The legal and ethical framework governing Body Donation in Europe - 1st update on current practice

Previously, we have reported on the legal and ethical aspects and current practice of body donation in several European countries, reflecting cultural and religious variations as well as different legal and constitutional frameworks. We have also established good practice in body donation. Here we shall further extend the legal and ethical frameworks in place and also focus on novelties in the law and different directives. Of particular interest are points that address the commercialization of human bodies and body parts and weaknesses in the legal directives. Therefore, it is important to define what is ethical and what needs to be considered unethical in body donation and the subsequent utilisation of human bodies for teaching and research (AU)

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Sentinel Surveillance: an option for surveillance of infectious intestinal disease.

Sentinel surveillance systems offer advantages over passive surveillance which is known to have limitations due to incomplete reporting. Sentinel surveillance gathering data from selected sources was piloted as an option for surveillance of infectious intestinal disease (IID) in Malta. Between October 2004 and May 2005, 22 general practitioners (GPs) voluntarily participated in the study and reported on the number of IID cases (by age and sex) and all primary care encounters in their practice. The GPs' reporting activity lasted for 35 weeks, covering a total of 55,425 primary care encounters, of which 1.95% concerned IID. For every case reported via the routine passive notification system, seven cases would be picked up by this enhanced sentinel surveillance.

Estimating the burden and cost of infectious intestinal disease in the Maltese community.

The aim of this study was to estimate the burden of infectious intestinal disease (IID) and cost of illness at the community level from a societal aspect. A retrospective, age-stratified cross-sectional telephone study was carried out in Malta in 2004-2005. The number of cases, resources used and cost of resources were computed. The resources involved direct costs (health-care services, stool culture tests, medicines and personal costs) and indirect costs (costs from lost employment by cases and caregivers). This study estimated 0.421 (95% CI 0.092-0.771) separate episodes of IID per person per year in Malta which corresponds to 164 471 (95% CI 35 941-301 205) episodes of IID per year or 450 (95% CI 98-825) episodes of IID each day. The largest proportion of cost is due to provision of health-care services with euro10 454 901 [Maltese liri (Lm) 4 558 970] per year; followed by euro963 295 (Lm 2 209 393) in lost productivity; euro1 286 286 (Lm 561 078) in medicines; euro152 335 (Lm 66 452) in stool culture testing and euro71 487 (Lm 31 183) in personal costs, giving a total cost of illness of over euro16 million (7 million Lm) per year. The burden and cost of IID are high enough to justify efforts to control the illness. Such estimates are important to assess the cost-effectiveness of proposed specific interventions.

The magnitude and distribution of infectious intestinal disease in Malta: a population-based study.

Routine sources of information on infectious intestinal disease (IID) capture a fraction of the actual disease burden. Population studies are required to measure the burden of illness. A retrospective age-stratified cross-sectional telephone study was carried out in Malta in order to estimate the magnitude and distribution of IID at population level. A random sample of 3504 persons was interviewed by a structured questionnaire between April 2004 and December 2005. The response rate was 99.7%. From the study, the observed standardized monthly prevalence was 3.18% (95% CI 0.7-5.74) with 0.421 (95% CI 0.092-0.771) episodes of IID per person per year. The monthly prevalence was higher in the <5 years age group and in females aged 31-44 years. The mean duration of illness was 6.8 days and a median duration of 3 days. A bimodal seasonal distribution was observed with peaks in June-July and October-November.

Challenges in identifying the methodology to estimate the prevalence of infectious intestinal disease in Malta.

Routine surveillance systems capture only a fraction of infectious intestinal disease (IID) that is actually occurring in the community. Different methodologies utilized among various international studies in the field were reviewed in order to devise an appropriate survey to obtain current estimates of prevalence of IID in Malta. An age-stratified retrospective cross-sectional telephone study was selected for the study due to its feasibility in terms of limited resources necessary (funds, time and human). The disadvantages of this type of study include the inherent biases such as selection bias (sampling, ascertainment and participation bias) and information bias (recall and observer bias). A pilot study was carried out using a random age-stratified sample of 100 persons over a 3-month period. A total of 5.0% (95% CI +/-4.27) of the population was estimated to have suffered from IID during that period. This estimate was used in order to assist in sample size calculations for a large-scale community study. It also served to test the survey instrument and methodology and to identify operational problems.

Circulating levels of placental protein 14 in ectopic pregnancy.

OBJECTIVE: To determine circulating levels of placental protein 14 (PP14) in complications of early pregnancy. DESIGN: Biochemical monitoring of women presenting with vaginal bleeding and/or abdominal pain. SETTING: An emergency gynaecological ultrasound clinic in a London teaching hospital. SUBJECTS: Venous blood samples were obtained from 67 women with normal pregnancy (n = 9), ectopic pregnancy (n = 26) and failed intrauterine pregnancy (n = 32). This group included anembryonic pregnancy (n = 18), missed miscarriage (n = 2), spontaneous miscarriage of a previously demonstrated live fetus (n = 6), incomplete miscarriage (n = 4), complete miscarriage (n = 1) and molar pregnancy (n = 1). MAIN OUTCOME MEASURES: Serum PP14 levels in the group of women with a failed intrauterine pregnancy in relation to the normal range for PP14. RESULTS: Eighty-one percent of women who miscarried spontaneously had normal serum PP14 levels; 81% of women with ectopic pregnancy had depressed (< 5th centile) serum PP14 levels. CONCLUSION: Measurements of PP14 may be useful in distinguishing spontaneous miscarriage from ectopic pregnancy, but not in the management of threatened miscarriage.

Prevalence screening for ovarian cancer in postmenopausal women by CA 125 measurement and ultrasonography.

OBJECTIVE: To assess the performance of the sequential combination of serum CA 125 measurement and ultrasonography in screening for ovarian cancer. DESIGN: The serum CA 125 concentration of each subject was determined and those with a concentration > or = 30 U/ml were recalled for abdominal ultrasonography. If ultrasonography gave abnormal results surgical investigation was arranged. Volunteers were followed up by annual postal questionnaire. SETTING: General practice, occupational health departments, ovarian cancer screening clinic. SUBJECTS: 22,000 women volunteers who were postmenopausal and aged over 45 years. MAIN OUTCOME MEASURES: Apparent sensitivity, specificity, positive predictive value, years of cancer detected. RESULTS: 41 women had a positive screening result and were investigated surgically. 11 had ovarian cancer (true positive result) and 30 had other disorders or no abnormality (false positive result). Of the 21,959 volunteers with a negative screening result, eight subsequently presented clinically with ovarian cancer (false negative result) and 21,951 had not developed ovarian cancer during follow up (apparent true negative result). The screening protocol achieved a specificity of 99.9%, a positive predictive value of 26.8%, and an apparent sensitivity of 78.6% and 57.9% at one year and two year follow up respectively. The estimated number of years of cancer detected by the prevalence screen was 1.4 years. CONCLUSIONS: This screening protocol is highly specific for ovarian cancer and can detect a substantial proportion of cases at a preclinical stage. Further investigation is required to determine the effect of the screening protocol on the ratio of early to late stage disease detected and on mortality from ovarian cancer.

Doppler ultrasonographic evaluation of abnormal pregnancies in the first trimester.

Doppler examination of uteroplacental vessels was performed in the first trimester of pregnancy in 111 women with a normal pregnancy outcome and in 10 women with pregnancies that had or subsequently failed due to anembryonic pregnancy (N = 4), missed abortion (N = 1), subsequent spontaneous abortion of live fetus (N = 2), and ectopic pregnancy (N = 3). Flow velocity waveforms (FVWs) were obtained three times by the same observer from subplacental vessels just within the myometrium. The Resistance Index (RI) of the FVWs was compared with the values obtained from 73 uncomplicated pregnancies and 38 women with threatened miscarriage and normal outcome. There was no apparent difference in the values for RI in the 10 patients whose pregnancies had failed, although the 3 live ectopic pregnancies studied had higher values. Although these studies may improve our understanding of the pathophysiology of early placentation, they are unlikely to be of value in the diagnosis of early pregnancy failure.

Circulating levels of placental protein 12 in ectopic pregnancy.

Maternal serum placental protein 12 (PP12) was measured at the time of presentation in 33 women with a histologically confirmed diagnosis of ectopic pregnancy [tubal pregnancy (n = 29), tubal pregnancy with a live fetus (n = 2), cornual pregnancy (n = 1) and ovarian pregnancy (n = 1)]. All but four of the 33 patients had PP12 measurements within the reference range. Two women had circulating PP12 levels above the 90th centile of the normal range, at 7 and 8 weeks gestation, respectively. One of these had a live ectopic gestation and the other patient conceived after in vitro fertilization. Two remaining patients (one each with a cornual and tubal pregnancy) at 11 and 12 weeks, respectively had levels below the 10th centile of the normal range. It is concluded that regardless of the implantation site, ectopic pregnancy is not associated with depressed maternal PP12 levels, suggesting that the decidual synthesis of this protein is independent of the intimate relationship between decidua and trophoblast.

Serum levels of CA 125 during the first trimester of normal outcome, ectopic and anembryonic pregnancies.

Single serum samples were obtained during the first trimester of pregnancies with a retrospectively normal outcome (n = 150), ectopic pregnancies (n = 38) and anembryonic pregnancies (n = 78). Serial samples during the first trimester were also obtained from 43 women achieving pregnancy following successful treatment for infertility and with a retrospectively defined normal outcome. Significant variation in serum CA 125 levels in relation to gestational age was observed in pregnancies with a normal outcome (P less than 0.0001). Peak serum CA 125 levels were observed at 6-7 weeks, the mean level at this gestation being 40.1 U/ml (range 31.7-50.7 U/ml) in the normal conception/normal outcome group and 36.5 U/ml (range 25.6-52.0 U/ml) in the assisted conception/normal outcome group. A rise and fall in serum CA 125 levels during the first trimester was observed in 42 of 43 assisted conceptions monitored serially, with peak levels ranging from 7 to 1398 U/ml (median 48.8 U/ml) occurring at 28-61 days (median 45 days) gestation. Mean serum CA 125 levels were higher in the anembryonic pregnancy group at 4-5 and 6-7 weeks gestation than in both normal pregnancy outcome groups (P less than 0.01).

Maternal serum alpha-fetoprotein levels in ectopic pregnancy.

Maternal serum alpha-fetoprotein (AFP) was measured at the time of presentation in 44 women with histologically proven ectopic pregnancy. Serum AFP levels were within the reference range in 32 women. Eleven women (25%) had AFP levels above the 90th centile of the normal range, including five women with a live fetus seen ultrasonically preoperatively. The two women with a ovarian pregnancy and a cornual pregnancy had levels below the median value for gestational age.

Ultrasound and circulating placental protein measurements in complications of early pregnancy.

Maternal serum levels of human chorionic gonadotrophin (hCG), Schwangerschaftsprotein 1 (SP1) and pregnancy-associated plasma protein A (PAPP-A) were measured in an unselected group of 624 women presenting with amenorrhoea and vaginal bleeding with or without abdominal pain to an emergency gynaecological ultrasound clinic. Abdominal sector scanning was used to assess uterine contents. Pregnancy was confirmed by ultrasound in 406 pregnancies. Histological confirmation was obtained in each case of pregnancy failure. A live fetus was demonstrated in 259 women of whom six subsequently miscarried; one of these had markedly depressed serum hCG and PAPP-A, but normal SP1 levels, and two had oligohydramnios. Of the 147 women without ultrasound evidence of fetal heart action 67 had a correct ultrasound diagnosis of anembryonic pregnancy. The predictive value of a depressed serum hCG level was 70% in this group, and 31% in samples taken at less than or equal to 7 weeks. The predictive value of a normal hCG level was 96%. In 34 women missed miscarriage was diagnosed readily by ultrasound; all but five had depressed hCG and PAPP-A levels. A clinical diagnosis of a complete or incomplete miscarriage was made in 45 women and easily confirmed by ultrasound. All of them had depressed hCG, SP1 and PAPP-A levels. These results indicate that the diagnostic value of ultrasound in threatened miscarriage is often better than that of biochemical tests.

Threatened miscarriage and intrauterine hematomas. Sonographic and biochemical studies.

In a prospective study of 406 women with threatened miscarriage (TMC), 22 (5.4%) had an intrauterine hematoma (less than 16 mL) noted ultrasonically, decreasing in size as the patients experienced repeated episodes of bleeding. Twenty (91%) of the hematomas visualized were subchorionic and two (9%) were retroplacental. None of these women subsequently miscarried. Human chorionic gonadotrophin (hCG), Schwangerschafts protein 1 (SP1), and pregnancy-associated plasma protein A (PAPP-A) levels measured in these patients were not significantly different in women with or without hematomas. We conclude that the presence of small intrauterine hematomas in women with TMC does not increase the risk of miscarriage.

Maternal serum alpha-fetoprotein levels in anembryonic pregnancy.

Maternal serum alpha-fetoprotein (AFP) levels were determined in 21 women with threatened miscarriage in whom an ultrasound diagnosis of anembryonic pregnancy was confirmed. Fourteen of the 21 patients had normal AFP levels; the remaining seven had levels above the 95th centile of the reference range. This is in contrast to earlier findings of an association between low levels of AFP in anembryonic pregnancy. It is concluded that most anembryonic pregnancies are pregnancies in which the fetus has been lost rather than pregnancies in which the fetus was never present.

Circulating levels of placental protein 12 in complications of first trimester pregnancy.

Serum placental protein 12 (PP12) levels were determined in 34 women with threatened miscarriage in whom a diagnosis of anembryonic pregnancy (n = 19), missed abortion (n = 4), complete or incomplete abortion (n = 5), hydatidiform mole (n = 1) and subsequent abortion of a live fetus (n = 5), was made ultrasonically and confirmed by histological examination. Twenty-four of the 34 patients had one or more levels between the 10th and 90th centiles of the reference range. In 7 of the 19 patients (37%) with anembryonic pregnancy and in 3 of the 4 patients (75%) with a missed abortion, PP12 levels were markedly elevated. However, in cases where serial measurements were available (n = 6), PP12 levels were seen to fall in all cases. It is concluded that pregnancies that have failed or will subsequently fail in the first or second trimester are not associated with depressed maternal PP12 levels, suggesting that the decidual synthesis of this protein is independent of the presence or viability of the fetus.

Can ultrasound reliably diagnose ectopic pregnancy?

A total of 252 women with amenorrhoea and with abdominal pain or vaginal bleeding, or both, had an emergency high-resolution ultrasound sector scan. In 100 women the symptoms were unrelated to any identifiable abnormal ultrasound finding, none of them was pregnant and their symptoms settled spontaneously; 33 other women had follicular or luteal cysts and 30 had pelvic inflammatory disease. Histological examination confirmed an ectopic pregnancy in 60 women (24%); in seven a live fetus was observed outside the uterus allowing a confident diagnosis of ectopic pregnancy; in 27 the thickness of the endometrium was greater than 10 mm (sensitivity 50%, specificity 84%, positive predictive value 28%, negative predictive value 87%); in 15 the uterine area measurement was less than 20 cm2 (sensitivity 72%, specificity 41%, positive predictive value 20%, negative predictive value 79%); and 43 had an adnexal mass volume greater than 10 ml separate from the ovary (sensitivity 85%, specificity 37%, positive predictive value 23%, negative predictive value 90%). Only three had negative ultrasound findings. The negative predictive value of an ultrasound examination could be increased to 96% by using a combination of these ultrasound features. The addition of hCG (greater than 25 i.u./l) improved the specificity to 98% and the negative predictive value to 100%. These criteria may improve the ultrasound diagnosis of ectopic pregnancy.