The Vaccine Adverse Event Reporting System (VAERS) received thousands of reports of adverse events that occurred after vaccine administrations from the post-marketing vaccine safety surveillance. However, the causality between vaccines and reported adverse events cannot be taken for granted. In this report several data mining methods were applied to VAERS database that is coded in MedDRA terms to discover possible associations between vaccines and adverse events. Efforts were devoted to identify events that are reported more frequently after administering one vaccine than other vaccines using the following data mining techniques: relative ratio (RR), statistical significance (LogP), proportional reporting ratio (PRR), and screened PRR (SPRR). The vaccine-event combinations that ranked top in each method varied substantially among the methods. RR and PRR gave excessive weight to small counts of vaccine-event pairs, but SPRR was able to correct this weakness. There are only 33 vaccine-event pairs that were shared among the top 1,000 ranked in each method. Evaluating the properties of these data mining methods and exploring other methods will help improve vaccine safety surveillance. / text

BACKGROUND: Adolescent idiopathic scoliosis (AIS) surgery is the most common reason for elective pediatric orthopaedic surgery. Minimization of adverse events is an important goal. Institute of Medicine (IOM) outlined 6 facets of healthcare quality improvement within the acronym STEEEP. Two of these facets, Safety and Timeliness for AIS surgery in Canada, are examined in this thesis. METHODS: A three - part study, using clinical records at the largest Canadian pediatric hospital and CIHI national administrative data, determined i) the relationship between surgical wait times and rates of adverse events, along with determination of an empirically derived access target, ii) accuracy of ICD-10 coding of surgical AIS cases along with an optimal search strategy to identify surgical AIS cases, and iii) the volume – outcome relationships for scoliosis surgery using hierarchical and conventional single level multi-variate regression analysis. RESULTS: Access target of 3 months minimized the adverse events related to waiting. Optimal search strategy for AIS surgical cases using ICD-10 coding required combination of codes as each code in isolation was inaccurate due to limitations in coding definitions. There was no significant volume – outcome relationship using appropriate modeling strategies. CONCLUSIONS: Ensuring timeliness of surgical treatment of less than 3 months is important in surgical cases of AIS given the potential for curve progression in higher risk individuals who are skeletally immature with large magnitude curves at time of surgical consent. At the administrative database level, knowledge of coding accuracy and optimal search strategies are needed to capture a complete cohort for analysis. In AIS, several ICD-10 codes need to be combined. AIS surgery cases captured through this optimal search strategy, revealed no significant volume-outcome relationships with appropriate modeling. Based on these results, minimum volume thresholds and regionalization of care for AIS surgery does not appear to be justified. However, a larger sample size was needed to determine whether there was a clinically significant difference in wound infection and blood transfusion rates. Furthermore, clinical variables, not part of an administrative database such as curve pattern were not included.

No description available.

BACKGROUND: Adolescent idiopathic scoliosis (AIS) surgery is the most common reason for elective pediatric orthopaedic surgery. Minimization of adverse events is an important goal. Institute of Medicine (IOM) outlined 6 facets of healthcare quality improvement within the acronym STEEEP. Two of these facets, Safety and Timeliness for AIS surgery in Canada, are examined in this thesis. METHODS: A three - part study, using clinical records at the largest Canadian pediatric hospital and CIHI national administrative data, determined i) the relationship between surgical wait times and rates of adverse events, along with determination of an empirically derived access target, ii) accuracy of ICD-10 coding of surgical AIS cases along with an optimal search strategy to identify surgical AIS cases, and iii) the volume – outcome relationships for scoliosis surgery using hierarchical and conventional single level multi-variate regression analysis. RESULTS: Access target of 3 months minimized the adverse events related to waiting. Optimal search strategy for AIS surgical cases using ICD-10 coding required combination of codes as each code in isolation was inaccurate due to limitations in coding definitions. There was no significant volume – outcome relationship using appropriate modeling strategies. CONCLUSIONS: Ensuring timeliness of surgical treatment of less than 3 months is important in surgical cases of AIS given the potential for curve progression in higher risk individuals who are skeletally immature with large magnitude curves at time of surgical consent. At the administrative database level, knowledge of coding accuracy and optimal search strategies are needed to capture a complete cohort for analysis. In AIS, several ICD-10 codes need to be combined. AIS surgery cases captured through this optimal search strategy, revealed no significant volume-outcome relationships with appropriate modeling. Based on these results, minimum volume thresholds and regionalization of care for AIS surgery does not appear to be justified. However, a larger sample size was needed to determine whether there was a clinically significant difference in wound infection and blood transfusion rates. Furthermore, clinical variables, not part of an administrative database such as curve pattern were not included.

The overall aim of the thesis was to investigate whether patient safety can be improved for patients with hip fracture by nutritional intervention and by pharmacological treatment with cranberry concentrate. Another aim was to describe the patients’ experience of involvement in their care. The thesis includes results from four studies that include both quantitative and qualitative design. Studies I and II were intervention studies with a quasi-experimental design, with intervention and comparison groups. Study III was a randomised, double-blind, placebo-controlled trial with intervention and control groups. Study IV took a qualitative approach. Study I showed that when patients with hip fracture received nutritional supplementation according to nutritional guidelines, from admission until five days postoperatively, fewer patients developed pressure ulcers. Study II showed that it is possible to objectively evaluate a short-term nutritional intervention through the nutritional biochemical marker IGF-1, as it was affected by a five-day high-energy regimen. The randomised controlled trial, Study III, showed that a short-term treatment from admission until five days postoperatively with cranberry as capsules does not seem to be useful in preventing positive urine cultures in female patients with hip fracture and a urinary catheter. Finally, Study IV showed that patients with hip fracture reported experiencing very little involvement in their nursing care, to the extent that fundamental aspects of nursing care went unfulfilled. Patients did not feel valued by the nurses and unbearable pain that affected rehabilitation was reported. Positive interactions with nurses, however, did encourage patients to be more active. It is possible for every nurse to improve patient safety at bedside when caring for patients with hip fracture. Simply by increasing caloric/energy intake, it is possible to prevent pressure ulcers. It is also important to involve patients in nursing care, since the patients have experienced low or almost no involvement in care. Nurses need to see each patient as a whole person with different wishes and needs. However, certain prerequisites have to be in place to give nurses the opportunity to increase patient safety at bedside for patients with hip fracture.

<p>I den svenska vården drabbas uppskattningsvis var tionde patient av en vårdskada, det vill säga en undvikbar skada direkt orsakad av vården (Socialstyrelsen, 2008; Ödegård, 2007). Vårdskador ska registreras som avvikelser som sedan ska analyseras för att finna orsak och ligga till grund för förbättringsarbete (Socialstyrelsen, 2008). Syftet med studien är att beskriva innehållet i de patientavvikelser som registrerats av personal på sjukhus. Innehållet beskrivs avseende vilka händelser som registrerats och vårdpersonalens beskrivningar av händelseförloppet. Studien innehåller både kvalitativa och kvantitativa delar. Den kvalitativa delen genomfördes med innehållsanalys enligt Graneheim och Lundman (2004). Den kvantitativa delen redovisas med hjälp av deskriptiv statistik. Resultatet av studien visar att de flesta avvikelser berör Organisation/regler/resurser, Vård och behandling samt Halk/fall. Patienter i åldern 70-90 år drabbas i störst utsträckning. Händelseförloppet är ofta detaljerat beskrivet. Personal är däremot mindre benägen att skriva vad de anser vara orsak till det inträffade, samt bidra med förbättringsförslag. Teman som kom ur den kvalitativa analysen var: ”Det blir arbetsamt när andra gör fel”, ”Att vara nära men inte inpå” och ”Att lindra lidande”.</p>

Bakgrund: Vårdskador är ett vanligt förekommande problem inom slutenvården. En vårdskada är en skada som hade kunnat undvikas. I Sverige drabbas årligen ungefär var tionde patient av en vårdskada vilket medför stora merkostnader både på individ- och samhällsnivå. I varje landsting finns en Patientnämnd vars syfte bland annat är att ta emot patienter och anhörigas synpunkter och klagomål på vården samt förmedla dessa vidare till berörd verksamhet. Syfte: studien granskade vilka vårdskador som anmäldes till Patientnämnden under hösten 2014 i ett landsting i Mellansverige samt vilka åtgärder som vidtogs från vårdgivarens sida efter kontakt från Patientnämnden. Metod: En empirisk studie med kvantitativ design, data erhölls från avslutade ärenden hos Patientnämnden. Resultat: 34,2 % av anmälda ärenden rörde vårdskador. Vanligast var att ärendet gällde en kvinna (69 %) och att patienten själv anmälde till Patientnämnden (71 %). Försenad och/eller felaktig behandling och/eller diagnos var de vanligaste anmälda vårdskadorna i denna studie. I 47,4 % fall vidtogs åtgärder från vårdgivarens sida. Slutsats: I 41 av 75 ärenden kontaktades inte berörd verksamhet för yttrande. Detta då Patientnämnden ej kunde gå vidare med ärendet eftersom skriftliga synpunkter uteblev från anmälande part. Anledningen till detta kan vara värd att studera vidare. Kanske behöver Patientnämnden utveckla ett alternativt anmälningssystem för att underlätta processen för att inte tappa denna grupp som kan behöva mer stöd för att fullfölja sin anmälan. Då även dessa synpunkter är viktiga för fortsatt arbete med kvalitetssäkring och en öka patientsäkerheten inom slutenvården. / Background: Adverse events are a common problem in inpatient care. An adverse event is an injury that could have been avoided. In Sweden every tenth patient are affected every year of injuries form health care which results in big costs both at an individual and a society level. Every county has a Patient Advisory Board whose purpose is to receive patients and relatives' opinions and complaints of the health care and to communicate these to the concerned care unit. Objective: The study examined reported adverse events to the Patient Advisory Board in the fall of 2014 in a county in central Sweden and the measures that were taken from the caregiver's side after being contacted by the Patient Advisory Board. Method: An empirical study using quantitative design, data were obtained from closed cases of this board. Results: 34.2 % of the studied cases concerned nursing injuries. Most commonly the case involved a woman (69 %), and in 71 % of reviewed cases the patients themselves contacted the Patient Advisory Board. Delayed and/or improper treatment and/or diagnosis were the most commonly reported adverse events in this study. In 34 cases, measures were taken from a health care provider. Conclusion: In 41 of the 75 cases the caregiver was not contacted because the Patients Advisory Board could not proceed since written comments regarding the case was not obtained from notifying party. In the future further studies may be needed to find strategies for helping those who have trouble reporting discontent in healthcare.

Current status: Medication errors within the context of safe and high quality health care are one of the most frequently discussed topics of recent years. They are part of the medical process, occur in different forms, affect patients of all ages and decrease the quality of provided health care. Prescriptions of medication in medical documentation have to be clearly legible and include all the required information. Nurses' role within the medicaiton process could be described as an ultimate "safeguard" that can prevent medication errors. Goals: The objectives of this research are to assess nurses' awareness of medication errors, ssess their ability to detect medication errors and find out the level of their knowledge regarding the correct procedures and measures following medication error detection.Methodology: The research was conducted using a qualitative research method. The in-depth interviews with nurses were carried out at a surgical critical care unit at the hospital in Jindrichuv Hradec. Following the collection of a sufficient amount of data the interviews were coded using the "pen and pencil" technique and then divided into categories.Research file: In order to achieve the highest level of objectivity the research was carried out with a group of nurses who work at the same unit of a hospital department. The research file included nurses who had varied levels of education and numbers of years of experience. Results: Surgical critical care unit nurses are not aware of the exact definition of medication errors. Only one nurse was able to discuss adverse events with related consequences. The remaining nurses' awareness of medication errors corresponded to the classification described in the relevant foreign and Czech academic literature. None of the interviewed nurses detected all the errors included in the simulated scenarios. Only one nurse, who is currently completing her qualification in this specialty, detected a wrongly prescribed antidote. The simulated scenarios also included a group of high-risk medications that is commonly used at the unit. The first medication included in this group was a 7.45% solution of potassium (KCl). A majority of the participants detected the high concentration of this high-risk medication. Another high-risk medication was a 10% concentrate of NaCl in an infusion; this error was also detected by the majority of the nurses. The third high-risk medication was a wrongly prescribed insulin (it lacked the detailed description of units, time and route). This prescription error was not detected by the majority of participating nurses. Another type of medication error included in the simulated scenarios was a group of medications used specifically in critical care. Only half of the participating nurses successfully detected the errors related to the prescription of this group of medications. The last type or medication errors focused on incomplete prescription by doctors. The most frequently detected error was a prescription of an opiate that lacked the route and the least frequently detected error was a wrong prescription of an infusion administration. It is evident that the nurses always inform the doctor when they detect a medication error. They are more willing to inform the ward sister in cases of incidents caused by somebody else. Only a small group of nurses are willing to inform the senior consultant, the head nurse or the hospital management. Only one nurse associated medication error reporting with an audit. However the majority of nurses agrees that it is important to report any medication errors.Conclusion: The analysed data suggested that the nurses were aware of medication errors. The analysis of the results of the simulated scenarios suggested that nurses' ability to detect medication errors in prescriptions was related to the number of years of experience and the level of education.

The quality issue of provided health care is the topic which is constantly getting more attention. In this area there is always even probably will be always - something to improve. The patients´ safety in healthcare facilities is affected by the so-called culture of safety.The research was conducted in six medical institutions of the South Bohemian Region, though seven were originally planned. However, I was not given the data here, probably due to the long term incapacity of the respondent. The research was focused precisely on the area of care quality and patient safety. A mixed method research (qualitative and quantitative) was deliberately used in this task. The aim was to map the most common causes of adverse events and then, based on the causes, to propose possible arrangements to prevent the occurrence of the causes. For this purpose five research questions were established.The outcomes obtained were processed into tables, plus the graphical representation of some was accompanied. Then, in the "discussion" chapter, the results were compared and analyzed in more detail.

Submitted by Geandra Rodrigues (geandrar@gmail.com) on 2018-01-11T10:31:03Z No. of bitstreams: 1 mariadosocorrolinavankeulen.pdf: 2261237 bytes, checksum: 42a025939206e7e1f657e3fb828feb4a (MD5) / Approved for entry into archive by Adriana Oliveira (adriana.oliveira@ufjf.edu.br) on 2018-01-23T12:39:01Z (GMT) No. of bitstreams: 1 mariadosocorrolinavankeulen.pdf: 2261237 bytes, checksum: 42a025939206e7e1f657e3fb828feb4a (MD5) / Made available in DSpace on 2018-01-23T12:39:01Z (GMT). No. of bitstreams: 1 mariadosocorrolinavankeulen.pdf: 2261237 bytes, checksum: 42a025939206e7e1f657e3fb828feb4a (MD5) Previous issue date: 2017-09-29 / Eventos adversos são danos desnecessários à saúde de um indivíduo causados pela atividade profissionais de saúde. No Brasil e no mundo, a saúde sofre com o alto custo do cuidado em saúde vinculado à incorporação tecnológica, ao aumento da carga de trabalho dos profissionais de saúde e à mudança no perfil epidemiológico da população, que apresenta maior longevidade e múltiplas doenças crônicas e emergem preocupações voltadas para a qualidade do cuidado, capacitação técnica e profissional e eficiência das organizações de saúde. O objetivo principal foi dimensionar os custos relativos ao tratamento de danos causados por eventos adversos no período de um ano na instituição proposta, em duas unidades: Unidade de Práticas Integradas de clínica e Unidade de Estrutura Funcional clínica, além de identificar e descrever os fatores relacionados à ocorrência de evento adverso. A população do estudo foi de pacientes hospitalizados para tratamento clínico. O desenho da pesquisa é observacional, seccional, com dados individuais e abordagem quantitativa, comparando dois setores de clínica médica do hospital para testar a hipótese de que não há diferença na quantidade de eventos adversos ocorridos entre duas unidades de tratamento clínico e um estudo tipo Cost of Illness, utilizando custos diretos como categoria analítica. Os critérios de inclusão foram: pacientes maiores de 18 anos, internados para tratamento clínico pelo Sistema Único de Saúde, com permanência maior que 24h e alta hospitalar a mais de 30 dias. Os critérios de exclusão são: pacientes internados para tratamento psiquiátrico. O método detecção de eventos adversos foi a Ferramenta Global Trigger Tool para, desenvolvida pelo Institute of Health Improvement. Foram detectadas 96 internações (20,0%) com pelo menos um (1) evento adverso, 144 eventos no total, correspondendo a uma média de 1,5 eventos por pacientes afetados, dos quais 31 (21,5%) estavam presentes na admissão e 125 (86,8%) foram considerados evitáveis. As características relacionadas a processos clínicos e cirúrgicos apresentaram razões de chance mais significativas: ter sido submetido à cirurgia aumentou a chance de ocorrer evento adverso em aproximadamente 8 vezes (OR 7,93) e o tempo de internação maior ou igual a 3 dias aumentou a chance de evento adverso em 4 vezes (OR 4,03). Ter sido internado em uma Unidade de Estrutura Funcional representou uma chance duas vezes e meia maior de sofrer um evento adverso em comparação com pacientes que foram internados em Unidade de Práticas Integradas. Foi observado que pacientes com evento adverso tiveram aumento na média do custo total de 98,83%, se comparados com pacientes que não tiveram evento adverso. Na Unidade de Práticas Integradas esta diferença representou um aumento de 131,2%, enquanto na Unidade de Estrutura Funcional, o custo de internações com evento adverso excedeu em 76,4% o custo de internações sem evento adverso. Para o Sistema Único de Saúde, a incidência de evento adverso custou um incremento na média da receita paga à instituição equivalente à 55%. Este custo médio na Unidade de Práticas Integradas foi de 61,5% e na Unidade de Estrutura Funcional foi de 36,9%. O estudo pode confirmar que eventos adversos são muito frequentes nesta amostra e representam um gasto excessivo para a instituição e para o Sistema Único de Saúde. / Adverse events are unnecessary damages to an individual’s health caused by professional’s health care. Brazil and other countries suffer from the high costs of health care related to technological incorporation, the increase of health professionals’ workload and the change in the epidemiological profile of the population that provides greater longevity and multiple chronic diseases. Concerns arises regarding the quality of care, technical and professional training, and the efficiency of health organizations. The main objective was to estimate the costs related to the treatment of damages caused by adverse events within one year in the institution, comparing two units: Integrated Practices Unit of Internal Medicine and Functional Structure Unit besides in order to measure the incidence and describe the factors related to the occurrence of adverse event. The study population was patients hospitalized for clinical treatment. This was a retrospective, observational, sectional design, using individual data and quantitative approach comparing two clinical practice sectors of a hospital to test the hypothesis that there is no difference in the adverse events’ amount between these two units. Besides that a study of Cost of Illness using direct costs as analytical category was done. Inclusion criteria were: patients over 18 years of age hospitalized for clinical treatment by Brasilian Health system: Sistema Único de Saúde, with length of stay longer than 24 hours and hospital discharge over 30 days. Exclusion criteria were: inpatients for psychiatric treatment. The method of adverse events’ detection was the Global Trigger Tool developed by the Institution of Health Improvement (IHI). In 96 hospitalizations (20.0%) at least one (1) adverse event was detected and 144 adverse events representing an average of 1.5 events per affected patients. Thirty-one adverse events (21.5%) were present in Admission and 125 (86.8%) were considered preventable. The characteristics related to clinical and surgical procedures had more significant odds ratio: being submitted to surgery increased the chance of AD occurring in approximately 8-fold (OR 7.93) and the hospital’s length of stay greater than or equal to 3 days increased the chance of adverse event in 4 times (OR 4.03). The admission to a Functional Structure Unit represented a two and a half times greater chance of suffering an adverse event compared to patients who were hospitalized in Integrated Practices Unit. It was observed that hospitalizations with adverse event costs of 98.83% to the institution if compared to hospitalizations without adverse event. In the Integrated Practices Unit adverse event represented an increase of 131.2% while in the Functional Structure Unit the costs of adverse event exceeded 76.4. The incidence of adverse event increased around 55% the amount SUS should pay the health service deliver. This average cost was 61.5% in Integrated Practices Unit and 36.9% in Functional Structure Unit. The study have shown that adverse events are very frequent in this sample and represent an excessive expenditure for the institution and the Unified Health System.