50 Years of the IAEA/WHO postal dose audit programme for radiotherapy: what can we learn from 13756 results?

Background: The IAEA/WHO postal dose audit programme has been operating since 1969 with the aim of improving the accuracy and consistency of dosimetry in radiotherapy in low-income and middle-income countries world-wide. This study summarises the 50 years' experience of audits and explores the quality of reference dosimetry in participating radiotherapy centres throughout the years.Material and methods: During the IAEA/WHO postal audits the dose determined from the mailed dosimeter is compared with that stated by the participant. Agreement to within ±5% is regarded acceptable whilst deviations outside ±5% limits trigger follow-up actions. Of particular interest in this study was the dependence of clinical dosimetry quality on factors related to the centre infrastructure and expertise in dosimetry of its staff.Results: The IAEA/WHO dose audit programme noted great increase in the overall percentage of acceptable results from about 50% in its early years to 99% at present, although there is some variability of results amongst participating countries. Whereas results for younger radiotherapy machines show the agreement rate between the measured and the stated doses well above 90%, for those over 20 years old the rate dropped to <80%. Linac dosimetry was always better than 60Co dosimetry and multi-machine centres generally performed better than single machine centres equipped with cobalt alone. Second and subsequent participation in audits showed higher quality dosimetry than the first participation. The implementation of modern dosimetry protocols resulted in more accurate dosimetry than the use of the older protocols.Conclusions: Over the 50 years that the IAEA has accumulated dosimetry audit data, practices in radiotherapy centres have significantly improved. Higher quality dosimetry confirmed in audits is generally associated with better infrastructure and adequate dosimetry expertise of medical physicists in participating centres.

U.S. Food and Drug Administration inspections of clinical investigators: overview of results from 1977 to 2009.

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research is responsible for evaluating drug safety and efficacy, including oversight of clinical trials and principal investigators. The FDA Clinical Investigator Inspection List (CIIL) contains online, detailed, relevant information of all FDA inspections. We reviewed FDA inspections of clinical investigators to ascertain their outcome and included all inspections on the list (July 1977 through December 31, 2009; n = 9,481 inspections). Eighty-eight percent of inspections were "data audit" (primary purpose = verification of data), and the rest (12%) were "for cause." The number of inspections each year significantly increased over time (P < 0.0001) and averaged 350 per year in the past decade. No deficiencies were found in only 11.2% of all "data audit" and 5% of all "for cause" inspections. Only 31% of inspections resulted in "no action indicated." About two thirds of inspections resulted in some finding, requiring either voluntary investigator action (61.3% of inspections) or official FDA action (3.9%). The most frequently cited deficiencies were failure to follow investigational plan (34%), inadequate informed consent form (28%), and inadequate/inaccurate records (27%). In conclusion, over the past decade, the FDA has performed approximately 350 inspections per year, with the number increasing over time. The vast majority of FDA inspections yield deficiency findings and, as a result, only about one third of inspections have an outcome of "no action indicated."

Patients admitted with an acute coronary syndrome (ACS) in New Zealand in 2007: results of a second comprehensive nationwide audit and a comparison with the first audit from 2002.

AIMS: To audit all patients admitted to a New Zealand (NZ) Hospital with an acute coronary syndrome (ACS) over a 14-day period, to assess their number, presentation type and patient management during the hospital admission and at discharge. To compare patient management in 2007 with the 1st NZ Cardiac Society ACS Audit from 2002. METHODS: We updated the established NZ ACS Audit group of 36 hospitals to 39 hospitals now admitting ACS patients across New Zealand. A comprehensive data form was used to record individual patient information for all patients admitted between 00.00 hours on 14 May 2007 to 24.00 hours on 27 May 2007. RESULTS: 1003 patients, 9% more than in 2002 (n=930), were admitted with a suspected or definite ACS: 8% with a ST-segment-elevation myocardial infarction (STEMI), 41% with a non-STEMI (NSTEMI), 33% with unstable angina pectoris (UAP), and 17% with another cardiac or medical condition. In 2007 non-invasive risk stratification following presentation remained similar to 2002 and was suboptimal: exercise treadmill tests (21% vs 20%, p=0.62), echocardiograms (19% vs 20%, p=0.85). An increase in utilisation of coronary angiography was noted (32% vs 21%, p<0.0001). In hospital revascularisation rates remained low in patients with diagnosed ACS (n=828): STEMI (45%), NSTEMI (23%) and UAP (7.3%). In comparison to 2002, changes were noted in revascularisation techniques with percutaneous coronary intervention (PCI) performed in 19% vs 7% (p<0.0001). The use of coronary artery bypass grafting (CABG) remained extremely low: 2.8% vs 3.5% (p=0.20). The use of hospital and discharge medication of proven benefit was also limited. CONCLUSIONS: A collaborative group of clinicians and nurses has performed a second nationwide audit of ACS patients. Despite a small increase in access to cardiac angiography, guideline recommended risk stratification following the index suspected ACS admission with a treadmill test or cardiac angiogram occurred in only 1 in 2 (48%) patients. Furthermore, in patients with a definite ACS, levels of revascularisation are low. (PCI 19%, CABG 2.8%). These aspects of care remain of significant concern and have not substantially changed in 5 years. There remains an urgent need to develop a comprehensive national strategy to improve all aspects of ACS patient management.

"Gearing to a time table"; the evolution of earlier surgical eschar excision in massive burns by British burns surgeons at the battles of Cassino, 1944: an example of real-time audit.

The effectiveness of burns care delivery is difficult to measure within a realistic workload and resource framework. In addition, workers must develop new tools for this purpose. We describe a historical example from World War II describing the evolution of burns excision in the context of thorough outcome assessment, during the allied advance from North Africa up the Italian peninsular, including the battles of Cassino 1942-1945. Patrick Clarkson and Rex Lawrie working as plastic surgeons in a small forward Maxillofacial Unit were able to fully assess the management and outcome of 800 burnt servicemen. 192 burns were full thickness and required grafting. Prospective data revealed that those burns which were surgically excised and grafted between 12 and 18 days recovered more quickly than those managed by conservative dressings until the eschar had sloughed off followed by grafting. Burns managed by excision and grafting in less than 5 weeks following burning (n=86) healed 8.6 days faster than those grafted later (n=106). This difference was increased for massive burns of over 1000 cm(2), with those grafted in less than 5 weeks (n=17) healing 13 days faster than the delayed group (n=27). Their transparent and simple method of prospective audit is described.

Amygdaloid neurosurgery for aggressive behaviour, Sydney, 1967-1977: chronological narrative.

OBJECTIVE: The aim of this paper is to record an historical narrative of amygdaloid neurosurgery at Callan Park Mental Hospital, Sydney in the period 1967-1977. In this paper, this is denoted the Amygdaloid Neurosurgery Project (ANP). The goal of the project was to ameliorate aggressive or self-harming behaviour by selective ablative surgery on the amygdaloid nucleus. CONCLUSIONS: In 1964, Professor Leslie Gordon Kiloh became acting director of the newly built neurosurgical research facility at Callan Park Mental Hospital. In 1966, he advised bilateral amygdaloidotomy for the treatment of a 16-year-old aggressive and self-harming male patient. Following major improvement in that patient's condition, a further 19 patients were treated by amygdaloid surgery. In 1974, Kiloh's team reported that 39% of the first 18 patients treated had persisting improvement but one patient sustained persisting hemiplegia. The program was suspended in 1977 by the New South Wales (NSW) Government, following allegations by a senior nurse that patients at the neurosurgical unit had been mistreated. A Ministerial Committee of Inquiry proposed that stringent legislative controls should be applied to psychosurgery. The Committee expressed reservations about amygdaloid psychosurgery in particular. Psychosurgery referrals declined after that date. Since 2007, under the revised NSW Mental Health Act, all forms of neurosurgery for psychiatric disorder are prohibited.

Amygdaloid neurosurgery for aggressive behaviour, Sydney, 1967-1977: societal, scientific, ethical and other factors.

OBJECTIVES: In 1967, despite escalating international hostility towards psychosurgery, a program of amygdaloid neurosurgery for the reduction of aggressive and self-harming behaviour commenced in Sydney. In this paper, the second of two articles on the Amygdaloid Neurosurgery Project (ANP), we analyse the relative contributions of seven nominated societal, ethical and other factors to the genesis and demise of the ANP, and consider implications of the history of the ANP for the future of neurosurgery for psychiatric disorders (NPD) in New South Wales (NSW) and elsewhere. CONCLUSIONS: Leadership and the availability of resources were crucial factors in the genesis of the project. Its scientific foundations were doubtful in 1967, and remain so in 2009. Ethical issues became the focus of hostile media and Government attention in 1977 and precipitated the project's demise. Lessons derived from an historical analysis of the ANP should assist the medical profession develop appropriate approaches to recent advances in NPD, including deep brain stimulation, new ablative procedures and stem cell implantation.

Royal Newcastle Hospital: the passing of an icon.

From the 1930s to the 1960s, Royal Newcastle Hospital was the centre for innovation in Australian health care. Many of the innovations were driven by a visionary medical superintendent, Chris McCaffrey, and the staff he appointed. Among the reforms he introduced were: an overarching emphasis on efficiency; the appointment of salaried specialist staff, now widespread; the unit record system for medical records, now universal; a domiciliary care service, now established in most of Australia; and an emphasis on audit and quality studies, now largely abandoned in the form pioneered in Newcastle. These innovations were vigorously opposed by organised medicine and barely tolerated by the health bureaucracy. They are unlikely to be replicated in the current environment where hospitals are run by managers in a culture dominated by budgetary considerations.

Auditoria de historias médicas orientada a problemas Centro Integral de la Familia, febrero 2004 Maracaibo / Audit of histories prescribes guide to problems Integral Center of the Family february 2004 Maracaibo

Estudio descriptivo cuyo objetivo es determinar la Calidad General de Registros en las Historias Orientada a Problemas (HOP). Aplicación de formatos de registros para revisión de 10 historias por médicos, seleccionadas al azar, con 3 niveles de llenado de cada sección de la historia, Calidad General de Registros en 5 niveles. Procedimiento estadístico en EPI INFO 6,04. El porcentaje promedio del nivel de llenado es de 35,4 por ciento de las historias en todos las secciones de la historia, en nivel 2 es de 41 por ciento, en nivel 1 de 23,5 por ciento. El 43,3 por ciento de las historias obtuvieron un nivel 3 de Calidad General de Registros, el 35,2 por ciento obtuvieron un nivel 4 y el 14,4 por ciento un nivel 2. Las secciones de la historia con mayor deficiencia fueron familigrama y hoja de mantenimiento de salud, la calidad general de registros es buena aunque mejorable. Este formato permitió calcular el cumplimiento de llenado de las historias como parte de la evaluación del desempeño del médico familiar

Jack Smyth: a major contribution to surgery.

This personal comment records the contributions of the late Dr John Smyth and Royal Newcastle Hospital to surgical audit and surgical training. Smyth introduced surgical audit to this country against considerable professional opposition. The first publication on the subject appeared in The Medical Journal of Australia in 1959.

[Surgical quality assurance in the former Cottbus district]. / Chirurgische Qualitätssicherung im ehemaligen Bezirk Cottbus.

30 years ago we began with systematical recording of dates from the main operation groups as cholelithiasis, gastroduodenal ulcer, goitre and appendicitis. This was followed by a regularly internal proving of this dates. A voluntary comparative audit was done between the 14 departments in the district. Besides surgical aspects there were also respected organisation and efficiency.

Audit in British general practice: domination or disillusionment?

The history of audit is traced over the past 30 years demonstrating how it has come to dominate attempts to improve the quality of patient care in British general practice. Nevertheless it is still uncertain whether audit usually or occasionally yields such improvements. There is much more to learn about audit including whether any benefits it brings are through professional education. I suggest that the use of audit as a foundation upon which clinical governance is built is not a secure one.

The history and achievements of the National Confidential Enquiry into Perioperative Deaths.

The National Confidential Enquiry into Perioperative Deaths started in 1989 as a direct development of a Confidential Enquiry in the United Kingdom in 1984. Different samples from the 20,000 deaths in hospital within 30 days of a surgical operation are selected each year. Questionnaires about these are examined by groups of anaesthetists and surgeons, and lessons about the quality of perioperative care are derived. Causation is not emphasized but examples of potential for improvement are sought. Changes of consultant practice, increase in medical audit, improvement in physiological monitoring, appropriate matching of specialist experience to patients' medical conditions and increased awareness of the need for critical care areas are believed to have been influenced by this unique enquiry.

Medical fallibility and the autopsy in the USA.

The theory of 'necessary fallibility', originated by Gorovitz & MacIntyre (1976, In Science, Ethics and Medicine, Hastings Center, NY), explains a major unfamiliar reason for unavoidable errors in medicine. A brief historical review is presented of autopsy studies assessing the accuracy of clinical diagnoses, and of changing perceptions of the public and physicians leading to the current misconception in the USA that all errors are avoidable. It is suggested that a prospective autopsy study is needed to test the theory of 'necessary fallibility'. Validation of this theory would benefit an understanding of medical fallibility by the public and physicians, and challenge current practices in the management of malpractice and patient injury.

From audit to effectiveness: an historical evaluation of the changing role of Medical Audit Advisory Groups.

MAAGs were introduced as a result of the 1989 White Paper 'Working for Patients', with the remit to direct, coordinate and monitor medical audit activities in general practice. They were funded through the new FHSA management budget and each MAAG was responsible to its own FHSA. They were accepted as a completely new institution as a part of the introduction of an innovative management structure in a reformed NHS. When viewed in an historical context, MAAGs can actually be seen as a part of an expanding culture of greater objectivity and critical analysis which has burgeoned in medical practice over the last two decades. Although MAAGs began with an educational role with uniprofessional medical audit, they have embraced multiprofessional clinical audit in primary care in the context of the wider aspects of quality in practice. The last 20 years have seen the development of clinical guidelines, evidence-based medicine and application of business management theory to clinical quality. All these have reflected the increasing demand for explicit standards of care which has also formed the basis of clinical audit and MAAG activity. MAAGs should be seen as an inevitable concomitant of this historical trend to improve the application of scientific rigour in medical practice. With the adoption of clinical effectiveness, incorporating all these themes, as one of the NHS Executive's six medium-term priority areas, MAAGs are uniquely placed to act as agents of change to enhance the quality of primary health care.