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New developments in mandatory blood testing legislation.

In November 2005, the Liberal government in Ontario introduced a bill that would allow policy officers, other community safety workers and victims of crime to find out more quickly whether they have been exposed to infection from certain viruses. Meanwhile, the Saskatchewan Medical Association (SMA) is opposing similar legislation enacted in that province.

AIDS Serodiagnosis↗

Mandatory HIV testing of newborns in New York State: what are the implications?

This paper presents an analysis of a public health law (Maternal-Pediatric HIV Prevention and Care Program) enacted by New York State in 1997 and how it strives to reduce the vertical transmission of AIDS. This policy is twofold. First, it strongly encourages voluntary HIV testing of all pregnant women. Secondly, it mandates HIV testing for all newborns. Those found to be positive are referred for medical care. This paper analyzes the State's implementation of this law to determine if it will: exert control over poor, mostly minority women; provide health care for infected woman and infants; protect public health; prevent the spread of HIV/AIDS; or sacrifice a woman's privacy. The potential benefits and shortfalls of this policy are discussed as other states may consider adopting similar legislation.

AIDS Serodiagnosis↗

Effectiveness of mandatory license testing for older drivers in reducing crash risk among urban older Australian drivers.

Most licensing jurisdictions in Australia maintain mandatory assessment programs targeting older drivers, whereby a driver reaching a specified age is required to prove his or her fitness to drive through medical assessment and/or on-road testing. Previous studies both in Australia and elsewhere have consistently failed to demonstrate that age-based mandatory assessment results in reduced crash involvement for older drivers. However studies that have based their results upon either per-population or per-driver crash rates fail to take into account possible differences in driving activity. Because some older people maintain their driving licenses but rarely if ever drive, the proportion of inactive license-holders might be higher in jurisdictions without mandatory assessment relative to jurisdictions with periodic license assessment, where inactive drivers may more readily either surrender or lose their licenses. The failure to control for possible differences in driving activity across jurisdictions may be disguising possible safety benefits associated with mandatory assessment. The current study compared the crash rates of drivers in Melbourne, Australia, where there is no mandatory assessment and Sydney, Australia, where there is regular mandatory assessment from 80 years of age onward. The crash rate comparisons were based on four exposure measures: per population, per licensed driver, per distance driven, and per time spent driving. Poisson regression analysis incorporating an offset to control for inter-jurisdictional road safety differences indicated that there was no difference in crash risk for older drivers based on population. However drivers aged 80 years and older in the Sydney region had statistically higher rates of casualty crash involvement than their Melbourne counterparts on a per license issued basis (RR: 1.15, 1.02-1.29, p=0.02) and time spent driving basis (RR: 1.19, 1.06-1.34, p=0.03). A similar trend was apparent based on distance travelled but was of borderline statistical significance (RR: 1.11, 0.99-1.25, p=0.07). Collectively, it can be inferred from these findings that mandatory license re-testing schemes of the type evaluated have no demonstrable road safety benefits overall. Further research to resolve this on-going policy debate is discussed and recommended.

Accidents, Traffic↗

The new AIDS virus--ineffective and unjust laws.

Public alarm about the spread of AIDS leads to public demand for drastic laws to contain the epidemic and to punish those who spread it. In this paper, attention is drawn to the limitations of the law in achieving the modification of human behavior. Successes and failures in public health education campaigns, directed to the same end, are mentioned. The author cautions against putting too much trust in the law to achieve containment of the AIDS virus. However, there are three reasons for optimism about the developing laws on AIDS. These are the necessity of a rare degree of international cooperation, the encouragement of attention to fresh approaches to laws on human sexuality and drug taking, and the vital importance of attention to the neglected issues of efficiency and cost effectiveness in the design of new laws. This last point leads to a suggestion that AIDS has produced three new viruses called "HIL" (highly inefficient laws). HIL-I is the mandatory testing of the entire population for HIV antibodies. HIL-II is the mandatory testing of specially vulnerable groups, especially foreigners. HIL-III is the mandatory requirement of HIV-free certificates at the frontier. The ineffectiveness and potential for injustice of such laws are exposed. The lesson derived is that there is no "quick fix" either for the AIDS virus itself or for the social and legal problems presented by it.

AIDS Serodiagnosis↗

HER2 testing by local, central, and reference laboratories in specimens from the North Central Cancer Treatment Group N9831 intergroup adjuvant trial.

PURPOSE: To evaluate concordance between local and central laboratory HER2 testing results in patients from the North Central Cancer Treatment Group (NCCTG) N9831 adjuvant trial of trastuzumab. PATIENTS AND METHODS: NCCTG N9831 is a randomized, phase III clinical trial comparing three drug regimens: doxorubicin/cyclophosphamide followed by paclitaxel with trastuzumab added concurrently, sequentially, or not at all as adjuvant therapy for women with HER2-positive resected breast cancer. Originally, patients were eligible if their tumors were HER2 positive by either local laboratory immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). A protocol modification in 2002 made central laboratory testing mandatory, with additional testing of discordant cases conducted by a reference laboratory. Concordance between local and central laboratory, and level of agreement between central and reference laboratory HER2 findings in discordant cases were examined. RESULTS: HER2 positivity was confirmed in 85.8% of 2,535 patients registered since March 2002. When local and central evaluation used the same methodology, concordance was 88.1% for FISH and 81.6% for a diagnostic test for presence of the HER2 protein. Among discordant cases examined at the reference laboratory, there was 94.3% agreement for IHC (0, 1+, 2+) and 95.2% agreement for FISH (not gene amplified). CONCLUSION: There was a high degree of discordance between local and central testing for IHC and FISH, but a high degree of agreement between central and reference laboratories. These findings support the importance of using high-volume, experienced laboratories for HER2 testing to improve the process of selecting patients likely to benefit from trastuzumab therapy.

Antibodies, Monoclonal↗

AIDS and South Africa--towards a comprehensive strategy. Part II. Screening and control.

In this, the second of a three-part series of articles in which we propose steps towards a comprehensive strategy for the control of HIV infection, we consider controversies relating to screening for HIV, the indications for and desirability of mandatory testing of certain groups at risk, and the place of voluntary testing in the control of HIV transmission and infection. Key recommendations are that mandatory testing of donors of blood and other vital tissues, patients on haemodialysis and haemodialysis unit staff is justified, and that children put up for adoption may require testing. We make further recommendations regarding HIV testing as a prerequisite for life insurance and recommend that voluntary testing be offered, supported by adequate pre- and post-test counselling. We consider that all health care workers should accept as their moral obligation the care and management of HIV-infected individuals, and that they should be adequately educated and skilled in such work. These recommendations were reached largely by consensus, although there were occasions when individual authors condoned recommendations with which they did not personally agree.

Acquired Immunodeficiency Syndrome↗

Clinicians and HIV infections: social policies and professional issues.

The human immunodeficiency virus (HIV) is a deadly infectious virus. Relatively hard to contract, it is the causative agent of acquired immunodeficiency syndrome. Nurses and other clinicians have an important role to play in influencing national and local management of the HIV infection through review and comment on policy. Policies recommending quarantine, isolation, mandatory testing of certain populations, and vigorous public education are explored. Quarantine, isolation of seropositive individuals, and mandatory testing of certain groups are explicated in the article as unethical, unmanageable or both. Some recommendations for vigorous, specific public education are made. The importance of the participation of health professionals in public policy debates is emphasized.

Acquired Immunodeficiency Syndrome↗

[Is DFT testing still mandatory?].

The automatic detection and termination of ventricular fibrillation is still the key function of implantable cardioverter defibrillator (ICD) therapy. The progress in generator and lead technology has overcome limitations in defibrillation efficacy in early transvenous defibrillator devices. Current, active pectoral biphasic devices provide a high defibrillation efficacy. More than 90% of all patients will meet accepted implantation criteria without any intraoperative system modifications. Is this enough to abandon the intraoperative assessment of defibrillation efficacy? Arguments for abandoning intraoperative device testing include: reduction of perioperative complications, time and cost saving, no worse prognosis for defibrillator patients with borderline defibrillation efficacy, DFT testing might be a barrier to an easy access to ICD implantation. Abandoning intraoperative assessment of defibrillation efficacy may result in inadequate defibrillation safety in up to 9% of all patients. The noninferior outcome of patients with nonadequate defibrillation efficacy is not already proven. Intraoperative device testing could be limited to a small number of VF inductions, the safety of these protocols is well established. A significant time and cost reduction is not really existing. The abandoning of defibrillation testing will not lead to an increase in ICD implant capacity. The intraoperative assessment of defibrillation efficacy should be an important part of ICD implantation.

Clinical Trials as Topic↗

Different diagnostic approaches to adult candidates for cadaveric kidney transplantation in Europe.

We investigated which diagnostic procedures are mandatory for all transplant candidates irrespective of their individual situation in European transplant centres, how homogeneously these are applied and what centre characteristics determine differences in the diagnostic approach. A questionnaire was sent to European renal transplant centres asking which of 45 listed diagnostic procedures are mandatory for every transplant candidate. The 154 participating centres require 15.6 +/- 5.6 (4-33) mandatory tests, with significantly less mandatory diagnostics in centres in the UK (8.5 +/- 3.9) and Scandinavia (9.8 +/- 2.3). Geographic location is the single significant factor in multifactorial analysis of possibly related factors. Detailed analysis revealed 16 tests that are required significantly less often in the north of Europe. There are significant differences in the evaluation of renal transplant candidates across Europe. In some parts of Europe transplant candidates are either investigated more discriminately or less comprehensively than in other regions.

Adult↗