Дисертації: "Medicine safety"

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Mabunda, Hitekani Tolerance. "Innovator Medicines Versus Generic Medicine Package Inserts Safety Amendments, the Reality in South Africa." University of the Western Cape, 2017. http://hdl.handle.net/11394/6317.

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Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)
Availability of clinically relevant and unbiased medicine information goes a long way in promoting rational use of medicines. The package insert (PI) is one of the sources of information utilised by healthcare professionals for accessing relevant medicine information such as indications, contra-indications and special precautions (Singh, Mohan, Kumar, & Gupta,2016). It is important that the PI contains updated safety information. The safety information in the PIs of the innovator and generic medicines are expected to be the similar since they contain the same active ingredients. Generic medicines have the same efficacy and safety as innovator medicines and are considered bioequivalent. Generic medicines are interchangeable with innovator medicines.

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Thornborrow-Geswind, Kirsten. "Evaluation of medicine safety reporting systems in South Africa." Thesis, Nelson Mandela Metropolitan University, 2017. http://hdl.handle.net/10948/21439.

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Pharmacovigilance is “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”. To date, no comprehensive study has been performed to evaluate the pharmacovigilance system in the public health sector in South Africa. The primary aim of this study was to evaluate the current status of pharmacovigilance systems within the public healthcare sector in South Africa, and the level of functioning of these systems, in order to provide relevant recommendations, where necessary, for improvement, using the Indicator-based Pharmacogivilance Assessment Tool (IPAT). National and provincial entities were deemed compulsory (n=14), while facilities were selected via random, stratified sampling to obtain a representation at each facility level (n=101). The IPAT was amended for relevance at each level of data collection. Indicators are classified as core and supplementary and compliance with core indicators shows the level of functioning National entities obtained an IPAT score of 36 out of a maximum of 72, achieving 50% compliance. Province D and Province G obtained overall IPAT scores of 29 and 12 respectively out of a maximum of 40, achieving an overall 72.5% and 30% compliance respectively Results at provincial and facility levels were not fully representative due to a limited response rate of 22.2% and 65.3% respectively. Regional/tertiary facilities and district facilities displayed increased awareness and implementation of pharmacovigilance activity than the lower levels of Community Health Centres (CHCs) and Primary Health Centres (PHCs). South Africa”s public healthcare system possesses the infrastructure for a well functioning pharmacovigilance system. However there are gaps in level of functioning at a national, provincial and facility level. Addressing these gaps would show a marked improvement in the system and go a long way towards the contribution of medicine safety information not only locally, but to aid other developing nations.

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Mann, Abbey. "A Medical Perspective on Firearm Safety." Digital Commons @ East Tennessee State University, 2019. https://dc.etsu.edu/etsu-works/6441.

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4

Denagamage, Thomas Nishantha. "Application of evidence-based medicine to veterinary science and food safety." [Ames, Iowa : Iowa State University], 2008.

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Moss, Brandon Price. "6-Month Effectiveness Safety and Tolerability of Ocrelizumab and Comparative Safety with Rituximab." Case Western Reserve University School of Graduate Studies / OhioLINK, 2020. http://rave.ohiolink.edu/etdc/view?acc_num=case1579784364389245.

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6

Mullen, Carrie. "Quality Assurance of forensic investigations in toxicology and traffic safety." Thesis, University of Glasgow, 2014. http://theses.gla.ac.uk/5465/.

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The work described in this thesis deals with three aspects of quality assurance in the field of forensic toxicology: proficiency testing schemes, validation of analytical methods for the piperazine group of abused drugs and validation of the police field impairment test, used at the roadside to test drivers for drug-induced impairment. Proficiency Testing: Long term reviews were performed for two forensic external quality assurance schemes. Rounds 30 (in 2007) to 48 (in 2012) of the UKAS-accredited commercial Quartz Forensic Blood Toxicology Proficiency Testing Scheme (PTS), and a ten year period from 1999 to 2009 of the freely-available United Nations Office on Drugs and Crime (UNODC) International Collaborative Exercises (ICE). Only limited ICE data could be made available as much of the original data had been stored on a database which had become obsolete, hence the data were only available as the original results forms provided to UNODC by the ICE participants. Data was entered to Microsoft Excel® spreadsheets and Microsoft Access® databases from the original forms for the years 1999, 2001 (2 rounds), 2003 (2 rounds) and 2005 (2 rounds), and summary data was extracted from the UNODC round reports for the years 2007, 2008 and 2009. Four methods of scoring quantitative performance were reviewed and the most suitable, a z-score using an assigned ‘true’ value and a percentage of the true value as acceptable deviation, was applied to reanalyse the participants’ results and assess their performance. Methods of scoring proficiency which relied upon participants’ data to determine acceptable variation were found merely to describe the data rather than challenge participants on whether or not they were performing fit-for-purpose analyses. Factors such as participation, analytes tested, participants’ methods of analysis and participants performance were summarised for each scheme before the performance of the two schemes, and that of their participants, were compared. ICE tested more analytes per annum but from a smaller test menu than Quartz. This resulted in more repetitive testing and allowed for some trend analysis and performance monitoring. It was not possible to observe performance trends with Quartz due to the wide variety of analytes tested. The smaller array of potential analytes and more repetitive nature of ICE testing also meant that performance monitoring and detection of bias were easier to perform, and ICE was shown to be more effective as external quality assurance (EQA). Quartz provided a good educational resource as it incorporated the wide range of drugs which a forensic toxicology laboratory could realistically encounter. Following the review, however, it was recommended for QUARTZ that, to provide a safeguard against bias, more repetitive testing was required and this has now been adopted. Piperazines: All piperazine analogues are now illegal in the UK, registered as Class C of the Misuse of Drugs Act (1971) and schedule 2, part III of the Misuse of Drugs Regulations (2001). Piperazines can elicit similar effects to some ATS and methods for their detection should be available in forensic toxicology laboratories. In the present study, methods were developed for the detection of a range of piperazines in blood using LC-MS/MS (p-MeOPP, p-FPP, BZP, o-MeOPP, p-MPP and TFMPP) and GC-MS (p-FPP, BZP, TFMPP, p-MPP, o-MeOPP, m-CPP, p-MeOPP and p-CPP). Quality assurance required both methods to be validated. For all piperazine analytes accuracy was within ±15% (20% at low concentrations) and precision was within 15% (20% at low concentrations). For both methods LLOD of all analytes was 5 ng/ml of blood and upper limit of quantification was 2 µg/ml of blood. For the GC-MS method lower limits of quantification (LLOQs) were in the range 20 to 30 ng/ml of blood. For LC-MS/MS, LLOQs ranged from 50 to 60 ng/ml of blood, although quantification by the LC-MS/MS method was restricted by the lack of availability of appropriate internal standards. There were no apparent significant matrix effects and recovery by both methods was >60 % and, therefore, acceptable. Short term stability of the piperazine analytes was investigated. Piperazines remain sufficiently stable when stored in the fridge for at least one week, and are stable through three freeze-thaw cycles. There was no detectable degradation when blood samples were left on the bench-top or when extracted ‘in-process’ samples were left in the autosampler for up to 72 hours. The LC-MS/MS method could provide a readily applicable screening method. A small aliquot of a basic drug extract could be screened by LC-MS/MS for the presence of piperazines, leaving the majority of the extract for other analyses, for example, piperazines confirmation or amphetamines analysis. The GC-MS method was suitably validated to provide quantification but application to casework samples remains to be evaluated. It is recommended that piperazine testing be performed for all suspected MDMA or ‘club drug’ intoxication cases. The Field Impairment Test: The detection of drugged drivers primarily depends on the current method which is the driver field impairment test (FIT). FIT comprises measurement of pupil diameter and four physical tasks (the Romberg balance test, walk and turn test, one legged stand and finger to nose test) intended to simultaneously test comprehension, short term memory, balance and motor function. Despite FIT having ISO accreditation, it has been recognised that police officers lack confidence with the protocol and do not apply the test as often as is necessary. The main difficulty arises from the requirement to make a subjective judgement of impairment and officers lack confidence in their ability to do so. FIT has never been fully validated. The present study was designed to meet the urgent requirement to develop FIT into an objective measurement, by determining what constitutes “normal” performance in FIT by unimpaired adults of different ages. FIT performance was recorded for 79 individuals, a statistically determined cohort size, confirmed by breath and oral fluid analysis not to be under the influence of impairing substances. Each error made during FIT, as defined by the FIT standard operating procedure, was recorded and collated in a Microsoft Excel® spreadsheet for analysis. It was found that the definition of ‘errors’ was too stringent as many which are required to be recorded are normal physiological or behavioural characteristics, such as body sway, and most subjects would be unable to complete the task without displaying them. A less stringent, evidence-based definition of “error” was developed which allowed statistically more significant analysis to be performed on the FIT results. A statistically significant difference (P=0.00578) was shown to exist between the FIT performance of individuals under the age of forty years and those aged forty and over. Based on the principles of a PTS, robust mean and standard deviation were used to determine what constituted acceptable performance. Those in the younger age group could be considered impaired if the police officer witnessed more than seven errors, or, in the older age group, more than fifteen errors. Using these criteria the frequency of false positives, i.e. unimpaired drivers being assessed as impaired is estimated to be (less than 3%). Also, the ranges of errors observed in both groups was large and overlapped, such that it may be possible for an impaired person to appear unimpaired. This requires further investigation.

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Al, Dhabbari Fatma. "Nurses' perceptions of patient safety culture in Oman." Thesis, University of Glasgow, 2018. http://theses.gla.ac.uk/30724/.

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Al, Salem Gheed F. "An assessment of safety climate in Kuwaiti public hospitals." Thesis, University of Glasgow, 2018. http://theses.gla.ac.uk/30685/.

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Background: Patient safety in healthcare organisations received global attention following the Institute of Medicine’s release of its hallmark report “To Err Is Human: Building a Safer Health System”, where it was estimated that 44,000–98,000 patients die annually in US hospitals as a result of errors in care. Similar rates of error and avoidable harm have been reported in different research studies in many modern health systems across the world. “Safety Culture” has been identified as a key element of healthcare organisations’ ability to learn from errors and reduce preventable harm to patients resulting from health care. The perceived importance of safety culture in improving patient safety and its impact on patient outcomes has led to a growing interest in the assessment of safety culture in healthcare organisations. The use of safety climate questionnaires is one of the most popular methods for assessing safety culture. These questionnaires are thought to help in measuring healthcare workers' perceptions of the prevailing safety culture or “safety climate” in their organisations. Since no surveys of safety climate have been conducted at public hospitals in the state of Kuwait, nor are valid or reliable survey instruments available, this thesis aimed to investigate patient safety climate in public hospitals in Kuwait. The main objectives of the study were: 1. To identify an existing safety climate tools to be employed in my PhD thesis. 2. To test the psychometric properties of the identified tool in a sample of Kuwaiti public hospitals. 3. To provide a measure of the prevailing safety climate in Kuwaiti public hospitals. 4. To explore with key stakeholders the main findings of the safety climate survey and identify the potential barriers and facilitators to safety improvement initiatives in Kuwaiti public hospitals. Based on the overall findings, a series of recommendations are made for clinical leaders, policy makers and others to consider and a conceptual model informing a systems’ based approach to safety culture theory and practice is proposed for future research. Methods: A multi-method, triangulated approach including both quantitative and qualitative methods was adopted for the study. There were four phases of the research: A systematic review of published literature on safety climate tools used in acute hospital settings was carried out using seven electronic databases, with manual searches of bibliographies of included papers and key journals. A suitable tool was identified. A cross-sectional survey of 1,511 healthcare staff in three public hospitals was conducted for two purposes: Firstly, to assess the psychometric properties of the identified tool and develop an optimum model for assessing safety climate in Kuwaiti hospitals. Secondly, to provide an assessment of the current state of safety climate in Kuwaiti hospitals. Finally, interviews with key personnel were conducted to extend the examination of the survey findings and provide a rounded picture of the current state of safety climate in Kuwaiti public hospitals. Results: The search strategy identified 3,576 potential papers. Of these, eighty-eight papers were reviewed, with five studies meeting the inclusion criteria. Three out of five studies, covering three tools, were rated as ‘good’ quality papers and reported more robust psychometric properties. The Hospital Survey on Patient Safety Culture (HSOPSC) was selected as the most appropriate for my PhD thesis (in terms of usability, applicability and psychometric properties), and was pilot tested with minor modifications. A modified version of the HSOPSC was used to conduct the survey using a sample of healthcare staff with an 87% (n=1,310) response rate. Results of psychometric evaluation, including exploratory factor analysis, confirmatory factor analysis, reliability and correlation analysis, showed an optimal model of eight factors and 22 safety climate items. General evaluation of the prevailing safety climate amongst the workforce in acute hospital settings was conducted. The dimensions “Teamwork within units” (84%), “organisational learning-continuous improvement” (82%), “supervisor/manager expectations and actions promoting safety” (77%) and “management support for patient safety” (74%) were identified as strongly positive areas for the three hospitals. The dimensions “Non-punitive response to error” (34%), “communication openness” (47%) and “frequency of event reporting” (50%) were identified as areas in need of improvement. Building on the survey findings, interviews with key stakeholders added rich insight into hospital employees' perceptions on safety and allowed exploration of emerging issues in more detail. The research findings of my PhD thesis, and of the literature informed the design of a preliminary framework that aims to extend the examination of the construct of safety climate beyond the domains and items that typically inform safety climate theory to include system wide factors which potentially influence the prevailing safety culture/climate. Conclusions: This is the first validation study of a Standardised safety climate measure in a Kuwaiti healthcare setting. The study assessed the psychometric properties of the HSOPSC questionnaire and constructed an optimal model for assessing patient safety climate in Kuwaiti hospitals. It highlighted important patient safety and staff wellbeing concerns to inform organisational and national learning, and provided a baseline for measuring patient safety climate in Kuwaiti hospitals. As such, my PhD thesis raises and emphasizes the critical importance of appropriate validation of safety climate questionnaires before extending their usage in different countries or healthcare contexts. It provided new knowledge about areas of strength and weakness in safety climate with the potential to drive local improvements in Kuwaiti public hospitals. It is recommended that future investigations of patient safety culture and climate combine both quantitative and qualitative approaches and adopt a system wide approach to inform safety climate theory and questionnaire development, leading to stronger frameworks guiding safety culture research and practice.

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Carson-Stevens, Andrew. "Generating learning from patient safety incident reports from general practice." Thesis, Cardiff University, 2017. http://orca.cf.ac.uk/104070/.

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Internationally, there is an emerging interest in the inadvertent harm caused to patients by the provision of healthcare services. Since the publication of the Institute of Medicine’s report, To Err is Human, in 1999, research and policy directives have predominantly focused on patient safety in hospital settings. More recently, the World Health Organization has highlighted 2-3% of primary care encounters result in a patient safety incident. Given around 330 million general practice consultations occur in the UK each year, unsafe primary care is a poorly understood, major threat to public health. 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. Over 40,000 incident reports have arisen from general practice. These have never been systematically analysed, and a key challenge to exploiting these data has been to generate learning from the largely unstructured, free-text descriptions of incidents. My thesis describes the empirical development and application of methods to classify (structure) incident report data. This includes the development of coding frameworks specific to primary care, aligned to the WHO International Classification for Patient Safety, to describe the incident, contributory factors and incident outcomes. I have developed a mixed-methods approach which combines a structured process for coding reports and an exploratory data analysis with subsequent thematic analysis. Analyses of reports can generate hypotheses about priorities for systems improvement in primary care at a local and national level. Existing interventions or initiatives to minimise or mitigate patient safety risks can be identified through scoping reviews. Future research and quality improvement activities should deepen understanding about the risks to patients, and generate knowledge about how interventions made in practice can improve safety.

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Elmi, Ahmed. "Safety of medicines with respect to drug counterfeiting in developing countries." Thesis, Cardiff University, 2013. http://orca.cf.ac.uk/52338/.

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Background: This thesis presents a study of the safety of medicines with respect to drug counterfeiting in developing countries (East Africa and the Middle East). Counterfeit medicines are also present in industrialised countries, but not on the same scale as in developing countries. The aim of the study was to establish the responsiveness of health care professionals at the practice level concerning the counterfeiting of medicinal products in developing countries focusing on six countries in the East African region and seven countries located in the Middle East. Method: The method of data acquisition used was by survey questionnaires issued in 13 developing countries (6 in East Africa and 7 in the Middle East). The questionnaires were delivered to the respondents either personally or by e-mail and the questionnaire, responses were returned by the same means. Respondents returned their questionnaire forms direct to the author either on the same day or later by e-mail. The data were analysed with regard to the specific questions. Results: The study findings suggested that the poorer the country, the higher the degree of counterfeiting. All the respondents (n: 2180) agreed that there was a fake or counterfeit medicine problem in their own country (71% of respondents in Africa and 63% of respondents in the Middle East considered this a major problem). Both branded and generic drugs were counterfeited and the extent of the problem and several other factors concerning counterfeited drugs differed significantly between industrialised and developing countries. The difference depended on drug regulation control and enforcement and also on the quality and the prices in the legal supply chain. In most industrialised countries like the USA, Japan or the members of the EU, the level v of drug counterfeiting is <1% of the total medicines market value. An exception is the former Soviet Union where up to 20% of the market is occupied by counterfeit drugs. In contrast, within regions of Africa, Asia and parts of Latin America, between 10-30% of the available medicines are fakes (WHO 2006) Conclusions: The study showed that healthcare workers were aware of the prevalence of counterfeit medicines and quite a number of them had encountered them in their supply role. There is an indication that the respondents tried to assure themselves of the quality of the drugs they purchased by using several methods. However, no rigorous effort was taken to confirm as well as report suspected counterfeit drugs to regulatory authorities. In the industrialised world, medicines regulatory authorities have developed strict standards and controls to ensure the safety and effectiveness of drugs. However, as this study has found, in less developed countries a lack of human and financial resources within the health sector as a whole restricted the activity of regulatory agencies, resulting in a sub-optimally regulated environment in which substandard drug production persisted without detection.

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Rooms, A. E. "Health and safety at work : Self regulation in the multi retail industry." Thesis, University of Salford, 1987. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.381663.

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Strandell, Johanna. "Drug interaction surveillance using individual case safety reports." Doctoral thesis, Linköpings universitet, Klinisk farmakologi, 2011. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-70424.

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Background: Drug interactions resulting in adverse drug reactions (ADRs) represent a major health problem both for individuals and society in general. Post-marketing pharmacovigilance reporting databases with compiled individual case safety reports (ICSRs) have been shown to be particularly useful in the detection of novel drug - ADR combinations, though these reports have not been fully used to detect adverse drug interactions. Aim: To explore the potential to identify drug interactions using ICSRs and to develop a method to facilitate the detection of adverse drug interaction signals in the WHO Global ICSR Database, VigiBase. Methods: All six studies included in this thesis are based on ICSRs available in VigiBase. Two studies aimed to characterise drug interactions reported in VigiBase. In the first study we examined if contraindicated drug combinations (given in a reference source of drug interactions) were reported on the individual reports in the database, and in the second study we examined the scientific literature for interaction mechanisms for drug combinations most frequently co-reported as interacting in VigiBase. Two studies were case series analyses where the individual reports were manually reviewed. The two remaining studies aimed to develop a method to facilitate detection of novel adverse drug interactions in VigiBase. One examined what information (referred to as indicators) was reported on ICSRs in VigiBase before the interactions became listed in the literature. In the second methodological study, logistic regression was used to set the relative weights of the indicators to form triage algorithms. Three algorithms (one completely data driven, one semi-automated and one based on clinical knowledge) based on pharmacological and reported clinical information and the relative reporting rate of an ADR with a drug combination were developed. The algorithms were then evaluated against a set of 100 randomly selected case series with potential adverse drug interactions. The algorithm’s performances were then evaluated among DDAs with high coefficients. Results: Drug interactions classified as contraindicated are reported on the individual reports in VigiBase, although they are not necessarily recognised as interactions when reported. The majority (113/123) of drug combinations suspected for being responsible for an ADR were established drug interactions in the literature. Of the 113 drug interactions 46 (41%) were identified as purely pharmacodynamic; 28 (25%) as pharmacokinetic; 18 (16%) were a mix of both types and for 21 (19%) the mechanism have not yet been identified. Suspicions of a drug interaction explicitly noted by the reporter are much more common for known adverse drug interactions than for drugs not known to interact. The clinical evaluation of the triage algorithms showed that 20 were already known in the literature, 30 were classified as signals and 50 as not signals. The performance of the semi-automated and the clinical algorithm were comparable. In the end the clinical algorithm was chosen. At a relevant level, 38% were of the adverse drug interactions were already known in the literature and of the remaining 80% were classified as signals for this algorithm. Conclusions: This thesis demonstrated that drug interactions can be identified in large post-marketing pharmacovigilance reporting databases. As both pharmacokinetic and pharmacodynamic interactions were reported on ICSRs the surveillance system should aim to detect both. The proposed triage algorithm had a high performance in comparison to the disproportionality measure alone.

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Hilario, Grace. "Patient Safety Problems, Procedures, and Systems Associated with Safety Reporting and Turnover." ScholarWorks, 2019. https://scholarworks.waldenu.edu/dissertations/7103.

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Research has shown that 400,000 people die every year due to preventable medical errors. Medical error reporting and safety is a responsibility of all members of a health care organization. Creating an environment that addresses and prevents potential or actual safety problems can help reduce the incidence of medical errors made by nurses in the workplace. The purpose of this quantitative research study was to determine if nurses' perceptions of safety problems and error-preventing procedures and systems affected their comfort in reporting safety problems and intent to leave. High-reliability theory was the theoretical foundation for this study. Data were obtained from 1,171 surveys completed by newly licensed registered nurses located in 51 different metropolitan statistical areas and 9 counties. SPSS Version 25 was used to conduct a secondary data analysis including descriptive statistics, bivariate analysis, and multiple logistic regression for each variable. Themes that emerged from the data analysis included the importance of education on safety protocols and improving nurse satisfaction and nurse retention. The findings of the study might contribute to social change by creating an increased awareness for nurse leaders, managers, and newly licensed registered nurses in ensuring that there is improved comfort of reporting and appropriate error-preventing procedures and system in the health care environment. Increased awareness will allow for action and improved protocols to enhance the overall safety and quality of care for nurses and their patients.

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Carr, T. L. "A study of innovation and the management of safety in the mining industry." Thesis, University of Nottingham, 1991. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.292252.

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Cohen, Kirsten Lesley. "Patient waiting times within public Emergency Centres in the Western Cape: describing key performance indicators with respect to waiting times within Western Cape Emergency Centres in 2013-2014." Master's thesis, University of Cape Town, 2017. http://hdl.handle.net/11427/27366.

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Background: Much emphasis has been placed on Quality Measurements or Key Performance Indicators in Emergency Medicine. Internationally, KPI's are used to measure and improve quality of care, with a major emphasis on waiting times, measured as time-based KPI's. These times are related to the various stages of a patient journey through the Emergency Center. In South Africa this has not been routinely done. The Western Cape has conducted audits in recent years to measure these. This study aims to provide a snapshot of waiting times (specifically time to triage, time to doctor, time to disposition decision and time to departure from the EC) within Cape Town public sector Emergency Centres. Methods: This is a retrospective descriptive study of waiting times for all patients presenting to Emergency Centres in the Western Cape in 2013-2014, as per six monthly waiting times audits conducted by the Western Cape Department of Health. A wide variety of emergency centers were audited, from 24 hour clinics to larger acute hospital based ECs. Results: The proportional acuity difference between hospitals and CHC for the first random 100 folders were statistically no different. Arrival to triage times were universally longer than internationally accepted as safe. The mean time for all-comers across all facilities was just under an hour, the higher acuity patients were triaged significantly faster (half an hour) than the lower acuity patients (hour or more). This difference was significant for hospitals, with a non-significant trend for CHCs. At hospital ECs, green patients were triaged significantly faster than yellow patients; this was not the case at CHCs. The mean time from triage to clinician consultation for all-comers across all facilities (over two hours) was significantly longer at hospitals as compared to clinics. Time from triage to clinician consultation, per triage category, were longer than the SATS guide times, although higher acuity cases were seen faster than lower acuity cases in a stepwise fashion. Red patients waited nearly an hour on average, with no significant difference between hospitals and CHCs. Orange patients had to wait one to two hours; this was significantly longer at hospitals. The mean time from assessment and management to a disposal decision for all-comers was significantly longer at hospitals as compared to CHCs across all priorities. Green patients took a lot longer at hospital compared to CHCs. A similar pattern was seen for the disposition decision to leaving time. The mean total time was significantly longer at hospitals as compared to clinics. Orange and yellow cases stayed significantly longer at hospitals as compared to CHCs; red and green cases also stayed longer at hospitals as compared to CHCs, though this was not significant. Red cases appeared to stay the longest at CHCs. Conclusions: Patients attending CHCs and hospitals are of similar illness acuity, despite policies dictating that sicker patients should be seen at hospitals not CHC level. CHCs have limited packages of care (decision making investigations, management options and expertise), and can only manage patients to a defined level. Thus, it takes longer for patients who are moderately or very ill to be seen and sorted in a CHC than a hospital, as at a CHC they are generally referred onwards to a hospital. Their journey through the EC will then begin again, so that for sicker patients the time spent in ECs in this study is underestimated. Models need to be explored so that patients receive care at point of contact as far as possible. Since CHC-based ECs see as many patients who are as ill as those in hospitals, these should have similar resources to hospitals, so that only those requiring definite admission need to be referred onwards. Point of care testing, bedside ultrasound, appropriate medications and EM skills should all be available at facilities closest to the patients with emergency conditions. Green patients, the lowest acuity, also take longer to be seen and sorted at hospitals versus CHCs, because investigations are available that are then done as an emergency versus outpatient basis. Efficient and timely outpatient appointments would help mitigate this.

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Murray, Brett Richard. "The use of emergency lights and sirens by ambulances and their effect on patient outcome and public safety." Thesis, Boston University, 2013. https://hdl.handle.net/2144/21225.

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Thesis (M.A.) PLEASE NOTE: Boston University Libraries did not receive an Authorization To Manage form for this thesis or dissertation. It is therefore not openly accessible, though it may be available by request. If you are the author or principal advisor of this work and would like to request open access for it, please contact us at open-help@bu.edu. Thank you.
The use of emergency lights and sirens as warning devices by ambulances is a hotly debated topic within the Emergency Medical Services. For the last few decades, research has shown that lights and sirens have only a minimal effect on time required to transport patients to the hospital, and essentially no positive effect on patient outcome. Meanwhile, thousands of ambulance crashes occur every year (usually during the operation of lights and sirens), and its possible that's tens of thousands of crashes are occurring as a result of a passing ambulance, though not directly involving the ambulance itself. This paper is meant to provide a thorough review of the science behind the use of lights and sirens, the risks they pose to EMS providers, patients, and the public, and strategies to help curb the cost they pose both in dollars and lives. The available literature on this subject all points to the use of lights and sirens being out dated, ineffective, and dangerous, and yet almost nothing has been done to solve the problems they cause. Continued research and development is needed to help make ambulances safer for their occupants, more effective driver training programs need to be offered to EMS providers, and protocols need to be adopted to limit the unnecessary use of L&S.
2031-01-01

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Walker, Janeane. "Nurses' Perception of Their Role in Patient Safety." ScholarWorks, 2018. https://scholarworks.waldenu.edu/dissertations/5434.

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Despite efforts to ensure patient safety in the United States, patients are being harmed by preventable errors. There is a gap in the literature from the nurse's perspective as to why medical errors continue to occur despite having evidence-based safety strategies available. The purpose of this constructivist grounded theory study was to develop a theory explaining nurses' perception of their role in patient safety and why medical errors are still occurring despite implementation of evidence-based safety strategies. The systems engineering initiative for patient safety (SEIPS) model provided the conceptual framework for the study. Data collection included interviews with 11 nurses who worked in a Magnet designated hospital. Data were sorted and analyzed using the constant comparative method. Three themes emerged: technology, work environment, and human factors. These themes aligned with components of the SEIPS model. An emphasis on how technology adds to the nurses' workload compounded with a busy work environment was noted as a contributing factor for bypassing safety systems. The bypass model theory was derived from the themes to describe the conditions that nurses work in that result in bypassing safety systems. Further research needs to go beyond engaging nurses with the implementation of health IT system by examining long-term impacts on workflow as changes are being made. Addressing the reasons why safety measures are bypassed can affect positive social change which will improve the quality and safety of patient care outcomes.

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Scarfe, L. N. "Investigating the safety and efficacy of regenerative medicine therapies in mouse models of kidney disease." Thesis, University of Liverpool, 2017. http://livrepository.liverpool.ac.uk/3008791/.

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Acute kidney injury (AKI) and chronic kidney disease (CKD) are serious health problems with high morbidity and mortality. There are currently no specific treatments available to patients with AKI or CKD, and many patients require renal replacement therapy to survive. Cell-based regenerative medicine therapies have shown potential for treating AKI and CKD in preclinical models, however conventional methods of measuring kidney function and tracking exogenously administered cells are not ideal. Novel imaging-based methods provide an alternative approach, allowing kidney function and cell biodistribution to be monitored longitudinally, without sacrificing many animals at multiple time points. The work in this thesis aimed to evaluate the use of two novel methods for assessing kidney function in mice, and apply them in the assessment of cell therapy efficacy in two preclinical models of kidney disease. Furthermore, preclinical imaging approaches were used to track cell biodistribution in vivo, in order to gain insights into the mechanism of action of cell therapy, and long-term safety. Two novel methods of measuring kidney function were assessed: 1) transcutaneous measurement of FITC-sinistrin clearance, and 2) photoacoustic imaging of IRDye clearance kinetics. The transcutaneous measurement of FITC-sinistrin clearance was found to be a superior method of measuring kidney function in mice, correlating more strongly with histological assessment of structural damage compared with traditional biochemical techniques in the adriamycin model of CKD, and the ischemia-reperfusion model of AKI. Photoacoustic imaging of IRDye clearance kinetics was also found to correlate better with histology in the adriamycin model, however the transcutaneous method was preferred for subsequent studies due to practical considerations including shorter anaesthesia time, higher throughput data collection, and ease of data handling. The efficacy of human kidney-derived cells (hKCs) was assessed following early and late administration in the adriamycin model. It was found that the hKCs induced a trend towards improved kidney function when administered on day one, but there was no effect when treatment was delayed until day 15, after overt proteinuria was established. Furthermore, bioluminescence imaging of luciferase+ hKCs demonstrated that intravenously administered hKCs remained trapped in the lungs, where they promptly died and did not migrate to the kidneys. These results support a paracrine/endocrine mechanism of action of cell therapy, and suggest that efficacy may be absent or diminished when treatment is administered later in the course of the disease. The efficacy of hKCs was also assessed in the ischemia-reperfusion model, and was compared with human mesenchymal stromal cells derived from either bone marrow or the umbilical cord. These results were unexpected, as it was found that none of the cell types tested had any effect on kidney structure or function, and furthermore, the cells did not die in the lungs within 24h of administration. These results may allude to a potential role of cell death in the mechanism of action of cell therapy, however this requires a great deal of further investigation. Finally, preclinical imaging techniques were used to optimise an intracardiac method of cell administration, and to compare the short- and long-term biodistribution of cells following intravenous and intracardiac administration. Intracardiac administration was shown to deliver cells to all organs of the body, including the kidney, and a multi-modal imaging approach enabled whole-body imaging of live cells by bioluminescence imaging, in conjunction with detailed organ-specific imaging of intra-organ biodistribution with magnetic resonance imaging. Longitudinal bioluminescence imaging demonstrated the effect of route of administration on tumour development, with intracardiac administration leading to more aggressive tumour development compared with intravenous administration. These results highlight the value of preclinical imaging in the assessment of regenerative medicine therapies, and show the importance of longitudinal monitoring of the safety of a cell therapy. Overall, the results of this thesis demonstrate the use of novel imaging-based methods of assessing kidney function and cell biodistribution in preclinical assessment of the safety and efficacy of cell-based regenerative medicine therapies. These minimally-invasive methods are more reliable than traditional analyses, and allow individual animals’ responses to be monitored over time, thus reducing the number of animals required for such experiments.

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19

Jones, Sarahjane. "A stakeholder derived framework for safety assessment in the NHS case management programme." Thesis, University of Warwick, 2014. http://wrap.warwick.ac.uk/64012/.

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Patient safety measurement methods are dominated by outcome measurement, reducing them to counts of harm or adverse events. Performance measurement recognises the limitations of the sole use of outcome indicators and proposes the use of measures throughout the system, in particular the determinants of the desired outcomes. Furthermore, it promotes stakeholder engagement in the design of measures in order to understand their expectations and how they contribute. This is particularly important in healthcare services, such as the NHS case management programme, where patient contribution is growing. This programme is a response to the ageing population and the subsequent increase in complex long term conditions, aiming to deliver care in the home to empower patients so they are able to care for themselves to a greater extent. In comparison to the institutionalised setting, the home setting is relatively unexplored. Therefore, this research has provided an opportunity to examine the concept of safety in a care service with an increasing demand from a vulnerable population. The research aimed to develop a conceptual framework for safety measurement that was: 1) reflective of key stakeholders; 2) able to incorporate the system; and 3) representative of the home-delivered healthcare of the case management programme. An exploratory, sequential mixed method design within the critical realist philosophy, which was guided by the principles of performance measurement, was adopted. A case study utilising 13 interviews with nine patients and six carers (two interviews were held jointly) and three focus groups with 17 case management nurses was deployed. This enabled in-depth exploration of their perspectives regarding safety, including: their definitions of safety, who was involved, the contributing factors, and which outcomes were most important. Intriguing, important or contradictory findings were further examined using a survey (patient n=35, carer n=19 and case management nurse n=26), which aimed to determine the level of agreement with these qualitative findings and identify any statistically significant differences between the stakeholder groups. Through engagement with stakeholders, this research has established a definition of safety that represents the type of care provided by the case management programme. In particular, it recognises the importance of meeting the care needs of this patient population, acknowledging that the alternative would facilitate disease progression, exposing patients to unnecessary harm. Understanding the patient perspective has proven to be particularly important because of the level of control asserted by patients on the structure, processes and outcomes of care. This level of control is an integral component of the proposed conceptual framework. Of greatest significance is the incorporation of the patients' living environments and their resources into the structure of care, as well as the involvement of their daily self-care activities in the processes of care. Consequently, the framework is inclusive of non-traditional safety outcomes, such as functional health status, because they help sustain patient controlled structures and processes, which in turn influence traditional measures of harm. The conceptual framework is a guide to the assessment of safety in case management that specifies a range of factors that facilitate the condition of safety, providing a holistic overview of the complex, nested system of care required to manage long term conditions.

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20

Berg, Hans-Yngve. "Understanding Subgroups of Novice Drivers : A Basis for Increased Safety and Health." Doctoral thesis, Linköping : Univ, 2001. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-5037.

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21

Mozid, Abdul M. "Safety and efficacy of bone marrow derived progenitor cells in patients with chronic ischaemic heart failure." Thesis, Queen Mary, University of London, 2012. http://qmro.qmul.ac.uk/xmlui/handle/123456789/8396.

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Bone marrow stem/progenitor cell (BMSC) therapy for cardiac repair in humans is yet to fulfil the exciting potential demonstrated in preclinical experiments. This thesis presents three clinical studies addressing some of the unresolved issues regarding the ideal delivery method, the effect of patient-related factors on progenitor cell concentration/function and the possible biological mechanism(s) of action. The first study describes the intramyocardial arm of the REGENERATE-IHD trial- a randomised controlled trial assessing the efficacy of mobilised BMSCs in patients with ischaemic heart failure. In summary, 30 patients were randomised 1:1 to receive injection of BMSCs suspended in autologous serum or serum alone (control group). All patients received a 5-day course of G-CSF prior to bone marrow harvest and intramyocardial injection. At 1-year, there was a significant increase in ejection fraction, the primary end-point, in patients treated with BMSCs. There were also significant improvements in the secondary end-points of NT-proBNP and symptoms. In the second study, progenitor cell concentration and function were assessed in patients with ischaemic heart failure (IHD), dilated cardiomyopathy (DCM) and acute myocardial infarction (AMI). Findings include ageing having an inverse association with circulating CD34+ cell concentration as well as blunting the effects of G-CSF on BMSC mobilisation. DCM patients had 2 3 significantly higher baseline circulating progenitor cell concentrations compared to IHD/AMI. The final study presents preliminary data regarding a novel imaging technique to detect angiogenesis which is recognised as a potential therapeutic effect of BMSCs. Nine patients with heart failure underwent nuclear imaging using a radio-tracer peptide with a high affinity for v 3, an angiogenesis-related integrin, before and after intracoronary infusion of BMSCs/serum. Preliminary results showed detectable baseline uptake of the radio-tracer suggesting a novel finding of persistent angiogenesis following remote myocardial infarction and also hint at a tantalising possibility that BMSC infusion may lead to therapeutic angiogenesis.

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22

Tang, Jessica Janice. "The implementation of occupational safety and health legislation and policies in Hong Kong schools." Thesis, University of Nottingham, 2011. http://eprints.nottingham.ac.uk/11904/.

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It is widely acknowledged that Hong Kong teachers are suffering from work-related health and safety problems (HKPTU, 2005). Reviews of Occupational Safety and Health (OSH) research suggest that there is a wealth of scientific data on OSH to establish policy level interventions, yet the implementation of OSH legislation and policies is complex and multi-faceted. This thesis focuses on the macro level of OSH interventions in schools by studying the OSH policy implementation from the top-down and organisational perspectives. This thesis begins with a systematic narrative review of the OSH policy and interviews with key stakeholders. These qualitative studies explore the background, context and implementation of the OSH legislation and policies that govern HK teachers‟ OSH. A subsequent quantitative study is conducted to examine the framework model of climate-behaviour-outcome relationship. The results of the qualitative studies present several issues of concerns in the current policy implementation, e.g. the ambiguity of the key terms in the legislation and the communication breakdown during the policy implementation process. The findings also give a hint to the factors which may affect the effectiveness of implementation; further investigations on these factors are carried out in a quantitative study. The results of the quantitative study present the climate-behaviour-outcome framework model with knowledge as the mediator and social capital as the antecedent. The implications of these results are discussed in the final chapter with the significant issues correspondence with the implementation of OSH legislation and policies in HK schools. It also discusses some recommendations in the practice such implementation.

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23

Zarychanski, Ryan. "Evaluating the efficacy and safety of unfractionated heparin in patients diagnosed with sepsis." Thesis, University of Ottawa (Canada), 2010. http://hdl.handle.net/10393/28822.

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Statement of the Problem: Unfractionated heparin (UFH) is an anticoagulant with anti-inflammatory properties. The efficacy and safety of UFH in severe sepsis or septic shock has yet to be evaluated in clinical trials. Methods of Investigation: We performed a systematic review to evaluate the current evidence regarding the use of heparin in patients with sepsis. We then conducted a cross-sectional survey to evaluate the perceived utility and current use of anticoagulants in sepsis, to assess the degree of certainty regarding clinical benefits and harms of heparin, and to assess the willingness of physicians to consider future clinical trials of heparin. Results: The pooled OR for mortality in 7 trials comparing heparin to any other intervention was 0.88 (95%CI 0.74 to 1.05, I2 0%, n=2473). A large observational cohort study also showed a similar reduction in death associated with heparin (HR 0.85, 95%CI 0.73 to 1.00, n=1390). Data from the national survey indicate that 89% (n=279) of critical care physicians believe that anticoagulant therapies used to modulate host inflammation in patients with severe sepsis or septic shock are clinically important, but not routinely used. Respondents were uncertain if UFH or LWMH are beneficial (67%, n=211), or harmful (61%, n=189) when used in this context, and 90%I(n=281) believe that further clinical trials or UFH or LMWH are warranted. Conclusion: Limited evidence to date suggests UFH may be beneficial when administered to patients with severe sepsis or septic shock. Future clinical trials are warranted and supported by a medical community that believes this avenue of research is clinically important and who is genuinely uncertain regarding the potential therapeutic benefits or harms of heparin in this patient population.

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Palminha, Joana Isabel Mariano. "Segurança de fármacos citotóxicos em medicina veterinária versus medicina humana." Bachelor's thesis, Universidade Técnica de Lisboa. Faculdade de Medicina Veterinária, 2010. http://hdl.handle.net/10400.5/2811.

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Dissertação de Mestrado Integrado em Medicina Veterinária
A utilização de fármacos citotóxicos em Medicina Humana iniciou-se na década de 40, e desde então tem vindo a evoluir, tornando-se numa prática corrente na terapêutica oncológica. A exposição a estes fármacos representa um risco de saúde ocupacional, documentado em diversos estudos. Por esta razão, em Medicina Humana, as regras de segurança para a manipulação destes fármacos constituem um assunto muito discutido, existindo um grande número de entidades e organizações que elaboram documentos, contendo as normas orientadoras para um contacto seguro com os fármacos citotóxicos. Apesar da sua extrema importância, a segurança na manipulação dos fármacos citotóxicos continua a ser um tema pouco abordado em Medicina Veterinária, existindo um número muito reduzido de documentos que referem as normas orientadoras para uma manipulação segura. Foi objectivo, do presente trabalho, comparar estas duas realidades distintas, Medicina Veterinária vs Medicina Humana, no que respeita ao contacto com os fármacos citotóxicos, de forma a contribuir para uma maximização da protecção dos profissionais de Medicina Veterinária, bem como a do próprio paciente e a do ambiente. Assim, foi realizado um questionário – a nível nacional – para determinar, através das respostas a questões específicas para as diferentes fases de manipulação dos fármacos citotóxicos, o grau de segurança com que se efectua essa mesma manipulação, na prática clínica diária. Dos 65 questionários respondidos, 53 referem-se a Centros de Atendimento Médico-Veterinário (CAMVs) e 12 a Hospitais Veterinários. No entanto, a prática de quimioterapia ocorre em apenas 44 estabelecimentos, dos quais 33 são CAMVs e 11 são Hospitais Veterinários. Este estudo permitiu concluir, que a classe médico-veterinária apresenta uma exposição bastante elevada aos fármacos citotóxicos, fazendo-o com um grau de protecção e segurança insuficientes, logo com risco elevado para a sua saúde. Assim, e considerando o que são as normas de segurança em Medicina Humana, e de forma a modificar esta situação são preconizadas várias normas protectoras que poderão ser de aplicação comum durante todas as fases de manipulação dos fármacos citotóxicos, mas que podem ser mais especificas em função da fase de manipulação dos fármacos citotóxicos em que será preconizada a sua aplicação.
ABSTRACT - Safety of Cytotoxic Drugs in Veterinary Medicine versus Human Medicine - The use of cytotoxic drugs in Human Medicine began in the 40s, and has evolved since then to become a standard in cancer therapy. It is documented in several studies that the exposure to these drugs poses an occupational health risk. For this reason, in Human Medicine, there are several entities and organizations regulating the safety rules for handling these drugs, with the elaboration of documents containing the guidelines for the safe contact with cytotoxic drugs. Despite its extreme importance, the safe manipulation of cytotoxic drugs continues to be a minor preocupation in Veterinary Medicine, with only a few documents referring the guidelines for a secure handling. The purpose of this study was to compare two distinct realities, Veterinary Medicine versus Human Medicine, regarding the use of cytotoxic drugs, in order to maximize the protection of the professionals, the patients and the environment. For this purpose, an inquiry was performed at a national level, to determine the safety practices used in each phase of manipulation of the cytotoxic drugs in hospitals and clinics. Of the sixty-five inquiries answered, 53 refer to Small Animal Veterinary Clinics and 12 to Veterinary Hospitals. Yet, the practice of chemotherapy occurs only in 44 establishments, including 33 Small Animal Veterinary Clinics and 11 Veterinary Hospitals. It was concluded, that the veterinary professionals are highly exposed to cytotoxic drugs, with a level of insufficient protection and safety, posing risks to human occupational health. Considering the safety rules in Human Medicine and with the aim to improve this situation, various protective recommendations are made that could be applied in all phases of manipulation of cytotoxic drugs and also specific measures for each phase of manipulation of these drugs.

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25

Ådahl, Kerstin. "On Decision Support in Participatory Medicine Supporting Health Care Empowerment." Doctoral thesis, Blekinge Tekniska Högskola, Sektionen för datavetenskap och kommunikation, 2012. http://urn.kb.se/resolve?urn=urn:nbn:se:bth-00515.

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The task of ensuring Patient Safety is, more than ever, central in Healthcare. The report “To Err is Human” [Kohn et al. 2000], was revealing alarming numbers of incidents, injuries and deaths caused by deficiencies in healthcare activities. The book initiated assessment and change of Healthcare methods and procedures. In addition, numerous reports to Swedish HSAN (Medical Responsibility Board) have shown a high rate of information and communication deficiencies in Healthcare has a direct or indirect cause of incidents, injuries and deaths. Despite numerous of new sophisticated tools for information management in recent years, e.g., tools such as Electronic Health Records (EHR) and Clinical Decision Support Systems (CDSS), the threats to Patient Safety have not been redeemed. Rather to the contrary. Underlying reasons for this paradox are twofold. Firstly, advancements in diagnosing techniques have given rise to increasing volumes of data at the same time as the number of patients has increased due to demographic changes and advancements in treatments. Secondly, the information processing systems are far from aligned to related workflow processes. In short, we do not at present have interoperability in our Healthcare systems. In this doctoral dissertation, we present an in-depth analysis of two different “HSAN-typical” cases, where Patient Safety was jeopardized by incomplete information flows and/or information breakdowns. The cases are mirroring the apprehension of Simplicity, that is, Occam´s Razor of Diagnostic Parsimony. A well-known protocol used in Healthcare and implemented in most (knowledge based) CDSS. This rule of thumb is the foundation for the well-known adage: “when you hear hoof beats, think horses, not zebras”. Hickam´s Dictum is one well known objection to the simplifications of Occam´s Razor stating "Patients can have as many diseases as they damn well please". Of course, this Dictum is harder to implement effectively! In the thesis we suggest a visualization tool Visual Incidence Anamneses (VIA) to provide middle out compromise between Ockham and Hickam but providing means to increase Patient Safety. The findings of our Study for the thesis have resulted in a number of Aspects and Principles as well as Core-principles for future CDSS design, That is, tools and methodologies that will support designing and validating Interoperability of Healthcare systems across patient-centric workflows. The VIA tool should be used as the initiating point in a patient (individual) centered workflow, quickly visualizing vital information such as symptoms, incidents and diagnoses, occurring earlier in the medical history, at different times, to ground further vital decisions on. The visualization will enable analysis of timelines and earlier diagnoses of the patient, using visually salient nodes for visualization of causalities in context. Furthermore, support for customization of the tool to the views of stakeholders, members of healthcare teams and empowerments of the patient, is crucial.

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Olayanju, Olatunde. "Efficacy and safety of novel and repurposed drugs for the treatment of drug-resistant tuberculosis." Doctoral thesis, Faculty of Health Sciences, 2020. http://hdl.handle.net/11427/32322.

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Background: There is widespread concern about the rise of drug-resistant TB because treatment outcomes of affected patients remain poor and treatment options are limited. After more than a forty-year gap without any breakthrough discovery, several new (bedaquiline and delamanid) and repurposed drugs (linezolid) are increasingly becoming available for use. However, data regarding the efficacy and safety of these drugs in drug-resistant TB patients, with or without HIV infection, from a real-life programmatic setting are lacking. This thesis aims to address that knowledge gap and provide information for management of drug-resistant TB in countries with high disease burden. Methods: A total of 326 drug resistant TB patients were prospectively followed up between January 2008 and April 2018. The efficacy and safety of two new drugs (bedaquiline and delamanid) and one repurposed drug (linezolid) was determined in these patients in three studies. In the first study, 24 months treatment outcomes and adverse event profiles were compared between extensively drug resistant (XDR) TB patients who received programmatic treatment regimens with the backbone of second line injectables and fluoroquinolones (nonbedaquiline-based) and those who received a bedaquiline- and/ or linezolid-based treatment regimen. The second study determined the frequency of system-specific adverse events associated with linezolid. The third study interrogated the safety and effectiveness of a strengthened treatment regimen containing a combination of delamanid and bedaquiline in patients with poor prognostic features compared to bedaquiline-based regimen. Results: In the first study, patients who received a bedaquiline-based treatment regimen had a significantly greater favourable outcome rate (66.2% vs 13.2%; p<0.001) ), more than a fourfold reduction in treatment failure rate (5.9% vs 26%; p<0.001 ) and less than a half of mortality rate compared to patients who received a non-bedaquiline-based regimen. The bedaquiline survival and favourable outcome effect remained significant in HIV-infected patients (p<0.001). The second study showed that linezolid interruption was common in patients receiving a bedaquiline-based treatment regimen, and that system-specific toxicity occurred within predictable time frames. It also showed that anaemia (77.3% versus 7.3%; p<0.001), peripheral neuropathy (63.6% versus 14.6%; p=0.003), and optic neuritis (18.2% versus 9.8%; p=0.34) occurred more frequently in linezolid interrupters than in non-interrupters. The third study showed that the use of delamanid-bedaquiline combination regimen was safe and efficacious in drug resistant TB patients with poor prognosis when compared with outcomes in the less sick patients who received a bedaquiline-based regimen. It also showed no significant difference in culture conversion rate at 6 months (92.5% versus 81.8%; p=0.26) or favourable treatment outcome rate (63.4% versus 67.5%; p=0.66) between the two groups. Although patients who received the combination regimen had more frequent occurrence of QTcF prolongation greater than 60 ms from baseline (p=0.001) and more episodes of QTcF greater than 450 ms during treatment (p=0.001), none of them were symptomatic or had delamanid or bedaquiline withdrawn from their regimen. Conclusion: These data demonstrated that new and repurposed drugs remarkably improved treatment outcomes in patients with drug-resistant TB. Although linezolid, which is an important component of the bedaquiline-based treatment regimen, is often associated with system-specific adverse events, these occurred at predictable time frames thereby guiding physicians to make informed management decisions. Lastly, drug resistant TB patients with poor prognosis may benefit from a regimen containing delamanid and bedaquiline which seems relatively safe from an adverse event perspective. These data, despite some limitations, make a case for a widespread and accelerated roll-out of new and repurposed drugs for the treatment of drug resistant TB.

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27

Cooter, Rodney D. "Craniofacial fracture patterns : a thesis submitted for the degree of Doctor of Medicine /." Title page, contents and abstract only, 1990. http://web4.library.adelaide.edu.au/theses/09MD/09mdc779.pdf.

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28

Jeyaretnam, Joseph S. "Occupational hazards and radiation safety in veterinary practice including zoo veterinary practice in Australia." Thesis, Edith Cowan University, Research Online, Perth, Western Australia, 2003. https://ro.ecu.edu.au/theses/1306.

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This thesis contains reviews and research on the occupational hazards of zoo veterinary practitioners in Australia. Although occupational hazards have long been recognised in the veterinary profession, little information is available on the number and magnitude of injuries to veterinarians in Australia, the United Kingdom or the United States. Apart from anecdotal accounts and some limited data, most of the available information is on occupational zoonoses, generally well recognized by veterinarians. Other occupational hazards to which veterinarians are exposed have received scant attention. The veterinary practitioner in a zoo environment has to treat a range of captive wild species which are much more unpredictable and dangerous than domesticated animals. A comprehensive study on occupational hazards sustained by veterinarians in zoological gardens has not been undertaken in Australia. Only one study had been undertaken in the US amongst zoo veterinarians, while comprehensive may not be able to be transposed to zoos in Australia as the species held in Australian zoos differ from those in the US. Personal communication with some senior veterinarians in the zoological gardens in Australia, have elicited further information on the prevalence of occupational hazards sustained by the zoo and wildlife park veterinarians. The prevalence of physical hazards including radiation, chemical and biological hazards reported by veterinary practitioners and the author's own experience as a veterinary practitioner, chairman of the safety committee, member of the animal ethics committee and manager, research In the zoological gardens in Perth, Western Australia have demonstrated a need for a comprehensive study on occupational hazards prevalent among zoo veterinarians. To investigate the occupational hazards including radiological hazards amongst zoo veterinarians in Australia, a self-administered 14-page comprehensive questionnaire comprising 58 questions was mailed to 27 practising zoo veterinarians in Australia. The questionnaire focused on physical injuries, chemical exposures, allergic and irritant reactions, biological exposures, radiological hazards including problems encountered with x-ray machines, use of protective gear and ancillary equipment for radiography, personnel involved in x-ray procedures and in restraining animals, compliance with the Australian National Health and Medical Research Council (NHMRC) Code of Practice (1982), Radiation Safety Regulations (1988) and National Standard for Limiting Occupational Exposure to Ionising Radiation (1995) The result of the study revealed that 60% of the participants sustained physical injuries such as crushes, bites and scratches inflicted by a range of species with some Injuries requiring medical treatment. Also, 50% of the participants suffered from back injuries while 15% reported fractures, kicks, bites necessitating hospitalization. Ninety percent of the participants sustained needlestick injuries ranging from one to 16+ times. Other significant findings include: necropsy injuries, animal allergies, formaldehyde exposure, musculoskeletal Injuries and zoonotic infections. The survey also identified that veterinary practitioners and their staff were exposed to radiation by not complying with the National Health and Medical Research Council (NHMRC) Australian Code of Practice for the Safe Use of Ionising Radiation (1982) which has been framed to minimize exposure to ionising radiation. The majority of the veterinarians in the study group indicated that radiation exposure Is a major occupational hazard to the veterinary profession. Subsequent to the review and research, discussions were held with few senior zoo veterinarians, the Registrar of the Veterinary Surgeons Board and a number of practising senior veterinarians In Australia to collect information on occupational hazards. Additional information was obtained on occupational injuries sustained by the zoo veterinarians through formal discussions with the Director and the two senior veterinarians In the zoological gardens in Sri Lanka. The discussions with the veterinary practitioners in government and private practice revealed that veterinarians experienced a range of occupational hazards including exposure to rabies. Discussions with the dean and the professor of the animal science department focused on the nature of injuries and preventive strategies. In order to obtain information on occupational hazards in the health care industry, the professor of anatomy of the faculty of medicine and a senior surgeon in Sri Lanka were interviewed. This study identified that the zoo veterinarians are routinely exposed to a wide range of occupational hazards. The literature review among veterinary practitioners In US, UK, Australia and Canada have also identified numerous occupational hazards sustained by the veterinarians. The discussions held in Sri Lanka with the professionals in veterinary and health care industry showed that occupational injuries have been common amongst them and they do not have appropriate preventive guidelines in place. This thesis has incorporated recommendations in the form of preventive strategies for minimizing occupational hazards among veterinary practitioners both in zoological gardens and veterinary practices In Australia and in the developed and developing countries.

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Reilly, Mark Stephen John. "Epidemiological and geographical aspects of the occupational safety and emergency survival of United Kingdom fishermen, 1961-85." Thesis, University of Dundee, 1988. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.302260.

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30

Tombs, Stephen Peter. "The nature and limitations of the legal regulation of health and safety in the UK chemical industry." Thesis, University of Wolverhampton, 1991. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.303691.

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This thesis examines the nature of the current legal regulation of occupational safety and health in Britain, and aims to understand the limitations of such regulation. This aim also leads us to consider the potential for, and the means of securing, improvements in safety and health performance in the UK chemical industry. Having set the research in context and addressed some pertinent methodological issues, the thesis begins by providing an overview of existing safety and health legislation, both in relation to manufacturing industry in general, and then in relation to the chemical industry more specifically. Here we establish the nature and significance of the self-regulatory system which was formalised in law by the Health and Safety at Work Act 1974. We then commence our assessment of the impact and efficacy of this system, considering the 'progress' of self-regulation through the 1970s and 1980s. We argue here that this system of selfregulation has proven an ineffective guarantor of safety and health at work. Our focus then shifts much more specifically onto the UK chemical industry. Having arrived at an understanding of key accidentgenerating factors in the UK chemical industry, we consider efforts within that industry to prevent these through selfregulatory efforts. This latter consideration is conducted at both theoretical and empirical levels. We conclude that while the chemical industry is in a relatively favourable position to self-regulate effectively, this is not being achieved. Thus we are led to further consider the role of external regulation. We conclude by arguing for the possibilities of more punitive and interventionist forms of legal regulation of safety and health at work, and we rather speculatively sketch out elements of these. Here, we once again encounter the limitations of the legal regulation of business in a capitalist social order

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31

Parihar, Vishal Singh. "Human listeriosis : sources and routes." Doctoral thesis, Örebro : Örebro University Library, 2008. http://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-2447.

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32

Fasting, Sigurd. "Routine based recording of adverse eventsduring anaesthesia : application in quality improvement and safety." Doctoral thesis, Norwegian University of Science and Technology, Faculty of Medicine, 2003. http://urn.kb.se/resolve?urn=urn:nbn:no:ntnu:diva-327.

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33

Rydningen, Lene Christin. "Medicine Management and Administration : How might we improve patient safety through medicine management and administration in inpatient care units in somatic hospitals in Sweden and Norway?" Thesis, Umeå universitet, Designhögskolan vid Umeå universitet, 2018. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-152356.

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Анотація:

Introduction

This thesis explores how we can increase patient safety through medicine management and administration in inpatient care units in somatic hospitals in Sweden and Norway by combining tools and systems which allows nurses to work safely, precicely, and efficiently whenever they are managing or administering medication to patients.

Background

Nurses have the formal, academic, and moral responsibility in medicine management and administration in hospitals (1). The nurse must ensure that the medication is given to the correct patient, that it is the correct kind of medication, correct form, correct strength, correct dose, correct administration method, and that it is given at the correct time (1). Regardless of these 7 points of control, adverse drug events still happen.

Methodology

Through a human centered design approach this thesis explores design challenges and opportunities to how we can improve the medicine managment and administration process within somatic hospitals in Sweden and Norway.

Result

The final design proposal, Memo, suggests an ecosystem which make all medication traceable by incorporating a closed loop medicine management approach, making information accessible and consistent across digital and physical platforms, and having a precise, accessible, and informative electronic medicine list. Memo eliminates risks of medicine errors by designing barriers within the system which make it harder for the nurse to make an error. The aim is to increase patient safety.

Memo is developed together with nurses and pharmacists from 3 different hospitals in Sweden and Norway.

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34

Pal, Arindom. "Development of a new class of ligand-targeted chemotherapeutics with enhanced safety and efficacy profile." Scholarly Commons, 2019. https://scholarlycommons.pacific.edu/uop_etds/3642.

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The hydrophobicity of many chemotherapeutic agents usually results in their nonselective passive distribution into healthy cells and organs causing collateral toxicity. Ligand-targeted drugs (LTDs) are a promising class of targeted anticancer agents. The hydrophilicity of the targeting ligands in LTDs limits its nonselective passive tissue distribution and toxicity to healthy cells. In addition, the small size of LTDs allows for better tumor penetration, especially in the case of solid tumors. However, the short circulation half-life of LTDs, due to their hydrophilicity and small size, remains a significant challenge for achieving their full therapeutic potential. Therefore, extending the circulation half-life of targeted chemotherapeutic agents while maintaining their hydrophilicity and small size will represent a significant advance towards effective and safe cancer treatment. Here, we present a new approach for enhancing the safety and efficacy of targeted chemotherapeutic agents. By endowing hydrophobic chemotherapeutic agents with a targeting moiety and a hydrophilic small molecule that binds reversibly to the serum protein transthyretin, we generated small hydrophilic drug conjugates that displayed enhanced circulation half-life in rodents and selectivity to cancer cells. To the best of our knowledge, this is the first demonstration of a successful approach that maintains the small size and hydrophilicity of targeted anticancer agents containing hydrophobic payloads, while at the same time extending their circulation half-life. This was demonstrated by the superior in vivo efficacy and lower toxicity of our conjugates in xenograft mouse models of metastatic prostate cancer.

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35

Chan, Derwin King Chung. "Integrating social psychological theories of motivation and intention to explain health and safety behaviours." Thesis, University of Nottingham, 2012. http://eprints.nottingham.ac.uk/12826/.

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The work within the thesis aimed to integrate concepts from three psychological frameworks, including self-determination theory (SDT), the theory of planned behaviour (TPB), and the hierarchical model of motivation (HMM), into a model to understand the processes that underpin motivation and intention toward health and safety behaviours. The first tenet of the model (derived from SDT and HMM), namely the trans-contextual effect of motivation, hypothesised that self-determined motivation for a given activity related to self-determined motivation for undertaking health-promoting behaviour associated with the activity. The second tenet of the model (derived from the strength, limitation, and theoretical assumptions of SDT and the TPB) speculates that the effects of self-determined motivation for health and safety behaviour on intention and behaviour were mediated by social cognitive variables. A total of eight studies were employed to test the two tenets of the integrated model across various health contexts (i.e., sport injury rehabilitation and prevention (Study 1 to 5)), occupational injury rehabilitation and prevention (Study 6 and 7), and myopia prevention (Study 8), and these studies are presented in five related research chapters (Chapters 2 to 6) in this thesis. The results provided preliminary evidence in support of both tenets of the integrated model, in which motivation from a general life domain is transferred to motivation, and antecedent social cognitive variables, for behaviour in a health and safety domain. The final chapter (Chapter 7) of the thesis summarises the findings of the eight studies and offers explanations and interpretations of the overall pattern of results. Conclusions were then drawn with respect to the theoretical and practical implications of the findings. Consideration was also given to the methodological limitations of the thesis and the scope for further studies to improve the predictive power, utility, measurement reliability, and evidence base for the model.

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36

Bleetman, Anthony. "Safety standards for police body armour." Thesis, University of Birmingham, 2000. http://etheses.bham.ac.uk//id/eprint/692/.

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Assaults on the Police continue to increase. Of particular concern is the threat of injury from edged weapons. Shootings remain rare. The Home Office has embarked on a program to provide all police officers with suitable body armour. Body armour has been on general issue to police officers in America for over twenty years and has a superb record in saving lives from shootings. Little is known about its ability to prevent serious stab wounds from knives, as this is a much less common threat in the American policing environment. Therefore the specification for armour for police use in this country must be set to provide protection against the threats in the UK policing environment. Current knife-resistance standards are based on animal experimentation and have not been examined by any other model. To understand the protective requirements of armour, it is necessary to understand the weapon threat, the assailant’s method of delivery, and the vulnerability of the target. The biophysics of human stabbing (the assailant’s method of delivery), is the subject of ongoing investigation, and is outwith the scope of this thesis. In this thesis, the history and development of body armour is reviewed. An overview of the materials and properties of modern armour is presented. To understand the threat, the epidemiology of assaults on police officers and civilians is described. To determine the ideal protective qualities of body armour for issue to the police, two studies are presented. The first is a retrospective cohort study of 500 civilian victims of penetrating injury. The frequency of wounding, and the severity of wounding by body region is plotted on anatomical charts. This will demonstrate the vulnerability, and hence the protection requirements of each body area to penetrating injury. No previous study has measured the depth of the internal organs from the skin. A CT study is presented. It describes the accessibility of the internal organs to the passage of a blade by measuring the shortest distances from the skin. By applying the results of these two studies to the location of the internal organs (which lie in fairly constant relation to surface anatomy landmarks), the ideal protective qualities of armour panels over corresponding areas of organ vulnerability are plotted. The case for adopting three levels of knife resistance protection is made. The ballistic protective requirements of body armour are discussed. Finally, proposals for zoned body armour are presented and ergonomic and production issues are described. The model presented in this thesis has been accepted in principle by the Police Scientific Development Branch of the Home Office with a view to establishing a zoned body coverage requirement for police body armour.

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37

Al-Ismail, Deana. "Clinical studies to broaden the application and improve the safety of psoralen and ultraviolet A (PUVA) phototherapies." Thesis, Cardiff University, 2016. http://orca.cf.ac.uk/100479/.

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This medical doctorate thesis contains clinical studies to broaden the application and to improve the safety and efficacy of ultraviolet (UV) A phototherapies, the main focus being to enhance the current clinical practice of topical psoralen photochemotherapy (PUVA). The thesis includes three studies: 1. The validation of a semi-automated Minimal Phototoxic Dose (MPD) Tester for topical photochemotherapy Thirty seven psoriasis patients referred to the phototherapy unit at St. Woolos, Newport were recruited. Patients had two sets of minimal phototoxic dose (MPD) tests performed on symmetrical, contralateral sites on the lower back. MPD test results from a panel of PUVA-lamps with a UV-opaque template and windows were compared to those from the modified hand-held MPD tester. The hand-held MPD results were linearly related to the PUVA-panel MPD results and this was therefore shown to be a convenient and reliable method of assessing MPD. However, the difference in MPD between the PUVA lamp and the modified handheld MPD tester (CFL TL-10 lamp) was much less than predicted from the PUVA action spectrum of previously published studies suggesting that formal re-evaluation of the erythema action spectrum for PUVA was now appropriate.

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38

Wenzel-Smith, Gisela. "Safety and efficiency of procedural sedation and analgesia (PSA) conducted by medical officers in a level one hospital in Cape Town." Master's thesis, University of Cape Town, 2011. http://hdl.handle.net/11427/10872.

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Objectives: This study aimed to research efficacy and safety of procedural sedation and analgesia (PSA) administered by medical officers (MOs), without formal anaesthetic training, in a South African district hospital. Design: This is a retrospective descriptive study. Setting: The study took place in the Emergency Department (ED) of False Bay Hospital (FBH), a level one hospital in the Southern suburbs of the Cape Town Metro health district.

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39

Cooper, Mark Dominic. "An examination of assigned and participative goal-setting in relation to the improvement of safety in the construction industry." Thesis, University of Manchester, 1992. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.284229.

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40

Bofill, Pumarola Andreu 1993. "The Impact of the human endogenous metabolome on drug pharmacology and safety." Doctoral thesis, TDX (Tesis Doctorals en Xarxa), 2021. http://hdl.handle.net/10803/671531.

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A great deal of efforts has been made to improve and expand pharmacological testing and optimisation of drug candidates during the discovery process. However, we are yet to understand fully why drugs require certain levels of affinity for their mechanism of action targets to exert their therapeutic effect. In parallel, the mechanistic understanding of the endogenous metabolome has been demonstrated to have incredible implications in drug discovery, being potentially one of the pillars of precision medicine. Endogenous metabolites are small molecules evolutionally optimised to interact in an appropriate way with its native protein with a specific level of affinity. This Thesis provides evidences that the level of affinity required by a drug to interact with its primary target and produce a therapeutic effect is related to the affinity of the native endogenous metabolite for that target. In addition, this Thesis also highlights the implications that the human endogenous metabolome could have to assess a more realistic drug polypharmacology landscape and the risk of safety events linked to it. Finally, an analysis of natural compound pharmacology on the perspective of the endogenous metabolome is also performed. All results indicate that understanding the role of the human metabolome and its implications on drug bioactivity could offer a new useful perspective in drug efficacy and safety
S’han realitzat grans esforços per millorar i ampliar l’avaluació farmacològica i l’optimització de les molècules candidates durant el procés de descobriment de fàrmacs. Tot i això, encara no es coneix amb exactitud per què els fàrmacs necessiten certs nivells d’afinitat amb les seves dianes d’acció per tal de produir l’efecte terapèutic buscat. Paral·lelament, s’ha demostrat que la comprensió del metaboloma endogen té grans implicacions en el descobriment de nous fàrmacs i és potencialment un pilar de la medicina de precisió. Els metabòlits endògens són molècules petites optimitzades evolutivament per interaccionar de forma apropiada amb la seva proteïna nativa amb un nivell d’afinitat específic. Aquesta Tesi aporta evidències que l’afinitat necessària per tal que un fàrmac interaccioni amb la seva diana primària i produeixi un efecte terapèutic concret està relacionada amb l’afinitat del metabòlit endogen natiu amb aquesta mateixa diana. A més, aquesta Tesi també posa de manifest les implicacions que pot tenir el metaboloma endogen humà per tal d’avaluar, de forma més realista, la polifarmacologia dels fàrmacs i els seus efectes secundaris associats. Finalment, també s’ha realitzat una anàlisi de la farmacologia dels compostos naturals incorporant la informació del metaboloma endogen. Tots aquests resultats indiquen que entendre el rol del metaboloma humà i les seves implicacions en la bioactivitat dels fàrmacs pot oferir una perspectiva nova i útil per a millorar l'eficàcia i la seguretat dels fàrmacs.

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41

BARBOZA, ALEX. "Gestao de rejeitos radioativos em servicos de medicina nuclear." reponame:Repositório Institucional do IPEN, 2009. http://repositorio.ipen.br:8080/xmlui/handle/123456789/9377.

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Made available in DSpace on 2014-10-09T12:26:21Z (GMT). No. of bitstreams: 0
Made available in DSpace on 2014-10-09T14:09:59Z (GMT). No. of bitstreams: 0
Dissertacao (Mestrado)
IPEN/D
Instituto de Pesquisas Energeticas e Nucleares - IPEN-CNEN/SP

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42

Barnett, Michael Leonard. "Human error and maritime safety : an exploration of the causes of marine casualties and the design of simulator-based training programmes to develop the skills of safe vessel control." Thesis, Cardiff University, 1989. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.325708.

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43

Wu, Hon-Fan. "A study of behavioural change in occupational safety in a metal works at Shenzhen, China." Thesis, University of Hull, 2001. http://hydra.hull.ac.uk/resources/hull:8284.

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The present study applied a combined behavioural and attitudinal approach in occupational safety in a Hong Kong-based metal house in Shenzhen, China in an attempt to modify the safety behaviours and attitudes of the workers by means of posted feedback plus goal-setting. To the best of the researcher's knowledge, this is the first study of this type to be attempted in a Chinese industrial setting. A total of 142 respondents from the four departments, namely Heavy Duty, Small Press, Hand Press and Drilling were involved in the survey with a multiple-based line design for an environment where random sampling was impossible. Meanwhile, the study also intended to explore the underlying factors that affected the safety attitudes of the respondents. These factors included influences from traditional culture and religions. A self-constructed observation checklist and a questionnaire adopted from the Health and Safety Executive Report No. 81 (HSE, 1996) on attitude investigation were the major research instruments. Percentaged analysis, ANOVA, T-Test and Fisher Exact Test set at 0.05 level were applied to determine the significance of differences in the workers' behaviours and attitudes before and after the intervention. From the results of the research, it was found that i) there were relationships between the workers' behaviours in occupational safety and posted-feedback plus goal-setting in the Heavy-duty Press, Small Press and Hand Press Departments; ii) there were relationships between the intervention and the workers' attitudes in terms of -'Supervisor Satisfaction' in the Heavy Duty and the Small Press Departments; -'Shop-floor Training' with the Heavy Duty Press and the Small Press Departments; -'Safety Meeting' with the Small Press Department; -' Safety Working Procedures' with the Heavy Duty Press and the Small Press Departments; iii) the results demonstrated that there were relationships between attitudes of the formally trained workers and those of their peer workers without formal training towards occupational safety in terms of -'Supervisor Satisfaction' with the Heavy Duty Press Department; -'Safety Meeting' with the Heavy Duty Press Department; -' Safety Working Procedures' with the Small Press department; iv) there were relationships between workers with self-reported accident rates and those without in terms of their safety attitudes towards -'Supervisor Knowledge' with the Heavy Duty Press Department; -'Shop-floor Satisfaction' with the Heavy Duty Press Department; -'Shop-floor Environment: Hardware' with the Small Press Department. Intervention was related to both the workers' attitudes and their behaviours in work safety in the Heavy-duty Press, the Small Press and the Hand Press departments. Throughout the investigation, no significant change was found with both the respondents' safety behaviours or attitudes in the Drilling Department during the periods when interventions were introduced to other departments. Concerning the controlling factors for the workers' attitudes towards work safety, cultural and religious factors could explain the workers' under-reporting of accidents and injuries. These findings implied that researchers needed to be aware of the tremendous local cultural and religious concerns when applying western rationales to constructing a safety culture in developing countries.

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44

Layland, Jamie. "Utility and safety of invasive (fractional flow reserve) and non-invasive (cardiac magnetic resonance imaging) diagnostic tests in patients with NSTEMI." Thesis, University of Glasgow, 2016. http://theses.gla.ac.uk/7713/.

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A prospective randomised controlled clinical trial of treatment decisions informed by invasive functional testing of coronary artery disease severity compared with standard angiography-guided management was implemented in 350 patients with a recent non-ST elevation myocardial infarction (NSTEMI) admitted to 6 hospitals in the National Health Service. The main aims of this study were to examine the utility of both invasive fractional flow reserve (FFR) and non-invasive cardiac magnetic resonance imaging (MRI) amongst patients with a recent diagnosis of NSTEMI. In summary, the findings of this thesis are: (1) the use of FFR combined with intravenous adenosine was feasible and safe amongst patients with NSTEMI and has clinical utility; (2) there was discordance between the visual, angiographic estimation of lesion significance and FFR; (3). The use of FFR led to changes in treatment strategy and an increase in prescription of medical therapy in the short term compared with an angiographically guided strategy; (4) in the incidence of major adverse cardiac events (MACE) at 12 months follow up was similar in the two groups. Cardiac MRI was used in a subset of patients enrolled in two hospitals in the West of Scotland. T1 and T2 mapping methods were used to delineate territories of acute myocardial injury. T1 and T2 mapping were superior when compared with conventional T2-weighted dark blood imaging for estimation of the ischaemic area-at-risk (AAR) with less artifact in NSTEMI. There was poor correlation between the angiographic AAR and MRI methods of AAR estimation in patients with NSTEMI. FFR had a high accuracy at predicting inducible perfusion defects demonstrated on stress perfusion MRI. This thesis describes the largest randomized trial published to date specifically looking at the clinical utility of FFR in the NSTEMI population. We have provided evidence of the diagnostic and clinical utility of FFR in this group of patients and provide evidence to inform larger studies. This thesis also describes the largest ever MRI cohort, including with myocardial stress perfusion assessments, specifically looking at the NSTEMI population. We have demonstrated the diagnostic accuracy of FFR to predict reversible ischaemia as referenced to a non-invasive gold standard with MRI. This thesis has also shown the futility of using dark blood oedema imaging amongst all comer NSTEMI patients when compared to novel T1 and T2 mapping methods.

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45

Huitfeldt, Anders. "Emulation of Target Trials to Study the Effectiveness and Safety of Medical Interventions." Thesis, Harvard University, 2015. http://nrs.harvard.edu/urn-3:HUL.InstRepos:23205172.

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Ideally, clinical guidelines would be informed by well-designed randomized experiments. However, it is generally not possible to conduct a randomized trial for every clinically relevant decision. Decision makers therefore often have to rely on observational data. Guidelines that rely on observational data due to the absence of randomized trials benefit when the analysis mimics the analysis of a hypothetical target trial. This can be achieved by explicitly formulating the protocol of the target trial, and thoroughly discussing the feasibility of the conditions that must be met in order to validly emulate the target trial using observational data. In chapter one, we discuss the emulation of trials that compare the effects of different timing strategies, that is, strategies that vary the frequency of delivery of a medical intervention or procedures, and provide an application to surveillance for colorectal cancer. In chapter two, we discuss a study design that attempts to avoid bias by comparing initiators of the treatment of interest with initiators of an “active comparator” that is believed to be inactive for the outcome, in order to emulate a randomized trial that compares the treatment of interest with an inactive comparator. In chapter three, we describe a new method that combines randomized trial data and external information to emulate a different target trial. We apply this method to a randomized trial of postmenopausal hormone therapy in order to emulate a trial of a joint intervention on hormone therapy and statin therapy.

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46

Kruger, Jeanne-Marié. "Efficacy and safety of acidified enteral formulae in tube fed patients in an intensive care unit /." Link to online version, 2006. http://hdl.handle.net/10019/564.

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47

Pajor, Nathan M. M. D. "Improving the Rate of Home Ventilator Alarm Use in a Pediatric Pulmonary Medicine Clinic." University of Cincinnati / OhioLINK, 2019. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1554214546651399.

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48

Dotterweich, Andy R. "University School Playground Inventory and Safety Evaluation." Digital Commons @ East Tennessee State University, 2012. https://dc.etsu.edu/etsu-works/3808.

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49

Farag, Mohamed S. "Development of Resilient Safety-Critical Systems in Healthcare Using Interdependency Analysis and Resilience Design Patterns." Thesis, The George Washington University, 2018. http://pqdtopen.proquest.com/#viewpdf?dispub=10981524.

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Анотація:

In the U.S. medical sector, software failures in safety-critical systems in healthcare have led to serious adverse health problems, including patient deaths and recalls of medical systems. Despite the efforts in developing techniques to build resilient systems, there is a lack of consensus regarding the definition of resilience metrics and a limited number of quantitative analysis approaches. In addition, there is insufficient guidance on evaluating resilience design patterns and the value they can bring to safety-critical systems.

This research employed the interdependency analysis framework to evaluate the static resilience of safety-critical systems used in the healthcare field and identified software subsystems that are vulnerable to failures. Resilience design patterns were first implemented to these subsystems to improve their ability to withstand failures. This implementation was followed by an evaluation to determine the overall impacts on system’s static resilience.

The methodology used a common medical system structure that collects common attributes from various medical devices and reflects major functionalities offered by multiple medical systems. Fault tree analysis and Bayesian analysis were used to evaluate the static resilience aspects of medical safety-critical systems, and two design patterns were evaluated within the praxis context: Monitoring and N-modular redundancy resilience patterns.

The results ultimately showed that resilience design patterns improve the static resilience of safety-critical systems significantly. While this research suggests the importance of resilience design patterns, this study was limited to explore the impact of structural resilience patterns on static resilience. Thus, to evaluate the overall resilience of the system, more research is needed to evaluate dynamic resilience in addition to studying the impact of different types of resilience design patterns.

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50

Chua, Ka Kit. "Randomized controlled clinical trials for the evaluation of efficacy and safety of Chinese medicine in treatment of neurodegenerative diseases." HKBU Institutional Repository, 2015. https://repository.hkbu.edu.hk/etd_oa/231.

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Background: Neurodegenerative diseases (NDD) are very common in the aging population, of which Parkinson’s disease (PD) and Alzheimer disease (AD) are the two most common. Since the etiology of the neuronal death in these diseases remains unclear, currently no curative therapy is available. Traditional Chinese medicine (TCM) has been used to treat certain diseases, which based on their symptoms we now know that they are included PD and AD, for thousands of years. However, our pervious systematic review reports that the quality of current TCM clinical trials related to this area had limited internal validity due to methodological flaws and insufficient data reporting. Methods: This study includes two add-on double-blinded randomized controlled trials (RCT), PD full-scale study and AD pilot study. It aims to provide evidence for the efficacy and safety of two specific TCM decoctions, Jia-Wei-Liu-Jun-Zi Tang (JWLJZT) and Di-tan decoction (DTD) in treating PD and AD, respectively. These clinical trials follow the Consolidated Standards of Reporting Trials (CONSORT) as well as the International Conference on Harmonization guidelines on Good Clinical Practice (GCP). Also, this two RCT obtained the approval from the Human and Animal Research Ethics Committee of Hong Kong Baptist University before the study and registered on the Chinese Clinical Trial Registry. Result: In the PD trial, 111 idiopathic PD patients were randomly assigned to receive either JWLJZT or placebo for 32 weeks. Although there was not significant difference in the primary outcome of Movement Disorder Society Sponsored Revision of Unified PD Rating Scale (MDS-UPDRS) Part I total score (p = 0.216), significant improvements was observed in the secondary outcome of Non-motor symptom assessment scale for Parkinson’s disease (NMSS) total score (p = 0.019), subtype of mood/cognition (p = 0.005) and hallucinations (p = 0.024). In addition, post-hoc analysis showed a significant reduction in constipation (p < 0.001). On the other hand, 40 AD patients were randomly assigned to receive either DTD or placebo for 24 weeks in the AD trial. There was an improvement trend in the primary outcome of the cognitive subscale of Alzheimer’s Disease Assessment Scale (ADAS-cog) total score in the DTD group though the difference relative to the placebo group was not statistically significant (p = 0.315). No significant difference was found in the secondary outcomes. Adverse events were mild and comparable between treatment and placebo groups in both trials. Discussion: JWLJZT did show some improvement in non-motor symptoms, including mood, cognition, and constipation, in PD patients, while, DTD did show a reducing trend in the cognitive impairment based on rigorous RCT. Further study focusing on the effective dosage, pharmacologic mechanism of JWLJZT and DTD are needed to give a fuller picture as well as better support for using them in human being as a routine treatment. In fact, JWLJZT and DTD are the only two examples of TCM for treating NDD. These two clinical trials are served as examples of how to evaluate efficacy and safety of TCM for the treatment of various diseases using rigorous RCT methods and standard. Keywords: Randomized Controlled Trials, Parkinson’s disease, Alzheimer disease, Traditional Chinese medicine, Jia-Wei-Liu-Jun-Zi Tang, Di-tan decoction, Efficacy, Safety

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