Quality/risk management system in radiotherapy: Changes afoot.

The French sanitary and regulatory context in which radiotherapy centres are comprised is evolving. Risk and quality management systems are currently adapting to these evolutions. The French nuclear safety agency (ASN) decision of July 1st 2008 on quality assurance obligations in radiotherapy has reached 10 years of age, and the French high authority of health (HAS) certification system 20 years now. Mandatory tools needed for the improvement of quality and safety in healthcare are now well known. From now on, the focus of healthcare policies is oriented towards evaluation of efficiency of these new organisations designed following ASN and HAS nationwide guidelines.

AUDCRED: ferramenta de apoio para auditoria de contas em saúde / AUDCRED: support tool for auditing health accounts

Introdução: Uma das ferramentas de qualidade mais eficientes para monitorar um sistema de gestão é a auditoria, pois, quando bem aplicada, diagnostica não conformidades no serviço avaliado, sendo executada por profissionais capacitados que apresentam, além do conhecimento técnico-científico, atributos pessoais como imparcialidade, prudência e diplomacia. Objetivos: O objetivo geral do estudo foi desenvolver uma ferramenta móvel que possa servir de apoio para o processo de auditoria de contas médicas e os objetivos específicos foram: identificar os requisitos necessários para o desenvolvimento da ferramenta de auditoria; apresentar um protótipo e desenvolver uma ferramenta garantindo os requisitos de segurança necessários à manutenção da informação pessoal, possibilitando sua implementação, distribuição e modificação e avaliar o impacto da ferramenta para a auditoria em saúde no âmbito da Marinha do Brasil. Método: Trata-se de um estudo descritivo, exploratório, de abordagem qualitativa, aplicado à produção tecnológica e destinado a desenvolver uma ferramenta informatizada móvel para apoio ao serviço de auditoria de contas médicas. Para desenvolvimento da ferramenta foi utilizada a metodologia de Pressman, seguindo as seguintes etapas: coleta e refinamento dos requisitos, elaboração de projeto rápido, construção do protótipo, avaliação pelo cliente e posterior refinamento quando há necessidade de ajustes finais do projeto, com o intuito de satisfazer da melhor forma as necessidades dos clientes. Resultados: Foram distribuídos 75 formulários para os auditores da Marinha e, tendo sido respondidos 65 (84,3%), observou-se que 40,9% dos entrevistados eram enfermeiros e 29% não tinham experiência em auditoria. As falas dos entrevistados foram analisadas, emergindo cinco categorias relacionadas a melhorias e uma a crítica, sendo estas respectivamente: ampliar o módulo para controle e previsão de custos; regular os serviços que serão prestados pela contratada; orientar profissionais a executarem a auditoria em saúde; ampliar módulo para que possam ser apresentados indicadores e relatório; disponibilizar mais informações sobre os credenciados e não entender o propósito da ferramenta. Conclusão: Acredita-se que a ferramenta irá contribuir para que os auditores recém-ingressos na Marinha possam executar o processo de auditoria de acordo com a técnica, gerando uniformidade, dando celeridade e, principalmente, evitando perdas para a organização. Dessa forma, favorecendo ao profissional mais habilidade e destreza em todo processo

Introduction: One of the most efficient quality tools to monitor a management system is the audit, because, when properly applied, it diagnoses non-conformities in the service evaluated, being performed by trained professionals who have, in addition to technical-scientific knowledge, personal attributes such as impartiality, prudence and diplomacy. The general objective of the study was to develop a mobile tool that can support the medical bills audit process and the specific. Objectives: The general objective of the study was to develop a mobile tool that can support the medical bill audit process and the specific objectives were: to identify the necessary requirements for the development of the audit tool; present a prototype and develop a tool ensuring the security requirements necessary for the maintenance of personal information, enabling its implementation, distribution and modification, and evaluating the impact of the tool for health auditing within the Brazilian Navy.Method: This is a descriptive, exploratory study with a qualitative approach applied to technological production, aimed at developing a mobile computerized tool to support the medical bill audit service. For development of the tool, Pressman's methodology was used, following the steps: collection and refinement of requirements, rapid design development, prototype construction, customer evaluation and further refinement when there is a need for final design adjustments, in order to satisfy the best way to meet the needs of customers. Results: 75 forms were distributed to the Navy auditors, with 65 (84.3%) answered, it was observed that 40.9% of respondents were nurses, 29.% had no experience in auditing. The speeches of the interviewees were analyzed emerging five categories related to improvements and one the criticism, respectively: expanding the module for cost control and forecasting; regulate the services that will be provided by the contractor; guide professionals to perform the health audit; expand module so that indicators and report can be presented; provide more information about the accredited and do not understand the purpose of the tool. Conclusion: It is believed that the tool will help auditors who have recently joined the Navy to perform the audit process according to the technique, generating uniformity, speeding up and, above all, avoiding losses for the organization. In this way, providing the professional with more skill and dexterity throughout the process

Epidemiology of trauma presentations to a major trauma centre in the North West of England during the COVID-19 level 4 lockdown.

PURPOSE: The COVID-19 pandemic has impacted healthcare systems globally, little is known about the trauma patterns during a national lockdown. The aim of this study is to delineate the trauma patterns and outcomes at Aintree University Teaching Hospital level 1 Major Trauma Centre (MTC) during the COVID-19 lockdown imposed by the U.K. government. METHODS: A retrospective cohort study data from the Merseyside and Cheshire Trauma Audit and Research Network database were analysed. The 7-week 'lockdown period' was compared to a 7-week period prior to the lockdown and also to an equivalent 7-week period corresponding to the previous year. RESULTS: A total of 488 patients were included in the study. Overall, there was 37.6% and 30.0% reduction in the number of traumatic injuries during lockdown. Road traffic collisions (RTC) reduced by 42.6% and 46.6%. RTC involving a car significantly reduced during lockdown, conversely, bike-related RTC significantly increased. No significant changes were noted in deliberate self-harm, trauma severity and crude mortality during lockdown. There was 1 mortality from COVID-19 infection in the lockdown cohort. CONCLUSION: Trauma continues during lockdown, our MTC has continued to provide a full service during lockdown. However, trauma patterns have changed and departments should adapt to balance these alongside the COVID-19 pandemic. As the U.K. starts its cautious transition out of lockdown, trauma services are required to be flexible during changes in national social restrictions and changing trauma patterns. COVID-19 and lockdown state were found to have no significant impact on survival outcomes for trauma.

Reducing caesarean delivery: An economic evaluation of routine induction of labour at 39 weeks in low-risk nulliparous women.

BACKGROUND: Clinical interventions known to reduce the risk of caesarean delivery include routine induction of labour at 39 weeks, caseload midwifery and chart audit, but they have not been compared for cost-effectiveness. OBJECTIVE: To assesses the cost-effectiveness of three different interventions known to reduce caesarean delivery rates compared to standard care; and conduct a budget impact analysis. METHODS: A Markov microsimulation model was constructed to compare the costs and outcomes produced by the different interventions. Costs included all costs to the health system, and outcomes were quality-adjusted life years (QALY) gained. A budget impact analysis was undertaken using this model to quantify the costs (in Australian dollars) over three years for government health system funders. RESULTS: All interventions, plus standard care, produced similar health outcomes (mean of 1.84 QALYs gained over 105 weeks). Caseload midwifery was the lowest cost option at $15 587 (95% confidence interval [CI] 15 269, 15 905), followed by routine induction of labour ($16 257, 95% CI 15 989, 16 536), and chart audit ($16 325, 95% CI 15 979, 16 671). All produced lower costs on average than standard care ($16 905, 95% CI 16 551, 17 259). Caseload midwifery would produce the greatest savings of $172.6 million over three years if implemented for all low-risk nulliparous women in Australia. CONCLUSIONS: Caseload midwifery presents the best value for reducing caesarean delivery rates of the options considered. Routine induction of labour at 39 weeks and chart audit would also reduce costs compared to standard care.

Modelling the costs and consequences of reducing healthcare-associated infections by improving hand hygiene in an average hospital in England.

OBJECTIVE: To assess the potential clinical and economic impact of introducing an electronic audit and feedback system into current practice to improve hand hygiene compliance in a hypothetical general hospital in England, to reduce the incidence of healthcare-associated infections (HCAIs). METHODS: Decision analysis estimated the impact of introducing an electronic audit and feedback system into current practice to improve hand hygiene compliance among front-line healthcare practitioners (HCPs). RESULTS: The model assumed 4.7% of adult inpatients (ie, ≥18 years of age) and 1.72% of front-line HCPs acquire a HCAI in current practice. The model estimated that if use of the electronic audit and feedback system could lead to a reduction in the incidence of HCAIs of between 5% and 25%, then the annual number of HCAIs avoided could range between 184 and 921 infections per hospital and HCAI-related mortality could range between 6 and 31 deaths per annum per hospital. Additionally, up to 86 days of absence among front-line HCPs could be avoided and up to 7794 hospital bed days could be released for alternative use. Accordingly, the total annual hospital cost attributable to HCAIs could be reduced by between 3% and 23%, depending on the effectiveness of the electronic audit and feedback system. If introduction of the electronic audit and feedback system into current practice could lead to a reduction in the incidence of HCAIs by at least 15%, it would have a ≥0.75 probability of affording the National Health Service (NHS) a cost-effective intervention. CONCLUSION: If the introduction of the electronic audit and feedback system into current practice in a hypothetical general hospital in England can improve hand hygiene compliance among front-line HCPs leading to a reduction in the incidence of HCAIs by ≥15%, it would potentially afford the NHS a cost-effective intervention.

Outcomes following colorectal cancer surgery: Results from a population-based study in Queensland, Australia, using quality indicators.

RATIONALE, AIMS AND OBJECTIVES: Colorectal cancer (CRC) is one of the most common cancers diagnosed worldwide, and rates are continuing to rise. Surgery is the primary treatment for CRC, and our aim was to examine clinical outcomes following major resection using a series of established quality indicators and to identify factors associated with poor clinical outcomes. METHOD: This population-based retrospective study included 4321 patients with diagnosed with CRC in 2012 and 2014 in Queensland, Australia, who underwent a major resection. Primary outcomes included in-hospital mortality, 30-day unplanned readmission, extended hospital stay (>21 days), and 30- and 90-day mortality. Multivariable logistic regression modelling was conducted to establish factors independently associated with each outcome of interest. RESULTS: Overall, in-hospital mortality was 1.5%, 3.0% had an unplanned readmission, 8% had an extended hospital stay, and 30- and 90-day postoperative mortality was 1.6% and 3.1%, respectively. After adjustment, we found that factors such as older age, presence of comorbidities, emergency admission, and stoma formation were significantly associated with poorer outcomes with these findings being consistent across each of the outcomes of interest. In addition to these factors, the risk of 90-day mortality was significantly elevated for patients with advanced stage disease (OR = 1.95, CI 1.35-2.82). Sex, primary site, hospital volume, residential location, nor socioeconomic status was found to be associated with any of the outcomes of interest. CONCLUSION: Overall, the risk of poorer clinical outcomes for CRC patients in Queensland, Australia, is low. There is however a subgroup of patients at particularly elevated risk of poorer outcomes following CRC. Strategies to reduce the poorer clinical outcomes this group of patients experience should be explored.

Community Assessment of COPD Health Care (COACH) study: a clinical audit on primary care performance variability in COPD care.

BACKGROUND: A thorough evaluation of the adequacy of clinical practice in a designated health care setting and temporal context is key for clinical care improvement. This study aimed to perform a clinical audit of primary care to evaluate clinical care delivered to patients with COPD in routine clinical practice. METHODS: The Community Assessment of COPD Health Care (COACH) study was an observational, multicenter, nationwide, non-interventional, retrospective, clinical audit of randomly selected primary care centers in Spain. Two different databases were built: the resources and organization database and the clinical database. From January 1, 2015 to December 31, 2016 consecutive clinical cases of COPD in each participating primary care center (PCC) were audited. For descriptive purposes, we collected data regarding the age at diagnosis of COPD and the age at audit, gender, the setting of the PCC (rural/urban), and comorbidities for each patient. Two guidelines widely and uniformly used in Spain were carefully reviewed to establish a benchmark of adequacy for the audited cases. Clinical performance was analyzed at the patient, center, and regional levels. The degree of adequacy was categorized as excellent (> 80%), good (60-80%), adequate (40-59%), inadequate (20-39%), and highly inadequate (< 20%). RESULTS: During the study 4307 cases from 63 primary care centers in 6 regions of the country were audited. Most evaluated parameters were judged to fall in the inadequate performance category. A correct diagnosis based on previous exposure plus spirometric obstruction was made in an average of 17.6% of cases, ranging from 9.8 to 23.3% depending on the region. During the audited visit, only 67 (1.6%) patients had current post-bronchodilator obstructive spirometry; 184 (4.3%) patients had current post-bronchodilator obstructive spirometry during either the audited or initial diagnostic visit. Evaluation of dyspnea was performed in 11.1% of cases. Regarding treatment, 33.6% received no maintenance inhaled therapies (ranging from 31.3% in GOLD A to 7.0% in GOLD D). The two most frequently registered items were exacerbations in the previous year (81.4%) and influenza vaccination (87.7%). CONCLUSIONS: The results of this audit revealed a large variability in clinical performance across centers, which was not fully attributable to the severity of the disease.

The Mealtime Audit Tool (MAT) - Inter-Rater Reliability Testing of a Novel Tool for the Monitoring and Assessment of Food Intake Barriers in Acute Care Hospital Patients.

OBJECTIVES: Barriers to food intake (FI) exist in hospital that could exacerbate insufficient FI and malnutrition. The Mealtime Audit Tool (MAT) is a staff-administered clinical assessment tool to identify FI barriers for individual patients. Two studies were completed. The objectives of the first study were to test a draft version of the tool and characterize barriers to food intake in older adults in four diverse hospitals, while the second study aimed to demonstrate the inter-rater reliability of the revised MAT. DESIGN: Multi-site, cross sectional. SETTING: Four acute care hospitals in Canada. PARTICIPANTS: Study 1: 120 older (65+ years, adequate cognition) medical or surgical patients. Study 2: 90 medical or surgical patients. MEASUREMENTS: In study 1, participants had barriers experienced at one mealtime assessed with MAT. Descriptive analyses characterized the prevalence of barriers across the hospitals. Revisions were made to the MAT based on recommendations from sites. A revised version was tested for inter-rater reliability in study 2. Intraclass correlation coefficient (ICC) was calculated for total MAT scores from 90 patient meals assessed by two raters. Kappa statistics were calculated for each of the 18 MAT items. RESULTS: Mean (+/- standard deviation) number of barriers experienced in Study 1 was 2.93 +/- 1.58, and in Study 2 was 2.51 +/- 1.19. The revised MAT was reliable with an ICC of 0.68 (95%CI: 0.52-0.79). Ten of 16 items in which kappa could be calculated had at least fair agreement. CONCLUSION: MAT is sufficiently reliable when used by auditors with minimal training. Routinely auditing mealtimes with MAT could be useful in identifying and removing barriers to food intake for older hospitalized patients.

A New Tool for Quality: The Internal Audit.

As health care systems aspire to improve the quality and value for the consumers they serve, quality outcomes must be at the forefront of this value equation. As organizations implement evidence-based practices, electronic records to standardize processes, and quality improvement initiatives, many tactics are deployed to accelerate improvement and care outcomes. This article describes how one organization utilized a formal clinical audit process to identify gaps and/or barriers that may be contributing to underperforming measures and outcomes. This partnership between quality and audit can be a powerful tool and produce insights that can be scaled across a large health care system.

A systematic checklist approach to immunosuppression risk management: An audit of practice at two clinical neuroimmunology centers.

There is no consensus approach to safety screening for immune intervention in clinical neuroimmunology. An immunosuppression risk evaluation checklist was used as an audit tool to assess real-world immunosuppression risk management and formulate recommendations for quality improvements in patient safety. Ninety-nine patients from two centres with 27 non-MS diagnoses were included. An average of 1.9 comorbidities with the potential to adversely impact morbidity and mortality associated with immunosuppression were identified. Diabetes and smoking were the most common, however a range of rarer but potentially life-threatening co-morbid disorders in the context of immunosuppression were identified. Inadequate documentation of risk mitigation tasks was common at 40.1% of total tasks across both cohorts. A routine, systematic immunosuppression checklist approach should be considered to improve immunosuppression risk management in clinical neuroimmunology practice.

Understanding the implementation and adoption of an information technology intervention to support medicine optimisation in primary care: qualitative study using strong structuration theory.

OBJECTIVES: Using strong structuration theory, we aimed to understand the adoption and implementation of an electronic clinical audit and feedback tool to support medicine optimisation for patients in primary care. DESIGN: This is a qualitative study informed by strong structuration theory. The analysis was thematic, using a template approach. An a priori set of thematic codes, based on strong structuration theory, was developed from the literature and applied to the transcripts. The coding template was then modified through successive readings of the data. SETTING: Clinical commissioning group in the south of England. PARTICIPANTS: Four focus groups and five semi-structured interviews were conducted with 18 participants purposively sampled from a range of stakeholder groups (general practitioners, pharmacists, patients and commissioners). RESULTS: Using the system could lead to improved medication safety, but use was determined by broad institutional contexts; by the perceptions, dispositions and skills of users; and by the structures embedded within the technology. These included perceptions of the system as new and requiring technical competence and skill; the adoption of the system for information gathering; and interactions and relationships that involved individual, shared or collective use. The dynamics between these external, internal and technological structures affected the adoption and implementation of the system. CONCLUSIONS: Successful implementation of information technology interventions for medicine optimisation will depend on a combination of the infrastructure within primary care, social structures embedded in the technology and the conventions, norms and dispositions of those utilising it. Future interventions, using electronic audit and feedback tools to improve medication safety, should consider the complexity of the social and organisational contexts and how internal and external structures can affect the use of the technology in order to support effective implementation.

Reducing socioeconomic inequalities in COPD care in the hospital outpatient setting - A nationwide initiative.

OBJECTIVE: Socioeconomic differences in quality of care have been suggested to contribute to inequality in clinical prognosis of COPD. We examined socioeconomic differences in the quality of COPD outpatient care and the potential of a systematic quality improvement initiative in reducing potential socioeconomic differences. METHODS: A mandatory national quality improvement initiative has since 2008 monitored the quality of COPD care at all national pulmonary specialized outpatient clinics in Denmark using six evidence-based process performance measures. We followed patients aged ≥30 years with a first-ever outpatient contact for COPD during 2008-2012 (N = 23,741). Adjusted year-specific relative risks (RR) of fulfilling all relevant process performance measures was compared according to ethnicity, education, income, employment, and cohabitation using Poisson regression. RESULTS: Quality of care improved following the implementation of the clinical improvement initiative with 11% of COPD patients receiving optimal care in 2008 compared to 57% in 2012. Substantial socioeconomic differences were observed the first year: immigrants (RR 0.41, 95% CI 0.21-0.82), the unemployed (RR 0.37, 95% CI 0.18-0.74), disability pensioners (RR 0.63, 95% CI 0.46-0.87) and patients living alone (RR 0.80, 95% CI 0.60-0.97) were less likely to receive all relevant care processes, whereas those with highest education (RR 1.22, 95% CI 0.92-1.63) were more likely to receive these processes. These differences were eliminated during the study period. CONCLUSION: A systematic quality improvement initiative including regular audits, knowledge sharing, and detailed disease-specific recommendations for care improvement may increase the overall quality of care and considerably modify the substantial socioeconomic inequalities in COPD management.

Dutch Melanoma Treatment Registry: Quality assurance in the care of patients with metastatic melanoma in the Netherlands.

BACKGROUND: In recent years, the treatment of metastatic melanoma has changed dramatically due to the development of immune checkpoint and mitogen-activated protein (MAP) kinase inhibitors. A population-based registry, the Dutch Melanoma Treatment Registry (DMTR), was set up in July 2013 to assure the safety and quality of melanoma care in the Netherlands. This article describes the design and objectives of the DMTR and presents some results of the first 2 years of registration. METHODS: The DMTR documents detailed information on all Dutch patients with unresectable stage IIIc or IV melanoma. This includes tumour and patient characteristics, treatment patterns, clinical outcomes, quality of life, healthcare utilisation, informal care and productivity losses. These data are used for clinical auditing, increasing the transparency of melanoma care, providing insights into real-world cost-effectiveness and creating a platform for research. RESULTS: Within 1 year, all melanoma centres were participating in the DMTR. The quality performance indicators demonstrated that the BRAF inhibitors and ipilimumab have been safely introduced in the Netherlands with toxicity rates that were consistent with the phase III trials conducted. The median overall survival of patients treated with systemic therapy was 10.1 months (95% confidence interval [CI] 9.1-11.1) in the first registration year and 12.7 months (95% CI 11.6-13.7) in the second year. CONCLUSION: The DMTR is the first comprehensive multipurpose nationwide registry and its collaboration with all stakeholders involved in melanoma care reflects an integrative view of cancer management. In future, the DMTR will provide insights into challenging questions regarding the definition of possible subsets of patients who benefit most from the new drugs.

Auditoría de oxígenoterapia de pacientes hospitalizados en establecimientos del Servicio de Salud Talcahuano / Audit on oxygen therapy in hospitalized patients from Public Health Service of Talcahuano, Chile

El oxígeno (O2) es una de las drogas más utilizadas en clínica, su uso no está exento de riesgos. Existen guias internacionales para su uso, pero en nuestro medio no sabemos si se aplican. Nuestro objetivo fue describir la forma en que se utiliza y controla la oxígenoterapia en los 3 hospitales de la red del Servicio de Salud Talcahuano. Aplicamos una encuesta un día de agosto de 2016 a los pacientes hospitalizados en las instituciones de la red que recibían O2 en ese momento. Se recolectaron datos sobre la prescripción, administración y seguimiento de la terapia de O2. De los 381 pacientes auditados, un 13,7% recibía oxígenoterapia. Los diagnósticos más frecuentes fueron de causa respiratoria (46,15%) y cardiológica (25%). La indicación la dio un médico en 88,5% de los casos y en un 3,8% no había registro. En un 17,3% de los pacientes no había fundamento para la indicación. Se indicó una dosis fija en el 75% con una meta de SaO2 en el 50%, siendo naricera y máscara de Venturi los métodos de administración más frecuentes monitorizándose con oximetría de pulso en los hospitales menos complejos y gasometría arterial en el hospital terciario. La duración media de la oxígenoterapia fue de 7,8 días. Habiendo un buen fundamento y control de la oxígenoterapia aún no se indican metas a obtener. No hay un buen registro de la indicación ni de los cambios realizados. Creemos útil la realización periódica de este tipo de control para optimizar su uso evitando los potenciales efectos adversos en los pacientes.

Abstract Oxygen is a commonly used drug in clinics and its use must be judicious. There are guidelines for oxygen therapy but we ignore if these are respected in our country. We conducted an audit of oxygen therapy by applying a survey to 381 patients in the three hospitals of Talcahuano Public Health Service. The day of the audit 13.7% of the hospitalized patients were on oxygen, most of them with respiratory (46.15%) or cardiovascular (25%) diseases. Indication of O2 administration was given by a physician in 88.5% and there was not registry in 3.8% of the cases. There was not foundation for supplying O2 in 13.3% of patients. A fixed dose was indicated in 75% of cases and 50% had an oximetry value as a target. Oxygen was administered in most of the cases by nasal prongs and Venturi masks. Monitoring was based on pulse oximetry in the less complex hospitals and on arterial blood gases in the tertiary hospital. 100% of patients at urgency ward were receiving a different dose from that indicated at their admission time and none of them had a registry of the new dose. Mean duration of therapy was 7.8 days. We believe our results might represent what is going on with oxygen therapy in our country; having a good foundation and monitoring, we still don t use targets and there is a bad system of registry. We think that it would be advisably to carry out audits on oxygen therapy at national level on regular basis.

Management of Older Inpatients Who Refuse Nonpsychiatric Medication Within Birmingham and Solihull Mental Health NHS Foundation Trust: Audit.

The effects of poor medication compliance are well documented and include increased morbidity, early mortality, and financial costs to the society. According to national guidelines, when a competent patient refuses medication, the doctor on duty has a responsibility to ensure the patient understands their proposed course of action. The aims of this audit were to evaluate whether this consultation was taking place within older in-patient units across Birmingham and Solihull Mental Health NHS Foundation Trust when patients refuse nonpsychiatric medicines. Poor compliance was defined as more than five refusals of a nonpsychiatric medication over a 4-week period. A discussion with the duty doctor occurred in 75% of cases (27/36), which resulted in a change in prescription or compliance in 59% (16/27 patients). After patient refusal of medication, a consultation with the duty doctor is likely to improve compliance and uncover salient issues particularly in regards to capacity and drug suitability.

Appropriateness of clopidogrel use according to current recommendations.

BACKGROUND: Clopidogrel is widely used in cardiovascular prevention. However, the prescription of clopidogrel in clinical practice does not match the recommendations concerning its indication and treatment duration. OBJECTIVE: To assess the appropriateness of clopidogrel prescription according to the accepted indications. METHODS: We undertook a retrospective observational analytical audit of the electronic clinical records in the region of Valencia, Spain (5 million inhabitants), selecting those patients on treatment with clopidogrel between 2007 and 2010. The primary outcome measure was the duration of the treatment. RESULTS: A total of 45721 patients started clopidogrel treatment during the study period. Treatment was for cardiologic disorders (CD) in 56.85% of the patients, neurologic disorders (ND) in 37.06% and peripheral arterial disease in 6.08%. Treatment duration was longer than that expected from clinical recommendations in 38.8% of the CD patients and 87.8% of the ND patients. The estimated avoidable cost ranged from 2 to 4.4 million Euros per year, according to whether a cheaper generic clopidogrel or a more expensive version was considered. CONCLUSIONS: Almost 40% of the cardiologic patients and 90% of the neurologic patients received excess treatment. Adjustment of treatment duration to international recommendations would result in savings of between 80.1 and 176.3 Euros per year and per patient treated.

[Economic evaluation in healthcare]. / L'évaluation économique dans le champ de la santé

Economics was only recently considered as a dimension of health technology assessment in France. Yet there are always limits in resources that we collectively agree to devote to health. A comparative "economic" appraisal is therefore needed to guide health choices and contribute to price regulation. Methodologies are based on the determination of incremental cost-effectiveness ratios compared with a reference. The interpretation of these ratios is never isolated from the context of the decision. Health economic evaluation is not involved in healthcare rationing, but it contributes to the rationality of decisions in the interest of the overall population.

[Intervention of psychological and ethical professionals of human science in obstetrical morbidity and mortality conferences]. / L'intervention des sciences humaines en psychologie et en éthique dans les revues de morbi-mortalité en obstétrique.

OBJECTIVE: To identify the defence mechanisms manifested by medical staff which could disturb the decision making, revealed by professionals of human science (PHS) in morbidity and mortality conferences (MMC). MATERIALS AND METHODS: Application of two methods of psychological intervention in MMC, conducted between March 1st, 2009 and November 30, 2010, in 20 randomized maternity among five perinatal networks: the method of inter-active problem solving targeted at the functioning of the teams and the method for developing professional practice centred on individual. The data collection was realized during analyse of case in MMC, with note-taking by two pair PHS. The oral expressions of RMM' participant were secondarily re-written, analyzed and classed by theme. RESULTS: Fifty-four MMC were performed. The mechanisms of defence have been identified by PHS intervention in MMC: denial of situation, pact of denegation, rift and overprotection. They were be identified by two PHS intervention methods, this consolidates these results. This intervention began staff medical to transformation at different level, in particular to improve the capacity of cooperation. CONCLUSION: The identification of the mechanisms of defence in MMC enables staff medical to improve communication and quality relationship between healthcare professionals. This could constitute an actual factor of practices improvement. However, complementary studies must be performed to confirm this hypothesis.

Assessment of audit methodologies for bias evaluation of tumor progression in oncology clinical trials.

As progression-free survival (PFS) has become increasingly used as the primary endpoint in oncology phase III trials, the U.S. Food and Drug Administration (FDA) has generally required a complete-case blinded independent central review (BICR) of PFS to assess and reduce potential bias in the investigator or local site evaluation. However, recent publications and FDA analyses have shown a high correlation between local site evaluation and BICR assessments of the PFS treatment effect, which questions whether complete-case BICR is necessary. One potential alternative is to use BICR as an audit tool to detect evaluation bias in the local site evaluation. In this article, the performance characteristics of two audit methods proposed in the literature are evaluated on 26 prospective, randomized phase III registration trials in nonhematologic malignancies. The results support that a BICR audit to assess potential bias in the local site evaluation is a feasible approach. However, implementation and logistical challenges need further consideration and discussion.

Barriers to conducting effective obstetric audit in Ifakara: a qualitative assessment in an under-resourced setting in Tanzania.

OBJECTIVE: To explore barriers to and solutions for effective implementation of obstetric audit at Saint Francis Designated District Hospital in Ifakara, Tanzania, where audit results have been disappointing 2 years after its introduction. METHODS: Qualitative study involving participative observation of audit sessions, followed by 23 in-depth interviews with health workers and managers. Knowledge and perceptions of audit were assessed and suggestions for improvement of the audit process explored. RESULTS: During the observational period, audit sessions were held irregularly and only when the head of department of obstetrics and gynaecology was available. Cases with evident substandard care factors were audited. In-depth interviews revealed inadequate knowledge of the purpose of audit, despite the fact that participants regarded obstetric audit as a potentially useful tool. Insufficient staff commitment, managerial support and human and material resources were mentioned as reasons for weak involvement of health workers and poor implementation of recommendations resulting from audit. Suggestions for improvement included enhancing feedback to all staff and managers to attend sessions and assist with the effectuation of audit recommendations. CONCLUSION: Obstetric staff in Ifakara see audit as an important tool for quality improvement. They recognise, however, that in their own situation, insufficient staff commitment and poor managerial support are barriers to successful implementation. They suggested training in concept and principles of audit as well as strengthening feedback of audit outcomes, to achieve structural health care improvements through audit.