Radiation therapy: Regulatory framework and constraints.

The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France.

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.

Coste-efectividad de los medicamentos en situaciones especiales en un hospital / Cost-effectiveness of drug therapy prescribed in special situations at hospital

OBJETIVO: La Comisión de Farmacia y Terapéutica, como órgano asesor de la Dirección Médica del hospital y bajo las condiciones del Real Decreto 86/2015, por el que se regula la Comisión de Farmacoterapéutica de las Islas Baleares, elabora un informe técnico donde evalúa la posibilidad de empleo interno de medicamentos off-label, uso compasivo y medicamentos no incluidos en la Guía Farmacoterapéutica del hospital. Asimismo, esta comisión realiza un seguimiento prospectivo de cada una de las solicitudes. El objetivo fue analizar la respuesta clínica alcanzada con el empleo de estos medicamentos, así como el coste asociado. MÉTODO: Estudio retrospectivo de los medicamentos solicitados a la Comisión de Farmacia y Terapéutica del hospital entre enero y diciembre de 2018. Se analizó si con cada tratamiento solicitado se alcanzó el objetivo propuesto por el clínico. Para el cálculo del coste se consideró la duración del tratamiento hasta alcanzar el objetivo propuesto o hasta su interrupción. RESULTADOS: De un total de 70 solicitudes analizadas, un 59% alcanzaron el objetivo terapéutico esperado, un 34% fueron consideradas como fracaso terapéutico y hubo un 7% de pérdidas de seguimiento. El coste de las 70 peticiones fue de 1.140.240 (Euro). La media de coste por solicitud fue de 16.288 (Euro). Más del 50% de las solicitudes fueron realizadas por los servicios de oncología y hematología y más del 75% del presupuesto fue destinado a estos dos servicios. CONCLUSIONES: Más de la mitad de los tratamientos considerados por la Comisión de Farmacia y Terapéutica del hospital alcanzan la finalidad terapéutica deseada, si bien el impacto económico de su empleo es elevado

OBJECTIVE: The Pharmacy and Therapeutics Committee is an advisory body to the medical management of our hospital. Following Royal Decree 86/2015, which regulates the Pharmacy and Therapeutics Committee of the Balearic Islands, this committee prepared a technical report in which it assessed the possible internal use of off-label drugs, drugs for compassionate use, and drugs not included in the hospital's pharmacotherapeutic guide. The objective was to analyse the clinical response achieved with the use of these drugs and their associated costs. METHOD: Retrospective study of drugs whose use was requested from the hospital's Pharmacy and Therapeutics Committee hospital between January and December 2018. We analysed whether the requested treatment achieved the objective established by the physician. The cost was calculated based on the duration of the treatment until the objective was achieved or until treatment was discontinued. RESULTS: In total, 70 requests were analysed: 59% achieved the expected therapeutic goal, 34% were considered to be therapeutic failures, and 7% were lost to follow-up. The overall cost of the 70 authorized treatments was (Euro)1,140,240. The average cost per request was (Euro)16,288. Oncology and Haematology services submitted more than 50% of the requests, and more than 75% of the budget was allocated to these medical services. CONCLUSIONS: More than half of the treatments analysed by the Pharmacy and Therapeutics Committee of the hospital achieved their therapeutic goal, although the economic cost of their use was high

Adolescents as perpetrators of aggression within the family.

Although family violence perpetrated by juveniles has been acknowledged as a potentially serious form of violence for over 30years, scientific studies have been limited to examining the incidence and form of home violence. The present study examined the prevalence of family aggression as perpetrated by youths; we examined groups drawn from clinic-referred and forensic samples. Two audits of case files were conducted to systematically document aggression perpetrated by referred youths toward their family members. The purpose of the first audit was fourfold: i) to identify the incidence of the perpetration of family aggression among clinical and forensic samples; ii) to identify whether there were any reports of weapon use during aggressive episodes; iii) to identify the target of family aggression (parents or siblings); and iv) to identify the form of aggression perpetrated (verbal or physical). The second audit aimed to replicate the findings and to show that the results were not due to differences in multiple deprivation indices, clinical diagnosis of disruptive behavior disorders, and placement into alternative care. A sampling strategy was designed to audit the case notes of 25 recent forensic Child and Adolescent Mental Health Service (CAMHS) cases and 25 demographically similar clinic-referred CAMHS cases in the first audit; and 35 forensic cases and 35 demographically similar clinic-referred CAMHS cases in the second audit. Using ordinal chi-square, the forensic sample (audit 1=64%; audit 2=82.9%) had greater instances of family violence than the clinical sample (audit 1=32%; audit 2=28.6%). They were more likely to use a weapon (audit 1=69%; audit 2=65.5%) compared to the clinical sample (audit 1 and 2=0%). Examining only the aggressive groups, there was more perpetration of aggression toward parents (audit 1, forensic=92%, clinical=75%; audit 2, forensic=55.17%, clinical=40%) than toward siblings (audit 1, forensic=43%, clinical=50%; audit 2, forensic=27.58%, clinical=30%). Based on these findings, we would urge professionals who work within the child mental health, particularly the forensic area, to systematically collect reports of aggression perpetrated toward family members.

Audit of the use of intravenous immunoglobulin for antibody deficiencies in a Clinical Immunology Unit

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Monitoring of clinical imaging guidelines part 3: norms, standards, and regulations.

It is known that the use of imaging in clinical situations is not always optimal, leading to suboptimal health care and potential radiation risk. There may be overuse of imaging, underuse, or use of the wrong modality. The use of clinical imaging guidelines is likely to improve the use of imaging, but roadblocks exist. Some of these relate to regulatory oversight and mandates. There is wide variation by country and region in the regulatory setting, ranging from actual absence of regulatory authorities to mandated availability of clinical imaging guidelines in the European Community. Collaborative efforts to ensure that clinical imaging guidelines are at least available is a good starting point. Regulatory oversight and support are necessary to ensure the use of clinical imaging guidelines. Regulations should address 3 areas: availability, clinical utilization, and adherence to and revision of guidelines. The use of both internal and external audits, with the aim of both use of and adherence to guidelines and quality improvement, is the best tool for enhancing use. The major challenges that need to be addressed, collaboratively, to ensure the dissemination and use of clinical imaging guidelines are the development of regulations, of regulatory structures that can be effectively deployed, and of benchmarks for adherence and for utility.

Long-term outcome of defibrillator recipients included in the federal audit conducted by the Department of Justice.

Institutions across the United States have been subjected to a federal audit for defibrillator implantable cardioverter defibrillator [ICD] implantations that violated the Centers for Medicare and Medicaid payment policy. We examined the long-term outcome of ICD recipients whose implantation procedures were audited by the Department of Justice (DOJ). Patients (n = 225) included in the DOJ audit at the University of Pittsburgh Medical Center between the years 2003 and 2010 were followed to the end point of all-cause mortality. A cohort of 206 consecutive and contemporary ICD recipients not included in the federal audit served as controls. Compared with the controls, the audited cases were older (p <0.001), had more preserved ejection fraction (p <0.001), and were less likely to be implanted for a primary prevention indication (p = 0.001). They also had significantly shorter time from myocardial infarction (p <0.001) or revascularization (p <0.001) to ICD implantation. Over a median follow-up of 3.6 years, 187 patients died and 71 received ICD therapy for ventricular arrhythmias. Patients whose cases were audited had worse survival compared with controls (hazard ratio 1.41, 95% confidence interval 1.05 to 1.90, p = 0.023) even after correcting for differences in baseline characteristics (hazard ratio 1.46, 95% confidence interval 1.05 to 2.02, p = 0.023). Rates of appropriate and inappropriate ICD therapies were similar between the audited cases and controls. In conclusion, patients whose ICD implantations were audited by the DOJ have worse long-term survival compared with nonaudited control patients. These data support compliance with the Centers for Medicare and Medicaid guidelines when the individual patient's clinical condition allows it.

The medico-legal investigation of sudden, unexpected and/or unexplained infant deaths in South Africa: where are we--and where are we going?

Sudden Infant Death Syndrome (SIDS) has been reported to be the leading cause of death in infants under 1 year of age in many countries. Unfortunately, a paucity of published research data exists in South Africa, with regard to the incidence of and investigation into the circumstances surrounding Sudden Unexplained Deaths in Infants (SUDI) and/or SIDS. Currently, even though most academic centers conform to a protocol consistent with internationally accepted standards, there exists no nationally accepted infant death investigation protocol in South Africa. It is the aim of this study to review the current practice of infant death investigation in two representative but geographically and demographically distinct centers. Retrospective case audit over a five-year period (2000-2004) was conducted at two large medico-legal mortuaries in Pretoria (Gauteng) and Tygerberg (Cape Town). Case files on all infants younger than 1 year of age were reviewed. The outcome measures included number of deaths, demographic details and the nature and final outcome of the post mortem examinations. A total of 512 cases were identified as possible SIDS cases and of these, 171 was classified as SIDS. The study showed marked inter-case and inter-divisional variation in terms of the investigation of infant deaths at the two institutions. It is envisaged that this study will focus attention on the current lack of usable data regarding sudden/unexplained/unexpected infant deaths in South Africa, and aid in the formulation and implementation of a practical (yet internationally accountable) infant death investigation protocol, which could facilitate comparisons with other countries and initiate further structured research in this field.

Another hospital saga: the chronicles of Professor Kossmann and Bayside Health.

There is almost a tradition in Australia for the suspect practices of hospitals to be exposed by whistleblowers rather than official governance or accreditation processes. The Bundaberg, King Edward, Canberra, Campbelltown and Camden hospitals have been investigated as a consequence of whistleblowing, but it seems the lessons learnt fail to travel beyond the subject institution. For five years, a number of senior surgeons at The Alfred Hospital in Melbourne complained about the clinical and billing practices of their colleague, Professor Thomas Kossmann, head of the trauma unit. Amid intense media interest, The Alfred eventually convened a peer review panel to investigate their concerns. Around the same time, two surgeons made disclosures to Ombudsman Victoria. The Ombudsman subsequently released two reports expanding on the findings of the peer review panel. The situation at The Alfred was remarkable for the numerous and diverse issues raised and the involvement of several external agencies. This article provides an overview and analysis of the peer review panel and Ombudsman's reports and the outcomes of the referrals and recommendations.

Self-audit y la acreditación de tutores / Self-audit and tutor accreditation

ObjetivoDescribir la experiencia de utilización del self audit (SA) como criterio de acreditación de los tutores de medicina familiar y comunitaria, analizar el conocimiento que tienen los tutores de esta metodología de autoevaluación y recoger su opinión respecto a este método.DiseñoEstudio descriptivo retrospectivo y análisis de un cuestionario de opinión.EmplazamientoUnidades docentes (UU.DD.) de medicina familiar y comunitaria de Cataluña.ParticipantesTutores de las UU.DD. de medicina familiar y comunitaria de Cataluña (julio de 2001 a julio de 2008).IntervencionesFormación de los tutores en la metodología SA, creación de un grupo de referencia y circuito de corrección. Corrección por pares de los SA realizados por los tutores según unos criterios determinados previamente y envío posterior de un informe-feedback. Encuesta de opinión autoadministrada a un grupo de tutores de las UU.DD.Mediciones y resultados principalesSe realizaron 673 SA. El tema más frecuentemente escogido fue la diabetes mellitus (27,9% de los casos). La valoración global de los SA desde un punto de vista metodológico fue correcta en el 44,5% de los casos, mejorable en el 45,3% y deficiente en el 10,2%.Mediciones y resultados principalesEn relación con los cuestionarios de opinión, se enviaron 300. El índice de respuesta fue de 151/300 (50,3%). Ante la pregunta sobre la utilidad del SA para la práctica profesional, un 12% lo consideraba muy útil; un 56%, bastante útil y un 32%, poco o nada útil.Mediciones y resultados principalesRespecto de si era un buen criterio para la reacreditación y acreditación de tutores, un 63% opinaba que no...(AU)

ObjectiveTo describe the experience of using self-audit (SA) as a means of accrediting family and community medicine tutors, to analyse the knowledge that the tutors have on this self-assessment methodology, and to record their opinions on this method.DesignRetrospective descriptive study and analysis of an opinion questionnaire.SettingFamily and community medicine teaching units (TU) in Catalonia.ParticipantsTutors from family and community medicine TU in Catalonia (July 2001–July 2008).MethodsTraining of the tutors in SA methodology, creation of a reference group and a correction cycle. Correction by peers of the SAs performed by the tutors according to previously determined criteria and subsequent issue of a report-feedback. Self-administered questionnaire by a group of TU tutors.Measurements and main outcomesA total of 673 SA were performed. The most frequent topic selected was diabetes mellitus in 27.9% of cases. The overall evaluation of the SA from a methodological point of view was correct in 44.5% of cases, improvable in 45.3%, and deficient in 10.2%.Measurements and main outcomesA total of 300 opinion questionnaires were issued. The response rate was 151/300 (50.03%). On the question about the usefulness of the SA in professional practice, 12% considered it very useful, 56% adequate, and 32% of little use or not useful.Measurements and main outcomesAs regards whether it was a good means for the re-accreditation or accreditation of tutors, 66% considered that it was not.ConclusionsA high percentage of the SAs analysed are not carried out correctly, which indicates that tutors do not know this self-assessment method very well. They consider that SAs are a useful tool for improving clinical practice, but not a good means for accreditation and re-accreditation(AU)

Assisted conception and the audit culture.

This paper explores the benefits and burdens of regulation in assisted conception, drawing on a series of interviews with practitioners and a range of recent writings on the social and political context of audit and bureaucracy. The process of regulation brings accountability and new competencies to assisted conception professionals, increasing their influence locally and nationally. Early career and laboratory staff are able to draw on protocols and standard operating procedures to improve their practice and enhance their authority within the assisted conception team and the wider institution. However, audit intensifies the focus upon paperwork rather than practice. Measures such as double witnessing can undermine trust amongst professionals, and this can have detrimental effects on performance. Systems such as incident reporting can become overloaded with minor problems, and do not necessarily allow sufficient time for reflection and feedback regarding the best ways of preventing errors. Performance data designed to increase patient choice can undermine it when clinics have to limit their treatment options or change practices to try to 'improve' their results. In conclusion, feedback and discussion between the regulator and a range of staff groups enhances the benefits of regulation and reduces its burdens.