cardiac surgery, combining the routinely collected data on process and outcome measures with a 2-stage structured review of 280 medical records performed by 3 expert clinicians, with the support of a methodologist.

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