Inspectors' ethical challenges in health care regulation: a pilot study.

There is an increasing body of research on what kind of ethical challenges health care professionals experience regarding the quality of care. In the Netherlands the Dutch Health Care Inspectorate is responsible for monitoring and regulating the quality of health care. No research exists on what kind of ethical challenges inspectors experience during the regulation process itself. In a pilot study we used moral case deliberation as method in order to reflect upon inspectors' ethical challenges. The objective of this paper is to give an overview of the ethical challenges which health care inspectors encounter in their daily work. A thematic qualitative analysis was performed on cases (n = 69) that were collected from health care inspectors in a moral case deliberation pilot study. Eight themes were identified in health care regulation. These can be divided in two categories: work content and internal collaboration. The work of the health care inspectorate is morally loaded and our recommendation is that some form of ethics support is provided for health care inspectors.

¿Son efectivos nuestros centros de reconocimiento médico valorando la aptitud psicofísica para permisos de conducción y licencias de armas? / Are our medical centres for fitness to drive and firearms licences effective?

Objetivos. Este artículo se propuso evaluar la efectividad de los centros de reconocimiento médico en la valoración de la aptitud psicofísica para permisos de conducción y licencias de armas, describiendo las diferencias observadas en sendas valoraciones. Método. Mediante un diseño transversal se tomó una muestra representativa de titulares de permisos de conducción y licencia de armas calificados como aptos en la provincia de Málaga durante 2014 (363 informes para permisos de conducción y 626 para licencia de armas), evaluando la concordancia de la aptitud psicofísica informada por los centros con los registros del Servicio Andaluz de Salud. Se estimó la proporción de dichos titulares que no reunirían los requisitos legales de aptitud, analizando el origen de las discordancias en relación con la información de la que dispusieron los centros. Resultados. Se estimó la discordancia en la valoración de la aptitud psicofísica para permisos de conducción en 15,4% (IC 95%: 12,0 a 19,4), proporción 2,7 veces mayor para licencias de armas (41,4%), relacionándose el origen de la discordancia con la información que dispuso el centro más que a la calificación realizada por estos. Conclusiones. Es limitada la efectividad de los centros en la valoración de la aptitud psicofísica para permisos de conducción y, especialmente, para licencias de armas. Podría mejorar con un mayor seguimiento de su actividad, disponiendo de personal sanitario con formación adecuada y acceso a los registros asistenciales de los solicitantes (AU)

Objectives. This article aimed to evaluate the effectiveness of medical centres in the assessment of medical fitness for driving and gun licences, as well as describing the differences between them. Method. Using a crossover design and a representative sample of holders of driving and firearms licences in the province of Malaga during 2014 (363 reports for driving licenses and 626 for firearms licenses), an assessment was made of fitness report issued by the centres by comparing it with the records of the Andalusian public health service. The proportion of those that would not meet the legal eligibility requirements was calculated. An analysis was made of the origin of the disagreements as regards the information made available by the centres. Results. The discordance in the assessment of fitness to drive was estimated as 15.4% (95% CI: 12.0 to 19.4), while for firearms licenses it was 2.7 times higher (41.4%). The origin of the discordance is related to the information provided to the centres, rather than the assessment made by them. Conclusions. The limited effectiveness of the centres in the assessment of fitness for driving and, especially, for firearms licenses, could be improved by increased monitoring of their activity, providing health workers with adequate training and access to healthcare records of applicants (AU)

The impact of local guidelines on the tumour marker requesting patterns of a General Surgery Department.

BACKGROUND: The inappropriate use of tumour markers (TMs) is a common problem. The aim of this audit was to evaluate the impact of local guidelines on the TM requesting patterns of a General Surgery Department. METHODS: CA 125, CA 19-9, CA15-3, CEA, AFP and HCG requests from all hospital surgical locations were audited over two periods of eight months before and after the implementation of local requesting guidelines. RESULTS: Postintervention, total TM requests decreased by 32% while patient requests decreased by 9.8%. Single TM requesting increased and requests for panels containing four or more TMs decreased from 279 to 60 requests (78% reduction). CONCLUSION: Interdepartmental collaboration and the implementation of local guidelines have resulted in a change in requesting behaviour, most notably a reduction in multiple TM panel requests.

Ethical issues: the multi-centre low-risk ethics/governance review process and AMOSS.

BACKGROUND: The Australasian Maternity Outcomes Surveillance System (AMOSS) conducts surveillance and research of rare and serious conditions in pregnancy. This multi-centre population health study is considered low risk with minimal ethical impact. OBJECTIVE: To describe the ethics/governance review pathway undertaken by AMOSS. METHOD: Prospective, descriptive study during 2009-2011 of the governance/ethical review processes required to gain approval for Australian and New Zealand (ANZ) maternity units with more than 50 births per year (n = 303) to participate in AMOSS. RESULTS: Review processes ranged from a single application for 24 NZ sites, a single application for eligible hospitals in two Australian states, full Health Research Ethics Committee (HREC) applications for individual hospitals, through simple letters of support. As of September 2011, 46 full/expedited ethics applications, 131 site governance applications and 136 letters of support requests were made over 33 months, involving an estimated 3261 hours by AMOSS staff/investigators, and an associated resource burden by participating sites, to obtain approval to receive nonidentifiable data from 291 hospitals. CONCLUSION: The AMOSS research system provides an important resource to enhance knowledge of conditions that cause rare and serious maternal morbidity. Yet the highly variable ethical approval processes required to implement this study have been excessively repetitive and burdensome. This process jeopardises timely, efficient research project implementation, without corresponding benefits to research participants. The resource burden to establish research governance for AMOSS confirms the urgent need for the Harmonisation of Multi-centre Ethical Review (HoMER) to further streamline ethics/governance review processes for multi-centre research.

Mortality meetings: ethical considerations and adherence to evidence-based practice from 6 years of experience in a mixed cardiac department.

OBJECTIVE: Most patients die unexpectedly in cardiac departments. We analyzed the ethical issues raised by poor outcomes and the leading causes of hospital deaths including organic causes of deaths, system failures, and questionable caregivers' attitudes. METHOD: We analyzed reports from 99 mortality conferences in a mixed cardiac department (surgery and interventional cardiology) where 146 patients died from 2002 to 2008. RESULTS: Patients were referred for cardiac surgery (n=115), interventional cardiology (n=25), or medical therapy (n=11). Highly recommended class I interventions were performed in most patients (n=120, 82%). A history of renal failure (25%), peripheral artery disease (21%), diabetes (18%), cancer (16%), or respiratory disease (16%) was frequently noticed. The areas most frequently identified as potentially problematic were preoperative strategy (58%), surgical technique (50%), monitoring (47%), reactivity (43%), drug prescription (32%), difficulties or delays in diagnosis (27%), and transfer (21%). At least one transgression from routine medical practice was identified in 66 (45%) patients, and a causal relationship between this transgression and the patient's death was suggested in 33 cases (23%). Serious errors were identified for five patients (3%), with a suggested causal relationship to death in two cases. Ethical discussions focused on alternatives in treatment (73%), good medical practice (44%), secondary recommendations (18%), information (12%), consent (12%), non-malfeasance (7%), and equity (6%). CONCLUSIONS: Mortality conferences provide an opportunity to identify many system failures. Poor outcome is multifactorial. Technical and ethical aspects should be considered for quality care improvement.

La atención hospitalaria al paciente con ictus en Cataluña. Resultados del ®Primer Audit Clínic de l'Ictus. Catalunya, 2005/2006» / NEW ARTICLEIn-hospital stroke care in Catalonia [Spain]. Results of the ®First Clinical Audit of Stroke. Catalonia, 2005/2006»

Objetivo: Analizar la calidad de la atención hospitalaria alpaciente con ictus en los hospitales públicos catalanes antesde la difusión de la Guía de Práctica Clínica (GPC) del ictus,estudiando el grado de adhesión a determinadas recomendacionesde la GPC.Métodos: Mediante revisión retrospectiva de historias clínicasde pacientes con ictus definidos mediante los códigos CIE-9 431, 433.x1, 434.x1, 436, e ingresados consecutivamenteen 48 hospitales públicos catalanes en el primer semestre de2005, se recogió información sobre distintos indicadores delproceso asistencial al ictus seleccionados según su evidenciacientífica o su importancia clínica. Los hospitales participantesreclutaron 20, 40 o 60 casos, según el número de ingresos/año. Se llevó a cabo una auditoría externa en el 9,3%de los casos reclutados en cada centro, tras selección aleatoria,para determinar la calidad de los datos recogidos. Losindicadores se agruparon en 6 perfiles relacionados con diferentesaspectos de la práctica clínica.Resultados: Se incluyeron 1.791 casos, un 53,9% hombres,con una media (desviación estándar) de edad de 75,6 (12,4)años. La concordancia global entre observadores fue de 0,7.El cumplimiento de los perfiles asistenciales (porcentajemedio [intervalo de confianza del 95%]) fue: calidad de la historiaclínica, 78,5% (77,5-79,4); estándares de atención básica,92,4% (91,5-93,2); evaluación neurológica, 38,3% (37,3-39,3); medidas iniciales del tratamiento rehabilitador, 44,9%(43,2-46,7); prevención y manejo de complicaciones, 68,4%(66,9-70), y medidas preventivas iniciales, 78,9% (77,3-80,4).Conclusiones: En 2005 la atención hospitalaria al ictus eramejorable, sobre todo los aspectos relacionados con la evaluacióny el seguimiento neurológico del paciente y la rehabilitación(AU)

Objective: To determine the quality of in-hospital stroke carein public acute care hospitals in Catalonia before the implementationof a clinical practice guideline (CPG) on stroke bydetermining adherence to specific recommendations of theCPG.Methods: We retrospectively reviewed the case notes of consecutivepatients with stroke (defined with ICD-9 codes: 431,433.x1, 434.x1, and 436) admitted to 48 Catalan hospitals withinthe first half of 2005. Data were collected on indicators ofthe healthcare process selected on the basis of their scientificevidence and/or clinical relevance. The participating hospitalsincluded 20, 40 or 60 stroke cases according to theirannual stroke caseload. After random selection, up to 9.3%of all cases recruited at each study center were externally monitoredto assess the quality of the data gathered. Indicatorswere grouped into six different dimensions related to distinctaspects of clinical practice.Results: We analyzed data from 1,791 stroke cases (53.9%men, mean age: 75.6 [12.4] years). Overall inter-observer agreementwas 0.7. Compliance with the six dimensions was asfollows (mean percentage [95%CI]): quality of medical records,78.5% (77.5-79.4); initial interventions, 92.4% (91.5-93.2); neurologicalassessment, 38.3% (37.3-39.3); assessment of rehabilitationneeds, 44.9% (43.2-46.7); prevention and managementof medical complications, 68.4% (66.9-70), and initialpreventive measures, 78.9% (77.3-80.4).Conclusions: In the first half of 2005, in-hospital stroke carein Catalonia showed room for improvement particularly in aspectsrelated to the neurological assessment and follow-up ofpatients and their rehabilitation process(AU)

Clinical audits: why and for whom.

Every surgical activity poses some element of risk to the public and should include a quality control initiative. Surgical audit is one strategy used to maintain and/or improve standards in surgical care. The Royal Australasian College of Surgeons is committed to ensuring best practice in surgical care and strongly endorses the use of audits to achieve this. This review provides an overview of clinical audit and its role in surgical practice.

Quality improvement in New Zealand healthcare. Part 3: achieving effective care through clinical audit.

In this third article in the Series on quality improvement, we examine the effectiveness of dimension of healthcare quality. To satisfy this dimension, two equally important facets must be attended to. First the best available evidence must be sought through research, and second that evidence must be applied--this second function is the domain of quality improvement activities generally and clinical audit in particular. Clinical audit is one of the main tools to establish whether the best evidence is being used in practice, as it compares actual practice to a standard of practice. Clinical audit identifies any gaps between what is done and what should be done, and rectifies any deficiencies in the actual processes of care. In this article, the steps involved in a clinical audit, how it is different to research, and the question of whether clinical audit requires ethical approval are explored.

Research audit and publication.

The ethics of research, audit and publication have developed mainly within the last fifty years. The Declaration of Helsinki is the universally accepted code of conduct for researchers worldwide. All research has to be approved by an ethics committee, all of which are governed by a centralised structure which is the Central Office for Research Ethics Committees (COREC) in the UK. This standardised system has been developed to oversee all research activity across the whole of Europe and every European county will have an equivalent organisation. The committees concern themselves with research but the differences between audit and research are difficult to discern in many places. If there is any doubt then the advice of the local research ethics committee should be sought. Only the individual him/herself can give consent. This may produce difficulties in cases of certain groups especially unconscious patients and children. The outcome of every study should be published whatever the results and the ongoing development of centralised (national) research trial databases will promote this philosophy. Publication of results thought to be of lesser importance may prove difficult, however, and so there is a temptation to falsify or modify data to make it more attractive. This, together with other activities such as the fabrication of data, plagiarism, dual publication, salami publication, conflicts of interest and irregularities in authorship, have given Editors of journals a number of problems. Many of these issues around publication ethics may prove difficult to detect but the fear of sanctions from employers and professional organisations is a useful deterrent.

A study on how mental health practitioners address ethical issues in clinical audit.

Although much debate has taken place within the literature on the differences between research and clinical audit, the ethical dimensions of audit have frequently been neglected. Furthermore, no research has of yet explored what ethical issues auditors consider in relation to their projects or how they manage them in practice. Using data collected from audit documentation, semi-structured interviews and a researcher-administered questionnaire, this study sought to advance this position by exploring how 14 clinicians undertook audits in one mental health Trust addressed the ethical dimensions of their project. Analysis of the data revealed that the Trust had no formal mechanisms for reviewing and monitoring audit projects whilst other informal mechanisms were not utilized by all auditors. A number of projects had contact with both clinicians and service users through interviews, focus groups and questionnaires; however, issues such as informed consent, confidentiality and anonymity were not adequately addressed by auditors. The implications of these findings are discussed and recommendations for practice outlined.

Advanced statistics: understanding medical record review (MRR) studies.

Medical record review (MRR) studies have been reported to make up 25% of all scientific studies published in emergency medical (EM) journals. However, unlike other study designs, there are no standards for reporting MRRs and very little literature on the methodology for conducting them. The purpose of this article is to provide the reader with methodological guidance regarding the strengths and weaknesses of these types of studies.

Autonomy and audit--striking the balance.

The Data Protection Act 1998 purports to implement European legislation which aims to protect the privacy of individuals. There were such concerns about the implications of the Act for certain research and audit that it became necessary to enact further legislation to enable such essential activities to continue. Although this empowers the Secretary of State for Health to approve proposals for these purposes, there should still be a requirement that the use of identifiable personal information without consent must be justified on compelling public interest grounds. It is this that can confound those seeking to rely on such justification. There can either be too cavalier an approach to the issue, and/or there is little sense of what considerations should come into play. This paper attempts to highlight some of the difficulties that are theoretically raised by some audit activities and set out the legal framework within which they must operate. However, the key focus is on how ethical considerations might inform the public interest argument.

Auditoría médica: demandas y responsabilidad por negligencias médicas: gestión y calidad: riesgos y conflictos / Medical audit: demands and responsibility by medical negligence: quality and management: risks and conflicts

El abismante aumento de las demandas por responsabilidad médica; problema que no es nuevo, sólo lo es su gran incremento; ha generado un aumento de los costos de todo tipo en la atención sanitaria y, en muchos casos, el ejercicio de una medicina defensiva. Esto ha llevado a las instituciones de salud al desarrollo de programas de Auditoría Médica que tienen por objeto la evaluación crítica periódica de la calidad de la atención médica que reciben los pacientes. Su objetivo específico es elevar la calidad de la atención sanitaria a través de acciones de evaluación y control periódico. Su aplicación en Radiología no difiere de otras áreas de la medicina, aun cuando en la gestión de riesgos y el manejo de conflictos tiene algunas características que le son propias.