An international survey on the role of the hospital transfusion committee.

BACKGROUND: Hospital transfusion committees (HTCs) can oversee all aspects of transfusion practice at a hospital. This survey sought to identify which quality variables were being reported at HTCs around the world. STUDY DESIGN AND METHODS: A working party composed of members of the Biomedical Excellence for Safer Transfusion (BEST) collaborative developed a survey of quality variables that could be potentially presented at HTC meetings. The survey was electronically sent to all BEST members who were encouraged to complete it if they were active on an HTC and to send it to other colleagues with similar experience. An expert panel was convened to determine which quality variables are the most important for review at HTC meetings. RESULTS: There were 121 respondents; the majority were from Europe (52%), Asia (19%), or North America (19%). Most respondents (68%) were at university hospitals. Of the 117 (97%) respondents with an HTC, the committee most often met quarterly (42%) and reviewed transfusion reactions (79%) and risk management-reported events (52%). The HTCs most commonly included transfusion medicine physicians, anesthesiologists, and other physicians who regularly transfuse blood products. Some of the most commonly reported quality variables included number of blood products transfused, wasted, and expired and the number of improperly labeled specimens. The expert panel analysis revealed that some variables that were deemed important were not being frequently reported at HTCs. CONCLUSION: There is variability in the variables being reported at HTCs around the world with some important variables not frequently reported.

The Neurostimulation Appropriateness Consensus Committee (NACC) Recommendations for Infection Prevention and Management.

INTRODUCTION: The use of neurostimulation for pain has been an established therapy for many decades and is a major tool in the arsenal to treat neuropathic pain syndromes. Level I evidence has recently been presented to substantiate the therapy, but this is balanced against the risk of complications of an interventional technique. METHODS: The Neurostimulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society convened an international panel of well published and diverse physicians to examine the best practices for infection mitigation and management in patients undergoing neurostimulation. The NACC recommendations are based on evidence scoring and peer-reviewed literature. Where evidence is lacking the panel added expert opinion to establish recommendations. RESULTS: The NACC has made recommendations to improve care by reducing infection and managing this complication when it occurs. These evidence-based recommendations should be considered best practices in the clinical implantation of neurostimulation devices. CONCLUSION: Adhering to established standards can improve patient care and reduce the morbidity and mortality of infectious complications in patients receiving neurostimulation.

The Neurostimulation Appropriateness Consensus Committee (NACC) Safety Guidelines for the Reduction of Severe Neurological Injury.

INTRODUCTION: Neurostimulation involves the implantation of devices to stimulate the brain, spinal cord, or peripheral or cranial nerves for the purpose of modulating the neural activity of the targeted structures to achieve specific therapeutic effects. Surgical placement of neurostimulation devices is associated with risks of neurologic injury, as well as possible sequelae from the local or systemic effects of the intervention. The goal of the Neurostimulation Appropriateness Consensus Committee (NACC) is to improve the safety of neurostimulation. METHODS: The International Neuromodulation Society (INS) is dedicated to improving neurostimulation efficacy and patient safety. Over the past two decades the INS has established a process to use best evidence to improve care. This article updates work published by the NACC in 2014. NACC authors were chosen based on nomination to the INS executive board and were selected based on publications, academic acumen, international impact, and diversity. In areas in which evidence was lacking, the NACC used expert opinion to reach consensus. RESULTS: The INS has developed recommendations that when properly utilized should improve patient safety and reduce the risk of injury and associated complications with implantable devices. CONCLUSIONS: On behalf of INS, the NACC has published recommendations intended to reduce the risk of neurological injuries and complications while implanting stimulators.

The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Bleeding and Coagulation Management in Neurostimulation Devices.

INTRODUCTION: The Neurostimulation Appropriateness Consensus Committee (NACC) was formed by the International Neuromodulation Society (INS) in 2012 to evaluate the evidence to reduce the risk of complications and improve the efficacy of neurostimulation. The first series of papers, published in 2014, focused on the general principles of appropriate practice in the surgical implantation of neurostimulation devices. The NACC was reconvened in 2014 to address specific patient care issues, including bleeding and coagulation. METHODS: The INS strives to improve patient care in an evidence-based fashion. The NACC members were appointed or recruited by the INS leadership for diverse expertise, including international clinical expertise in many areas of neurostimulation, evidence evaluation, and publication. The group developed best practices based on peer-reviewed evidence and, in the absence of specific evidence, on expert opinion. Recommendations were based on international evidence in accordance with guideline creation. CONCLUSIONS: The NACC has recommended specific measures to reduce the risk of bleeding and neurological injury secondary to impairment of coagulation in the setting of implantable neurostimulation devices in the spine, brain, and periphery.

Barriers to Effective Deliberation in Clinical Research Oversight.

Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve value judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call "deliberative pathologies," or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research.

Preventable mortality: does the perspective matter when determining preventability?

BACKGROUND: We report a novel approach to mortality review using a 360° survey and a multidisciplinary mortality committee (MMC) to optimize efforts to improve inpatient care. METHODS: In 2009, a 16-item, 360° compulsory quality improvement survey was implemented for mortality review. Descriptive statistics were performed to compare the responses by provider specialty, profession, and level of training using the Fisher exact and chi-square tests, as appropriate. We compared the agreement between the MMC review and provider-reported classification regarding the preventability of each death using the Cohen kappa coefficient. A qualitative review of 360° information was performed to identify the quality opportunities. RESULTS: Completed surveys (n = 3095) were submitted for 1683 patients. The possibility of a preventable death was suggested in the 360° survey for 42 patients (1.40%). We identified 502 patients (29.83%) with completed 360° surveys who underwent MMC review. The inter-rater reliability between the provider opinions regarding preventable death and the MMC review was poor (kappa = 0.10, P < 0.001). Of the 42 cases identified by the 360° survey as preventable deaths, 15 underwent MMC review; 3 were classified as preventable and 12 were deemed unavoidable. Qualitative analyses of the 12 discrepancies did reveal quality issues; however, they were not deemed responsible for the patients' death. CONCLUSIONS: The mortality survey yielded important information regarding inpatient deaths that historically was buried with the patient. Poor agreement between the 360° survey responses and an objective MMC review support the need to have a multipronged approach to evaluating inpatient mortality.

Development of the Australasian vascular surgical audit.

OBJECTIVE: The purpose of this study was to describe the development of the Australasian Vascular Audit that was created to unify audit activities under the umbrella of the Australian and New Zealand Society for Vascular Surgery as a Web-based application. METHODS: Constitutional change in late 2008 deemed participation in this audit compulsory for Society members. The Web-based application was developed and tested during 2009. Data for all open vascular surgery and for all endovascular procedures are collected at two points in the admission episode: at the time of operation and at discharge, and entered into the application. Data are analyzed to produce risk-adjusted outcomes. An algorithm has been developed to deal with outliers according to natural justice and to comply with the requirements of regulatory bodies. The Audit is protected by legislated privilege and is officially endorsed and indemnified by the Royal Australasian College of Surgeons. Confidentiality of surgeons and patients alike is ensured by a legally protected coding system and computer encryption system. Validation is by a verification process of 5% of members per year who are randomly selected. The application is completely funded by the Society. RESULTS: Data entry commenced on January 1, 2010. Over 40,000 vascular procedures were entered in the first year. The Audit application allows instantaneous on-line access to individual data and to deidentified group data and specific reports. It also allows real-time instantaneous production of log books for vascular trainees. The Audit has already gained recognition in the Australasian public arena during its first year of operation as an important benchmark of correct professional surgical behavior. Compliance has been extremely high in public hospitals but less so in private hospitals such that only 60% of members received a certificate of complete participation at the end of its first year of operation. CONCLUSION: An Internet-based compulsory audit of complete surgical practice is possible to create and be maintained by a society of surgeons with a membership of just over 200. The 60% compliance rate for complete data entry has created an immediate constitutional challenge for the Society. Future challenges are to improve total participation to an acceptable level and to ensure accurate data entry via a robust validation system.

Building better hospital transfusion committees for Ontario.

Hospital transfusion committees can be instrumental in ensuring appropriate blood utilization and that best practice standards are followed. In Ontario, Canada, the provincial Ministry of Health and Long-Term Care Blood Programs Coordinating Office has implemented several initiatives to support these multi-disciplinary hospital committees to fulfill their mandate. The primary goal is to improve patient safety and the secondary goal is to reinforce the importance of appropriate use of blood components and blood products. Recognizing the challenges in developing a fully functional hospital transfusion committee, several initiatives have been launched to provide educational resources and tools to achieve a successful outcome. The number of hospital transfusion committees in Ontario has increased over the past 5 years. Attendance at the annual educational forum for transfusion committees continues to be high. The majority of hospitals are using the resources and tools being provided. More work is needed to achieve the success of this strategy.

To detain or to release? Correlates of dispositions for individuals declared not criminally responsible on account of mental disorder.

OBJECTIVE: The extent to which risk assessment advances have influenced release decision-making by review boards (RBs) of individuals found not criminally responsible on account of mental disorder (NCRMD) remains unclear. Our objective is to identify the psychosocial, criminological, and risk measure correlates of RB decision-making. METHOD: Data were collected through structured interviews and file reviews conducted between October 2004 and August 2006 in the sole forensic psychiatric hospital in Quebec and in 2 civil psychiatric hospitals in a large metropolitan area designated to care for people found NCRMD. The final sample consisted of 96 men. RESULTS: Dynamic, clinical risk factors are associated with decisions to detain or release people found NCRMD, rather than traditional historical risk factors such as criminal history. CONCLUSION: Dynamic variables seem appropriate for the RBs to consider given the intention of the NCRMD legislation. Further, dynamic variables provide direction for titration of treatment and supervision. Results are discussed regarding enhancing evidence-informed RB dispositions.

Consensus statement: the use of intravenous immunoglobulin in the treatment of neuromuscular conditions report of the AANEM ad hoc committee.

Intravenous immunoglobulin (IVIG) is a therapeutic biologic agent that has been prescribed for over two decades to treat various neuromuscular conditions. Most of the treatments are given off-label, as little evidence from large randomized trials exists to support its use. Recently, IGIV-C has received an indication for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). Because of the lack of evidence, an ad hoc committee of the AANEM was convened to draft a consensus statement on the rational use of IVIG for neuromuscular disorders. Recommendations were categorized as Class I-IV based on the strength of the medical literature. Class I evidence exists to support the prescription of IVIG to treat patients with Guillain-Barré syndrome (GBS), CIDP, multifocal motor neuropathy, refractory exacerbations of myasthenia gravis, Lambert-Eaton syndrome, dermatomyositis, and stiff person syndrome. Treatment of Fisher syndrome, polymyositis, and certain presumed autoimmune neuromuscular disorders is supported only by Class IV studies, whereas there is no convincing data to substantiate the treatment of inclusion body myopathy (IBM), idiopathic neuropathies, brachial plexopathy, or diabetic amyotrophy using IVIG. Treatment with IVIG must be administered in the context of its known adverse effects. There is little evidence to advise the clinician on the proper dosing of IVIG and duration of therapy.

Complaints handling in hospitals: an empirical study of discrepancies between patients' expectations and their experiences.

BACKGROUND: Many patients are dissatisfied with the way in which their complaints about health care are dealt with. This study tested the assumption that this dissatisfaction consists - in part at least - of unmet expectations. METHODS: Subjects were 279 patients who lodged a complaint with the complaints committees of 74 hospitals in the Netherlands. They completed two questionnaires; one on their expectations at the start of the complaints handling process, and one on their experiences after the complaints procedure (pre-post design; response 50%). Dependent variables are patients' satisfaction and their feeling that justice was done; independent variables are the association between patients' expectations and their experiences. RESULTS: Only 31% of the patients felt they had received justice from the complaints process.Two thirds of the patients were satisfied with the conduct of the complaints committee, but fewer were satisfied with the conduct of the hospital or the medical professional (29% and 18%). Large discrepancies between expectations and experiences were found in the case of doctors not admitting errors when errors had been made, and of hospital managements not providing information on corrective measures that were taken. Discrepancies collectively explained 51% of patients' dissatisfaction with the committee and one third of patients' dissatisfaction with the hospital and the professional. The feeling that justice was done was influenced by the decision on the complaint (well-founded or not), but also by the satisfaction with the conduct of the committee, the hospital management and the professional involved. CONCLUSION: It is disappointing to observe that less than one third of the patients felt that justice had been done through the complaints handling process. This study shows that the feeling that justice had been done is not only influenced by the judgement of the complaints committee, but also by the response of the professional. Furthermore, hospitals and professionals should communicate on how they are going to prevent a recurrence of the events that led to the complaint.

The rise and fall(acy) of clinical directorates in Italy.

Clinical Directorates (CDs), in the sense of "intermediate organizational arrangements through which defined parts of larger hospitals health services are managed", were introduced in the Italian National Health Service (INHS) by law after the major reform of 1992. By means of such reform, accountability chains within INHS hospitals were streamlined. Changes looked at strengthening the role of management in hospitals as a strategy to improve efficiency in the provision of services. From this stream of managerialism emerged the attempts to re-organize hospital activities along the lines of clinical directorates. The aim of this paper is to outline the context in which CDs initially developed in Italy as the "one best way" to address current hospital problems and the reasons why they are now challenged due to not coming up to expectations. To do so we run through the last 10 years of history of CDs in Italy and propose an interpretative framework to understand the grounds for their partial failure and success.

[Possibilities of medical opinionating in cases associated with "exposure to direct danger of death or serious health damage"]. / Mozliwosci opiniowania lekarskiego w sprawach o "narazenie na bezposrednie niebezpieczenstwo utraty zycia lub ciezkiego uszczerbku na zdrowiu".

In the opinion of some forensic medicine experts, assessment of potential consequences in keeping with Article 160 of the Polish Penal code, which refers to the crime of "exposure to direct danger of death or severe health damage", lies within the competence of medicolegal specialists. This view is accepted by courts and prosecution offices. However, the knowledge of physicians in the field of predicting consequences which did not occur is only somewhat better than that of lawyers. In simple cases, e.g. in trauma involving a sensitive area of the body, passing an opinion confirming a serious danger is not associated with any major problems. Similarly, no problems arise when passing an opinion on the lack of such a danger e.g. in the case of traumawithout any injuries. In complex cases, however, which include the majority of medical error cases, passing an opinion on exposure to direct danger of death or severe health damage may be not feasible.

A Model for Incident Review Committees in Behavioral Health Settings.

Despite the fact that incident review committees have been a key component of quality improvement in behavioral health settings for decades, specific models of how these committees are structured and operate are not well described. We present a model for an incident review committee that has been implemented in 2 large, academic acute care psychiatric hospitals. We believe the model not only permitted us to efficiently and effectively review untoward incidents, but that it also provided an approach to calibrating standards of care for the institution, engaging physicians in an interdisciplinary effort, promulgating a culture of quality review and improvement throughout the organization, promoting continuity and sustainability of the incident review process, and, most importantly, driving beneficial change in clinical practice. Demonstration of the effectiveness of this model requires formal investigation.

Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute.

PURPOSE: To describe the rationale for independent data monitoring committees (DMCs) for National Cancer Institute (NCI)-sponsored phase III cooperative group clinical trials. DESIGN: We review the necessity for interim monitoring of outcome data during the course of randomized clinical trials and summarize the reasons for establishing DMCs with requisite expertise and with appropriate independence from study investigators. RESULTS: The important components of the policy for cooperative group DMCs are described with a focus on the makeup of these bodies and on the complementary roles of study committee leadership and DMCs in protecting patient safety during the conduct of randomized clinical trials. CONCLUSION: The cooperative group DMCs that are independent of the study committees and that have the requisite expertise to examine accumulating data and to base decisions on monitoring guidelines that are specified in advance by the study committee provide a body able to protect patient safety, to protect the integrity of the clinical experiments on which patients have consented to participate, and to assure the public that conflicts of interest do not compromise either patient safety or trial integrity.

Critical analysis of the current American Joint Committee on Cancer staging system for cutaneous melanoma and proposal of a new staging system.

PURPOSE: To critically review the accuracy of the current American Joint Committee on Cancer (AJCC) staging system for cutaneous melanoma and propose a more useful staging system. METHODS: Retrospective evaluation of the published data as well as a reanalysis of the University of Alabama and Sydney Melanoma Unit (UAB/SMU) data bases (n = 4,568) for patients with primary melanoma was performed to examine specifically the impact of level of invasion and ulceration on the prognostic value of tumor thickness. In addition, an overlay graphic technique was used to compare the Kaplan-Meier survival curves of patients with local recurrences, satellites, in-transit metastases, and nodal metastases reported in the literature. RESULTS: Tumor thickness and ulceration remained the most powerful prognostic indicators in patients with stage I and II disease. Level of invasion provided statistically significant prognostic information only in the subgroup of patients with tumor thickness < or = 1 mm, but the absolute 10-year survival differences were small and inconsistent (level II, 95%; level III, 85%; level IV, 89%). The best statistical fit for tumor thickness cutoffs was at 1 versus 2 versus 4 mm. The overlay graphic technique showed that patients who developed satellite lesions or local recurrence had prognoses similar to those of patients with stage III disease. The most important prognostic factor for patients with nodal metastases was number of involved nodes rather than size. CONCLUSION: Our analysis showed that the current AJCC staging system has many inaccuracies that should be modified to conform to published data. On the basis of our analysis and review of the literature, we propose a new and more accurate staging system.

[Medico-legal opinion in establishing "exposure to direct danger of death or grave detriment to health"]. / Opiniowanie sadowo-lekarskie a ustalanie "narazenia na bezposrednie niebezpieczenstwo utraty zycia lub ciezki uszczerbek na zdrowiu".

This paper deals with the problem of competence of the forensic expert opinions on the exposure to "direct danger of death or grave detriment to health". According to the analysis of judicial verdicts and the comments of lawyers "direct danger" depends closely on the probability, time and number of occurrences between the behavior of the perpetrator and the threatening act. The competence of the forensic expert does not allow for the legal qualification of the act but for the assessment of from the medicolegal point of view, defining the threat and possible outcomes in a descriptive fashion. The assessment of "direct danger" should be the result of close cooperation between the judicial representative and forensic expert.

Alimentos para usos médicos especiales en la Unión Europea: una actualización legislativa incompleta / Foods for special medical purposes in the European Union: an incomplete legislative update

Este artículo analiza el desarrollo, desde 1989 hasta 2019, de la legislación de la Unión Europea sobre los alimentos para usos médicos especiales dirigidos a pacientes y examina cómo desde 1997 los organismos científicos competentes de la Unión Europea y de los Estados Unidos de América han establecido valores de referencia de la dieta, así como niveles de ingesta superior tolerable para vitaminas y minerales basados en su seguridad. La actualización, mediante el Reglamento (UE) 2016/128, de la legislación de la Unión Europea de esta categoría de alimentos parece adecuada en el caso de los lactantes. Sin embargo, para los pacientes mayores de un año, los mínimos y máximos de vitaminas y minerales por 100 kcal de la Directiva 1999/21/CE no fueron modificados en este Reglamento, ignorando así los valores de referencia de la dieta y los niveles de ingesta superior tolerable del periodo 1997-2015, establecidos ambos por los citados organismos científicos

This article analyses, from 1989 until 2019, the development of the European Union legislation on food for special medical purposes, aimed at patients, and examines how from 1997 the competent scientific bodies of the European Union and the United States of America have established dietary reference values, as well as tolerable upper intake levels for vitamins and minerals based on their safety. The update, through the Regulation (EU) 2016/128, of the European Union legislation on this food category seems appropriate in the case of infants. However, for patients older than one year, the minimums and maximums of vitamins and minerals per 100 kcal from the Directive 1999/21/EC were not modified in this Regulation, thus ignoring the dietary reference values and the tolerable upper intake levels from the period 1997-2015, both established by the aforementioned scientific bodies

The war against junk science: the use of expert panels in complex medical-legal scientific litigation.

In the legal context, junk science is defined as evidence that is outside of mainstream scientific or medical views. Junk science does not have indicia of reliability and is not generally accepted. Despite the lack of scientific reliability, US courts, expert witnesses and juries are increasingly reliant on junk science in making causation decisions in complex medical liability cases. Courts have accepted junk science even where reliable scientific evidence is available. The United States silicone gel breast implant litigation is a prime example of this phenomenon. The issue of whether silicone breast implants are associated with disease has been a controversial subject for scientists and physicians, an emotional issue for women who have breast implants, and a lucrative business for the lawyers and expert witnesses who are the proponents of junk science. Junk science has provided to juries a quick and convenient explanation for claimed diseases or syndromes which have required years for reliable scientists to conclude are not related to breast implants. The breast implant litigation highlights the often dramatic difference between decisions based upon junk science and decisions grounded in scientific method, fact and reality. Recently, judges involved in the breast implant litigation have become concerned about the use of junk science in light of the growing body of legitimate scientific evidence that breast implants do not cause disease. Several judges have been motivated to take the unique and novel approach of convening scientific panels of independent experts to study the scientific issues and make findings to the court. Through the use of independent scientific experts, several judges have meaningfully assessed the evidence that the litigants present and have prevented or strictly limited the use of junk science in the courtroom. Using this procedure, other judges are weighing the evidence for future cases. This paper will briefly explore the background of mass tort medical products litigation and the development of junk science. The paper will then focus on the history of the breast implant litigation and the steps that the courts have already taken to combat junk science, including the use of scientific panels.