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PubMed1993

Anaesthesia equipment safety in Canada: the role of government regulation.

Medical device problems as detected by the Health Protection Branch (HPB) of Health and Welfare Canada were studied in order to examine the frequency and safety priority of problems in the subgroup of anaesthesia devices. Data pertaining to the time period from April 1, 1987 to November 30, 1992 were gathered from the Medical Devices Notification Database and the DAFFY Reporting System. The Medical Devices Notification Database contains all notifications for newly marketed medical devices in Canada and the DAFFY Reporting System keeps record of all submitted problem reports and manufacturer recalls along with their designated safety priority status. When an important safety hazard is associated with a medical device as determined from information submitted to HPB, an Alert-Medical Devices may be issued to inform hospitals and health care professionals of the problem. During the studied time period, the percentages of problem reports and recalls as well as Alerts were compared with the percentage of newly marketed anaesthesia devices. It was found that although only 2.3% of the newly marketed medical devices were classified as anaesthesia devices, 8.6% of all problem reports/recalls and 37.5% of all Alerts originated from the field of anaesthesia devices. Comparison of the percentages of problem reports/recalls (8.6%) and Alerts (37.5%) with the percentage of marketed devices for anaesthesia (2.3%) showed differences (P < 0.05). As well, the percentage of class I priority (the highest safety priority) problem reports/recalls for anaesthesia devices was 10.2% compared with 4.9% for non-anaesthesia devices (P < 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Anesthesiology↗
PubMed2003

Risk of drug-induced agranulocytosis: the case of calcium dobesilate.

BACKGROUND: In the last 20 years, some cases of agranulocytosis associated with calcium dobesilate consumption in Spain have been reported. A high risk of dobesilate-associated agranulocytosis (121 cases per million per year) calculated using both a case-control and a case-population strategy has been published. However few spontaneous reports have been noted in the same period of time. No explanation exists for this disagreement. METHODS: Estimated incidence rates of agranulocytosis in the IAAAS study and the calculated risk of dobesilate-associated agranulocytosis were used as background risks in a Poisson-based methodology, to calculate the number of coincidental reports of agranulocytosis among patients treated with dobesilate. The influence of treatment duration, notification rate and population characteristics were calculated. RESULTS: During the period 1978-2000, a total of 23 cases would have taken place if the background risk of agranulocytosis were 4.7 per million per year (IAAAS's risk); however, only 9 spontaneous cases of agranulocytosis associated to dobesilate were noted. A simulation showed that with notification rates equal to or higher than 17%, it was not possible to exclude that the 9 cases were false-positives. With notification rates equal or inferior to 16%, it would be unlikely that cases of agranulocytosis were noted in this population with a risk of 4.7 per million per year; therefore, it is necessary to assume a higher agranulocytosis risk. More than 1 case per year could be a false-positive if the background risk of agranulocytosis is 9.5 per million per year, this being the appropriate risk for a population of patients older than 60 years. The duration of treatment beyond 30 days increases the probability of a random coincidence of the intake of drug and an agranulocytosis event. CONCLUSIONS: The disagreement between calculated dobesilate-associated agranulocytosis risk and the number of noted spontaneous reports may be explained by at least three different factors: under-reporting, duration of treatment and age of patients. It is possible, with the methodology presented, to estimate the influence of these factors to avoid confusion with possible false-positive cases and then to design the correct prospective trial that can provide the true agranulocytosis risk.

Adverse Drug Reaction Reporting Systems↗
PubMed1993

Study of factors that influence the clinical response to ciguatera fish poisoning.

A 1-year observational study of all standardized medical records of ciguatera fish poisoning notified cases was conducted in French Polynesia. The objective was to determine the factors that influence the clinical response to ciguatera fish poisoning. During the year 1991, there were 551 cases notified on standardized code sheets by physicians (notification rate 276 per 100,000). The mean age was 36.6 years (S.D. 15.6). The largest age group was that between 30 and 49 years old (notification rate 562 per 100,000). The gender ratio (M/F) was 1.6. Of the 551 cases, 257 (47%) presented with a history of a previous attack. A clinical score was calculated to assess the outcome for each case. The adjusted odds ratio (OR) for a severe disease (33% with a score greater than 5) was significantly increased when the fish ingested was carnivorous (OR = 1.62, P = 0.02) and when a history of a previous attack was reported (OR = 1.71, P = 0.006). The increased severity of multiple episodes and the increase of the notification rate with age suggest a possible accumulation of toxin in the human organism.

Adolescent↗
PubMed1975

Pulmonary tuberculosis in Scotland: a national sample survey and follow-up (1968-70). 1. The characteristics of the cases notified in 1968.

A survey has been undertaken of a 50 per cent random sample of 865 patients notified as having pulmonary tuberculosis in 1968 in Scotland. The estimated notification rate for the total population was 33.3 per 100,000. The highest rate for males was 89.8 for those aged 55 or more and for females 29.5 for those aged 25 to 54. The rates for bacteriologically confirmed cases were 51.6 and 16.0, respectively, for these two groups. An independent radiological assessor reported the characteristic appearances of active tuberculosis in 50 per cent of the chest radiographs. Nearly half the patients were referred by general practitioners and 20 per cent were hospital inpatients when diagnosed. Contacts and mass radiography services produced many fewer cases and the proportion of infectious cases in these groups was low. The notification procedure is discussed and it is suggested that as progress towards eradication is made notification information is inadequate, and that standardised supplementary information on severity of disease and infectiousness should be collected, annually or periodically.

Adolescent↗
PubMed1987

Effectiveness of BCG vaccination in England and Wales in 1983.

The effectiveness of BCG vaccination, at about age 13 years, in the prevention of tuberculosis at ages 15-24 years in England and Wales in 1983, has been determined by the same method as in two previous surveys in 1973 and 1978. In 1983, the tuberculosis notification rate among those vaccinated in the schools' scheme was 3.30 per 100,000, compared with an estimated rate of 13.20 per 100,000 among those who were tuberculin negative and not vaccinated in the scheme. The protective effectiveness of BCG vaccination at ages 15-24 years in England and Wales in 1983 is thus estimated as 75%; the estimated efficacy in the white ethnic group is closely similar, namely 76%. The estimated efficacy of BCG at ages 15-19 and 20-24 years in the three surveys, both in the white ethnic group and in the entire cohort, has been compared with that found in the Medical Research Council's controlled trial of tuberculosis vaccines which began in 1950. There is no evidence of any decrease in the protective efficacy of BCG vaccination between the four cohorts of young adults, which span a total period of 29 years. However, there were steep decreases between the cohorts in the annual notification rates for the white ethnic group; these decreases occurred in the BCG vaccinated and in the tuberculin negative unvaccinated groups, as well as among those found tuberculin positive (and not vaccinated) in the schools' scheme. It is concluded that the level of protective efficacy of BCG vaccination at ages 15-24 years is high, and has remained unchanged since the start of the BCG in schools' scheme. However, as the tuberculosis notification rate in young adults has decreased steeply throughout this period, and is continuing to decrease, the benefits to be expected from the BCG in schools' scheme will decrease equally rapidly.

Adolescent↗
PubMed2005

Congenital anomaly surveillance in England and Wales.

The National Congenital Anomaly System (NCAS) was set up in 1964, following the thalidomide epidemic, as a monitoring system designed to detect changes in the frequency of reporting of malformations. Its original aim was to detect anomalies reported within 7 days of birth. The NCAS is voluntary at all stages and covers all live- and stillbirths. It has two tiers; a 'passive system' receiving congenital anomaly notifications through a standard paper notification form, known as the SD56, and the congenital anomaly registers that send notifications electronically. Congenital anomalies are classified using the International Classification of Diseases codes and 10 monitoring groups. The Office for National Statistics performs a statistical analysis on a monthly, quarterly and annual basis, using the cumulative sum technique, which is the basis upon which surveillance alerts are raised within the system. The NCAS is now an open database where congenital anomalies can be notified whenever they are detected. The aim of this paper is to describe the current operation and uses of the NCAS based on guidelines for the evaluation of public health surveillance systems published by the Centers for Disease Control and Prevention.

Congenital Abnormalities↗
PubMed2005

Surveillance system of vaccine adverse events and local data analysis--the experience in a middle-sized city in Brazil, 1999-2001.

We reviewed all vaccine adverse events (VAE) notified in a middle-sized Brazilian city (n=247) to the National Immunisation Program between January 1999 and December 2001. Vaccine doses used in that period were considered for rate estimates. Aspects of the surveillance system (SS) and their influences on collected data were considered, searching for contributions of local data analysis to investigation of VAE and to the monitoring of vaccine safety. Notification rates in our study were higher when compared to national data. Changes in the notification pattern were observed following vaccination campaign periods. An increase in aseptic meningitis cases temporally associated to yellow fever vaccine was detected. The analysis of local data provided information unperceived in national consolidated data. Through this analysis we detected: events related to application technique and handling; people's perception changes on VAE; and the local SS's ability to raise new hypothesis. We suggested changes to the notification form regarding data entry criteria and analysis.

Adolescent↗
PubMed1984

Validity of the recording of meningococcal disease according to various sources of information.

A study was made in Belgium in order to assess the completeness and specificity of the recording of meningococcal disease by routine sources of information. Ninety-three cases identified in a hospital survey were linked with those recorded in mortality statistics, in the notification of communicable diseases, and by the National Reference Laboratory for meningococci. Statistics based on mortality data appeared to be of low validity. The overall completeness of recording was 44% for the notification of communicable disease, and 40% for the reference laboratory. When these two sources were used for surveillance, the completeness of case-finding increased to 56%. When the analysis was restricted to bacteriologically-confirmed cases, the completeness of recording was 62% for the notification system, 70% for the laboratory, and 84% for both sources. The surveillance of communicable diseases should rely on various sources of information. Laboratory data should be systematically used in order to improve both the completeness of recording and the specificity of case-ascertainment.

Adolescent↗
PubMed1995

Hawthorne effect: implications for prehospital research.

STUDY OBJECTIVE: The phenomenon of altered behavior or performance resulting from awareness of being a part of an experimental study has been termed the "Hawthorne effect." Prehospital studies generally involve paramedics or are designed to use data collected by paramedics. Our objective was to determine whether paramedic performance, as measured by frequency of documentation, can be modified by (1) written notification of the importance of documentation, (2) written notification of a research project involving paramedic documentation, or (3) written notification of a quality-improvement audit of paramedic documentation. DESIGN: Prospective, sequential intervention study with five study phases. SETTING: Urban, all-advanced life support public utility model emergency medical services system with 55,000 emergency calls per year. PARTICIPANTS: One hundred forty-five paramedics who completed all ambulance run reports from August 1992 to May 1993. RESULTS: A total of 30,828 run reports was entered into the study. Baseline undocumented parameters ranged from 3.7% to 6.5%. Compared with baseline, a memo to heighten awareness (phase 2) did not alter documentation (P > or = .08). A medication study memo (phase 3) improved medication documentation (P = .0005) and allergies documentation (P = .037). A quality-improvement audit memo (phase 4) improved documentation of all parameters (P < or = .001). CONCLUSION: The Hawthorne effect occurs in prehospital research. It does not require direct observation, nor does it require direct feedback. However, it may require a perceived demand for performance. The Hawthorne effect must be considered in the design of prehospital studies and interpretation of data collected by paramedics.

Data Collection↗
PubMed1998

Death in the emergency department.

Issues regarding the deaths of patients in the ED arise on a regular basis for emergency physicians. These issues include physician discomfort with death notification, the approach to families after ED deaths, autopsies, donation of organs and tissues, and procedures on the newly dead. If physicians were more comfortable with death notification, not only would families be better served but benefits to society could be realized through the increased use of autopsy and organ/tissue donation. The controversial topic of physician education through practice of medical procedures on the newly dead weighs the benefits to society against the rights of the individual. Improved physician education, including the need for a death notification plan and enlistment of the support of nursing personnel, social workers, and clergy, may improve the experience of events surrounding ED deaths for physicians, families, and society. We review the literature and give recommendations on approaches to deal with these issues.

Attitude to Death↗
PubMed1998

Non-accidental burns in children.

A retrospective review of five hundred and seven consecutive admissions to a state-wide paediatric burns unit over a three year period was made to assess the characteristics of the burn injuries and to see which, if any, characteristics would help to distinguish accidental burns from burns which were due to abuse or neglect. In 86% of admissions (the 'accident group') it was considered that the injury was accidental, with no evidence of deliberate injury or gross neglect. Eight percent of admissions (the 'abuse/neglect group') were referred to the State Department of Community Services for abuse or neglect resulting in the Department becoming involved in the family's management. In six percent of cases (the 'concern group') the Unit had concerns that the family's emotional or social situation was a significant factor in the child's injury, or made further injury more likely, and discussed the family's situation with the Department, but formal intervention was not undertaken by the Department. There were no differences between the groups in age or mortality. Children in the 'abuse/neglect' and the 'concern' groups were more likely to require skin grafting and treatment in the intensive care unit. They were more likely to come from single parent families and were more likely to have burns involving both hands or both legs. There were few other distinguishing factors. The incidence of prior notification for abuse and neglect was four percent for the 'accident' group, 14% for the 'concern' group and 46% for the 'abuse/neglect' group. This is considerably higher in the 'concern' and 'abuse/neglect' groups than the annual state incidence of 1.73% for abuse and neglect notifications. While the clinical features of a burn may often not be helpful in reaching a diagnosis of abuse or neglect as a cause of the burn, it appears that many children who have non-accidental burns have also had prior notifications for other types of abuse or neglect.

Accidents↗
PubMed2005

[The epidemiology of occupational asthma in Belgium].

INTRODUCTION: A national surveillance programme of occupational asthma was set up to estimate the incidence and identify the causes of this disorder in Belgium. MATERIALS AND METHODS: The programme was based on the voluntary notification of new cases of occupational asthma by chest specialists and occupational physicians during the period 2000-2002. RESULTS: 92% of the reported cases included occupational asthma of an immunological type and 8% bronchial irritability. According to the opinion of the reporting physicians the diagnosis was considered certain in 39%, probable in 29% and possible in 32% of cases. On the basis of these notifications the mean annual incidence of occupational asthma is estimated as 23.5 cases per million workers (95% confidence interval 19.2-28.8). The most frequently incriminated substances were isocyanates (16%), cereals (12%) and latex (10%). At the time of diagnosis 38% of patients had not applied for compensation. CONCLUSION: The results of this programme of notification of occupational asthma agree with the data available from other countries and provide information complementary to the medico-legal statistics.

Adult↗
PubMed2002

Psychological impact of genetic testing in women from high-risk breast cancer families.

Psychological adjustment in 90 women (30 carriers and 60 non-carriers) who had undergone genetic testing for mutations in BRCA1 and BRCA2 breast/ovarian cancer susceptibility genes was compared with that of 53 women who were not offered genetic testing. Women were assessed prior to genetic testing and 7-10 days, 4 and 12 months after carrier status disclosure using self-administered questionnaires. Compared with women not offered testing, mutation carriers had significantly higher breast cancer distress 7-10 days (t=2.80, P=0.005) and 12 months (t=2.01, P=0.045) post-notification. Non-carriers showed a significant decrease in state anxiety 7-10 days post-notification (t=2.27, P=0.024) and in depression 4 months post-notification (t=2.26, P=0.024), compared with women not offered testing. These data show that non-carriers derive psychological benefits from genetic testing. Women testing positive may anticipate a sustained increase in breast cancer distress following disclosure, although no other adverse psychological outcomes were observed in this group.

Adult↗
PubMed2001

[Evaluation of the immediate transfusion reaction incident reporting system at the Brest University Hospital Center].

The Haemovigilance Unit of Brest University Hospital has had a reporting system of transfusion reactions since october 1994. Reporting "any unexpected or undesirable effect due or likely to be due to the administering of blood cell components" must be done on an answering machine immediately or in the next eight hours. The main goal of the evaluation of this epidemiological surveillance system was to assess its sensitivity, its positive predictive value, its acceptability, its timeliness and its simplicity, according to the Centers for Disease Control criteria. An exhaustive monitoring of the immediate transfusion reactions (ITR) occurring within the 24 hours following the procedure was conducted from April 1, to June 30, 1998. Two sources of information were used, the spontaneous notification to the Haemovigilance Unit using the answering machine, and a telephone survey of the nurse responsible for the transfusion or post-transfusion follow-up. During the survey, 19 ITR, among which 12 were reported to the Haemovigilance Unit on the answering machine, were recorded. The incidence rate of the I.T.R. was estimated at 5@1000 transfused blood cell components. The sensitivity of the notification system was estimated at 63% (95% confidence interval: 41-85) and the positive predictive value at 70% (95% confidence interval: 48-92). This notification system is operational. The function of sanitary alert is ensured at the primary level of the system surveillance. The undernotification of the ITR (37% of false negative) must be corrected by specific recommendations.

Academic Medical Centers↗
PubMed1995

Tuberculosis in inner London: evidence for an increase in young adults and immigrants.

We report a marked increase in the rate of notifications of tuberculosis in young adults in the London Borough of Lambeth. Analysis of notifications made to the Proper Officer over a 10-year period showed that the age specific notification rate in the cohort aged 20-44 years increased from 30/100,000 in 1983 to 51/100,000 in 1992. Analysis of St. Thomas' Hospital laboratory records of patients seen between 1984 and 1991 from whom Mycobacterium tuberculosis was isolated showed an increase in the number of patients of African origin from five in the first half of the study period (1984-7) to 25 in the second half (1988-91): 21 of these 25 had immigrated into England within 4 years of their illness. This finding is being further investigated in a prospective study of ethnicity, travel history and date of immigration of Lambeth residents notified with tuberculosis.

Adolescent↗
PubMed2001

The impact of diagnosis by legionella urinary antigen test on the epidemiology and outcomes of Legionnaires' disease.

Legionnaires' disease is an uncommon but important cause of life-threatening community-acquired or nosocomial pneumonia. The urinary antigen enzyme immunoassay test, used in Victoria since 1995, now accounts for the majority of initial laboratory notifications (81% in 1999). We review the impact of the test on the disease epidemiology and the public health investigative process. We focus on the major subgroup of cases due to Legionella pneumophila serogroup 1, comparing delays until notification and mortality for urinary antigen detected cases with culture detected cases. The urinary antigen test facilitates a 5-day reduction for the delay between onset of illness and notification. We observed that there was minimal clinical heterogeneity of urinary antigen detected cases whether they were subsequently culture confirmed or not. We encourage clinician use of the urinary antigen test in cases of community-acquired pneumonia where Legionnaires' disease is a possible diagnosis, in conjunction with culture of clinical specimens.

Adult↗
PubMed2002

Epidemiology of measles, mumps and rubella in Italy.

A serosurvey for measles, mumps and rubella was conducted in Italy; incidence based on statutory notifications over the last three decades was also calculated. In Italy the diseases followed an endemic-epidemic pattern, with an incidence peak every 2-4 years, and had a limited reduction of incidence attributable to childhood immunization. Lower notification rates were observed in the Southern regions. This is possibly related to greater under notification in the South and is confirmed by our seroprevalence data. Incidence of measles and rubella and proportion of cases among young adults increased significantly in the three decades considered, but not for mumps. Serological data confirmed that these infections are still very frequent in Italy, without significant geographic variation in the country. In the age groups 2-4 and 5-9 years the percentage of individuals still susceptible to each virus was higher than 30%. The proportion of susceptible subjects older than 15 years was similar for the three infections (6.1, 11.7 and 8.8% for measles, mumps and rubella, respectively). The low vaccine coverage for rubella and measles in Italy has so far only partially affected the occurrence of the diseases. No impact of mumps vaccination is visible. The average number of deaths, for each disease, has decreased during the three study periods. Today the priority in Italy is to halt the progressive increase of the mean age of acquisition of the three infections, to eliminate differences in coverage among regions and to conform to European standards. This will be achieved through a combination of increasing MMR vaccine coverage before 2 years of age, implementing vaccination campaigns for low seroprevalence age groups, and/or introducing a second dose of MMR, depending on the level of current MMR coverage.

Adolescent↗
PubMed2005

Sensitivity of the Swedish statutory surveillance system for communicable diseases 1998-2002, assessed by the capture-recapture method.

To assess the sensitivity of the Swedish surveillance system, four notifiable communicable diseases in Sweden were examined during 1998-2002 with the two-sources capture-recapture method, based on parallel clinical and laboratory notifications. The sensitivity (proportion of diagnosed diseases actually being notified) was highest for salmonellosis (99.9%), followed by meningococcal infection (98.7%), and tularaemia (98.5%). For penicillin-resistant pneumococci, introduced as a notifiable disease in 1996, the overall sensitivity was 93.4%--increasing from 86.5% in 1998 to 98.5% in 2002. The system benefited from parallel reporting, with a sensitivity of clinical and laboratory notifications alone (all diseases combined) of 91.6% and 95.9% respectively. The sensitivity of both clinical and laboratory notifications was markedly higher in counties using the national electronic reporting system, SmiNet. Thus, sensitivity was higher for diseases with a long tradition of reporting, and there is a run-in period after a new disease becomes notifiable.

Communicable Disease Control↗