Mandatory Reports Research Articles

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO)

Objective: To present from the Danish Database for Biological Therapies in Rheumatology (DANBIO) the frequencies and types of adverse events as well as risk factors during treatment with biological agents in clinical practice.Methods: Adverse events during the first 2 years of clinical use of biological agents in Denmark were reported to the nationwide DANBIO and compared to the mandatory reports to the Danish Medicines Agency.Results: Almost 90% of the patients treated with biological agents were registered in the DANBIO, and the database picked up 20 times as many adverse events as the Danish Medicines Agency. Infections and hypersensitivity reactions were the most prevalent adverse events. Age, disease duration, and previous number of disease‐modifying anti‐rheumatic drugs (DMARDS) were found to be risk factors for bacterial infections.Conclusion: A routine‐based Danish database for biological therapies covers approximately 90% of patients and improves the reporting of adverse events.

Women Workers in Male Dominated Industrial Manufacturing Organisations: Contrasting Workplace Case Studies from Australia

mrev management revue , Seite 458 - 474

Symptoms of Pulmonary Blastomycosis: Northern Wisconsin, United States

Pulmonary disease is the most common manifestation of the systemic fungal infection, blastomycosis. This study examines symptoms of pulmonary blastomycosis and possible age and gender differences in a 22-year case series. Laboratory-confirmed cases of blastomycosis were identified from mandatory reports to the Vilas County Health Department (1984--2001) and from hospital records and case contacts before mandated reports (November 1979--1983). Symptoms were ascertained by interviews of respondent cases (or next of kin) by using a standard form. Proportions were compared with the chi-square test or Fisher exact test. One hundred seventy cases of blastomycosis (mean age 44, 56% male) were identified and pulmonary manifestations were present in 154 (91%). Of the 118 interviewed cases, the following symptoms were common: cough (90%), fever (75%), night sweats (68%), weight loss (66%), chest pain (63%), dyspnea (54%), and aches (50%). Hemoptysis occurred in 18%, and nearly all queried patients had fatigue. The dyad of cough and fever occurred in 73%, and triads of fever-cough-night sweats, fever-cough-weight loss, and fever-cough-chest pain occurred in 58%, 57%, and 51%, respectively. Among men, fever (P = .03), cough and fever (P = .03), fever-cough-weight loss (P = .03), and fever-cough-night sweats (P = .03) were less common in those 50 years of age and older. Symptoms did not vary by duration of illness. Cough, fever, night sweats, weight loss, chest pain, dyspnea, and aches are common symptoms of pulmonary blastomycosis. Symptom constellations that included fever were less common in men 50 years of age and older. There was no apparent difference in symptoms between acute and chronic blastomycosis.

News and Notes

News and Notes

Network computer-assisted transfusion-management system for accurate blood component-recipient identification at the bedside.

ABO-mismatched transfusions caused by human error are among the most serious problems in transfusion therapy. The major cause is misidentification of a recipient or a blood component at the bedside. A network computer-assisted transfusion-management system has been developed with bar coding as a fail-safe/fool-proof system for accurate component-recipient identification at the bedside, which allows us to monitor the usage of blood components in real time. The efficacy of this system was evaluated to prevent human errors by monitoring the transfusion process via the network and analyzing voluntary and mandatory reports with regard to transfusion errors over a 3-year period. The crossmatch-to-transfusion ratio for operations and outdate rate of RBCs were calculated to assess economic benefit. More than 60,000 blood components have been transfused perfectly to the intended recipients via the network, and one human error was prevented by the system. After establishment of the network system, the crossmatch-to-transfusion ratio for operations and outdate rate of RBCs have been gradually reduced from around 2.5 to 1.8 and from 3.9 to 0.32 percent, respectively. The network computer-assisted management system greatly contributes to safe and efficient transfusion therapy.

Fleet Dynamics of the Commercial Lake Trout Fishery in Michigan Waters of Lake Superior during 1929–1961

Understanding fishing fleet dynamics is important when using fishery dependent data to infer the status of fish stocks. We analyzed data from mandatory catch reports from the commercial lake trout ( Salvelinus namaycush) fishery in Michigan waters of Lake Superior during 1929–1961, a period when lake trout populations collapsed through the combined effects of overfishing and sea lamprey ( Petromyzon marinus) predation. The number of full-time fishermen increased during 1933–1943 and then decreased during 1943–1957. Addition of new fishermen was related to past yield, market prices, World War II draft exemptions, and lost fishing opportunities in Lake Huron and Lake Michigan. Loss of existing fishermen was related to declining lake trout density. Large mesh (≥ 114-mm stretch-measure) gill net effort increased during 1929–1951 because fishermen fished more net inshore as lake trout density declined, even though catch per effort (CPE) was often higher in deeper waters. The most common gill net mesh size increased from 114-mm to 120-mm stretch-measure during 1929–1957, as lake trout growth increased. More effort was fished inshore than offshore and the amount of inshore effort was less variable over time than offshore effort. Relatively stable yield was maintained by increasing gill net effort and by moving some effort to better grounds. Because fishing-up caused yield and CPE to remain high despite declining lake trout abundance, caution must be used when basing goals for lake trout restoration on historical fishery indices.

Intraoperative and postoperative risk factors for respiratory failure after coronary bypass

Background Unlike preoperative events, the influence of intraoperative or postoperative events on respiratory failure after coronary artery bypass grafting (CABG) remains unclear. The purpose of this study was to identify intraoperative and postoperative risk factors that predispose respiratory impairment after CABG. Methods A single institutional database combined with a mandatory report submitted to the Cardiac Surgery Registry of the New York State Department of Health was used. A total of 8,802 consecutive patients who underwent primary CABG with or without a concomitant cardiac operation from January 1993 through December 2000 were included. Respiratory failure was defined as the need for postoperative mechanical ventilatory support longer than 72 hours. Univariate and multivariate logistic regression model was used in the analysis. Results Of 8,802 consecutive patients (6,234 males and 2,568 females) who underwent CABG with or without a concomitant operation, 491 patients (5.6%) suffered from postoperative respiratory failure. Although univariate analysis identified 39 statistically significant preoperative risk factors for post-CABG respiratory failure, only six preoperative risk factors were statistically significant by multivariate analysis ( p < 0.001). CPB time (in 30 minutes increments) was the only validated intraoperative variable that increased the risk of postrespiratory failure (odds ratio [OR], 1.2; p less than 0.0001). Postoperative events contributing significantly to an increased risk of post-CABG respiratory failure were (1) sepsis and endocarditis (OR, 90.4; p < 0.0001), (2) gastrointestinal bleeding with or without infarction and perforation (OR, 38.8; p < 0.0001), (3) renal failure (OR, 30.7; p < 0.0001), (4) deep sternal wound infection (OR, 11.3; p < 0.0001), (5) new stroke, intraoperative at 24 hours (OR, 9.3; p < 0.0001), and (6) bleeding that required reoperation (OR, 5.5; p < 0.0001). All perioperative variables together accounted for only 28.6% (R 2) of the variation. Conclusions Respiratory function after CABG is readily influenced by postoperative occurrence of extracardiac organ or system complications.

Legislation regarding social protection of children and youth in Sweden with particular emphasis on protection from abuse and neglect

Protection of children from abuse and neglect is a current problem in the world. The consequences of violence against children are very important because they can leave behind permanent bodily injuries up to severe invalidity, as well as psychological consequences which very often lead to transmission of violence into next generations. In most extreme cases death occurs as a consequence of abuse and neglect. In this paper authors present legislation which regulate social protection of children and youth in Sweden, with special emphasis on protection from abuse and neglect. Sweden is a country in which social care of most vulnerable groups including children, was always at the top of priorities. Authors made comparative analysis of Swedish and domestic (Serbian) laws regarding protection of children from violence, with particular emphasis on mandatory report of these cases from professionals who are in regular professional contact with children. Authors will also put emphasis on duties of medical doctors in the system of protection of children and youth from abuse and neglect.

Conservatism, Optimal Disclosure Policy, and the Timeliness of Financial Reports

We develop a theory of the relation between biases in financial reporting and managers' incentives to issue timely voluntary disclosures. We find that firms with relatively more conservative accounting are less likely to make timely voluntary disclosures than firms with less conservative accounting. Therefore, price is more timely in reflecting the news of firms with less conservative accounting. Prior research has assumed that the timeliness by which news is impounded in price is uncorrelated with the nature of accounting earnings and has ascribed a concave earnings-return relation to the accounting system reporting bad news on a more timely basis than good news. In our theory, a concave relation is not necessarily attributable to a difference in the way the accounting system reports good vs. bad news. Rather, our prediction stems from how biases in mandatory financial reports determine which firms optimally choose to make voluntary preemptive disclosures and which do not. Hence, our theory provides an alternative explanation for the empirical findings and cautions against interpreting them as evidence that accounting is conservative. Finally, we identify means of empirically distinguishing between the alternative explanations.

Physicians' database searches as a tool for early detection of epidemics.

We analyzed retrospectively the use of Physician Desk Reference Database searches to identify epidemics of tularemia, nephropathy, Pogosta disease, and Lyme disease and compared the searches with mandatory laboratory reports to the National Infectious Diseases Register in Finland during 1995. Continuous recording of such searches may be a tool for early detection of epidemics.

Linking impact assessment to an environmental management system. Case study: a downstream upgrading petroleum plant in Venezuela

A proponent of a downstream upgrading petroleum plant in Venezuela requested to carry out the mandatory complete EIA report with an Environmental Management System in mind. In Venezuela, a complete EIA report is a document that includes: the Environmental Impact Assessment, the Supervision Plan, the Surveillance Plan, and the Guidelines for a Contingency Plan. For this task, a methodology was proposed to review the role of a complete EIA report within the framework of the requirements of a future Environmental Management System. The outcome was a Proposed Working Model that was applied to the case study. The results showed that the linkage sustains the ongoing use of the complete EIA report in the process of environmental evaluation throughout the life cycle of an industrial plant. In addition, outcomes from the linkage substantially improved the Environmental Supervision Plan in particular.

Sudden Death in Patients Receiving Clozapine Treatment: A Preliminary Investigation

The risk of sudden death during clozapine treatment is controversial. The authors present a review of sudden deaths that occurred at Sha'ar Menashe Mental Health Center between January 1991 and August 1997. The number of cases of deceased inpatients was retrieved from the hospital's computerized database and divided into three groups: sudden death, suicide, and disease-related death. Copies of mandatory reports of sudden death filed with the Ministry of Health were obtained, and the corresponding patient records were reviewed. The rates of sudden death, suicide, and disease-related deaths were calculated for clozapine-treated patients (CTPs) during and after treatment and for patients treated with other psychiatric agents (non-CTPs). Among 561 CTPs, there were 4 sudden deaths during treatment, 2 sudden deaths after treatment, 2 suicides during treatment, and 2 disease-related deaths during treatment. Among 4918 non-CTPs, there were 14 sudden deaths, 5 suicides, and 86 disease-related deaths, all of which occurred during treatment with other psychiatric agents. CTPs who experienced sudden death were 10.37 years younger and healthier than non-CTPs who experienced sudden death. The sudden death rate was 3.8 times higher for CTPs than for non-CTPs, whereas the rate of disease-related death was 5 times higher for non-CTPs than for CTPs. Contrary to expectations, the rate of suicide among patients currently receiving clozapine in this sample was 3.6 times higher than among non-CTPs. Because CTPs who experienced sudden death were also younger and healthier, it seems that treatment with clozapine may present a greater risk for sudden death than treatment with other psychiatric medications. The limited number of sudden death cases and deaths from other causes should be noted so that these findings are considered with caution.

The release of unsuitable units through misinterpretation of laboratory results transmitted by facsimile.

Preventable errors in transfusion medicine that have a significant risk of adverse outcome include the erroneous administration of blood of the wrong type or blood with unsuitable laboratory test results. Mandatory reports of errors by facilities providing blood services in New York State offer the opportunity for review and analysis of common factors. The state also collects statistics on the collection, laboratory testing, distribution, and disposition of blood in these facilities. Three serious errors in transfusion medicine occurred within 3 months as a result of the misinterpretation of laboratory test results transmitted by facsimile. Two unsuitable units of blood were erroneously released, and a unit mislabeled as to the ABO group was incorporated into the hospital inventory. One of the unsuitable units was repeatedly reactive for HIV (although negative on confirmatory testing), and the other was confirmed positive for HCV. The vast majority of blood collected in New York State is tested by reference laboratories. Results are often transmitted by facsimile. Facsimile results may be misinterpreted because of distortion during transmission, misreading, or failure to note a separate report of pending results. Such misinterpretation results in an increased risk of adverse outcome for transfusion recipients. Laboratory results to be transmitted by facsimile could readily-and should-be clarified.

Record-linkage between two anonymous databases for a capture-recapture estimation of underreporting of AIDS cases: France 1990-1993. The Clinical Epidemiology Group from Centres d'Information et de Soins de l'Immunodéficience Humaine.

To estimate the completeness of the French mandatory AIDS surveillance system (Declaration Obligatoire DO) over the 1990-1993 period using a capture-recapture approach, by matching the mandatory reports with the AIDS cases present in the French Hospital Database on HIV infection (FHDH). An anonymous record-linkage algorithm was developed to identify those cases common to both anonymous surveillance systems. The linkage was based on sex, date of birth, and infection risk group, all strictly matched, and on the dates of AIDS diagnosis and of death, the places of diagnosis and residence, and the AIDS-defining diseases at diagnosis. The total number of AIDS cases and completeness of both surveillance systems were estimated using a capture-recapture approach, assuming independence of the ascertainment sources. The completeness of the mandatory reporting was estimated at 83.6% (95% CI: 82.9-84.3), and that of the FHDH at 47.6% (95% CI: 46.9-48.3) for the surveillance of AIDS cases diagnosed among adults in France between 1990 and 1993. The completeness of the system based on FHDH increased over the study period as more hospitals joined the project, while the completeness of the DO surveillance system remained stable. This approach was useful in estimating the underreporting of AIDS cases in France. Regularly performed, it will allow the impact of underreporting to be monitored over time.

Mandatory reporting of intimate partner violence: safety or retaliatory abuse for women?

We wished to ascertain abused women's perspectives on mandatory reporting of intimate partner violence. A consecutive sample of 161 abused women accessing the criminal justice system were asked six questions. Most women (81%) thought there should be a law making the nurse or doctor report the abuse, with less than half of the women (45%) reporting they would have been at greater risk for abuse following a mandatory report. Although these 161 abused women support mandatory reporting of partner abuse, it remains unclear if such a law would deter further abuse. Outcome and evaluation studies of mandatory reporting laws are urgently needed.

Historical Accounting and the Endogenous Credibility of Current Disclosures

In this paper I examine how an untimely mandatory accounting system -- one that gives an accurate report of past value -- can enhance the credibility of a firm's more timely discretionary disclosures. I develop a model of firm disclosure in a simple setting with information asymmetry and adverse selection. The communication of the firm's current private information about value, if possible, enables the firm to issue equity at a fair price and adverse selection does not occur. However, the mandatory accounting system can only report the firm's value with a significant time lag, and there is no other exogenous mechanism that would make a firm's more timely disclosures credible. Nonetheless, I show that the existence of an accurate mandatory report of the firm's historical value is sufficient to make the firm's current disclosures credible most of the time. It does this by providing a lagged ex post check on the firm's more timely disclosures. Thus, while the capital market participants can be fooled by a dishonest disclosure, in time the mandatory accounting system will reveal this. The result is that firms will typically disclose their private information truthfully, capital market participants will rationally believe the disclosures, and adverse selection will be greatly reduced. The model also allows for the possibility that, in some periods, the firm may not be able to resist the temptation to lie, such as when management is selling shares or needs to raise capital quickly on favorable terms. When the accounting system later reveals the false prior disclosure, the model describes how market participants ignore the firm's subsequent disclosures for a period of time, causing adverse selection and the loss of profitable capital market transactions. But, after a sufficient number of periods, the market believes the firm's disclosures again and efficient trade resumes. The paper studies how the timeliness of the mandatory accounting measure affects the frequency of cycling in and out of the efficient state where communication is truthful and adverse selection is held at bay. Financial reporting has recently come under considerable criticism. SEC Chairman Arthur Levitt recently spoke out strongly against perceived abuses of the flexibility in financial reporting, and has undertaken an initiative to reduce the amount of discretion in restructuring charges, acquisition accounting, and the unfettered use of reserves. But the results of this paper suggest that eliminating the discretion in GAAP indiscriminately would eliminate a powerful source of communication between the firm and the market. An alternative solution would be to modify the system to more clearly identify firms who have abused the discretion in the past.

On the Frequency, Quality, and Informationl Role of Mandatory Financial Reports

In this paper we study the relation between the frequency of mandatory financial disclosures, the amount of information voluntarily disclosed by privately informed managers, and the resulting informational efficiency of stock prices. Our analysis emphasizes the confirmatory role of mandatory financial reports and uses frequency to highlight the difference between this view of reporting and the prevailing view of mandatory disclosures as sources of information. We model the mandatory financial disclosures as verifiable but noisy and, possibly, late signals of management's private value-relevant information. Accordingly, financial statements may be of little use as a timely, primary source of information for the purpose of valuing the firm. However, since the audited statements can be used to evaluate the truthfulness of management's past voluntary disclosures (i.e., to confirm that they are indeed truthfully, they may be useful in creating an environment in which management

Discussion of on the Frequency, Quality, and Informational Role of Mandatory Financial Reports

* What information about firms' financial conditions should be released to investors and other stakeholders in their financial reports? * Where should the information be released: should it be recognized explicitly in the body of the firms' financial statements, disclosed in notes, or revealed in some other fashion? * When should the information be disclosed: immediately upon receipt of information, after enough information is accumulated to suggest the probability of an economic event involving the firm exceeds some threshold, immediately after an economic transaction takes place, or at some time following the transaction associated with the information? * How should the information be recorded: at historical cost, at market value, based on estimates, discounted? * Why should the information be included in financial reports, that is, why should the information be mandated to appear in financial statements, as opposed to being left up to the discretion of individual firms?

North Carolina board of pharmacy releases figures from mandatory reports of drug-related deaths

North Carolina board of pharmacy releases figures from mandatory reports of drug-related deaths

The Role of Declarations in UNSCOM's Program in Iraq

Written declarations have been identified as one of the most useful tools in determining a nation's potential for a biological warfare capability. Declarations are defined as mandatory reports (provided on a periodic basis) that describe various aspects of a state's biological infrastructure, including both academic and governmental programs. Specifically included are descriptions of facilities, summaries of research projects, and other information considered relevant to making an evaluation of that country's capabilities. Notifications of specific events of interest are also considered as part of the required declaration. As part of the confidence-building measures (CBMs) of the Biological and Toxin Weapons Convention (BWC), between 25 and 30 of the State Parties have been providing written declarations for a number of years. With specific regard to the Iraqi experience, the government of Iraq was required (under the auspices of United Nations Security Council Resolution 687) to provide specific declarations about any and all facilities potentially associated with their biological warfare program. UNSCOM inspectors have the responsibility of verifying the accuracy of the information provided by Iraq in declarations.