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At least 1,243 records · Page 69Linked to original sources
PubMed1998

Notification of Pap smear results. A Victorian survey.

OBJECTIVE: To determine health practitioners' use of preprinted tear-off sections attached to all Papanicolaou (Pap) smear reports as a means of notifying women of their test results and to assess possible barriers to the use of these. METHOD: A questionnaire was sent to health practitioners who used the Victorian Cytology Service for their Pap smear reporting. RESULTS: A 74% response rate was achieved (1402/1886); 70.4% (987/1402) of respondents routinely used the tear-off section. Use was more common for negative Pap smear reports (62.8%) than for abnormal Pap smear reports (46.1%). The main barriers nominated by non users were a preference for an alternative approach and the impersonal nature of the communication. CONCLUSIONS: After 18 months, we conclude that preprinted tear-off sections appear to have an encouraging level of acceptability among practitioners. The laboratory has decided to maintain this initiative as a permanent feature.

Communication↗
PubMed1998

[Extrapyramidal toxicity caused by metoclopramide and clebopride: study of voluntary notifications of adverse effects to the Spanish Drug Surveillance System].

OBJECTIVE: To clarify if there is any basis for the hypothesis that Clebopride leads to more extrapyramidal reactions than Metoclopramide. DESIGN: Observational, longitudinal, retrospective and comparative study of two series of cases. SETTING: The entire Spanish healthcare system. PATIENTS: Those notified to the Spanish Drug watch system as possibly having suffered an adverse reaction to Metoclopramide (n = 98) or Clebopride (n = 123) between 1/1/1990 and 10/6/1997. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: 84.3% of suspected adverse reactions to Clebopride and 51.6% of those to Metoclopramide had a non-hospital precedence (P < 0.001). In 48.0% of suspected adverse reactions to Metoclopramide and 72.4% of those to Clebopride, there was extrapyramidal toxicity (P = 0.021). CONCLUSIONS: There is a basis for the hypothesis that Clebopride causes more extrapyramidal reactions than Metoclopramide. It was reasonable to realize a study based on this hypothesis.

Adult↗
PubMedDate not supplied

FDA recognition of consensus standards in the premarket notification program.

"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors.

Equipment Safety↗
PubMed1991

[Sexually transmitted diseases: notification in Chile, in the V region and in the Vinã Del Mar-Quillota health service (1977-1988)].

Reports of sexually transmitted diseases in the Vth Region of Chile from 1977 to 1988 were analyzed and compared to nationwide reports and to figures for the Viña del Mar-Quillota area. Overall rates of syphilis decreased during the period. In contrast both number of cases and risk of disease increased for gonorrhoea. Risk of syphilis and gonorrhoea was highest in the Vth Region. HIV infection is increasing, especially in the area covered by the Health Service in Viña del Mar-Quillota. Sexually transmitted diseases not subject to reports were screened along with routine examinations for cancer of the cervix. Infection rates of 9.9% for trichomona and 1.09% for candida were thus detected.

Acquired Immunodeficiency Syndrome↗
PubMedDate not supplied

Reporting notifiable diseases: methods for improvement, attitudes and community outcome.

Notification is an important source of health information. However, it suffers from the serious limitation of under-reporting, especially in 'third world' countries. The aims of this study were to assess the impact of a special notification nurse and ward notification register on the rate of notification from a general medical unit, the knowledge and attitudes of intern medical officers regarding notification, and the community outcome of notification in a Sri Lankan setting. Overall, appointment of a special nurse improved notification rates from 9.7% to 62.1%, and the addition of a special ward notification register further improved the rate to 95.1% The results also indicated that, although a majority of intern medical officers were aware of notifiable diseases and the importance of notification, only a few of them always notified notifiable diseases. One of the main reasons given for this was that the majority of them felt that no useful action was taken on notifications by the preventive health authorities, a view that was held because there was no feedback information regarding the notifications. However, during the period of this study nearly 80% of all notifications were successfully investigated by the relevant medical officer of health office. The appointment of a nurse dedicated to notification and introduction of a ward notification register could greatly improve notification rates. Better communication between curative and preventive health sectors would improve attitudes of doctors regarding notification.

Disease Notification↗
PubMedDate not supplied

[Reporting new HIV cases in Catalonia, Spain: is technical consensus feasible?].

OBJECTIVE: To describe the process performed in Catalonia (Spain) to design an information system for monitoring new cases of HIV infection. METHODS: A survey was used to evaluate perception of the need for notification of HIV infection by health care professionals (n = 106), as well as their opinions of the various possibilities for the implementation of the notification system. As a result of this evaluation, a specific technical report defining the objectives and technical characteristics of the new notification system was produced. The feasibility of the system in health centres was evaluated through discussions with health care professionals, health authorities and Non-Governmental Organizations, and a second survey was designed to evaluate the use of a personal identification code (PIC) from the individual health card (IHC). This process took plabe between 1998 and 2000. RESULTS: A total of 84.5% of the health care professionals believed that HIV notification should be mandatory and confidential; 90.4%, were of the opinion that notification would enable identification of the epidemiological characteristics of infected individualos, and 75% believed that these individuals would have to be identified by name. Finally, 66% of the health care professionals believed that the use of the PIC from the IHC would be feasible as the personal identifier in HIV notification. A final proposal was draw up and 1 January, 2001 was set as the date to initiate the pilot phase of the new HIV notification system. CONCLUSIONS: Most of the health care professionals surveyed expressed the need for notification of HIV infection, and for such notification to receive institutional endorsement. They also believed that, as with other diseases of individualized mandatory reporting, notification should be carried out with a single personal identifier. The information obtained from notification of HIV infection is essential for the optimal planning of preventive programs and the provision of health services. The main difficulties observed were that HIV infection has not been included among the diseases of mandatory reporting, as well as the low implantation of the PIC in the hospitals' clinical registries. All the sectors involved have an important role to play in creating the conditions necessary for the notification system of new cases of HIV infection to be feasible and useful.

Consensus↗
PubMed2004

Timeliness of case reporting in the Swedish statutory surveillance of communicable diseases 1998--2002.

To prepare for a new communicable disease act in Sweden, we performed an in-depth analysis of the performance of the present notification system (1998--2002). Four diseases were selected for analysis (meningococcal infection, salmonellosis, infection with penicillin-resistant pneumococci and tularaemia). Each step in the double notification flow (clinical and laboratory notifications) was studied and paper-based and electronic notifications compared. More than 15 possible single dates in the notification flows were analysed for 27,000 cases. The shortest notification flows (from date of sample collection to when the first notification was received at SMI--clinical or laboratory notification) were seen for meningococcal infections and salmonellosis (median 7 d) and the longest for tularaemia (11 d). Laboratory notifications were faster than clinical notifications, and electronic reporting 1.5-1.7 times faster than paper notifications. Further gains should be expected from the new electronic reporting system (SmiNet2), which will allow also clinical reporting electronically over the internet.

Communicable Diseases↗
PubMed2003

Computerized recruiting for clinical trials in real time.

STUDY OBJECTIVE: Success of prospective studies, particularly in the emergency department, often depends on immediate identification of eligible patients to ensure timely sample collection and initiation of study interventions. We report use of a real-time automated notification system to identify potential patients for a clinical trial at the time of ED registration on the basis of information routinely collected. We hypothesize that the automated notification system improves the rate of investigator notification. METHODS: We performed a prospective comparison of the notification rate by the automated notification system compared with that by ED clinicians. RESULTS: In the 11 months before use of the automated notification system, the investigator was notified by ED staff for 56% of 61 potentially eligible patients. During 10 months of using the automated notification system, the investigator was paged by the automated notification system for 84% of 49 potentially eligible patients. CONCLUSION: The automated notification system improves study investigator notification. Use requires online linked registration, a database, and paging systems. The automated notification system is a potentially valuable tool in the recruitment of patients for clinical trials.

Clinical Trials as Topic↗
PubMed1997

Australia's notifiable diseases status, 1996. Annual report of the National Notifiable Diseases Surveillance System.

In 1996 there were 65,024 notifications to the National Notifiable Diseases Surveillance System. The record high number of Ross River virus infection notifications was of particular note. The highest rates were recorded in Western Australia, where an outbreak was documented in the South West, and in Queensland. Most cases occurred in the late summer and early autumn months. The number of measles cases has continued to fall markedly following the outbreak in 1993 and 1994. Rubella notifications also fell in 1996. The number of cases of pertussis remained at a similar level to that recorded in recent years, the highest notification rate being recorded for children under the age of one year. A peak in late 1996 marked a resurgence in the pertussis epidemic which has continued into 1997. Notifications of Haemophilus influenzae type b continued to decline reaching a record low rate of 0.3 notifications per 100,000 population. For the enteric diseases, the number of cases of campylobacteriosis rose, with an annual adjusted notification rate of 100.4 per 100,000 population; more notifications were received for this disease than for any other in 1996. The number of hepatitis A cases also rose relative to 1995. This is a reversal of the trend observed in recent years when the notification rate fell. The number of cases of salmonellosis and shigellosis remained stable. Notifications for chlamydial infection and gonococcal infection rose relative to 1995, whilst those for syphilis fell.

Alphavirus Infections↗