Kontinuerlig infusion med levodopa/karbidopa gel hos patienter med avancerad Parkinsons sjukdom har visat sig vara en effektiv behandling men innebär även komplikationer. Studiens syfte är att kartlägga vilka behandlingskomplikationer som redovisas i litteraturen. Metoden är en systematisk litteraturstudie där databaserna PubMed, Cochrane, Cinahl och Embase har genomsökts. Resultatet grundar sig på 12 observationsartiklar och en randomiserad kontrollerad studie som visar att behandlingskomplikationer är vanliga, de är varierande i allvarlighetsgrad och kan indelas i fyra grupper beroende på om de är relaterade till kirurgi, det tekniska systemet, den medicinska behandlingen eller inte relaterat alls till behandlingen utifrån dagens kunskap. Slutsats: Det vetenskapliga underlaget är otillräckligt för att sammanställa hur de redovisade behandlingskomplikationerna hör ihop med behandlingen. Därför rekommenderas ytterligare forskning där samband kopplat till baslinjevariabler och socioekonomiska variabler samt samband mellan de olika behandlingskomplikationerna att undersökas ytterligare. / Continuous levodopa/carbidopa intestinal gel is reported to be efficient in the treatment of advanced Parkinson Disease but also associated with adverse events. The aim of this study was to provide an overview of the reported adverse events through a systematic review. The databases PubMed, Cochrane, Cinahl and Embase were searched. The results are based on 12 observational studies and one randomized control trial and shows that adverse events are common and the degree varies. Four categories to which the adverse events can be related were identified; due to the surgery, the device, the medication or not related to the treatment at all. Conclusions: The evidence is considered inadequate to base a statement of how the adverse events are correlated to the treatment why further studies with evaluation of baseline and socioeconomic variables as well as among the different adverse events are recommended.

The military recently recognized the importance of taking sociocultural factors into consideration. Therefore, Human Social Culture Behavior (HSCB) modeling has been getting much attention in current and future operational requirements to successfully understand the effects of social and cultural factors on human behavior. There are different kinds of modeling approaches to the data that are being used in this field and so far none of them has been widely accepted. HSCB modeling needs the capability to represent complex, ill-defined, and imprecise concepts, and soft computing modeling can deal with these concepts. There is currently no study on the use of any computational methodology for representing the relationship between adverse events and infrastructure development investments in an active war theater. This study investigates the relationship between adverse events and infrastructure development projects in an active war theater using soft computing techniques including fuzzy inference systems (FIS), artificial neural networks (ANNs), and adaptive neuro-fuzzy inference systems (ANFIS) that directly benefits from their accuracy in prediction applications. Fourteen developmental and economic improvement project types were selected based on allocated budget values and a number of projects at different time periods, urban and rural population density, and total adverse event numbers at previous month selected as independent variables. A total of four outputs reflecting the adverse events in terms of the number of people killed, wounded, hijacked, and total number of adverse events has been estimated. For each model, the data was grouped for training and testing as follows: years between 2004 and 2009 (for training purpose) and year 2010 (for testing). Ninety-six different models were developed and investigated for Afghanistan iv and the country was divided into seven regions for analysis purposes. Performance of each model was investigated and compared to all other models with the calculated mean absolute error (MAE) values and the prediction accuracy within ±1 error range (difference between actual and predicted value). Furthermore, sensitivity analysis was performed to determine the effects of input values on dependent variables and to rank the top ten input parameters in order of importance. According to the the results obtained, it was concluded that the ANNs, FIS, and ANFIS are useful modeling techniques for predicting the number of adverse events based on historical development or economic projects’ data. When the model accuracy was calculated based on the MAE for each of the models, the ANN had better predictive accuracy than FIS and ANFIS models in general as demonstrated by experimental results. The percentages of prediction accuracy with values found within ±1 error range around 90%. The sensitivity analysis results show that the importance of economic development projects varies based on the regions, population density, and occurrence of adverse events in Afghanistan. For the purpose of allocating resources and development of regions, the results can be summarized by examining the relationship between adverse events and infrastructure development in an active war theater; emphasis was on predicting the occurrence of events and assessing the potential impact of regional infrastructure development efforts on reducing number of such events.

No description available.

Yes / Objectives: Making a medical error can have serious implications for clinician wellbeing, affecting the quality and safety of patient care. Despite an advancing literature base, cross-country exploration of this experience is limited and a paucity of studies has examined the coping strategies used by clinicians. A greater understanding of clinicians¿ responses to making an error, the factors that may influence these, and the various coping strategies used are all essential for providing effective clinician support and ensuring optimal outcomes. The objectives were therefore to investigate a) the professional or personal disruption experienced after making an error, b) the emotional response and coping strategies used, c) the relationship between emotions and coping strategy selection, d) influential factors in clinicians¿ responses, and e) perceptions of organisational support. Methods: A cross-sectional, cross-country survey of 265 physicians and nurses was undertaken in two large teaching hospitals in the UK and USA. Results: Professional and personal disruption was reported as a result of making an error. Negative emotions were common, but positive feelings of determination, attentiveness and alertness were also identified. Emotional response and coping strategy selection did not differ due to location or perceived harm, but responses did appear to differ by professional group; nurses in both locations reported stronger negative feelings after an error. Respondents favoured problem-focused coping strategies and associations were identified between coping strategy selection and the presence of particular emotions. Organisational support services, particularly including peers, were recognised as helpful, but fears over confidentiality may prohibit some staff from accessing these. Conclusions: Clinicians in the UK and US experience professional and personal disruption after an error. A number of factors may influence clinician recovery; these factors should be considered in the provision of comprehensive support programmes so as to improve clinician recovery and ensure higher quality, safer patient care. / This research was funded by the Bradford Institute for Health Research as part of a PhD studentship and supported by a travel grant through the Postgraduate Study Visits scheme by the British Psychological Society.

Today, in 21st century healthcare at least 10% of hospitalised patients are subjected to some degree of unintended harm as a result of the treatment they receive. Despite the growing patient safety agenda there is little empirical evidence to demonstrate that patient safety is improving. Patient Safety Leadership Walk Rounds (PSLWR) were introduced to the UK, in March 2005, as a component of the Safer Patients Initiative (SPI), the first dedicated, hospital wide programme to reduce harm in hospital care. PSLWR are designed, to create a dedicated ‘conversation’ about patient safety, between frontline staff, middle level managers and senior executives. This thesis, explored the use of PSLWR, as a proactive mechanism to engage staff in patient safety discussion and detect patient harm within a Scottish healthcare system- NHS Tayside. From May 2005 to June 2006, PSLWR were held on a weekly basis within the hospital departments. A purposive sample, (n=38) of PSLWR discussions were analysed to determine: staff engagement in the process, patient safety issues disclosed; recognition of unsafe systems (latent conditions) and actions agreed for improvement. As a follow-up, 42 semi-structured interviews were undertaken to determine staff perceptions of the PSLWR system. A wide range of clinical and non-clinical staff took part (n=218) including medical staff, staff in training, porters and cleaners, nurses, ward assistants and pharmacists. Participants shared new information, not formally recorded within the hospital incident system. From the participants perspectives, PSLWR, were non threatening; were easy to take part in; demonstrated a team commitment, from the Board to the ward for patient safety and action was taken quickly as a result of the ‘conversations’. Although detecting all patient harm remains a challenge, this study demonstrates PSLWR can be a useful tool in the patient safety arsenal for NHS healthcare organisations.

Background: The increasing consumption of dietary supplements (DS) has drawn the attention of regulatory agencies, researchers and healthcare professionals. The US Food and Drug Administration (FDA) does not require premarketing assessment of DS considering them safe unless proven otherwise. However, the reporting rate of DS adverse events (DS-AE) is low. Objective: To describe pharmacists’ attitudes and knowledge of DS and DS information resources, and to determine the importance of selected attributes in pharmacists’ decisions to report a DS-AE. Methods: A convenience sample of practicing pharmacists in Virginia was surveyed using a web-based self-administered questionnaire. A conjoint analysis exercise was developed using several scenarios based on a set of five attributes: patient’s age, initiation of DS, last modification in drug therapy, evidence supporting the AE, and outcome of the AE. Participants were asked to indicate their decision to report the AE in each scenario to prescriber, drug manufacturer, DS manufacturer and FDA on a 6-point ordered scale. Participants’ attitude, knowledge of DS, demographic information, and DS information resources were also requested. Linear regression models were used to determine the relative importance of the profile attributes on a pharmacist’s decision to report the AE. The effects of other characteristics on the importance of the attributes were assessed. Results: Participants’ overall attitudes were relatively positive for the clinical use of DS but negative for safe of DS. Formal training on DS was associated with better knowledge of DS regulation. The average knowledge score of DS identification was relatively good but was low for DS regulation. Lexi-Comp® was the most widely used and available information resource and the Natural Medicines Comprehensive Database was the most useful once. The most important attribute that a pharmacist considered in the decision to report a DS-AE to DS manufacturer, drug manufacturer and FDA was the outcome of the AE followed by the evidence supporting the AE. Ranking of these two factors was the reversed in reporting to prescriber. Conclusions: Outcome and evidence of the AE are the most important factors participants considered when reporting. Other characteristics do not have an impact on the relative importance of the attributes.

No description available.

O avanço econômico, científico e tecnológico, vem levando a um aumento da expectativa de vida e consequente envelhecimento da população. Assim, o idoso requer atenção especial pela maior incidência de doenças crônicas e degenerativas e pelo aumento concomitante no uso de fármacos, podendo ocasionar complicações pela sua maior vulnerabilidade à eventos adversos (EAs), uso inapropriado e abusivo, exposição à interações medicamentosas sérias, e casos de iatrogenias. Acrescenta-se o fato particular de um aumento abusivo no uso de benzodiazepínicos (BDZs). O objetivo deste trabalho foi rever e sintetizar as evidências geradas por ensaios clínicos controlados e randomizados sobre a incidência de EAs relacionados ao uso de BDZs em idosos com ansiedade ou insônia em comparação àqueles que, sob as mesmas condições clínicas, não o utilizaram. Desenvolveu-se a recuperação de artigos em cinco bases de dados eletrônicas na área da saúde (PubMed, SCOPUS, Web of Science, Cochrane Central, e LILACS), para posterior análise combinada (metanálise) dos resultados evidenciados. / The economic, scientific and technological progresses have provided an increase in life expectancy and the consequent process of aging. Thus, the elderly requires special attention due to the higher incidence of chronic and degenerative diseases and the higher concomitant increase in the drugs use that may cause complications by increasing ulnerability for adverse events (AEs); nappropriate and abusive use; exposition to serious drug interactions, and iatrogenic cases. Add to these the particular abusive increase in benzodiazepine (BDZ) use. The objective of this study was to review and synthesize the evidence generated by randomized controlled trials on the incidence of AEs related to therapy with BDZs in elderly with anxiety or insomnia compared to those under the same clinical conditions, not medicated. The articles were recovered in five healthcare electronic databases (PubMed, SCOPUS, Web of Science, Cochrane Central, and LILACS), for subsequent combined analysis (meta-analysis) of the results.

Syftet för föreliggande studie var att undersöka olika sätt att organisera primärvårdens om- händertagande av patienter med psykisk ohälsa och hur det påverkar patienters nöjdhet med vården. Studiens frågeställningar syftade att undersöka 1) skillnader i nöjdhet mellan patienter som erbjuds sedvanlig Integrerad Beteendehälsa (IBH) med Brief Interventions (BI) och de som får utökad bedömning med vägledd självhjälp 2) om patienters vardagliga funktion förbättras och om förbättringen har ett samband med deras upplevelse av nöjdhet 3) hur vanligt negativa upplevelser är inom behandlingsmetoderna. Av 41 randomiserade primärvårdspatienter kunde 30 analyseras utifrån deras upplevda nöjdhet inom vården. Båda grupperna var i genomsnitt nöjda med vården och skattade besöken som hjälpsamma. Patienter som efter utökad bedömning fick vägledd självhjälp skattade tidigt i behandlingen högre grad av nöjdhet och den skillnaden kvarstod. Det fanns en signifikant förändring av vardaglig funktion till det bättre för patientgruppen som helhet, men förändringen korrelerade inte signifikant med nöjdhet. Det fanns en tydlig skillnad i antal rapporterade negativa upplevelser. 14 negativa upplevelser rapporterades av patienter som fått Brief Interventions, medan en negativ upplevelse rapporterades av patienterna som fått vägledd självhjälp. Slutsatser från föreliggande studie bekräftar tidigare forskning kring att nöjdhet går att uppfylla med kortare behandlingsinterventioner samt strukturerade behandlingar. / The purpose of the present study was to examine different ways of organizing primary care for patients with general mental disorders, and how the treatment affects the patient’s satisfaction with the care. The study aimed to examine 1) if there is a difference in patient satisfaction between patients offered brief interventions within the primary care behavior health model, and patients offered an extended assessment with guided self help 2) if the patients everyday function improves and correlates with their experience of satisfaction 3) how common adverse events are within the two treatment methods. Out of 41randomized primary care patients, 30 could be analyzed based on their perceived satisfaction in health care. The result showed that both treatment groups were overall satisfied with the care and estimated the care visits as helpful. Patients who received guided self-help estimated a higher degree of satisfaction earlier in the treatment, and the level of satisfaction remained high throughout the treatment. Regarding the patient group as a whole, there was a significant change in everyday function; the patients improved their everyday function although it did not correlate with satisfaction. There was a significant difference in the number of adverse events between the two treatment groups. 14 adverse events were reported from patients who received Brief Interventions and 1 adverse event was reported from a patient who received guided self-help. Conclusions from the present study confirm findings from previous research that it is possible to achieve patient satisfaction with brief treatment interventions and structured treatment plans.

INTRODUÇÃO: A análise de eventos clínicos em um ensaio randomizado estabelece a eficácia e segurança de um novo tratamento. Os eventos clínicos são divididos em eventos adversos (EAs) e desfechos clínicos. A literatura é escassa em informações sobre o processo de coleta de eventos clínicos em estudos, bem como sobre a variabilidade entre os centros de pesquisa em reportar eventos clínicos. OBJETIVOS: Descrever todos os eventos clínicos (EAs e desfechos clínicos) reportados pelos centros participantes do estudo APPRAISE-2 (Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome) e caracterizar a sua seriedade. Avaliar a variabilidade entre os centros de pesquisa em reportar eventos clínicos, além de identificar características basais dos participantes associadas ao ato de reportar eventos. MÉTODOS: Os investigadores clínicos foram responsáveis por reportar todos os eventos apresentados pelos participantes em formulários específicos. Formulários para EAs e para cada um dos desfechos clínicos do estudo foram disponibilizados (infarto agudo do miocárdio ou angina instável, acidente vascular encefálico e sangramento). Suspeitas de desfechos clínicos foram enviadas ao comitê de classificação de eventos clínicos (CEC), que as validou de acordo com critérios pré-estabelecidos. Tanto os desfechos clínicos quanto os EAs foram classificados como \"sérios\" ou \"não-sérios\" pelos investigadores clínicos. Para avaliar a variabilidade em reportar eventos clínicos, somente centros com inclusão de >= 10 participantes foram considerados. Modelos estatísticos foram utilizados para avaliar a influência de região geográfica e de características dos participantes na variabilidade entre os centros em reportar eventos. Os dados coletados estão concentrados no Instituto de Pesquisa Clínica da Universidade de Duke, na Carolina do Norte, Estados Unidos. RESULTADOS: Um total de 13.909 eventos clínicos foram reportados por 858 centros de pesquisa em 39 países. A maioria desses eventos foram EAs (91,6%), sendo os demais desfechos clínicos. Dentre os desfechos clínicos reportados, 66,0% foram confirmados pelo CEC. A maior parte dos desfechos confirmados pelo CEC (94,0%) preencheu critérios de seriedade, enquanto que 63,2% dos desfechos negados pelo CEC foram considerados sérios. De todos os EAs, 17,9% foram sérios. O critério de seriedade mais comumente observado foi hospitalização (N=2594), seguido de morte (N=321). Um ajuste para região geográfica explicou 28,7% e 26,4% da variabilidade entre os centros em reportar desfechos clínicos e EA sérios, respectivamente; a adição de características dos participantes ao modelo explicou mais 25,4% da variabilidade entre os centros em reportar desfechos clínicos e 13,4% em reportar EAs sérios. Os ajustes promoveram pouco impacto em explicar a variabilidade em reportar EAs não-sérios. Diversas características clínicas foram associadas ao ato de reportar eventos clínicos. CONCLUSÃO: Em um ensaio clínico multicêntrico de fase III, a maioria dos eventos clínicos reportados foram EAs não-sérios. Região geográfica e características dos pacientes influenciaram a variabilidade entre os centros em reportar desfechos clínicos e EAs sérios, com pouco impacto em EAs não-sérios. Uma coleta integrada de desfechos clínicos e EAs é viável, informativa e ilustra as características que estes eventos compartilham / BACKGROUND: The collection of adverse events (AEs) and clinical endpoints determines the overall efficacy and safety of the study treatment in clinical trials. However, AEs and clinical endpoints are captured and processed separately with limited information on various aspects of this data collection, its integration, and its variation across sites. OBJECTIVES: To describe all site-reported clinical events in the APPRAISE-2 (Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome) trial and report their seriousness. To evaluate the variability in reporting clinical events across sites and identify characteristics associated with clinical event reporting. METHODS: All clinical events were collected in case report forms (CRF) by site-investigators, as AEs or suspected endpoints. Data on suspected endpoints were collected in specific CRFs (myocardial infarction or unstable angina, cerebrovascular event and bleeding) and sent to review by a clinical events committee (CEC) that adjudicated these events according to predefined criteria. Seriousness criteria was collected for all AEs and suspected endpoints. To explore site-level variability i n event reporting, sites with >=10 participants were i ncluded. Statistical models explored the influence of geographic region and patient characteristics in between-site variability in event reporting. All collected data is centered in the Duke Clinical Research Institute, North Carolina, Unites States. RESULTS: A total of 13.909 clinical events were reported by 858 sites in 39 countries. Most clinical events were AEs (91.6%), followed by suspected endpoints. Of suspected endpoints reviewed by CEC, 66.0% were confirmed. Most CEC-confirmed endpoints met serious criteria (94.0%) and, of CEC-negatively adjudicated endpoints, 63.4% were serious. Of all AEs, 17.9% were considered serious events. Hospitalization was the most common criterion for classification as serious event (N=2594), followed by death (N=321). In models accounting for geographic region, site variation in reporting endpoints and serious AEs was explained by 28.7% and 26.4%, respectively; adding patient characteristics further explained site variation by 25.4% for endpoint reporting and 13.4% for serious AE reporting. Non-serious AE reporting variation was not explained by patient characteristics or region. Several clinical characteristics were associated with clinical event reporting. CONCLUSION: In a multicenter phase III clinical trial, the majority of reported events were non-serious AEs. Geographic region and patient characteristics influenced between-site variability in reporting of clinical endpoints and serious AEs, with limited impact in non-serious AEs. An integrated collection of endpoints and AEs is feasible, possible in a multinational trial and illustrates the shared characteristics of events