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Introduction: The evaluation of clinical trial (CT) safety is the main task of CT vigilance units. In addition to the management of adverse events, the units must review the literature to identify information that may impact the benefit-risk assessment of studies. In this survey, we investigated the literature monitoring (LM) activity of French Institutional Vigilance Units (IVU) from the working group "REflexion sur la VIgilance et la SEcurite des essais cliniques" (REVISE)., Material and Methods: We sent a questionnaire of 26 questions, divided into four themes, to the 60 IVU: (1) Presentation of the IVU and the LM activity; (2) Used sources, queries and criteria for selecting articles; (3) Valuation of the LM and (4) Practical organisation., Results: Of the 27 IVU that responded to the questionnaire, 85% of them carried out LM. This was mainly provided by medical staff to improve general knowledge (83%), to detect Adverse Reactions (AR) not listed in the reference documents (70%) and to detect new safety information (61%). Due to lack of time, staff, available recommendations and sources, only 21% of IVU conducted LM for all CT. On average, units reported four sources: ANSM information (96%), PubMed database (83%), EMA alerts (57%) and the subscription to APM international (48%). The LM had an impact on the CT of 57% of the IVU such as changing the conditions of a study (39%) or suspending a study (22%)., Discussion/conclusion: LM is an important but time-consuming activity with heterogeneous practices. According to the results of this survey, we proposed seven ways to improve this practice: (1) Target the highest risk CT; (2) Refine the PubMed queries; (3) Use other tools; (4) Create a decision flowchart for the selection of PubMed articles; (5) Improve training; (6) Value the activity and (7) Outsource the activity., (Copyright © 2023 Société française de pharmacologie et de thérapeutique. 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 2002, all healthcare facilities must have a food and nutrition liaison committee. The aim is to improve the management of food and nutrition related issues in hospital. The players concerned undertake a global and cross-disciplinary approach to ensure better food, notably for elderly patients at risk of protein-energy malnutrition., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

Background: The experience feedback committee (EFC) is a tool designed to involve medical teams in patient safety management, through root cause analysis (RCA) within the team., Objectives: To investigate the functioning of EFCs in the departments of a large university-affiliated hospital in France and to consider its potential contribution to the management of patient safety., Methods: Cross-sectional, observational study, based on an analysis of the documents produced by the EFCs for 1 year. Data were collected independently by two investigators in meeting minutes, adverse event reports and event analysis reports., Results: The study included all 20 EFCs operating in the hospital's medical departments. During the study year, committees held 164 meetings, reviewed 1707 adverse events, conducted 91 event analyses and decided on 206 corrective actions. The median number of corrective actions adopted by each EFC was five actions (range, 0-62). A root cause analysis (RCA) was present in 76% of the analysis reports, and these analyses were complete in only 23% of the reports. There was also a lack of planning corrective actions: an implementation deadline was only defined in 26% of the actions., Conclusions: Healthcare professionals adhered to the system-based approach to patient safety, but we observed difficulties in holding regular meetings and deviations from the theoretical framework. These findings confirm the difficulties of practicing RCA in the healthcare setting. Nevertheless, EFCs can be vectors of safety culture and teamwork., Competing Interests: The authors have declared that no competing interests exist.

Objective: To systematize knowledge on the activities developed by the committees involved in the prevention of infant and fetal deaths., Method: Integrated literature review conducted in November 2015 at PubMed, CINAHL, Scopus, LILACS, BDEnf and SciELO databases using keywords and descriptors of infant mortality, infant death, infant deaths, fetal death, fetal deaths, fetal mortality, neonatal mortality, professional committee, committee, committees, advisory committees. The 34 selected studies were organized and analyzed using Microsoft Excel®., Results: International, national, regional, state and local committees analyze the deaths and conduct activities aimed to qualify maternal and childcare and feed the health information systems., Conclusion: The committees for the prevention of infant and fetal mortality collect, produce, analyze and disseminate information related to these deaths in order to reduce infant and fetal mortality rates.

Compassionate care is based on an individual and collective dynamic process. Otherness, recognition, the meaning given to actions are fundamental preliminary considerations of any approach in this direction. A group of engaged professionals can initiate and support a project for promoting compassionate care in an institution., (Copyright © 2016 Elsevier Masson SAS. All rights reserved.)

By performing a systemic analysis of medication errors which occur in practice, the multidisciplinary teams can avoid a reoccurrence with the aid of an improvement action plan. The methods must take into account all the factors which might have contributed to or favoured the occurrence of a medication incident or accident., (Copyright © 2016 Elsevier Masson SAS. All rights reserved.)

This column shares the best evidence-based strategies and innovative ideas on how to facilitate the learning of EBP principles and processes by clinicians as well as nursing and interprofessional students. Guidelines for submission are available at http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1741-6787., (© 2015 Sigma Theta Tau International.)

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.)

Productivity is the main concern of hospitals as organizations providing health services. As the role of hospital committees is increasing and their productivity and performance improvement is very important, the present study was performed to identify weaknesses and strengths of committee sessions. This analytical-descriptive study was conducted cross- sectional from January to April in 2012. Summary of 405 committee session's agendas related to 11 kinds of committees in 8 hospitals (out of 23 hospitals) of capital cities in 3 provinces of Sistan and Balouchestan, South Khorasan and Khorasan Razavi in Iran were extracted. Data was collected through a form and was analyzed by SPSS16 software using descriptive statistics and variance analysis and content analysis technique. This study showed that the number of hospital committee's sessions holding in 2012 was more than 2011.The differences between public and private hospitals in terms of the following subjects were significant (P-Value < 0.001). In terms of the number of selected policies, participants of the committees, and the duration of the sessions the public hospitals had better conditions. And regarding documentation process, feedback of decisions to personnel and the implementation of the formulated policies in the committees, private hospitals performed better. According to the results of this study, to improve the productivity of hospital committees, it is suggested to motivate senior, tactical and operational managers to appropriately participate in the committees and necessary planning for the committees in advance is mandatory.

Aim: The aim of this study was to reduce crossmatch to transfusion ratio through development of a new Blood Utilization Committee., Background: Blood utilization hinges on the cooperation between transfusion services, medical staff, nursing and administration. Transfusion committees have attempted to bring about better oversight and bridge the gap between departments but in our institution this did not work until we had a catalyst to drive the effort. The unabashed desire and enthusiasm of one of our cardiac surgeons for self-improvement led to the formation of a new Blood Utilization Committee in October of 2012., Study Design and Methods: Crossmatch and transfusion data were gathered from our blood bank information system starting with the 4th quarter of 2011 through the 1st quarter of 2013. The crossmatch to transfusion ratio (C:T) was calculated and comparisons were made between the results from before and after the initiation of the committee., Results: At the commencement of the committee the initial C:T for the cardiac team was 2.48. We calculated a decrease of the C:T to 1.5 four months after the November 2012 formation of the new committee. The P-value calculated (P<0.0005) proved that the decrease was statistically significant., Conclusion: The initial impulse generated by the cardiothoracic surgery team is now spreading to other DRG groups in our hospital and we are seeing a drop in their C:T as well. Better blood utilization is attainable when the physicians who perform most transfusions lead the charge., (Copyright © 2015. Published by Elsevier SAS.)

The residents and relatives committee is an area for exchange and expression concerning the running of the facility or unit caring for a resident. It is an important body which places the user at its centre but which can however reveal disparities in the way it operates.

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.)

High quality comprehensive palliative care is a critical need for millions of patients and families, but remains only a dream in many parts of the world. The failure to do a strategic planning process is one obstacle to advancing education and pain prevention and relief. The Middle Eastern Cancer Consortium Steering Committee attendees completed an initial strategic planning process and identified "developmental steps" to advance palliative care. Underscoring the multi-disciplinary nature of comprehensive palliative care, discipline-specific planning was done (adult and pediatric cancer and medicine, pharmacy, nursing) in a separate process from country-specific planning. Delineating the layers of intersection and differences between disciplines and countries was very powerful. Finding the common strengths and weaknesses in the status quo creates the potential for a more powerful regional response to the palliative care needs. Implementing and refining these preliminary strategic plans will augment and align the efforts to advance palliative care education and pain management in the Middle East. The dream to prevent and relieve suffering for millions of patients with advanced disease will become reality with a powerful strategic planning process well implemented.

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.)

Created in 2007, COMUSA is a multiprofessional committee comprising speech therapy, otology, otorhinolaryngology and pediatrics with the aim of debating and countersigning auditory health actions for neonatal, lactating, preschool and school children, adolescents, adults and elderly persons. COMUSA includes representatives of the Brazilian Audiology Academy (Academia Brasileira de Audiologia or ABA), the Brazilian Otorhinolaryngology and Cervicofacial Surgery Association (Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico Facial or ABORL), the Brazilian Phonoaudiology Society (Sociedade Brasileira de Fonoaudiologia or SBFa), the Brazilian Otology Society (Sociedade Brasileira de Otologia or SBO), and the Brazilian Pediatrics Society (Sociedade Brasileira de Pediatria or SBP).

Magnet status for a facility indicates excellent nursing practice, positive and improved patient outcomes, and professional working environments. To maintain Magnet status, hospitals must show improved outcomes and clinical practice based on current evidence. Evidence-based practice (EBP) committees provide a streamlined approach for improving clinical/bedside practice decisions based on current research. The Magnet program is designed to guide nurses in clinical practice and making recommendations, and the EBP committee is a mechanism by which to do this. Participating in an EBP committee encourages professional growth and improved patient outcomes.

Purpose: Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB., Experimental Design: sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed., Results: Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0% versus 40.3%, P < 0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93% versus 26%, P < 0.05). Some key clinical information was discrepant between the two sources., Conclusions: The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients.

In this issue of Critical Care, the study from Laterre and colleagues offers suggestions for the role of clinical evaluation committees (CECs) in future sepsis trials. Despite encouraging preliminary results, all randomized controlled trials (RCTs) devoted to potential compounds in severe sepsis have failed to show survival benefit. One of the reasons might be related to RCT-related factors that inevitably occur within a heterogeneous septic patient population. A patient population free from confounding events would seem to provide the most suitable platform upon which to judge therapeutic effect. To solve this issue, CECs have been introduced into RCTs in sepsis to ensure uniform data for analysis and to identify such 'optimal cohorts' for which the therapy was initially designed to treat. More recently, some RCTs have reported positive results in sepsis. The role of CECs has shifted to become a more integral part of the detailed analysis of drug safety and efficacy in large databases, and to identify subgroups of patients in which a therapy might be less or more effective and/or safe. As an example, the retrospective analysis by Laterre and colleagues focuses on patients with severe community-acquired pneumonia (sCAP) within a large, failed RCT (on recombinant tissue factor pathway inhibitor (rTFPI)). However, the results should be interpreted with great caution, and should be viewed as exploratory and a hypothesis-generating activity. This question of potential benefit of rTFPI in patients with sCAP will be definitively answered by the results of the recently completed RCP.

In dosimetry-based treatment planning protocols, patients with rapid clearance of the radiopharmaceutical require a larger amount of initial activity than those with slow clearance to match the absorbed dose to the critical organ. As a result, the dose-rate to the critical organ is higher in patients with rapid clearance and may cause unexpected toxicity compared to patients with slow clearance. In order to account for the biological impact of different dose-rates, radiobiological modeling is beginning to be applied to the analysis of radionuclide therapy patient data. To date, the formalism used for these analyses is based on kinetics derived from activity in a single organ, the target. This does not include the influence of other source organs to the dose and dose-rate to the target organ. As a result, only self-dose irradiation in the target organ contributes to the dose-rate. In this work, the biological effective dose (BED) formalism has been extended to include the effect of multiple source organ contributions to the net dose-rate in a target organ. The generalized BED derivation has been based on the Medical Internal Radionuclide Dose Committee (MIRD) schema assuming multiple source organs following exponential effective clearance of the radionuclide. A BED-based approach to determine the largest safe dose to critical organs has also been developed. The extended BED formalism is applied to red marrow dosimetry, as well as kidney dosimetry considering the cortex and the medulla separately, since both those organs are commonly dose limiting in radionuclide therapy. The analysis shows that because the red marrow is an early responding tissue (high alpha/beta), it is less susceptible to unexpected toxicity arising from rapid clearance of high levels of administered activity in the marrow or in the remainder of the body. In kidney dosimetry, the study demonstrates a complex interplay between clearance of activity in the cortex and the medulla, as well as the initial activity ratio and the S value ratio between the two. In some scenarios, projected BED based on both the cortex and the medulla is a more appropriate constraint on the administered activity than the BED based on the cortex only. Furthermore, different fractionated regimens were considered to reduce renal toxicity. The MIRD-based BED formalism is expected to be useful for patient-specific adjustments of activity and to facilitate the investigation of dose-toxicity correlations with respect to dose-rate and tissue repair mechanism.

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.

The results of two observational studies of clinical directorates (CDs) are presented. The paper exposes fresh perspectives about the management of hospitals and CDs, and suggests that the most important axis on which hospital decision-making rests continues to be profession rather than the CD, even though CDs are designed at least in part to mitigate professional tribalism and bridge professional divides. In empiricising social structural and cultural theories it seems clear that changes to the prescribed organisational framework, which CDs represent, have had negligible effects on behaviour. This being the case, the paper questions the benefits alleged to have accrued from establishing CDs and calls for more effective, micro-behavioural change strategies than merely altering the structure.

Recommendations are proposed to enhance the role of the pathologist in the hospital-based tumor conference (tumor board). The modifications focus on two components integral to the conference: the presentation of salient pathologic features of each tumor selected for discussion within the time constraints allotted, and the pathologist's role as a principal institutional educator with respect to neoplastic processes. Opportunities to utilize conference presentations as a resource in other educational settings are also considered.

Given the increase in novel agents and difficulty with planning and completing many phase III studies, various phase II trial design options should be considered to more effectively guide phase III trial plans. The need for novel phase II trial designs has increased, given the number of novel molecular targeted therapies now available for testing, an abundance of cytostatic agents, and limited resources to conduct phase III studies for all interesting agents or combinations. This review will focus on options for phase II trial designs. We review randomized phase II designs with placebo control, randomized selection designs, and randomized discontinuation designs. As agents become available for testing in the clinic, the strengths and weaknesses of different phase II trial designs should be considered to optimize a trial development plan that guides phase III trial decisions more effectively.

Purpose: In conjunction with curricular changes, a process to develop integrated examinations was implemented. Pre-established guidelines were provided favoring vignettes, clinically relevant material, and application of knowledge rather than simple recall. Questions were read aloud in a committee including all course directors, and a reviewer with National Board of Medical Examiners (NBME) item writing and review experience. This study examines the effectiveness of this process to improve the quality of in-house examinations., Methods: Five hundred and twenty items were randomly selected from two academic years for initial comparison; 270 from 2000 to 2001, and 250 from 2001 to 2002. The first set of items represented the style, content and format when courses and tests were departmentally/discipline based, assembled by course directors, and administered separately. The latter group represented similar characteristics when courses and tests were organ-system-based, committee-reviewed and administered in an integrated examination. Items were randomized, blinded for year of origin, and rated by three NBME staff members with extensive item review experience. A five-point rating scale was used: one indicated a technically flawed item assessing recall of an isolated fact; five indicated a technically unflawed item assessing application of knowledge. To assess continued improvement, a follow-up set of 250 items from the 2002 to 2003 academic year was submitted to the same three reviewers who were not informed of the purpose or origin of this set of test items., Results: The mean rating for items from 2000 to 2001 was 2.51 +/- 1.27; analogous values for 2001-2002 were 3.16 +/- 1.33, (t = 5.83; p < 0.0001), and in 2002-2003; 3.59 +/- 1.15 (t = 10.11; p<0.0001)., Conclusion: Pre-established guidelines and an interdisciplinary review process resulted in improved item quality for in-house examinations.

The Sarbanes-Oxley Act is intended to improve corporations' financial accountability, but boards of not-for-profit hospitals are taking their own cues from its provisions.