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PubMed2004

[Massive fetomaternal hemorrhage revealed by decreased perception of active fetal movements].

Massive fetomaternal hemorrhage is rare. Without risk factors, early diagnosis is difficult to establish. The clinical and paraclinical manifestations are not specific and depend on fetal compensatory reactions; the Kleihauer test will confirm the diagnosis. Two cases of massive fetomaternal hemorrhage preceded by decreased fetal movements are presented here. An emergency delivery by cesarean section saved one child. Despite a favorable clinical and laboratory evaluation, one fetal death could not be avoided. Early diagnosis and specialised management are essential to improve prognosis. These observations indicate that it is mandatory to carry out a Kleihauer test whenever a decrease of fetal movements is observed.

Adult↗
PubMed2006

Reducing substances in urine: a paradigm for changes in a standard test.

Detection of reducing substances in urine has been a standard laboratory procedure for about 50 yr. It is used as a screening test for inborn errors of carbohydrate metabolism. Although the test has poor specificity and most states perform mandatory newborn screening for the common genetic defects, most clinical laboratories still perform this as a reflex test on all pediatric urine samples. We suggest that laboratories should perform this test only at the specific order of a physician and that they should review their test menu frequently to delete tests that no longer have a clinical rationale.

Chemistry, Clinical↗
PubMed2002

Do we need a "Chair of alternative methods", and where?

During the last two decades, the field of in vitro technology has been successfully developed and its use is continuously growing. Advanced tests avoiding animal experiments will be increasingly required for routine industrial applications e.g. for pharmacological high-throughput screening. Moreover and even more importantly, the availability of human cell based methods is essential for future quality assurance and risk assessment in the fields of health and consumer protection as well as environmental protection. Thereby, the potential of such advanced in vitro methods extends far beyond the mere replacement of regulated tests. In practice, the introduction and expansion of this technology has been achieved predominantly by offering funding and awards to the scientific community. After this initiation phase, the next consequent step to exploit this knowledge clearly consists in academic promotion of this new scientific culture in an institutionalised form. The tasks of such a chair focussed on advanced in vitro tests - most probably the first of its kind world-wide - would cover in addition to (a) research and (b) teaching, (c) the sharpening of social conscience for the topic. (a) While the validation of alternative methods was formally established by founding institutions like ZEBET in Berlin on the national and ECVAM in Ispra on the European level, the development of further new and more sophisticated in vitro methods to date emerge predominantly as a by-product of basic research. A considerable push might now be given by the structured search for new methods with a spill-over for research-based up-to-date teaching. (b) The field of alternative methods is more than a panel of advanced in vitro techniques: A culture of systematic evaluation and validation of in vitro tests has been developed, which has bearing far beyond the replacement of animal experiments. In vitro systems inherently prone to artefacts require the highest level of quality control and assurance. A successful initiative to establish a Good Cell Culture Practice (GCCP) in analogy to Good Laboratory Practice (GLP) has evolved out of the field of in vitro alternatives. The concept of validating the relevance of an in vitro test in comparison to the respective in vivo situation represents a consequent translation of evidence-based medicine into in vitro biomedicine. In other words: It does no longer suffice that an in vitro model is plausible - it has to prove its suitability and quality. (c) The broad implementation of advanced in vitro technology into curricula implies development of lectures, courses and other teaching materials including virtual education offers. Such a basis will allow efficient spreading of knowledge and ease transnational acceptance. Last but not least, taking over the leadership for erecting a chair for alternative methods represents a major political signal that demonstrates to the public the willingness to adapt academic education to modern social awareness. A location for such an initiative needs to be found that is in the centre of Europe, has the necessary infrastructure of surrounding biomedical research, international networks for the evaluation and validation of tests, technology transfer to industrial use and access to relevant publication organs. The unequivocal answer to the question in the heading is therefore: we need a chair for in vitro alternatives because (i) the patient is our primary concern but the animal is not just secondary (ii) man's responsibility for the integrity of all creatures including the own species makes it mandatory.

Animal Testing Alternatives↗
PubMed1990

Drug testing: medical, legal, and ethical issues.

Laboratory testing for drugs is a controversial issue in America. The authors present arguments for mandatory use under specific circumstances. Physical limitations of each test are discussed in terms of applicability as well as protection of the person being tested.

Ethics, Medical↗
PubMed1990

Are pesticides immunotoxic?

So far there is little evidence that occupational or environmental exposure to pesticides has led to clinically significant immunosuppression, and hence to an increased risk of developing infection or cancer. In addition, the incidence of hypersensitivity reactions to pesticides is generally low. Experiments have been conducted in experimental models that indicate that certain pesticides are immunosuppressive to animals. The majority of these experiments, however, have used high (frankly toxic) doses of pesticides and immunosuppression has been monitored using in vivo or in vitro immune function tests, the results of which are difficult to interpret in terms of effects on health. One exception is tributyltin oxide which, in the rat, causes immune dysfunction at doses below those that cause general toxicity, and which compromises the ability of the animals to resist bacterial and parasitic infection. Predictive assessment of possible immunotoxicity induced by exposure to a pesticide should be structured within the current framework of acute, subacute and chronic testing procedures used for regulatory purposes. With the exception of predicting some hypersensitivity reactions (respiratory allergy and autoimmunity), which would require the development of novel specialized methods, indications of potential immunotoxicity can be obtained from standard haematological investigations and by evaluation of lymphoid organs and tissues such as the spleen, thymus, lymph nodes, and bone marrow. Pathological and histopathological examination of the lymphoid system is a mandatory requirement of nearly all subchronic testing guidelines for pesticides worldwide. The incorporation of specialized, and in particular in vitro, immune function tests into the routine toxicological assessment of a pesticide is not only time-consuming and potentially wasteful of animals, but is also scientifically unacceptable; the significance of changes in such tests must await further research on the reserve capacity of the immune system.

Animals↗
PubMed2004

Updated European recommendations for the clinical use of HIV drug resistance testing.

In most European countries, HIV drug resistance testing has become a routine clinical tool. However, its practical implementation in a clinical context is demanding. The European HIV Drug Resistance Panel was established to make recommendations to clinicians and virologists on this topic and to propose quality control measures. The panel recommends resistance testing for the following indications: i) drug-naive patients with acute or recent infection; ii) therapy failure, including suboptimal treatment response, when treatment change is considered; iii) pregnant HIV-1-infected women and paediatric patients with detectable viral load when treatment initiation or change is considered; and iv) genotype source patient when post-exposure prophylaxis is considered. In addition, for drug-naive patients with chronic infection in whom treatment is to be started, the panel suggests that resistance testing should be strongly considered and recommends testing the earliest sample for drug resistance if suspicion of resistance is high or prevalence of resistance in this population exceeds 10%. The panel does not favour genotyping over phenotype, however it is anticipated that genotyping will be used more often because of its greater accessibility, lower cost and faster turnaround time. For the interpretation of resistance data, clinically validated systems should be used to the greatest extent possible. It is mandatory that laboratories performing HIV resistance tests take regular part in quality assurance programs. Similarly, it is necessary that HIV clinicians and virologists take part in continuous education and meet regularly to discuss problematic clinical cases. Indeed, resistance test results should be used in the context of all other clinically relevant information for predicting therapy response. The panel also encourages the timely collection of epidemiological information to estimate the impact of transmission of resistant HIV and the prevalence of HIV-1 non-B subtypes in the different European countries.

Anti-HIV Agents↗
PubMed1998

Cost-effectiveness of mandatory compared with voluntary screening for human immunodeficiency virus in pregnancy.

OBJECTIVE: To determine the cost-effectiveness of mandatory screening for human immunodeficiency virus (HIV) in pregnancy compared with that of voluntary screening under varying assumptions about patient behavior. METHODS: Using a health care system perspective, a decision-analysis model was constructed to estimate the outcomes and costs of the two strategies. Average and incremental cost-effectiveness ratios were calculated for each strategy. Sensitivity analyses were performed to test the effects of different values on the results of the simulation. In particular, we examined the potential effects of changes in patient behavior resulting from mandatory screening on our estimates of cost-effectiveness. RESULTS: At a prevalence of 170 per 100,000, average costs per case prevented were $255,158 and $367,998 for mandatory and voluntary screening, respectively. The incremental cost-effectiveness of mandatory compared with voluntary screening was $29,478. These values decreased as prevalence of HIV increased, or as the estimated lifetime cost of pediatric HIV infection increased: above an estimated cost for pediatric HIV of $129,250, mandatory screening was less expensive and more effective than voluntary screening. Assumptions about patient behavior affected these results: a 40% reduction in zidovudine acceptance in women identified only through mandatory screening increased the incremental cost-effectiveness to $112,434. The impact of behavior increased as the prevalence of HIV increased. CONCLUSION: Mandatory screening will prevent more cases of pediatric AIDS, but at a somewhat higher cost than voluntary screening under baseline assumptions. The cost-effectiveness of mandatory screening will be influenced by patient behavior, especially acceptance of zidovudine treatment among women who would have refused voluntary screening.

AIDS Serodiagnosis↗
PubMed1999

[An experimental quality assurance program for asbestos measurements performed with x-ray diffractometry in bulk samples].

A quality assurance program for the diffractometric determinations of asbestos in bulk samples is presented. The program, developed upon request of the Italian Health Ministry, includes two tests: the qualitative determination of the asbestos forms present in three samples and their quantitative measurements. The samples to be analyzed, the asbestos standards and the criteria for results evaluation are described in detail. The program will start in the year 2000. Compliance with the tests minimum requirements will be considered mandatory for a public or private laboratory be legally allowed to work in the field of asbestos determinations by X-ray diffractometry. The description of the program is preceded by an in-depth discussion on the definition of the terms "quality control" and "quality assurance", which are often confused, and on their operational meaning when they are applied to laboratory measurements. The analytical difficulties involved with the measurement procedures currently used are also discussed. Moreover, the results of a preliminary intercalibration test among fifteen Italian laboratories of proven experience are reported since they provided important information for the arrangement of the present quality assurance program.

Asbestos↗
PubMed2003

Hepatitis C virus-polymerase chain reaction minipool testing: 3 years in the largest Swiss blood transfusion service.

BACKGROUND AND OBJECTIVES: Hepatitis C virus-polymerase chain reaction (HCV-PCR) minipool testing can improve the safety of labile blood products owing to a reduction in the diagnostic preseroconversion window period. In Switzerland, HCV-PCR minipool testing for the release of labile blood components became mandatory in September 1999. In the largest Swiss blood transfusion centre, HCV-PCR minipool testing began in January 1999. This report analyses the performance of the test during a 3-year period: 1 January 1999 to 31 December 2001. MATERIALS AND METHODS: EDTA-blood was collected in either standard tubes or plasma preparation (PPT) tubes from 10 blood transfusion services in Switzerland and then sent to the Blood Transfusion Service SRC Berne. Up to 48 donor samples were pooled overnight using Tecan Genesis RSP 200/8 pipettors. Viral RNA was extracted by using the Qiagen QIAamp 96 viral RNA BioRobot kit on a BioRobot 9604. For PCR amplification and detection of HCV or internal control (IC) sequences, the Roche Cobas Amplicor v2.0 test kit was used. Data management, pool resolution and identification of positive samples were performed using the PMS Software from Tecan. RESULTS: In the 3-year period from 1 January 1999 to 31 December 2001, 839056 blood donor samples were tested in minipools of up to 48 samples. Thirty-five HCV-PCR-positive donations were identified. Thirty-four samples had antibodies against HCV and were therefore also detected by screening for antibody to HCV (anti-HCV). In October 2001, one seronegative (but PCR-positive) donor was detected. CONCLUSIONS: HCV-PCR minipool testing was successfully introduced in the largest Swiss blood transfusion service. It was shown that the release of HCV-PCR minipool results can be accomplished concurrently with the results of serological analysis. The challenge with a seronegative, but PCR-positive, donor demonstrates that the minipool testing strategy adds additional safety to blood products.

Blood Preservation↗
PubMed2002

Multiple endocrine neoplasia 1--current recommendations for diagnosis and treatment.

BACKGROUND: The principally affected glands in the MEN 1 syndrome (parathyroids, pancreas, pituitary and adrenal glands) are often diffusely or multi-centrically involved, making different therapeutic approaches necessary. METHODS: In a retrospective analysis of 10 patients with genetically proven (n = 7) or clinically suspected (n = 3) MEN 1 syndrome, recommendations for diagnosis, timing of interventions and surgical procedures are reviewed. RESULTS: All patients had primary hyperparathyroidism (PHPT). An extended bilateral exploration localized 4 or more enlarged glands in 6 patients and subtotal parathyroidectomy (SPTX) was performed. In 4 patients, only one (n = 2) or two (n = 2) enlarged glands were removed. Two patients were reoperated for persistent PHPT and one patient developed recurrent PHPT. In 3 out of 6 patients, neuroendocrine pancreatic tumors were the first manifestation. 2 patients had solitary, one patient multiple benign and one patient multiple malignant insulinomas. Tumors were removed by enucleation, distal pancreatic resection or a combination of both. Out of the 2 patients with gastrinomas, one underwent partial pancreatoduodenectomy and the other has refused operation up to now. During follow-up, no persistence or recurrence of hormone excess was diagnosed. Three patients had non-functioning bilateral lesions of the adrenal glands, and one of these additionally had a small, clinically insignificant pheochromocytoma. Adrenalectomy was performed during pancreatic surgery in 2 patients, and endoscopically in one patient. Pituitary tumors were treated in 3 patients. CONCLUSION: A high index of clinical suspicion, biochemical screening and menin gene testing, according to current guidelines, is mandatory for early diagnosis of MEN 1. In PHPT with multiglandular involvement and neuroendocrine pancreatic tumors, meticulous surgery can achieve a long-term cure in the majority of patients, with low morbidity.

Adolescent↗
PubMed2002

Clinical evaluation of the man with chronic prostatitis/chronic pelvic pain syndrome.

The various investigative procedures used in clinical, laboratory, and imaging evaluations for the patient presenting with chronic pelvic pain are discussed and categorized as mandatory, recommended, or optional procedures. These categories primarily serve to rule out underlying pathology because there is no diagnostic test for chronic prostatitis/chronic pelvic pain syndrome (CPPS). Mandatory category investigations should be performed in all patients with CPPS, and those procedures categorized as recommended or optional are generally prompted by specific findings in the history or physical examination, or by poor response to standard therapies.

Chronic Disease↗
PubMed1998

[Fetomaternal hemorrhage: a series of 9 cases].

AIM: This study was designed to stress the importance of early diagnosis of fetomaternal hemorrhage (FMH) in attempt to prevent the subsequent adverse outcome on the fetus and the newborn. PATIENTS AND METHODS: Nine newborns were admitted because of neonatal anemia to our neonatal unit from October 1989 through September 1995. The diagnosis of FMH was made by the sigma diagnostic fetal hemoglobin that is the Kleihauer test in our hematologic laboratory. Other causes of neonatal anemia have been ruled out. RESULTS: Seven out of the nine cases have expressed early signs of fetal distress in term of abnormal fetal monitoring and/or thick meconium associated with decreased fetal movements. At birth, a wide clinical spectrum depending on the amount of the hemorrhage was seen, ranging from mild anemia with no symptoms (four cases), hypovolemic shock (one case), respiratory distress syndrome (two cases) and maladjustment to extra-uterine life (one case). There was one death at 48 hours after birth; one infant survived with severe encephalopathy. CONCLUSION: These results indicate that it is mandatory to carry out a Kleihauer test whenever a high suspicious index of FMH is faced or an unexplained neonatal anemia is found.

Anemia, Neonatal↗
PubMedDate not supplied

The case against mandatory preoperative HIV screening in Africa.

Surgeons are treating an increasing number of HIV-infected patients for surgical problems both related and unrelated to HIV infection. There had been vehement debate surrounding the question of preoperative HIV testing of patients. Supporters of preoperative HIV testing argued that members of the surgical team had the right to know whether they were at risk for acquiring a fatal infection after exposure to a patient's blood. However, the testing was opposed by many because of the civil rights implications of a positive HIV test result and the fear that HIV-positive patients would receive sub-optimal treatment. This paper reviewed available literature and made recommendations based on available scientific evidence with particular emphasis on the situation in Africa.

Africa↗
PubMed2005

Cost-effectiveness of HIV screening for incarcerated pregnant women.

Antiretroviral therapy (ART) initiated on a prenatal basis in HIV-infected pregnant women is a highly effective method for preventing mother-to-child HIV transmission. We developed a decision analytic model to project the clinical and economic outcomes of alternative HIV screening strategies (voluntary prenatal screening [VPS], routine prenatal screening [RPS], and mandatory newborn screening [MNS]) for a high-risk population of incarcerated pregnant women. Data for the decision model came from the HIV voluntary counseling and testing program at Connecticut's sole correctional facility for women and a comprehensive anonymously linked serosurvey of all inmates who entered the facility during the 2-year period beginning in October 1994. Based on serosurvey results, in the absence of any HIV screening program, 2.5 cases of pediatric HIV infection would be expected per 1000 pregnancies. Multiplied by the discounted lifetime cost per case of $247,000, this translates to a cost of $624 per testing-eligible prison entrant. Entrants were considered eligible if they were pregnant and their HIV status was unknown. MNS would save money, cost $364 per eligible entrant, and simultaneously reduce the rate of infections to 1.1 per 1000 pregnancies. Doing both MNS and RPS is most effective in reducing the rate of new infections (down to 0.2 per 1000 pregnancies). It would, however, increase costs to $430 per eligible entrant. This would result in an incremental cost of $73,603 per additional pediatric HIV case averted when compared with MNS alone. If mandatory newborn testing was not considered a feasible option, RPS would dominate VPS and would be cost-saving compared with no screening. RPS compares favorably with alternative uses of HIV prevention and treatment resources. In correctional facilities where voluntary newborn screening is already in place, our findings show that there remains a small marginal benefit to be realized from switching to RPS. In settings where HIV screening policies are not in place, however, the implementation of RPS can be expected to significantly reduce pediatric HIV cases and net health care expenditures.

Adult↗
PubMed2004

Mandatory second opinion to reduce rates of unnecessary caesarean sections in Latin America: a cluster randomised controlled trial.

BACKGROUND: Latin America has a high rate of caesarean sections. We tested the hypothesis that a hospital policy of mandatory second opinion, based on the best existing scientific evidence, reduces the hospital caesarean section rate by 25%, without increasing maternal and perinatal morbidity and mortality. METHODS: 36 hospitals in Argentina (18), Brazil (eight), Cuba (four), Guatemala (two), and Mexico (four), were randomly assigned to intervention or control in a matched pair design. All physicians in the intervention hospitals deciding a non-emergency caesarean section had to follow a policy of mandatory second opinion. The primary outcome was the overall caesarean section rate in the hospitals after a 6-month implementation period. We also assessed women's satisfaction with labour and delivery care and physicians'acceptance of the second opinion policy. FINDINGS: A total of 34 hospitals attending 149?276 deliveries were randomised and completed the protocol. The mandatory second opinion policy was associated with a small but significant reduction in rates of caesarean section (relative rate reduction 7.3%; 95% CI 0.2-14.5), mostly in intrapartum sections (12.6%; 0.6-24.7). Other maternal and neonatal outcomes and women's perceptions and satisfaction with the process of care were similarly distributed between the groups. INTERPRETATION: In hospitals applying this policy of second opinion, 22 intrapartum caesarean sections could be prevented per 1000 deliveries, without affecting maternal or perinatal morbidity, and without affecting mothers' satisfaction with the care process.

Adult↗
PubMed1999

Development and clinical application of new polyvalent combined paediatric vaccines.

The availability of combined vaccines containing protective antigens against the majority of (ideally all) diseases for which universal immunization is recommended in infancy would simplify the implementation, increase the acceptance, reduce the global cost of immunization programmes and improve disease control, while offering the possibility of disease elimination or even pathogen eradication. The desirability of combined vaccines is further enhanced, and made more urgent, because of the increasing number of diseases that can be prevented by vaccination. The complicated logistics of administering different vaccines that each require several inoculations is a significant barrier to successful immunization of a population. Furthermore, interest in immunization is continuously gaining momentum since it is now generally recognised that vaccines are among the safest and most cost-effective medical interventions for infectious diseases that continue, in spite of the widespread use of efficacious antimicrobial drugs, to be an important cause of morbidity and mortality. This burden is likely to increase due to the development of antimicrobial resistance. Basic research on new vaccines or improvement of existing ones such as the use of new technologies may be carried out in academic or other non-industrial laboratories but development work, including the necessary extensive clinical testing, that lead to products that can be approved for routine use is usually co-ordinated and financed by commercial companies. The decision to develop any particular combined vaccine will therefore be influenced not only by its medical desirability and technical feasibility but also the potential financial returns that the required investments in time and resources may bring to the company. All major vaccine manufacturers are currently working, either alone or through strategic alliances, towards developing more polyvalent vaccines by adding antigens such as inactivated polio virus, conjugated Haemophilus influenzae type b polysaccharide and hepatitis B surface antigen to the diphtheria-tetanus-pertussis vaccine either in its 'classical' (whole-cell) or more purified (acellular) formulations. Experience is showing that the development of combined vaccines involves much more than the simple mixing of existing antigens. Possible incompatibilities or mutual interferences between the antigens themselves, or between excipients, preservatives, adjuvants, residual contaminants, stabilisers and suspending fluids make it mandatory that each formulation be thoroughly tested for quality, stability, efficacy and safety. Furthermore the ability to produce and control it consistently must be established before it can be licensed for commercial use. The progress being made in this field is reviewed.

Child↗
PubMed2003

Minimizing risks: the ethics of predictive diabetes mellitus screening research in newborns.

Type 1 diabetes mellitus is the most common metabolic disease of childhood. Two states offer newborn screening to identify children with a genetic predisposition to it. It is a voluntary test offered in conjunction with the mandatory newborn metabolic screening. There are no preventive treatments, but children discovered to be at increased risk may participate in follow-up studies to determine whether and when the child develops autoantibodies (preclinical disease) or overt diabetes. This study examined the ethics of predictive genetic research in newborns for type 1 diabetes. Prediction research has serious psychosocial implications, and research designs must account for them. The study concluded that, to minimize harm to infants and their families, (1) if the research does not incorporate a prevention strategy, studies should avoid disclosure of results; and (2) if disclosure is necessary, then the research should be restricted to newborns with an affected first-degree relative.

Diabetes Mellitus, Type 1↗