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This work examines the impact of the SARS-CoV2 epidemic and the organizational recommendations that have been issued since March 16 on tumor boards (TB) activity. The tumor board activity was measured from tumor board sheets extracted from the oncologic electronic file between January 7, 2019 and April 24, 2020. The pre-containment activity was compared to the activity of the containment periods but also to the equivalent periods in 2019. The number of meetings held, the average number of files reviewed per meeting including first presentations and the average number of physicians' attendance were the evaluation criteria. The study covered 191 TB that held 3943 multidisciplinary team meetings (MTM) and reviewed 72,070 files (including 30,127 first submissions). There was a moderate decrease of 8 % in the number of meetings after March 16, 2020. The number of files examined decreased by 23 % in the following month and even more by 33 % in the third period. The physicians' number who attended MTM also decreased by 25 %. The negative impact was higher in the Mediterranean part of the region. This first study of tumor board activity, covering a large region but little affected by the pandemic, shows that its impact on the participation to the MTM has been moderate. In addition, tumor boards have followed the recommendations for optimizing quorum. However, the decrease in average MTM activity, particularly for first submissions, suggests a potential delay in patient management. Complementary qualitative and quantitative works are warranted to estimate the real impact on carcinologic outcomes., (Copyright © 2020 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Onco, the Regional oncology network of Northern France, in partnership with Cronor, is piloting a project to harmonize radiotherapy practice. In 2016, a working party "Quality in Radiotherapy" was set up to encourage all centres in the network to participate in regional experience feedback committees. These committee meetings allow for analysis and handling of adverse events in radiotherapy within predefined areas of expertise. The purpose is to formalize and issue recommendations based on good practice by the use of regional bulletins. This article details how such experiential feedback committees are implemented, what they can contribute and the barriers to such work at each stage of the project., (Copyright © 2018 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.)

Since the late 2,000 years, under the incentive of the French agencies ANAP (previously MEAH) and HAS and following the decision DC-0103 of the ASN, experience feedback committees (known as 'Comité de retour d'expérience or Crex' in French) have widely been implemented within radiation oncology departments in France. Based on the declaration of error/near misses (precursor events) occurring during medical care to patients, an intuitive method of systematic analysis of these events is basically the aim of such committees (such as the Orion method(©) derived from the air transportation industry). Our article aims at summarizing the paths and pitfalls attached to this methodology, emphasizing what could be the next step, beyond the 'Crex' committees, in the long march to know how to secure care to patients within a radiotherapy medical team., (Copyright © 2015 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.)

Objective: To evaluate how the size of an outcome adjudication committee, and the potential for dominance among its members, potentially impacts a trial's results., Study Design and Setting: We conducted a retrospective analysis of data from the six-member adjudication committee in the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) Trial. We modeled the adjudication process, predicted the results and costs if smaller committees had been used, and tested for the presence of a dominant adjudicator., Results: Use of smaller committee sizes (one to five members) would have had little impact on the final study results, although one analysis suggested that the benefit in reduction of reoperations with reamed nails in closed tibial fractures would have lost significance if committee sizes of three or less were used. We identified a significant difference between adjudicators in the number of times their original minority decisions became the final consensus decision (χ(2)=9.67, P=0.046), suggesting that dominant adjudicators were present. However, their impact on the final study results was trivial., Conclusion: Reducing the number of adjudicators from six to four would have led to little change in the final SPRINT study results irrespective of the significance of the original trial results, demonstrating the potential for savings in trial resources., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Morbidity and Mortality conferences (M&M) are used to meet many of the Core Competencies required by the Accreditation Council of Graduate Medical Education for residency training programs. This study seeks to describe and quantify different types of M&M conferences among Emergency Medicine (EM) training programs., Methods: A confidential survey was e-mailed to the Program Directors (PD) or Assistant PD of all United States (US) Emergency Medicine residency training programs with functional e-mail addresses listed in the Society for Academic Emergency Medicine residency catalog. Descriptive statistics and 95% confidence (CI) intervals are reported., Results: Of 124 surveys sent out, 89 (72%) completed surveys were returned. There were 88 programs (99%, CI 93-100%) that reported having an M&M. Conferences are held monthly at 67% (CI 57-76%) of programs. Cases for discussion are identified by an EM attending, quality assurance committee, or resident (70%, 57%, and 48%, respectively). Half of programs reported that > 40% of the cases involve systems errors. Twenty percent of programs report that > 40% of the cases involve deaths. Consultants are invited at 44% of programs, and 20% of programs specifically invite radiologists. If a medical error is identified in the M&M, 79% (70-86%) of programs have a protocol for addressing the error., Conclusion: EM training programs almost uniformly have an M&M, but these conferences vary in frequency, content, and attendance. Future studies are needed to investigate resident and faculty perceptions of M&M, its educational impact, and ways to improve the conference., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)

The structured report (SR) summarizing the multidisciplinary decision making for referred cancer patient is a new opportunity to ameliorate communication between GPs and cancer specialists. The aim of this study was to investigate how GPs value this structured report. We carried out a questionnaire-audit on SR GPs assessment. The SR had included: the list of committee participants, short summary of clinical history and characteristics, tumour location and size, TNM classification, precise histological diagnosis, practice guidelines used, possibility of clinical trial, identification of specialist in charge of patient, and a short conclusion. The enrolled patients were treated for soft tissue sarcoma, melanoma or carcinoma with unknown primary. The response rate was 47% (52/110). 79% of GPs are satisfactory with the structured report. The analysis of responses suggest 3 amelioration axes: (i) accompany the report with a short summary of guidelines used, (ii) describe clearly the potential cancer treatment side effects and suggest some treatments of those side-effects, (iii) and send this structured report more rapidly during the clinical pathway. This SR appears clearly an opportunity of communication amelioration between care providers. This SR is appreciated by GPs. But, it is necessary to include more practical information.

In this study we sought to identify variables associated with institutional review board (IRB) decisions to develop an efficient "pre-IRB" review model. We explored several variables, including relationships among the identification of trainees as investigators, external sources of funding, and initial approval. The sample consisted of all new submissions reviewed by the 2 medical IRBs at the University of Miami (UM) during a 1-year period. Trainees included students, residents, and fellows. At least 1 trainee had to be identified for a proposal to be considered a trainee submission. The medical-science committees (MSCs) were similar with regard to the numbers of new submissions they reviewed during convened meetings (MSC-A 242, MSC-B 241) and the percentages of proposals that were initially approved (MSC-A 52.9%, MSC-B 53.1%). Approved submissions were defined as those initially approved or conditionally approved pending minor modifications. We noted a robust statistical difference between the percentages of trainee submissions initially approved (39.9%) and submissions that did not identify a trainee (59.4%) ( P <.0001). Of the proposals that were initially not approved (tabled [deferred] or rejected [not approved]), 28.9% of those including a trainee were rejected, compared with 11.0% without a trainee ( P <.001). Proposals in which the source of funding was identified were more likely to be approved (64.2%) than were those in which it was not (30.8%) ( P <.0001). Funding also seemed to influence the trainee and initial-approval interaction. Our results show that new submissions that identified trainee investigators were more likely to be deferred or not approved than those that did not. Nonapproved proposals that identified a trainee were 3.8 times more likely to be initially rejected than those that did not. A prereview model could target those submissions that list a trainee, lack funding, or both.

The field of psychiatry has an opportunity to construct a more refined, perhaps more enduring understanding of the ethical basis of mental illness research. The aim of this paper is to help advance this understanding by 1) tracing the evolution of the emerging ethic for biomedical experimentation, including recent recommendations of the President's National Bioethics Advisory Commission, and 2) reviewing data and concepts related to compelling ethical questions now faced in the study of mental disorders. Empirical findings on informed consent, the ethical safeguards of institutional review and surrogate decision making, and the relationship between scientific and ethical imperatives are outlined. Psychiatric researchers will increasingly be called upon to justify their scientific approaches and to seek ways of safeguarding the well-being of people with mental illness who participate in experiments. Most importantly, psychiatric investigators will need to demonstrate their appreciation and respect for ethical dimensions of investigation with special populations. Further empirical study and greater sophistication with respect to the distinct ethical issues in psychiatric research are needed. Although such measures present many challenges, they should not interfere with progress in neuropsychiatric science so long as researchers in our field seek to guide the process of reflection and implementation.

Federal regulations governing human subjects research call for additional protections for the "mentally disabled." However, there is currently no consensus definition of mental disability or guidelines for how these research subjects should be protected. This ambiguity complicates the work of institutional review boards (IRBs) charged with the review and approval of protocols involving psychiatric medication discontinuation and symptom provocation. It is particularly important for these studies to be reviewed within the larger context of the research program in which they are conducted. The author proposes a process for IRB review of these studies, which includes the implementation of additional safeguards for subjects determined by the IRB to be vulnerable. Recommendations also are made for training psychiatric clinical investigators in issues related to research bioethics.

Medical decision making, especially in oncology, is more and more assisted by pre-established therapeutic protocols. But applying these protocols for particular cases is sometimes difficult; then, local expertise intervenes. For solving these difficult cases, Alexis-Vautrin like other centers, organizes committees for therapeutic decisions. This paper aims to describe, from a field study, the tools for medical decision making and the difficulties of using them. These result of the analysis of decision committee for breast cancers in a center using of protocols, which the first were established twenty years ago. This analysis was carried out by a team of oncologists and ergonomists; it stresses on collective decision making as a mean for adapting rules and exchanging knowledge. Furthermore, these findings lead to discuss using of decision committee for advancement and particularization of protocols themselves.

Data monitoring committees for randomized clinical trials must frequently decide what action, if any, is required for trials whose accrual has been slower than expected, or whose event rates have been less than expected. We discuss in this article some of the practical issues concerning modifying or closing such trials, including what data and analyses could be helpful to the data monitoring committee in their deliberations.

Purpose: A national survey of institutional review boards (IRBs) was conducted to determine: (1) the current practices of IRBs concerning consent for adolescent minors; and (2) the existence of support for changes in the federal regulations for research on adolescents., Methods: Six hundred surveys were mailed in two waves to all IRB chairs in the United States, with the exception of highly specialized institutions. The survey consisted of three sections. Section 1 assessed demographic data, such as institution type; presence of personnel trained in adolescent health; and number of protocols involving adolescents reviewed annually. Section 2 presented a series of twelve scenarios for which respondents stated whether their IRB would waive parental consent under present federal regulations. These scenarios varied the sensitivity of information and procedural invasiveness, and ranged from simple satisfaction surveys to experimental drug treatment for AIDS. Section 3 assessed whether respondents would recommend changes in current federal regulations that would enable adolescent minors to provide their own consent to research participation. To this end, respondents indicated whether minor consent alone is sufficient or if parental consent should be required for 10 general research categories that paralleled the level of invasiveness of the scenarios presented in Section 2., Results: Two hundred and thirty-three surveys (39%) were returned and 183 (30%) were fully scorable. Within group comparisons for IRBs were conducted using Chi-square statistics. Seventy percent of respondent IRBs required parental consent for all research on minors, and IRBs reviewing more than 10 adolescent protocols per year were less likely to require parental consent (p < .01). Responses did not differ by institution type or presence of personnel trained in adolescent health. Fifty-two percent of respondent IRBs required parental consent for a simple satisfaction survey, and only 29% of IRBs would waive parental consent for an anonymous HIV seroprevalence study. Over one-half of IRBs supported changes in regulations that would enable minors to provide informed self-consent for seven of 10 general research categories: anonymous surveys (supported by 93%), research involving sensitive material if nothing more than survey (89%) or venipuncture (53%) were involved, and research on diseases for which minors may consent to treatment including survey (93%), venipuncture (68%), or medication approved for use in pediatric patients (57%)., Conclusion: Even though IRBs practice under the same federal regulations there is a broad spectrum of interpretation. Considerable support exists for changing the guidelines for certain categories of research involving adolescents. Federal regulations need to be clarified for meaningful and necessary research on adolescents to take place.

Consent forms in research are a source of current and retrospective information for the subject, a "prompt" for the person who is obtaining consent, and a documentation of the "informed" consent process and its adequacy. Occasionally, these forms may be administered by inexperienced trainees or ancillary personnel, and thus stand virtually alone. Therefore, the forms must be inherently comprehensible to the subjects. To test whether this is the case, 65 new applications were randomly selected from 13 consecutive IRB agendas, and their consent documents were computer-analyzed (Flesch/Fry scoring) after correction for expected confounding features, such as lists, tables, and polysyllabic proper names and jargon. Mean U.S. school grade for 70% comprehension (Fry score) was 15.03 +/- 0.19 (standard error of the mean), implying readability by 37.4 +/- 1% of the U.S. adult population. In contrast, a consecutive sampling of 21 Ann Landers columns yielded a mean Fry score of 7.67 +/- 0.5 (p < 0.01; readable by 75 +/- 3%). Fifteen Reader's Digest articles yielded a mean Fry score of 9.95 +/- 0.65 (p < 0.01; readable by 59.1 +/- 3%), and 15 "Talk of the Town" columns from The New Yorker averaged a grade level of 13.3 +/- 0.83; p < 0.01; readable by 42.7% +/- 4.8%). No document was improved by more than one grade level by the IRB review process, and most were unchanged.(ABSTRACT TRUNCATED AT 250 WORDS)

Ten years after the beginning of CREX in radiotherapy departments we wanted to know about users' feeling. We sent a survey to 168 centers in the whole country and a hundred of them answer. The time, top management's involvement and professionals' training seem to be the key success factors. Systemic analysis methods and mainly the Orion © one are not identified as an issue. The main challenge for the next years will be the effectiveness check of actions., (Copyright © 2019 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.)

As an advisory group appointed by and directly accountable to the sponsoring agency, the advisory board has a unique relationship with the coordinating center. The coordinating center provides the data and analyses by which the board assesses progress and monitors safety of a trial. Although assessment of quality of performance of the units of the study is the direct concern of the coordinating center, corrective measures frequently become advisory board matters. Ideally, the relationship between the coordinating center and the advisory board is one of mutual trust and support in pursuit of the goal of a trial that is planned carefully, conducted with tight control of performance and safety, and reported accurately to the appropriate professional groups.

Individuals who care for children are sometimes reluctant to participate in experimental research because of concern about withholding a potentially helpful intervention from some of their patients and their impressions about the effects of the treatment being studied. These concerns may conflict with investigators' interests in obtaining subjects for protocols. This report describes the use of an external review committee to assess the appropriateness of enrolling patients in a randomized clinical trial. The committee served as a mechanism for assessing the validity of physicians' concerns about randomization of a given patient and for reconciling clinicians' differences about enrollment. It appears to have helped implement randomization by affording a procedure to ensure patients' rights and quality of care. It is offered as a technique for resolving the practical dilemmas of those conducting clinical research while at the same time respecting the rights of patients.

OBJECTIVE: This study aimed to verify the performance of blood transfusion committees in transfusion services linked to the public blood bank network of the state of Minas Gerais. METHODS: A cross-sectional observational study was conducted between 2007 and 2008 using questionnaires and proficiency tests to evaluate the reporting and investigation of transfusion reactions comparing transfusion services with and without transfusion committees in the public transfusion services of the state of Minas Gerais. RESULTS: Nineteen of Hemominas own transfusion services and 207 that contracted the services of the foundation located in 178 municipalities were visited between 2007 and 2008. Established transfusion committees were present in 63.4% of the services visited. Transfusion incidents were reported by 53 (36.8%) transfusion services with transfusion committees and by eight (9.6%) without transfusion committees (p < 0.001) with 543 (97.5%) and 14 (2.5%) notifications, respectively. Of the reported transfusion incidents, 40 (75.5%) transfusion services with transfusion committees and only two (25%) of those without transfusion committees investigated the causes. CONCLUSION: The incidence of notification and investigation of the causes of transfusion reactions was higher in transfusion services where a transfusion committee was present. Despite these results, the performance of these committees was found to be incipient and a better organization and more effective operation are required.

Peer review serves as an important adjunct to other hospital quality and safety programs. Despite its importance, the available literature contains virtually no guidance regarding the structure and function of effective peer review committees. This Clinical Perspective provides a summary of the purposes, structure, and functioning of effective peer review committees. We also discuss important legal considerations that are a necessary component of such processes. This discussion includes useful templates for case selection and review. Proper committee structure, membership, work flow, and leadership as well as close cooperation with the hospital medical executive committee and legal representatives are essential to any effective peer review process. A thoughtful, fair, systematic, and organized approach to creating a peer review process will lead to confidence in the committee by providers, hospital leadership, and patients. If properly constructed, such committees may also assist in monitoring and enforcing compliance with departmental protocols, thus reducing harm and promoting high-quality practice., (Copyright © 2016 Elsevier Inc. All rights reserved.)

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., (© 2017 International Neuromodulation Society.)

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., (© 2017 International Neuromodulation Society.)

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., (© 2017 International Neuromodulation Society.)

Background: Strategies for successful implementation of hospitalwide glucose control efforts were addressed in a conceptual model for the development and implementation of an institutional inpatient glucose management program. CONCEPTUAL MODEL COMPONENTS: The Glucose Steering Committee incrementally developed and implemented hospitalwide glucose policies, coupled with targeted education and clinical decision support to facilitate policy acceptance and uptake by staffwhile incorporating process and outcome measures to objectively assess the effectiveness of quality improvement efforts. The model includes four components: (1) engaging staff and hospital executives in the importance of inpatient glycemic management, (2) educating staff involved in the care of patients with diabetes through structured knowledge dissemination, (3) executing evidence-based inpatient glucose management through development of policies and clinical decision aids, and (4) evaluating intervention effectiveness through assessing process measures, intermediary glucometric outcomes, and clinical and economic outcomes. An educational curriculum for nursing, provider, and pharmacist diabetes education programs and current glucometrics were also developed., Outcomes: Overall the average patient-day-weighted mean blood glucose (PDWMBG) was below the currently recommended maximum of 180 mg/dL in patients with diabetes and hyperglycemia, with a significant decrease in PDWMBG of 7.8 mg/dL in patients with hyperglycemia. The program resulted in an 18.8% reduction in hypoglycemia event rates, which was sustained., Conclusion: Inpatient glucose management remains an important area for patient safety, quality improvement, and clinical research, and the implementation model should guide other hospitals in their glucose management initiatives.

Background: Venous thromboembolism (VTE) is a cause of significant morbidity and mortality in hospitalized patients in the United States. Quality improvement (QI) strategies to increase the rates of prophylaxis in patients at-risk for VTE have been shown to be successful. The development of a formal, active strategy addressing the prevention of VTE, as a written, institutionwide VTE prophylaxis policy, presents a challenge for hospitals, Methods: In 2007 a multidisciplinary VTE committee was initiated to develop and implement a hospitalwide QI program to standardize VTE risk assessment and prophylaxis prescribing practices at Saint Francis Hospital (Tulsa, Oklahoma). The QI program included clinician education, VTE order set and electronic trigger implementation, and changes in mechanical prophylaxis usage., Results: The VTE prophylaxis order set was successfully piloted and implemented hospitalwide within three months of the project's initiation. Standardization of VTE prophylaxis practices across surgical and medical specialties was the key aim of this QI program. As a result, patient-related outcomes were also improved. The number of hospital-acquired VTE events decreased from 123 (0.39%) in 2008 to 99 (0.32%) in 2009 and 87 (0.27%) in 2010, and a reduction in the VTE rate between 2008 and 2010 of 31.6%. There was a significant decrease between 2008 and 2010 in the number of hospital-acquired VTE events (p = .035)., Conclusions: Keys to the success of this QI program included leveraging multidisciplinary VTE committee members, physician champions, multiple approaches to communication and education, and providing evidence to support the changes. Sharing the hospital's QI process may provide a model for other hospitals challenged with developing and sustaining positive outcomes in patients at risk for VTE.