Competency-Based Medical Education in the Internal Medicine Clerkship: A Report From the Alliance for Academic Internal Medicine Undergraduate Medical Education Task Force.

As medical educators continue to redefine learning and assessment across the continuum, implementation of competency-based medical education in the undergraduate setting has become a focus of many medical schools. While standards of competency have been defined for the graduating student, there is no uniform approach for defining competency expectations for students during their core clerkship year. The authors describe the process by which an Alliance for Academic Internal Medicine task force developed a paradigm for competency-based assessment of students during their inpatient internal medicine (IM) clerkship. Building on work at the resident and fellowship levels, the task force focused on the development of key learning outcomes as defined by entrustable professional activities (EPAs) that were specific to educational experiences on the IM clerkship, as well as identification of high-priority assessment domains. The work was informed by a national survey of clerkship directors.Six key EPAs emerged: generating a differential diagnosis, obtaining a complete and accurate history and physical exam, obtaining focused histories and clinically relevant physical exams, preparing an oral presentation, interpreting the results of basic diagnostic studies, and providing well-organized clinical documentation. A model for assessment was proposed, with descriptors aligned to the scale of supervision and mapped to Accreditation Council for Graduate Medical Education domains of competence. The proposed paradigm offers a standardized template that may be used across IM clerkships, and which would effectively bridge competency evaluation in the clerkship to fourth-year assessment as well as eventual postgraduate training.

The new opt-out Dutch National Breast Implant Registry - Lessons learnt from the road to implementation.

An estimated 1-3% of all women in the Netherlands carry breast implants. Since the introduction five decades ago, problems with a variety of breast implants have emerged with direct consequences for the patients' health. Plastic surgeons worldwide reacted through campaigning for auditing on long-term implant quality, surgeon performance, and institutional outcomes in implant registries. Especially, the PIP implant scandal of 2010 demonstrated the paucity of epidemiological data and uncovered a weakness in our ability to even 'track and trace' patients. In addition, a recent report of the Dutch Institute of National Health showed a lack of compliance of 100% of breast implant producers to CE requirements. These arguments stress the need for an independent implant registry. Insufficient capture rates or dependence from the implant producers made the variety of national and international patient registries unreliable. The Dutch Breast Implant Registry (DBIR) is unique because it is an opt-out registry without the need for informed consent and thus a high capture rate. Furthermore, an estimated 95% of breast implants are implanted by board-certified plastic surgeons. Funding was received from a non-governmental organisation to increase the quality of health care in the Netherlands, and maintenance is gathered by 25 euros per implant inserted. This article describes the way the Dutch have set up their system, with special attention to the well-known hurdles of starting a patient registry. Examples include: funding, medical ethical issues, opt out system, benchmarking, quality assurance as well as governance and collaboration. The Dutch consider their experience and data shareware for others to be used globally to the benefit of patient safety and quality improvement.

Fourth consensus of the International Society for Premenstrual Disorders (ISPMD): auditable standards for diagnosis and management of premenstrual disorder.

Whilst professional bodies such as the Royal College and the American College of Obstetricians and Gynecologists have well-established standards for audit of management for most gynaecology disorders, such standards for premenstrual disorders (PMDs) have yet to be developed. The International Society of Premenstrual Disorders (ISPMD) has already published three consensus papers on PMDs covering areas that include definition, classification/quantification, clinical trial design and management (American College Obstetricians and Gynecologists 2011; Brown et al. in Cochrane Database Syst Rev 2:CD001396, 2009; Dickerson et al. in Am Fam Physician 67(8):1743-1752, 2003). In this fourth consensus of ISPMD, we aim to create a set of auditable standards for the clinical management of PMDs. All members of the original ISPMD consensus group were invited to submit one or more auditable standards to be eligible in the inclusion of the consensus. Ninety-five percent of members (18/19) responded with at least one auditable standard. A total of 66 auditable standards were received, which were returned to all group members who then ranked the standards in order of priority, before the results were collated. Proposed standards related to the diagnosis of PMDs identified the importance of obtaining an accurate history, that a symptom diary should be kept for 2 months prior to diagnosis and that symptom reporting demonstrates symptoms in the premenstrual phase of the menstrual cycle and relieved by menstruation. Regarding treatment, the most important standards were the use of selective serotonin reuptake inhibitors (SSRIs) as a first line treatment, an evidence-based approach to treatment and that SSRI side effects are properly explained to patients. A set of comprehensive standards to be used in the diagnosis and treatment of PMD has been established, for which PMD management can be audited against for standardised and improved care.

[Physicians with access to point-of-care tests significantly reduce the antibiotic prescription for common cold]. / Los médicos que disponen de pruebas rápidas disminuyen significativamente la prescripción de antibióticos en el resfriado común.

OBJECTIVE: This study was aimed at evaluating the effect of two levels of intervention on the antibiotic prescribing in patients with common cold. METHODS: Before and after audit-based study carried out in primary healthcare centres in Spain. General practitioners registered all the episodes of common cold during 15 working days in January and February in 2008 (preintervention). Two types of intervention were considered: full intervention, consisting in individual feedback based on results from the first registry, courses in rational antibiotic prescribing, guidelines, patient information leaflets, workshops on rapid tests -rapid antigen detection and C-reactive protein tests- and provision of these tests in the surgeries; and partial intervention, consisting of all the above intervention except for the workshop and they did not have access to rapid tests. The same registry was repeated in 2009 (postintervention). In addition, new physicians filled out only the registry in 2009 (control group). RESULTS: 210 physicians underwent the full intervention, 71 the partial intervention and 59 were assigned to the control group. The 340 doctors prescribed antibiotics in 274 episodes of a total of 12,373 cases registered (2.2%).The greatest percentage of antibiotic prescription was found in the control group (4.6%). The partial intervention increased the antibiotic prescription percentage from 1.1% to 2.7% while only doctors who underwent the complete intervention lead to a significant reduction of antibiotics prescribed, from 2.9% before to 0.7% after the intervention (p<0.001). CONCLUSION: Only physicians with access to rapid tests significantly reduced antibiotic prescription in patients with common cold.

An institutional review board-based clinical research quality assurance program.

Despite the acknowledged importance of quality assurance in the clinical research process, the problem of how such a program should be implemented at the level of an academic teaching hospital or a similar institution has not been addressed in the literature. Despite the fact that quality assurance is expected in programs which certify and accredit Institutional Review Boards (IRBs), very little is known about the role of the IRB in programs of clinical research quality assurance. In this article we consider the definition of clinical research quality assurance, and describe a program designed to achieve it. The key elements of such a program are education at the site level, which has both mandatory and voluntary components, and an auditing and monitoring program, which reinforces the education on quality assurance. The role of the IRB in achieving the program goals and the organizational placement of the quality assurance program within the IRB structure and function are important items of discussion.

Audit of audit: review of a clinical audit programme in a teaching hospital intensive care unit.

OBJECTIVE: A comprehensive review of the clinical audit programme in a teaching hospital intensive care unit. DESIGN: A retrospective analysis of the clinical audit projects undertaken within the intensive care unit over the preceding 2 years and compared with published national guidelines for clinical audit. SETTING: A 27-bedded teaching hospital intensive care unit in the UK. MEASUREMENTS: Each audit project was reviewed independently by two assessors. The following questions were assessed. 1. Were the projects true audits? 2. Were they prospective of retrospective? 3. Did the projects have input from appropriate members of the multidisciplinary team. 4. How many of the audit projects were re-audits? 5. Of the re-audits how many showed evidence of service improvement? each audit project was also scored against the Audit Project Assessment Tool produced by the UK Clinical Governance Support Team. RESULTS: Of the twenty five audit projects reviewed twenty two were considered to be true audits. All of the projects used only retrospective data. Audit projects were contributed from all sections of the multidisciplinary critical care team but there were few truly multidisciplinary projects. Four of the audit projects were re-audits, of these three showed service improvement and one showed deterioration. Of the twenty two true audit projects reviewed, eleven were classified as good quality projects using the Audit Project Assessment Tool. CONCLUSIONS: Despite the clinical audit programme being active and well supported, objective evidence of clinical governance benefit was lacking. The overall clinical audit programme has been revitalised by a series of improvements since undertaking this review and this approach is recommended to other organizations who are interested in improving their clinical audit performance.

[Scientific monitoring of the visitation procedure in inpatient rehabilitation centres of the German statutory pension insurance fund--the "Visit II" Project]. / Wissenschaftliche Begleitung der Weiterentwicklung des Visitationsverfahrens für Reha-Kliniken der Deutschen Rentenversicherung Bund--Das Projekt "Visit II".

Visitation procedures are an established method of external quality assurance. They have been conducted for many years in the German statutory pension insurance's medical rehabilitation centres and have continuously been refined and standardized. The overall goal of the visitation procedure implemented by the German statutory pension fund is to ensure compliance with defined quality standards as well as information exchange and counselling of rehabilitation centres. In the context of advancing the visitation procedure in the German statutory pension funds' medical rehabilitation centres, the "Visit II" Project was initiated to evaluate the perspectives and expectations of the various professional groups involved in the visitations and to modify the materials used during visitations (documentation form and manual). Evaluation data from the rehabilitation centres visited in 2008 were gathered using both written surveys (utilization analysis) and telephone-based interviews with administration managers and chief physicians. The utilization analysis procedure was evaluated with regard to its methodological quality. In addition, the pension insurance physicians in charge of patient allocation during socio-medical assessment were surveyed with regard to potential needs for revision of the visitation procedure. Data collection was complemented by expert panels with auditors. Interviews with users as part of the formative evaluation of the visitation procedure showed positive results regarding acceptance and applicability of the visitations as well as of the utilization analysis procedures. Various suggestions were made with regard to modification and revision of the visitation materials, that could be implemented in many cases. Documentation forms were supplemented by current scientifically-based topics in rehabilitation (e. g., vocationally oriented measures), whereas items with minor relevance were skipped. The manual (for somatic indications) was thoroughly revised. The transparent presentation of visitation processes and visitation criteria has proven to be a useful basis for strengthening the cooperation between the statutory pension insurance funds and the rehabilitation centres. Moreover, it is a helpful tool for the systematic and continuous advancement of this complex method by including all parties involved.

A clinical audit programme for diagnostic radiology: the approach adopted by the International Atomic Energy Agency.

The International Atomic Energy Agency (IAEA) has a mandate to assist member states in areas of human health and particularly in the use of radiation for diagnosis and treatment. Clinical audit is seen as an essential tool to assist in assuring the quality of radiation medicine, particularly in the instance of multidisciplinary audit of diagnostic radiology. Consequently, an external clinical audit programme has been developed by the IAEA to examine the structure and processes existent at a clinical site, with the basic objectives of: (1) improvement in the quality of patient care; (2) promotion of the effective use of resources; (3) enhancement of the provision and organisation of clinical services; (4) further professional education and training. These objectives apply in four general areas of service delivery, namely quality management and infrastructure, patient procedures, technical procedures and education, training and research. In the IAEA approach, the audit process is initiated by a request from the centre seeking the audit. A three-member team, comprising a radiologist, medical physicist and radiographer, subsequently undertakes a 5-d audit visit to the clinical site to perform the audit and write the formal audit report. Preparation for the audit visit is crucial and involves the local clinical centre completing a form, which provides the audit team with information on the clinical centre. While all main aspects of clinical structure and process are examined, particular attention is paid to radiation-related activities as described in the relevant documents such as the IAEA Basic Safety Standards, the Code of Practice for Dosimetry in Diagnostic Radiology and related equipment and quality assurance documentation. It should be stressed, however, that the clinical audit does not have any regulatory function. The main purpose of the IAEA approach to clinical audit is one of promoting quality improvement and learning. This paper describes the background to the clinical audit programme and the IAEA clinical audit protocol.

[Clinical safety and patient oriented care: descriptive study of 113 Spanish hospitals and similarities in other European countries]. / Seguridad clínica y orientación al paciente: estudio descriptivo en 113 hospitales españoles y similitudes en otros países europeos.

OBJECTIVES: This study describes the stage of development of the Spanish acute care hospitals quality improvement systems. It also presents data on their achievement of some specific requirements related to clinical safety and patient oriented care. Additional data from seven other European countries are included, in order to provide a comparative reference for the analysis of results. MATERIAL AND METHODS: Cross-sectional descriptive study developed in acute care hospitals with more than 100 beds from 8 European countries. Data was gathered using an on-line questionnaire that had more than 500 close questions. In order to validate the responses, a sample of the hospitals that had answered the questionnaire received an evaluation by external assessors. RESULTS: A total of 113 public and private Spanish hospitals participated in the study, which represented 34% of the total group that met the inclusion criteria. Another 276 hospitals from 7 other countries also answered the questionnaire. The results associated with quality management, clinical safety and patient oriented care from both groups are presented. CONCLUSIONS: Improvements must be made in those areas where Spanish hospitals have a lower developmental level than the rest of the participating countries: public dissemination of results from external quality assessments, development of some key mechanisms to promote clinical safety and patient involvement in organisational management.

[Evaluation of healthcare quality for acute cerebrovascular disease in the context of the service level agreement]. / Evaluación de la calidad de la atención a la enfermedad cerebrovascular aguda en el marco del contrato programa.

BACKGROUND: The service level agreement establishes the quality requirements for those services contracted by the Basque Government Health Department from Osakidetza-Servicio Vasco de Salud. Acute cerebrovascular disease (ACVD) is one of the care processes with quality specifications. OBJECTIVE: To outline the procedure adopted to evaluate ACVD care and the results obtained in four hospitals in Vizcaya between 2003 and 2007. MATERIAL AND METHODS: In 2003, a work group consisting of clinicians, hospital and quality assurance managers, and experts from the Regional Health Board chose a series of indicators which would be measured by an external auditor. This group reviews the results annually and sets objectives for the following financial year. RESULTS: The improvement in almost all the indicators has been significant, and those with high ratings from the beginning have maintained their level. The percentage of patients who had a CAT scan in the first six hours after arriving at hospital increased from 57% to 85%, and the administration of anticoagulants within 12 hours increased from 70% of cases to 90%. The fibrinolysis rate was 3.8% in two hospitals. The percentage of patients who began rehabilitation whilst admitted was less than 3%. CONCLUSIONS: After operating for five years, the procedure adopted, which involves collaboration between clinical, management and planning staff, has been shown to be viable and effective in improving the quality of ACVD care.

Reduction in diabetic amputations over 11 years in a defined U.K. population: benefits of multidisciplinary team work and continuous prospective audit.

OBJECTIVE: To assess changes in diabetic lower-extremity amputation rates in a defined relatively static population over an 11-year period following the introduction of a multidisciplinary foot team. RESEARCH DESIGN AND METHODS: All diabetic patients with foot problems admitted to Ipswich Hospital, a large district general hospital, were identified by twice-weekly surveillance of all relevant in-patient areas and outcomes including amputations recorded. RESULTS: The incidence of major amputations fell 62%, from 7.4 to 2.8 per 100,000 of the general population. Total amputation rates also decreased (40.3%) but to a lesser extent due to a small increase in minor amputations. Expressed as incidence per 10,000 people with diabetes, total amputations fell 70%, from 53.2 to 16.0, and major amputations fell 82%, from 36.4 to 6.7. CONCLUSIONS: Significant reductions in total and major amputation rates occurred over the 11-year period following improvements in foot care services including multidisciplinary team work.

[Audited teaching program for the treatment of rectal cancer in Spain: results of the first year]. / Proceso docente auditado del tratamiento del cáncer de recto en España: resultados del primer año.

INTRODUCTION: Rectal cancer (RC) is one of the tumors showing the greatest discrepancies in outcomes, both in terms of local recurrence (LR) and survival. In Spain, the overall LR rates are unknown, but several European studies have demonstrated that the introduction of national training programs have decreased these rates and have increased survival. The aim of the present study was to present a descriptive analysis of the first results of a national teaching program in total mesorectal excision (TME). MATERIAL AND METHOD: The Spanish Association of Surgeons initiated the organization of the teaching process and its scientific committee was made responsible for selecting the group that started the project, based on multidisciplinary teams that met the established requirements. A database containing all the variables studied was designed. RESULTS: Over the 1-year period, data on 346 patients with RC were gathered. Of these, the tumor was located in the upper third of the rectum in 109 patients, in the middle third in 150, and in the lower third in 87 patients. Endoanal ultrasonography was performed in 222 patients (64.1%) and magnetic resonance imaging in 237 (68.5%). A total of 313 patients were suitable for surgery; 69.3% underwent open surgery and 30.7% underwent laparoscopy. The conversion rate was 21.9%. Sphincter-preserving surgery was performed in 224 patients (71.5%). Morbidity was 37% and mortality was 3%. The quality of the mesorectum was satisfactory in 76% and unsatisfactory in 7%. CONCLUSIONS: Based on the results obtained during the first year, we believe that the implementation of a national teaching program on TME is feasible and, moreover, that it would improve surgical outcomes.

IRQN Award article: Radiology audit: a program developed for remote or solo-practicing radiologists: a New Zealand quality initiative.

New Zealand radiologists working in solo or locum tenens practice away from colleagues in hospital departments or at large practices may have problems satisfying peer review and audit requirements for the Medical Council of New Zealand and Royal Australian and New Zealand College of Radiologists. This paper describes a practical audit program developed by a small group of New Zealand radiologists that commenced in 2005. Each year, a set of cases with known clinical and pathologic outcomes is sent from one radiologist to the next on a rota system. Reports are e-mailed back, then audited, with comments being returned again by e-mail. Each radiologist therefore acts as both reporter and auditor, ensuring a spectrum of audit around the group. The cases are reported blind, but usually, a limited amount of clinical information is provided, as would be the case on a request form in clinical practice. The process of audit is described, and the reaction to and acceptance of the program by the participants have been surveyed at the end of the first year of operation. The program has achieved overall acceptance by the group and is approved by the continuing medical education committee of the college, hence satisfying the Medical Council of New Zealand.