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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.

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.)

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: 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.

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.)

Objective: To investigate the role of the residency interview in admission to the University of Toronto ophthalmology program., Design: Retrospective observational study., Participants: One hundred and sixty-nine candidates for admission to the University of Toronto ophthalmology program, 1998-2008., Methods: Admissions scores were analyzed retrospectively to determine how the interview affected final candidate rank. Interviewers were not blinded to the candidates' applications. Candidate impressions of interview day were investigated through 2 surveys conducted in 2000 and 2005. Twenty-six of the 33 interviewed candidates responded, for a response rate of 79%., Results: Pre-interview rank was found to correlate with final rank (r = 0.826, p < 0.001, n = 169, 2-tailed) and interview rank (r = 0.426, p < 0.001). Interview rank was also independently correlated with final rank (r = 0.774, p < 0.001). Half the candidates had final ranks within 1 of their pre-interview rank, and 80% were within 3 ranks. The range of rank change was from a loss of 10 ranks to a gain of 11. Survey responses demonstrated that candidates found the interview experience very valuable (14/14) and that it affected their opinion of the program positively (20/26)., Conclusions: While the interview frequently does not substantially change candidate rank order, the occasional large changes suggest that it has the power to make corrections to application scores should they be necessary. The nonblinded design allows interviewers to ask candidates questions specific to their application, resulting in more profound discussion. The surveys show that candidates find the interview to be a valuable experience and likely results in them ranking Toronto's program higher in the match.

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.

Objective: To better understand the impact of USMLE scores and interview scores on the National Resident Matching Program (NRMP) rank of applicants to the residency program at The Children's Hospital of Philadelphia., Methodology: We evaluated 935 applicants' files from 2000, 2001, and 2002. For each candidate, one interviewer had access to the full application, while the other interviewer was blinded to USMLE scores and grades. Interview scores were generated by both interviewers. Statistical analysis was performed to evaluate relationships between USMLE scores, interview scores, and NRMP rank list number., Results: There were a wide range of USMLE scores among candidates who interviewed (range 181 to 269, 227.7 +/- 17.1, M +/- standard deviation). USMLE scores were weakly correlated to nonblinded interview scores (r = -0.17), final committee scores (r = -0.26), and NRMP ranking (r = -0.21): P < .0005. Blinded interviews did not correlate with USMLE scores. Both nonblinded and blinded interviews had stronger correlations with NRMP rank list number (r = 0.49, P < .0005 and r = 0.36, P < .0005, respectively). The nonblinded interview accounted for 20.6% of variance in the NRMP rank list order., Conclusions: Interview scores were the most important variable for candidate ranking on the NRMP list. Furthermore, when interviewers had access to board scores, there was a modest correlation to performance on the USMLE. While interviews may reflect a candidate's personality, they may not effectively measure desired characteristics when access to academic markers is unrestricted. We suggest incorporating blinded interviews into the selection process to give candidates a better opportunity to display communication skills, emotional stability, and "fit" for the program.

The correlation between results obtained with the European Committee on Antibiotic Susceptibility Testing (EUCAST) antifungal susceptibility testing procedure (document 7.1) and four commercial systems was evaluated for a collection of 93 clinical isolates of Candida spp. Overall, agreement between the EUCAST procedure and the Sensititre YeastOne and Etest methods was 75% and 90.4%, respectively. The correlation indices (p < 0.01) between the EUCAST and commercial methods were 0.92 for Sensititre YeastOne, 0.89 for Etest, - 0.90 for Neo-Sensitabs, and 0.95 for Fungitest. Amphotericin B MICs obtained by Sensititre YeastOne were consistently higher than with the EUCAST method and, although very major errors were not observed, 91% of MICs were misclassified. Amphotericin B- and fluconazole-resistant isolates were identified correctly with Sensititre YeastOne, Etest and Fungitest. Neo-Sensitabs identified amphotericin B-resistant isolates, but misclassified > 5% of fluconazole-resistant isolates as susceptible. The commercial methods, particularly Etest and Fungitest, appeared to be suitable alternatives to the EUCAST procedure for antifungal susceptibility testing of clinical isolates of Candida.

We evaluated the impact of an evaluation committee (EC) on patients' overall response status in a large multicenter trial in oncology. We identified reasons for disagreements between investigators and the EC. The Cancer Renal Cytokine (CRECY) study was a French multicenter trial that tested cytokine therapy in 489 patients with metastatic renal cell carcinoma. Objective response (OR) evaluation included medical imaging and was studied according to international guidelines. A blinded peer review of all responders and litigious cases was performed by an EC. Major disagreements occurred in 43% and minor disagreements in 10.5% of the reviewed files. The number of significant tumor responses was reduced by 23.2% after review by the EC. Reasons for disagreements included errors in tumor measurements, errors in selection of measurable targets, intercurrent diseases, and radiologic technical problems. These reasons for disagreements are analyzed and discussed. We conclude that all therapeutic trial results should be reviewed by peer analysis of all presumed responders by an EC. International guidelines for response evaluation should be updated by including more reliable methods of measurements and definition of minimal imaging procedures.

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.

Several lines of investigation have contributed to the increasing recognition of the biological basis of psychiatric disorders. Symptom provocation studies have made important contributions toward this. With the emergence of novel methodologies, the role of symptom provocation studies has come under increasing scrutiny and debate. The scientific contributions and risks of symptom provocation studies are discussed using the psychostimulant paradigm in schizophrenia research as the prototypical study. The application of studies in other areas of medicine that carry risks similar to those associated with symptom provocation studies, are also reviewed. The authors draw on the parallel of cardiac stress testing to highlight risks: benefits issues. Finally, the authors discuss the future of symptom provocation studies and emphasize that these studies will need to meet the highest scientific standards, ethical standards and safeguards.

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.

Most large randomized clinical trials have a data monitoring committee that periodically examines efficacy and safety results. A typical data monitoring committee meets every 6 months, but the interim monitoring guidelines for many trials specify formal analyses that are years apart. In this article we argue that study protocols should include monitoring guidelines with formal looks at each data monitoring committee meeting. Such guidelines are shown to reduce the average duration of a trial with negligible effect on power and estimation bias. Some of the common statistical monitoring guidelines require extreme evidence to stop a trial early and do not distinguish between stopping a trial during active accrual and follow-up stages. We propose practical solutions for these issues.

I have presented a variety of methods of helping practitioners evaluate products. It does not appear that the frustrating challenge of product evaluation will become less complex. Practitioners should use all of the concepts enumerated in this article to aid in their selection of products and be thankful that we have the freedom to select the products that we believe, after due consideration, are best for our patients.

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.

Background: Almost 10% of breast and ovarian cancer are inherited, and the majority are linked to BRCA1 and BRCA2 germline mutations. Despite the uncertainty, consensus guidelines were defined to assist practitioners', and patients' decisions about the health care decisions to be made., Methodology: The ad hoc committee consisted of 14 experts designated by the French National Institute for Health and Medical Research. They all attended eleven workshops at which a systematic analytical review of more than 3,500 articles was carried out. Five additional experts critically analyzed the first version of the report., Process: Two thresholds were defined on a probability scale giving the risk of developing breast or ovarian cancer, to serve as a means of deciding as whether an intervention is worthwhile. The first threshold is that above which an intervention can be envisaged or recommended; the second is that under which an intervention can be ruled out; between the two, the decision has to be made on a each by case basis. SCREENING AND PREVENTIVE STRATEGIES ANALYZED: About breast cancer: 1) hormonal interventions; 2) primary prevention (diet, family planning and chemoprevention); 3) screening (breast self-examination, clinician breast examination, tumor markers, imaging); 4) prophylactic mastectomy. About ovarian cancer: 1) hormonal stimulation; 2) screening (clinical screening, ultrasound and tumor markers); 3) prophylactic oophorectomy., Main Conclusions: With each strategy the following points were dealt with: the information to be delivered to the consult and, the procedure and the indications. The committee's opinion about BRCA mutation screening is that population-based or even large scale implementation are not justified. The committee feels that specific management is indispensable and advocates the use of defined and evaluated procedures, and involvement in clinical trials.

We developed methodology for prospective randomized effectiveness studies using a demonstration project at a multispecialty practice, health maintenance organization, and hospital in academic medical center. An operational unit called the effectiveness registry was developed to design and support comparisons of potential practice improvements with standard care. The studies differ from observational effectiveness studies in that they provide long-term follow-up of randomized comparison groups. Physician involvement in data collection is limited. No tests or observations are made other than those required for clinical care. Follow-up and data collection are modeled after tumor registry procedures. Patients who refuse randomization enter the study in whichever treatment arm they choose. The protocol for each study is approved by the institutional review board (IRB) before recruitment begins, and all patients, randomized and nonrandomized, sign an informed consent document. Between its beginning on October 7, 1993 and April 7, 1997, the IRB approved 14 trials. Four were terminated after entering at most a few patients. Recruitment is complete in four trials and continues in six. Randomization was accepted by 74% (596/804) of the patients. Over 800 patients in 10 studies are being followed at least annually. Major peer-reviewed journals have accepted reports of initial findings for two studies. Prospective randomized effectiveness studies are feasible in the multipractice setting and have potential to provide useful and reliable assessment of treatment outcomes. Collaborative arrangements between several institutions are needed to provide larger sample sizes.

Despite demonstrations of the utility and cost effectiveness of behavioral methods for improving care for people with psychiatric impairments, they are seldom employed effectively in inpatient settings. This study evaluated the impact of an administrative procedure to effect a behavioral consultation for cases of high seclusion/restraint utilization. Seclusion/restraint use for the 53 cases was reviewed for a time period of 6 months before and 6 months after development of a behavioral treatment plan resulting from this procedure. The data revealed a 62% reduction in seclusion/restraint use after development of an approved plan. There was also a reversal in serial trend from increasing use during the months prior to plan development to decreasing use during months after plan development. The procedure is described and implications of the results for clinicians and administrators of psychiatric inpatient programs are discussed.

The principles of total quality management (TQM) were used to improve the infant metabolic screening program in a large urban hospital. Three quality indicators needed improvement; unsatisfactory specimen quality, delayed delivery to the state laboratory for testing, and specimen slips missing the date of collection. A multidisciplinary team identified the root causes of the poor quality and implemented remedies. Dramatic improvement in three infant screening indicators occurred within a 4-month period. Evaluation of the three indicators continued for the following 3-year period. Quality improvement programs that involve a multidisciplinary approach benefit the patient and staff and may reduce costs.

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.

Investigators form the National Institutes of Health (NIH), in the United States, have prospectively studied 60 patients with Takayasus's arteritis over a period of 20 years. Unique observations resulted from the requirement that all patients be part of Institutional Review Board-approved standardized protocols that required periodic complete clinical, laboratory and angiographic evaluations, regardless of degree of disease activity. Patients judged to have active disease received protocol defined treatment that always included prednisone, and to which cytotoxic agents were added in the event that relapse followed tapering or withdrawal of corticosteroids. The prospective standard approach applied to this cohort has provided new insights into the presentation, course and treatment-responsiveness of Takayasu's arteritis. This article will focus on the questions raised by this study and implications for patient care.

Much of today's medical care relies on experience unsupported by investigation, and emergency medical care is no exception; research is necessary to improve this care. Critically ill and injured patients are the patients who will benefit the most from improvements in emergency medical diagnostic and treatment methods. Yet, the federal bureaucracy has effectively banned research on these patients, since they cannot generally give "informed consent." We argue that, with the proper safeguards, research on critically ill and injured patients should be performed in the emergency medicine (EDs and EMS) settings without informed consent. To require such consent when not obtainable compromises both the researchers who must get such consent and the patients who must continue to endure old, and often untested therapies.

Interim analyses of randomized trials enable investigators to make more efficient use of limited research resources and to satisfy ethical requirements that a regimen be discontinued as soon as it has been established to have an inferior efficacy/toxicity profile. Unfortunately, the integrity and credibility of these trials can be compromised if inappropriate procedures are used in monitoring interim data. In this paper we discuss how group sequential designs provide useful guidelines that enable one to satisfy the valid objectives of interim monitoring while avoiding undesirable consequences, and we consider how flexible one can be in the way such designs are implemented. We also provide motivation for the role of data-monitoring committees in preserving study integrity and credibility in either government- or industry-sponsored trials. In our view, these committees should have multidisciplinary representation and membership limited to individuals free of apparent significant conflict of interest, and ideally should be the only individuals to whom the data analysis center provides interim results on relative efficacy of treatment regimens. Finally, we discuss some important practical issues such as estimation following group sequential testing, analysis of secondary outcomes after using a group sequential design applied to a primary outcome, early stopping of negative trials, and the role of administrative analyses.

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)

Although most hospitals use computer systems in other areas, many nurses have had limited hands-on experience with computers. The issues to address when a bedside computer system is selected and introduced into a labor and delivery unit are presented.

Epidemiological studies raise somewhat different ethical issues than those that usually confront IRBs in their review of biomedical research. Although epidemiologic research seldom risks direct harm to subjects, it may still wrong them if it invades their interests (such as privacy) or treats them merely as means. Review by an IRB is thus justified if it improves the benefit-risk ratio; even more important, in most circumstances, informed consent should be obtained in advance from subjects, to promote subjects' autonomy, to improve the quality of research, to regularize the relationship of investigators and potential subjects, and to protect subjects' privacy. Nonetheless, in certain circumstances-illustrated here by considering three hypothetical studies-alternatives to the usual consent rules are acceptable.

Consistency between death certificates and clinical records from 5 general hospitals in Kuwait was studied for 470 deaths with the following underlying or associated causes: hypertensive (HYP), ischaemic heart diseases (IHD), cerebrovascular diseases (CVD) and diabetes mellitus (DM). Direct causes were not considered since they are of little interest analytically. Only deaths with definite or most probable ascertainment were included. One cardiologist, who was provided with the WHO criteria and relevant documents on death certification, independently reviewed the records. To test the reviewer's bias and the reliability of his judgement, an adjudication process was effected by having one senior cardiologist re-review a random subsample of 140 records. The two reviewers showed good agreement. Specific diagnoses criteria for deciding the underlying cause of death in multiple morbid conditions by the reviewer were followed. Due to possible reviewer bias, we aimed at measuring the difference between initial certifiers and the reviewer rather than measuring the diagnostic accuracy of initial certifiers in reference to the reviewer. The agreement index kappa showed poor agreement between original and revised certificates. The original certificates under-estimated CVD as an underlying cause of death by 69.2%, DM by 60%, IHD by 33.5% and HYP by 31.8% in our sample. Associated causes were also consistently under-estimated by initial certifiers as compared with the reviewer. This bias calls for basing mortality statistics in Kuwait on hospital death committees' reports rather than on initial certifier death certificates, use of multiple-causes of death instead of one underlying cause and adequate training of the medical profession on the value and process of death certification.