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General practitioners' views on the screening for genital Chlamydia trachomatis infection and partner notification.

A postal survey of general practitioners (GPs) in the East Riding of Yorkshire was undertaken to find out their views about screening for Chlamydia trachomatis infection, the reasons for their inability to screen the high-risk population, facilities available for screening in the primary care setting, treatment regimen and the views about partner notification. Although all GPs had the facilities for chlamydial testing, their views on chlamydial screening differed widely and very few offered opportunistic screening. Most of the GPs would prefer the sexual health clinics (genitourinary medicine [GUM] clinics) to undertake partner notification. Less than half of the GPs surveyed offered the ideal antimicrobial therapy against chlamydial infection, as recommended by the Central Audit Group in Genito-urinary Medicine. This survey shows the necessity to disseminate proper guidelines for the management of uncomplicated C. trachomatis infection in the community. Sexual health clinics should make adequate provision to deal with additional workload resulting from the increased referrals of partners to the clinics when the opportunistic screening is widely provided by the GPs.

Attitude of Health Personnel↗

Audit of HIV partner notification in a district general hospital.

We evaluated partner notification for HIV in a district general hospital over a two-year period. The majority of current partners were notified and 60% were found to be HIV-positive. No previous partners were successfully notified. We make recommendations intended to improve the rate of notification and testing.

Contact Tracing↗

HIV-positive notification and behavior changes in Montreal injection drug users.

This study examined the effect of an HIV-positive notification on the sexual and injection behaviors, living conditions, and medical demands of injection drug users (IDUs) in Montreal. The behavior changes of 73 IDUs who received an HIV-positive test result, and 219 IDUs who tested negative were compared, and the net difference (ND) in the proportion of IDUs adopting the particular change was determined. No significant changes were found in drug use or needle sharing practices. A higher proportion of IDUs who received an HIV-positive notification acquired unstable living conditions, ND = 20.7% (95% CI = 3.3, 38.1), began medical follow up, ND = 34.4% (95% CI = 20.8, 48.7), and increased needle exchange program (NEP) utilization, ND = 20.5% (95% CI = 8.3, 32.8). Compared with HIV-negative males, more HIV-positive male IDUs stopped sexual relations, ND = 24.6% (95% CI = 0.4, 48.9), and sex work, ND = 31.8% (95% CI = 12.4, 51.3), and fewer began new relations, ND = -38.2% (95% CI = -52.6, -23.9). The medical community and NEPs have an important role in providing support for newly diagnosed IDUs.

Adolescent↗

Effect of patient notification of formulary change on formulary adherence.

OBJECTIVE: To evaluate the impact of patient notification of impending formulary changes on formulary adherence. METHODS: This pilot program in a large, Midwest-based health insurer utilized a randomized controlled trial research design. A list of 30 chronic-use medications that were to change formulary status were selected for the pilot. A review of adjudicated pharmacy claims records was performed to identify patients receiving one or more of the formulary change medications on the list. Members of 112 individual health plans of this large health insurer, all of whom were subject to the same drug formulary, were randomized to either the intervention (letter) or control arm. Patients in the intervention arm were sent a targeted communication that described the patient.s formulary change medication(s) and provided therapeutic option(s) for the formulary change medication(s). Pharmacy claims for patients in both arms were examined at 110 days after the date of the mailing to determine if there was a switch to a formulary alternative. Multivariate regression modeling was performed to adjust for baseline differences between the arms. RESULTS: A total of 7,247 unique formulary change medication regimens were identified (3,817 in the control arm and 3,430 in the letter arm) for 6,518 subjects (3,387 in the control arm and 3,131 in the letter arm). A higher proportion of formulary change medication regimens in the intervention arm were switched to a formulary alternative compared with the control arm (19.2% vs. 12.0%, P<0.001). After adjustment for baseline differences, regression modeling indicated that subjects in the intervention arm were 1.33 times more likely to switch to a formulary alternative (P<0.001). CONCLUSION: A letter-based, formulary change notification program is a pragmatic and effective strategy to increase drug formulary adherence. Such a program does not restrict access to medications but, rather, provides education and personalized information that may allow patients to participate more actively in their pharmacotherapy decision making.

Female↗

Minor women obtaining abortions: a study of parental notification in a metropolitan area.

Data were collected from 141 women under age 18 attending an abortion clinic that did not require parental notification. Most of them informed their girl friend but not their parents of the plans for abortion. Younger minors and those who perceive their parents to hold positive attitudes toward abortion were more apt to inform parents. Reasons for not informing parents included fears of physical retaliation. Implications for parental notification legislation are discussed.

Abortion Applicants↗

To tell or not to tell: the ethical dilemmas of HIV test notification in epidemiologic research.

Epidemiologic studies involving HIV (human immunodeficiency virus) antibody testing create ethical dilemmas, particularly about notifying asymptomatic seropositive subjects. Four study designs address this problem: mandatory notification, optional notification, anonymous testing, and blind testing. No single design consistently optimizes the trade-off between valid and ethical research. Each strategy differs substantially from the others in its effect on response rates, bias, ability to perform longitudinal studies, numbers of subjects who learn their test results, and the number of subjects counseled about HIV risk reduction. Both local institutional review boards and potential subjects of study (and their sexual partners) should participate in decisions regarding the conduct of sensitive AIDS (acquired immunodeficiency syndrome) research.

Epidemiologic Methods↗

Partner notification for control of HIV: results after 2 years of a statewide program in Utah.

OBJECTIVES: We sought to evaluate the utility of partner notification for control of human immunodeficiency virus (HIV) infection and to identify subgroups in which it may be most effective. METHODS: All persons reported to be HIV-positive during a 2-year period were interviewed. Outcome measures included proportion of index patients cooperating; number of partners named, located, counseled, and tested; number of persons newly testing positive; and costs. RESULTS: Of 308 index patients, 244 (79%) cooperated. They named 890 partners; 499 (70%) of in-state partners were located. Of these, 154 (34%) had previously tested HIV-positive. Of 279 partners tested for the first time, 39 (14%) were HIV-positive. Injecting drug users were significantly more likely to cooperate than persons in other risk groups (93% vs 76%) and named more partners (median 4 vs 1). Women and persons choosing confidential testing were more likely to cooperate and named more partners. The estimated cost of the program was $62,500 per year. CONCLUSIONS: Partner notification identified a group with a high seroprevalence of HIV. It was not successful among populations that may be difficult to reach with other interventions.

AIDS Serodiagnosis↗

Efficiency of a semiautomated coding and review process for notification of critical findings in diagnostic imaging.

OBJECTIVE: When a significant unexpected finding such as malignancy is noted on a study, the standard of care generally holds that the radiologist communicate the findings to the referring physician and document the communication in the radiology report. Despite this standard, for a variety of reasons it remains possible that the direct care provider might receive such notification but not initiate an appropriate workup. On the basis of prior root cause analysis, we developed and instituted a semiautomated process for notification of critical diagnostic imaging findings. We now report our 12-month experience with the process. MATERIALS AND METHODS: A diagnostic code was attached to every radiology report. When a significant unexpected finding occurred, our radiologists, in addition to contacting the appropriate clinician, gave the report the designation code 8. On a weekly basis, a list of code 8 cases was passed to the cancer registrar at our institution, who tracked the cases to ensure that they were appropriately followed up. RESULTS: In the 12-month period after initiation of this system, we performed 37,736 radiologic examinations at our institute. Of these, 395 cases were given code 8. All code 8 cases were followed up by the tumor registrar. In 35 cases, no workup was documented after 2 weeks. Of these, eight cases would have been completely lost to follow-up if this safety net had not been in place. CONCLUSION: Failures of communication, documentation errors, and various system failures may lead to an untoward outcome for the patient. We devised a simple system to ensure that significant unexpected findings on imaging received appropriate attention. An additional level of redundancy has increased the probability of optimal patient outcome.

Critical Illness↗

[State of infectious disease notification (I.D.N.'s) in Navarra. 1996].

The System of Infectious Disease Notification (I.D.N.) encompasses the notification of 41 infectious transmissible diseases to which are added epidemic outbreaks of any etiology or cause. In Navarra, the I.D.N.'s are reported to the Section of Vigilance and Epidemiological Control of the Public Health Institute. A sharp increase of alimentary toxic-infections is observed due to two community outbreaks produced by Salmonella enteritidis that affected 410 persons. The incidence of pulmonary tuberculosis, 15.37 cases per 100,000 inhabitants has remained at the same levels as previous years and with lower rates than those published in neighbouring Autonomous Communities such as La Rioja and the Autonomous Community of the Basque Country. In the group of Exanthematic Diseases, an outbreak of German measles is noteworthy that affected males between the ages of 16 and 20. During the year 1996 there were 17 cases of Meningococcal Disease that meant a rate of 3.27 per 100,000 inhabitants, the second lowest rate in the last 25 years after the rate of 2.29 of 1994. With respect to the causative serogroup, serogroup C was isolated on 7 occasions, serogroup B on four occasions and on 6 it could not be grouped. Hydatidosis through reports of I.D.N.'s and active search in the hospitals remained steady, with 26 cases, remaining within the regular values of recent years. An important decline with respect to recent years was observed in cases of hepatitis A, hepatitis B and brucellosis.

English Abstract↗

[Surveillance report on Diseases of Compulsory Notification in Navarra. 1999].

The Epidemiological Surveillance System of Navarra includes the notification of 33 transmissible infectious diseases, to which epidemic outbreaks of any aetiology and cause are added. Reporting to the system is carried out on a weekly basis by every doctor who suspects or diagnoses any of these processes. In our autonomous community, Diseases of Compulsory Notification (DCN) are reported to the Section for the Control of Infectious Diseases and Outbreaks of the Public Health Institute on a weekly basis by the doctors of Primary and Specialised Care. Subsequently, the information is sent to the National Epidemiology Centre where data from the autonomous communities is centralised. In 1999, under the heading of diseases of respiratory transmission, 59,159 cases of Flu were reported; 65% of total annual cases were reported in the first 9 weeks of the year, with a maximum in week 4 when 6,826 cases were reported. 18 cases of Meningococcal Disease were reported to the system. Sixteen cases were confirmed microbiologically and appeared in a sporadic way. With respect to the causative serogroup, serogroup C was isolated on 8 occasions. On 7 occasions Neisseria meningitidis serogroup B was isolated. By age groups, 4 cases were declared in infants of 2 years of age (Rate: 46.1 per 100,000), nine cases in children between 2 and 9 years of age (1.53 per 100,000) and the remaining 2 cases in persons aged 20 years or over (0.49 per 100,000). 15 cases of Legionellosis were declared in 1999, all under the clinical form of pneumonia. These were isolated cases in persons of middle or advanced age. No indication was found of prior tourist trips to areas of high prevalence. In the majority of cases the origin was considered to be in the community, while one outbreak was identified as nosocomial. Similarly, there was a notable increase in the declaration of cases of Paludism, with 16 cases (EI: 5.33) affecting travellers and immigrants.

English Abstract↗

Patients with bacteremia dying before notification of positive blood cultures: a 3-year clinical study.

In a 3-year prospective survey of bacteremia in a Danish county, 102 patients (4.6%) died before notification of positive blood cultures. Clinical records were available for 99 patients (ED group) with a male/female ratio of 1.15 and a median age of 74 years. The predominant pathogens were Escherichia coli (32%), Streptococcus pneumoniae (17%) and Staphylococcus aureus (16%). Streptococcus pneumoniae was the only pathogen found to be more frequently in the ED group than among patients who were alive when notification was issued (ALIVE group) (17% vs 10%). All but 2 patients with meningococcal disease had a predisposing condition. Infection was deemed to be the direct cause of death in 62%, a contributory factor in 31% and of marginal significance in 6%. Compared with the ALIVE group, the ED group was older and more frequently had a focus within the respiratory tract. Conversely, the urogenital tract and intravascular devices were less common foci. The detection time was similar for the ED and ALIVE groups (median 22 and 24 h, respectively). 78% of ED patients had received antibiotic therapy and the coverage was appropriate in 59%. The possibility of bacteremia had not been responded to by institution of antibiotic therapy in the remaining patients. We conclude that physicians must consider antibiotic therapy when ordering sampling of blood for culture and empirical antibiotic therapy should basically provide coverage for pneumococci, S. aureus and E. coli.

Bacteremia↗

Partner notification in the management of sexually transmitted infections in Nairobi, Kenya.

OBJECTIVE: To assess utilization of partner notification as a tool in prevention and control of Sexually transmitted infections in Nairobi City Council clinics. DESIGN: A cross-sectional study carried out between April and September 2000. SETTING: Nairobi City Council health clinics were stratified into eight administrative divisions and a total of 16 out of 54 primary health clinics with at least four STIs patients per day were selected. A standard questionnaire was administered to every fourth patient with clinical diagnosis of STIs who gave consent on exist. Sexual partners referred by index cases during the five day period from each clinic were also enrolled into the study. An additional questionnaire was administered to HCP who were managing STIs patients and their sex partners. RESULTS: Of 407 STIs patients recruited between April and September 2000, 20.6% were primary and 2% were secondary referrals giving an average referral rate of 23%. Respondents with multiple sex partners were less likely to refer their partners compared to those who had one partner (17.9% vs 82.1%, p < 0.005). Counseling of STI patients on the importance of partner referral was more effective than issuing referral cards alone (72.8% vs 56.8% % p = < 0.006). Barriers to partner notification included partners being out of town (44.6%) fear of quarrels and violence from partners (32.5%) and casual partners (15.1%) whose sex partners were unknown. CONCLUSION: Counseling and understanding of STIs patients on the need to treat all sexual partners is pivotal to the success of partner referral.

Adolescent↗

Partner notification: can it control epidemic syphilis?

STUDY OBJECTIVE: During 1987, the rate of syphilis among heterosexual adults in Oregon increased 159%, yet the number of cases of gonorrhea remained stable. Our study was done to evaluate why the same control measures contained gonorrhea but not syphilis in this population. DESIGN: Exploratory case-control study. SETTING: Public health clinics in Portland, and Salem, Oregon. PATIENTS: All 146 heterosexual adults with early syphilis and all 164 heterosexual adults with acute gonorrhea reported to the public health clinics during April to July 1988. INTERVENTION: A questionnaire was administered to all syphilis case-patients and control patients (those with gonorrhea) at the beginning of the routine, sexually transmitted disease (STD), investigative interview. MEASUREMENTS AND MAIN RESULTS: Syphilis case-patients had contact with an average of 5.0 sex partners for whom they could not supply locating information sufficient to initiate partner notification. In contrast, patients with gonorrhea had contact with an average of 0.4 sex partners for whom they could not supply locating information (P less than 0.005). The 28% (41 of 146) of syphilis case-patients who reported having exchanged sex for drugs or money accounted for 72% (527 of 729) of the unlocatable partners exposed to syphilis. In contrast, the 17% (28 of 164) of patients with gonorrhea who reported having exchanged sex for drugs or money accounted for 36% (25 of 69) of the unlocatable partners exposed to gonorrhea. CONCLUSIONS: Because patients infected with syphilis have relatively large numbers of anonymous sexual encounters, prevention strategies that supplement partner notification are urgently needed to control the syphilis epidemic among adults.

Adolescent↗

Infectious disease notification--a neglected legal requirement.

The Acheson Report expressed concern about doctors' knowledge of the infectious disease notification system. This study was undertaken in order to quantify doctors' knowledge of the system, and guide action to improve its efficiency. A survey of 176 hospital doctors in one large Health District showed that, although 82% knew of the legal obligation to notify, 70% did not know where to obtain a notification form, and 40% did not know whom to notify. Over a third of those surveyed did not know that food poisoning and tuberculosis are notifiable diseases. Proposed changes in the law relating to infectious disease control will not compensate for such lack of knowledge. Consultants in Communicable Disease Control should take the lead in improving this vital information system.

Communicable Disease Control↗

Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.

The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).

Chemistry, Clinical↗

Controlled clinical trials in drug research: permission versus notification.

1. Controlled clinical trials by competent investigators in appropriate clinics or scientific institutions should be allowed upon notification of the health authority. 2. The notification should include the pharmacological and toxicological data, the name of the principal investigator and the institution he or she is working for. 3. In countries where there are no specific statutory provisions concerning clinical trials, the protocol should be approved by an ethics committee. In the case of a multicentre study, the approval of one committee should be sufficient. 4. Local law should provide the authorities with the power to stop or curtail the study if it appears to become dangerous.

Clinical Trials as Topic↗

Notification of real-time clinical alerts generated by pharmacy expert systems.

We developed and implemented a strategy for notifying clinical pharmacists of alerts generated in real-time by two pharmacy expert systems: one for drug dosing and the other for adverse drug event prevention. Display pagers were selected as the preferred notification method and a concise, yet readable, format for displaying alert data was developed. This combination of real-time alert generation and notification via display pagers was shown to be efficient and effective in a 30-day trial.

Clinical Pharmacy Information Systems↗

Medical devices; exemptions from premarket notification; class II devices; vascular tunnelers. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is publishing an order granting in part a petition requesting exemption from the premarket notification requirements for vascular tunnelers with certain limitations. This rule will exempt from premarket notification stainless steel vascular tunnelers of single unit construction. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Device Approval↗