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Objective The objective of this study was to compare midwife-led and consultant-led obstetrical care for women with uncomplicated low-risk pregnancies. We estimated costs and maternal outcomes in both units to achieve a cost-effectiveness ratio. Design The cost-analysis was made according to the “intention to treat” concept in order to minimize bias associated with the non-randomization of participants. At the obstetric-led unit, women received care from both midwives and medical staff while those in the alternative structure called ‘Le Cocon’ only received care from midwives. Setting The obstetric-led unit of the Erasme University-Hospital in Brussels and its alongside midwife-led unit. Participants The study population included all low-risk pregnant women from 1 March 2014 until 31 October 2015 who were affiliated to the MLOZ (Mutualites Libres-Onafhankelijke Ziekenfondsen; third Belgian statutory health care insurer). Interventions The cost calculation involved a bottom-up approach. The health care consumption of each participant was obtained from MLOZ's data. The study included costs occurred the beginning of pregnancy until 3 months post-partum. Clinical data were extracted from the patient medical records. Findings Compared to the traditional obstetric-led unit, the alternative midwife-led unit was associated with a cost reduction for the national payer (∆ = −€397.39, p = 0.046) and for the patient (∆ = − €44.19, p = 0.016). There were no significant differences in rates of caesarean, instrumental birth and epidural analgesia between MLU and OLU. A sensitivity analysis was performed (Appendix C) but does not change the overall results and conclusions. Key conclusions Due to the small size of the samples, no statistical differences were found. More analysis is needed to evaluate the cost-effectiveness regarding the use of epidural analgesia, caesarean and instrumental birth rates in the midwife-led unit. Implications for practice Given the economical findings, this could contribute to reduce health expenditures for both women (out of pocket) and state (public payer via health care insurers).

Background In cancer follow-up, in addition to the evaluation of survival probabilities, there is a fundamental need of assessing recurrence dynamics for optimal disease management. Although the time-dependent effect of the oestrogen receptor (ER) status of the tumour has already been described, so far no factor has proven to disentangle the multi-peak behaviour observed for breast cancer recurrences. Here, we aimed at investigating whether adiposity at diagnosis, reflected by increased patient's body mass index (BMI), could be associated with breast cancer recurrence patterns over time after primary cancer therapy. Methods We retrieved BMI from 734 of 777 patients with node-positive breast cancer from a phase III randomised clinical trial, which compared different chemotherapy regimens and had a median follow-up of 15.4 years. Cumulative incidence estimation as well as piecewise exponential models were carried out to estimate the distant recurrence dynamics, in all patients, as well as in subgroups based on the ER status, with the ER-positive group being further split according to the menopausal status. Results In patients with ER-negative breast cancer, time-dependent analyses revealed that the hazard of late relapses could mainly be attributed to the overweight and obese patients. Within the subgroup of premenopausal patients with ER-positive tumours, obesity was associated with an early high narrow peak of distant recurrences followed by another main peak after 5 years of follow-up. The risk for overweight patients was intermediate between obese and normal-weight patients. In the postmenopausal subgroup of patients with ER-positive tumours, the distant recurrence rate was significantly more elevated in the overweight patients compared to the other BMI categories, and a second late peak of recurrences was also observed for the obese patients. Conclusion These results demonstrate that the patient's BMI at diagnosis is associated with cancer recurrence dynamics. Patient adiposity should therefore be central to the exploration of late adjuvant treatment modalities.

Most women with uterine myoma are asymptomatic and do not require any treatment. However, myoma can also lead to menorrhagia, pressure symptoms, abdominal pain, and infertility. Management of symptomatic women with myoma depends on several factors, including age, desire for fertility, and myoma characteristics. Uterine myoma that distorts the uterine cavity, either submucous myoma or intramural myoma, with a submucous component reduces fertility, and is associated with increased uterine bleeding. The treatment of choice is hysteroscopic myomectomy or abdominal myomectomy, preferably by laparoscopy. Robotic assistance in laparoscopic myomectomy leads to outcomes similar to conventional laparoscopic myomectomy. However, it is expensive. Newer techniques include either laparoscopic or transcervical radiofrequency thermal ablation.

Mature ovarian teratoma is the most frequent benign tumor in premenopausal women. It is usually asymptomatic but complications are possible such as adnexal torsion, infection, malignant transformation or cystic rupture. The latter can be spontaneous or more often occurs during surgery of excision of dermoid cyst. It can rarely result in chemical peritonitis, which is due to the irritation of the peritoneal serosa by the aseptic content of the tumour. We report the case of a patient who undrewent an emergency laparotomy for a chemical peritonitis following a spontaneous rupture of a dermoid cyst. Afterwards, she developed an acute respiratory distress syndrome that required an admission in the intensive care unit and subsequent surgery.Le tératome mature de l’ovaire est la tumeur ovarienne bénigne la plus fréquente chez la femme en pré-ménopause. Le plus souvent, il est asymptomatique, mais il peut se compliquer par une torsion annexielle, une infection, une dégénérescence maligne ou une rupture kystique. Celle-ci peut être spontanée ou, plus souvent, survenir lors d’une chirurgie d’exérèse du kyste. Rarement, elle peut entraîner une péritonite chimique. Celle-ci est consécutive à l’irritation de la séreuse péritonéale par le contenu aseptique da la tumeur. Nous rapportons ici le cas d’une patiente opérée en urgence pour une péritonite chimique suite à une rupture spontanée d’un kyste dermoïde. Dans les suites opératoires, la patiente a développé un syndrome de détresse respiratoire aigu qui a nécessité une prise en charge aux soins intensifs et une nouvelle intervention chirurgicale.

This paper questions the signification of reinforcing the active role of elderly between societal injunction to feel responsible of the costs to the collectivity and the freedom to choose one's way of life and having the means to realize it. It describes two experiences in two Brussels communes of a model of co-construction with the elderly of a project to live in one's own home, to reinforce the active roles of persons. We want to illustrate the difficulty of such an approach in Belgium, separating the organization and the financing of medical and social care, that does not foster the accompanying and the active role of elderly. The conflict of interest between the different actors is not allowing the proper multidisciplinary approach to empower and allow the maintenance of elderly capability of choice and well being.

Hysteroscopy has become an important tool to evaluate intrauterine pathology. In most cases, the pathology can be diagnosed and treated in the office or outpatient setting. The ability to use normal saline as a distending medium allows the procedure to be performed using bipolar energy. During hysteroscopic myomectomy, visualization can remain unobstructed with the use of a hysteroscopic morcellator. Its use is also associated with decreased operating time. The use of Essure(®) to block the proximal fallopian tube by a hysteroscopic approach is an approved procedure for tubal sterilization. However, it has been increasingly used to prevent hydrosalpinx fluid from entering the uterine cavity in women undergoing in vitro fertilization. The hysteroscopic approach has also been used to treat a variety of conditions such as treatment of interstitial pregnancy, caesarean scar pregnancy and retained placenta. However, the number of cases is still relatively small, and no randomized trial has ever been conducted. One of the potentially important developments is the use of falloposcopy to obtain distal tubal cytology as a screening for ovarian cancer. The technique remains to be refined.

BACKGROUND: The Belgium medical home (MH) model, which has been garnering support of late, resembles its US counterpart in that it aims at improving the quality of health care while containing costs. OBJECTIVES: To compare the quality of care offered by MHs with that offered by traditional individual practices (IPs) in Belgium in terms of the extent of their adherence to clinical practice guidelines in antibiotherapy, cervical-cancer screening, influenza vaccination, and the management of diabetes. RESEARCH DESIGN: This is a retrospective study using public insurance claims data. Data consisted of a random sample of patients using the services of MHs and IPs who were previously matched according to sex, age category, location, disability, and socioeconomic status. We applied the McNemar test, the t test, or the Wilcoxon test, depending on the type of variable being compared. SUBJECTS: The final sample comprised 43,678 patients in the year 2004. MEASURES: On the basis of a review of the literature, we selected 4 themes, corresponding to 25 indicators: antibiotherapy, cervical-cancer screening, influenza vaccination, and the management of diabetes. RESULTS: MHs were more likely than IPs to adhere to evidence-based clinical practice guidelines. They prescribed less and more appropriate antibiotherapy, provided wider influenza-vaccination coverage for target groups, and provided a better follow-up for diabetics than did IPs. In regard to cervical-cancer screening, no significant differences were found. CONCLUSIONS: MHs, as they combine a greater adherence to guidelines and savings in secondary care, are a cost-effective alternative to traditional IPs and therefore should be encouraged.

BACKGROUND: The medical home (MH) model has prompted increasing attention given its potential to improve quality of care while reducing health expenditures. OBJECTIVES: We compare overall and specific health care expenditures in Belgium, from the third-party payer perspective (compulsory social insurance), between patients treated at individual practices (IP) and at MHs. We compare the sociodemographic profile of MH and IP users. RESEARCH DESIGN: This is a retrospective study using public insurance claims data. Generalized linear models estimate the impact on health expenditures of being treated at a MH versus IP, controlling for individual, and area-based sociodemographic characteristics. The choice of primary care setting is modeled using logistic regressions. SUBJECTS: A random sample of 43,678 persons followed during the year 2004. MEASURES: Third-party payer expenditures for primary care, secondary care consultations, pharmaceuticals, laboratory tests, acute and long-term inpatient care. RESULTS: Overall third-party payer expenditures do not differ significantly between MH and IP users (€+27). Third-party payer primary care expenditures are higher for MH than for IP users (€+129), but this difference is offset by lower expenditures for secondary care consultations (€-11), drugs (€-40), laboratory tests (€-5) and acute and long-term inpatient care (€-53). MHs attract younger and more underprivileged populations. CONCLUSIONS: MHs induce a shift in expenditures from secondary care, drugs, and laboratory tests to primary care, while treating a less economically favored population. Combined with positive results regarding quality, MH structures are a promising way to tackle the challenges of primary care.

Objectives: The number of countries adopting per case hospital payment systems has been continuously increasing in recent years. Nonetheless, debates persist regarding their consequences for equity of access to services. This concern relates to the failure of diagnostic classifications properly to take into account patients’ care requirements, raising the threat of case selection (‘cream skimming’). We examine the heterogeneity of costs within diagnostic categories related to socioeconomic (SE) factors using length of stay (LOS) as a proxy measure of care needs and costs. We evaluate its consequences in terms of fairness in resource allocation between hospitals. Methods: We employ data on all discharges in 2002-03 from a sample of 60 Belgian hospitals (617,275 observations), measuring the association between LOS and SE factors using generalized linear models. We design a resource allocation formula based on the Belgian financing scheme, where non-medical activity is paid based on a normative number of in-patient days, and measure financial penalties and rewards according to whether payment is adjusted for the SE characteristics of patients or not. Results: Both patients’ SE status and hospitals’ area SE profile have a significant impact on LOS, which persists after controlling for detailed diagnostic and hospital characteristics. Hospitals treating low income patients are financially penalized as a result. Conclusion: SE factors are a predictor of in-patient LOS and should be taken into account in per case resource allocation among hospitals.

Objective: To report a case of Guillain-Barré syndrome (GBS) following a dose of influenza A (H1N1) vaccine (Arepanrix). Case Summary: An 11-year-old boy was admitted to the hospital after presenting with facial diplegia; abdominal, forehead, and thigh pain; and acute cervical pain. He had received the Arepanrix H1N1 subcutaneous vaccine 13 days before symptom onset. The neurologic examination also revealed a symmetric bilateral paralysis of the VIIth cranial nerve and intense pain, proximal weakness of the shoulder girdles and pelvis, and preserved deep tendon reflexes. Cerebrospinal fluid analysis revealed an albuminocytologic dissociation. Therefore, a diagnosis of atypical GBS following vaccination against H1N1 influenza was made. Discussion: Based on the clinical evaluation, laboratory test results, neurologic features, and the exclusion of alternative diagnoses, the Naranjo probability scale revealed a probable relationship between the clinical manifestations of GBS and the vaccine against influenza A (H1N1) received by the patient. This is the first published case for the 2009 influenza pandemic in children. Conclusions: While recent studies have found inconclusive results on the association between influenza vaccine and GBS, all suspected cases should be published for further evaluation.

Rationale, aims and objectives 'Real world data' are needed to assess the quality of pharmacological treatments in clinical practice. The aim of this study was to determine whether administrative databases can be used to assess the quality of prophylaxis with low-molecular-weight heparin after major orthopaedic surgery. Methods The study was performed in a Belgian university hospital. Patients undergoing total hip replacement (THR), total knee replacement (TKR) or hip fracture surgery (HFS) were selected retrospectively from the hospital's 2002 and 2003 administrative databases. Readmissions during the same year as the procedure were also analysed. Three quality indicators were assessed: incidence of venous thromboembolism (VTE), major bleeding and death; adherence to guidelines; and the costs of care. Results Although 70% of data were collected from administrative databases, patients' records also had to be examined. During the period studied, VTE and major bleeding events were rare. Patients undergoing HFS were at greater risk of having a pulmonary embolism [Exact odds ratio (OR) = 3.78; 95% confidence interval (CI) = 1.13-16.22; P = 0.03] or of death from any cause (Exact OR = 2.15; 95% CI = 1.52-infinity; P < 0.01) than patients undergoing THR or TKR. The hospital's prophylaxis protocol was not always followed. Half the patients received higher prophylaxis doses than recommended and 11% received lower doses but no impact on adverse events was demonstrated. Conclusion Results show that administrative databases contain enough information to measure the frequency of adverse events but complementary data on patient weight and on non-reimbursed drugs must be extracted from the patients' records to evaluate adherence to guidelines. Our findings stress the need for better integration of information systems.

Objectives:The increasing use of full economic evaluations has led to the development of various instruments to assess their quality. The purpose of this study was to compare the frequently usedBritish Medical Journal(BMJ) check-list and two new instruments: the Consensus Health Economic Criteria (CHEC) list and the Quality of Health Economic Studies (QHES) instrument. The analysis was based on a practical exercise on economic evaluations of the surgical treatment of obesity.Methods:The quality of nine selected studies was assessed independently by two health economists. To compare instruments, the Spearman rank correlation coefficient was calculated for each assessor. Moreover, the test–retest reliability for each instrument was assessed with the intraclass correlation coefficient (ICC) (3,1). Finally, the inter-rater agreement for each instrument was estimated at two levels: comparison of the total score of each article by the ICC(2,1) and comparison of results per item by kappa values.Results:The Spearman's rank correlation coefficient between instruments was usually high (rho > 0.70). Furthermore, test–retest reliability was good for every instruments, that is, 0.98 (95 percent CI, 0.86–0.99) for the BMJ check-list, 0.97 (95 percent CI, 0.73–0.98) for the CHEC list, and 0.95 (95 percent CI, 0.75–0.99) for the QHES instrument. However, inter-rater agreement was poor (kappa < 0.40 for most items and ICC(2,1) ≤ 0.5).Conclusions:The study shows that the results of the quality assessment of economic evaluations are not so much influenced by the instrument used but more by the assessor. Therefore, quality assessments should be performed by at least two independent experts and final scoring based on consensus.

BACKGROUND: Blood is a sparse commodity. Transfusion needs increase while the number of donors decreases. These constraints incite Belgian authorities to pay more attention to transfusion financing. This implies pathologic knowledge of the epidemiology of in-hospital transfusion and the consumption of blood products. STUDY DESIGN AND METHODS: This study is a retrospective analysis of in-hospital stays from the year 2000 and includes data from all 124 Belgian hospitals. The database contains information on diagnoses, procedures, and all-patients refined diagnosis-related groups (APRDRGs) but also on expenses linked to blood products transfused and to transfusion-related pharmaceutical products. RESULTS: Three percent of surgical patients used 55.7 percent of transfusion resources and 75.4 percent of transfusion costs were associated with 24 APRDRGs. In the medical group, 3 percent of the patients accounted for 80.2 percent of transfusion costs and 20 APRDRGs consumed 71.9 percent of transfusion resources. The variables with the highest impact on the proportion of patients transfused were severity, pathology, and age. The effect of hospitals remained significant but had less impact. No substitution of blood products by transfusion-related pharmaceutical products was observed in our analysis. CONCLUSION: Our study confirms that transfusion now centers on a limited number of pathologic entities and, within those, in small subsets of patients. This implies that the costs linked to setting up and running the transfusion system can no longer be shared by a large number of patients who receive transfusions but rely increasingly on patients at higher risks of more unpredictable needs. The system must nevertheless be able to cope with them at any time.

To evaluate use rates and immediate postoperative complications of the use of an adhesion barrier in myomectomy or hysterectomy.This was a retrospective cohort study. Using the Healthcare Cost and Utilization Project Nationwide Inpatient Sample, we examined the records of women with primary discharge diagnosis of uterine myoma during the period 2003-2011. We evaluated use rates and complications among 473,788 women treated by myomectomy or hysterectomy.Of 473,788 women treated by myomectomy or hysterectomy, adhesion barrier was used in 3,392 of 62,563 myomectomies (5.4%) and 5,590 of 411,225 hysterectomies (1.4%). The rate of ileus after myomectomy in the nonbarrier group (1,290/59,171 [2%]) was lower than in the barrier group (109/3,392 [3%]; adjusted odds ratio [OR] 1.50 [1.22-1.83]) and similar after hysterectomy (10,329/405,635 [2.5%] compared with 288/5,590 [5%]; adjusted OR 1.97 [1.75-2.23]). Postoperative fever was also higher in the adhesion barrier group after myomectomy (4.4% compared with 2.9%, adjusted OR 1.44 [1.21-1.71]) as well as after hysterectomy (2.5% compared with 1.6%, OR 1.65 [1.40-1.96]). Small bowel obstruction after hysterectomy in the nonbarrier group (804/405,635 [0.2%]) was less frequent than in the barrier group (23/5,590 [0.4%]; OR 1.90 [1.25-2.89]), but not after myomectomy.Although the use of adhesion barrier remains very low, the use is associated with a slightly higher incidence of fever and ileus after myomectomy and hysterectomy and with bowel obstruction after hysterectomy.

Uterine fibromatosis is a frequent benign gynaecological disease causing heavy menstrual bleeding and in some cases anaemia. Until now, medical treatment aimed to obtain amenorrhea by administration of progestins or Gn-RH agonists. By inducing hypo-oestrogenism, a reduction of myoma size is observed with Gn-RH agonists but after cessation of the treatment, initial myoma size is noted. The impact of progesterone in myoma growth is nowadays demonstrated and use of selective modulators of progesterone receptors represents a new medical approach of this disease.

Summary Background The predictive role of HER-2 in node-positive breast cancer patients receiving CMF or an anthracycline-based adjuvant therapy remains unclear. In addition, topo-isomerase II alpha (topo IIα), as the cellular target of anthracyclines. might have value as a predictive marker. Patients and methods Four hundred eighty-one archival primary tumor samples were collected among 777 patients entered into a multicenter phase III trial comparing classical CMF with epirubicin-cyclophosphamide (HEC) as adjuvant therapy of node-positive breast cancer. HER-2 was evaluated by immunohistochemistry (IHC) using different antibodies (Abs). Topo IIα was evaluated by (IHC) using the Ab KiS 1. In each subgroup of patients identified by HER-2 and topo IIα, adjusted hazard ratios for event-free survival (EFS) and the corresponding 950025 confidence intervals have been calculated for the different study comparisons. An interaction test has been performed to investigate the role of HER-2 and topo IIα, as predictive markers. Results When HER-2 was evaluated by CB-11 and 4D5 mAbs, the EFS adjusted hazard ratios (HR) for the main study comparison HEC vs. CMF were: HER-2 positive: 0.33 (950025 confidence interval (950025 Cl): 0.09–1.27, P=0.08), HER-2 negative: 1.16 (950025 Cl: 0.71–1.90, P=0.56); the P-value for the interaction test was 0.10. When HER-2 was evaluated by TAB-250+pAb1 Abs, the adjusted HR for the same comparison were: HER-2 positive: 1.06 (950025 Cl: 0.45–2.52, P=0.90), HER-2 negative: 0.99(950025 Cl: 0.58–1.68. P=0.97); the P-value for the interaction test was 0.84. With regard to topo 11α, the adjusted HR for the EFS comparison HEC vs. CMF were: topo 11α positive: 0.66 (950025 Cl: 0.32–1.36, P=0.25), topo 11α negative: 1.26(950025 Cl: 0.63–2.50, P=0.51): the P-value for the interaction test was 0.13. Conclusions This study suggests that in node-positive breast cancer patients randomly treated with CMF or an epirubicin-based regimen, the predictive value of HER-2 may vary according to the Abs used in the immunohistochemistry assay. In addition, the study supports the concept that topo 11α might be involved in the determination of tumor responsiveness to an anthracycline-based adjuvant therapy.

Background Despite the efficacy of raltegravir in reducing viral load in HIV-infected patients, evidence for its safety in late pregnancy is lacking. A high rate of placental transfer was recently demonstrated. Case A treatment-naive 34-year-old HIV-1-positive woman of African origin began treatment with zidovudine/lamivudine, lopinavir/ritonavir, and raltegravir at 35weeks of pregnancy. After 11days of treatment with raltegravir, a substantial reduction in viral load was achieved. Concurrently, she had a 23-fold increase in serum alanine aminotransferase and a 10-fold increase in serum aspartate aminotransferase, both of which returned to normal when raltegravir treatment was discontinued. A healthy boy was delivered at term. The infant's tests for HIV were negative at five months, and he had no health problems at eight months. Conclusion This is the first case report, to our knowledge, of increased maternal serum transaminase levels following the use of raltegravir in a woman at a late stage of pregnancy.

The present article proposes an analysis of the USA-Bolivia relationships in the health sector between 1971 and 2010 based on a grey and scientific literature review and on interviews. We examined United States Agency for International Development (USAID) interventions, objectives, consistency with Bolivian needs, and impact on health system integration. USAID operational objectives-decentralization, fertility and disease control, and maternal and child health-may have worked against each other while competing for limited Ministry of Health resources. They largely contributed to the segmentation and fragmentation of the Bolivian health system. US cooperation in health did not significantly improve health status while the USAID failed to properly tackle anti-drugs, political, and economic US interests in Bolivia. Copyright © 2012 John Wiley & Sons, Ltd.

The main objective is to describe the incidence of adverse drug reactions (ADR) coded by medical archivists from patient medical records. The secondary objective is to determine the drug classes causing ADRs according to age and to compare the incidence according to the revision of the International Classification of Diseases (ICD) used.This is a non experimental and descriptive study of ADR in a teaching hospital. All ADR codes (i.e. codes E930 to E949 in ICD-9 version and codes Y40 to Y59 in ICD-10 version) in medical records of patients aged 18 and under have been included. The research protocol has been accepted by the institutional review board committee of CHU Sainte-Justine.We calculated on average 225.7±65.1 ADRs coded per year for an annual average incidence of pediatric ADRs of 1.64%±0.41% (n=4740 ADRs, average 1.3 ADR per patient) for a total of 294,480 admissions between April 1st, 1989 and March 31st, 2010. ADRs coded occurred amongst 0 to 2 years old and 12 to18 years old in a proportion of 30.5% and amongst 3 to 11 years old in a proportion of 39%. ADRs are caused by antibiotics (28%), anticancer drugs (18%), opiates (6%) and steroids (6%) which represent around 50% of all ADRs.The incidence of pediatric ADRs is increasing throughout the studied period, mainly because a more complete codification of episodes of care by medical archivists has been prioritized by the hospital administration.

PURPOSE We compared prospectively the antitumor efficacy of two combination chemotherapy regimens with two different dose levels of epirubicin as first-line treatment for advanced breast cancer. PATIENTS AND METHODS One hundred forty-one fully assessable patients were randomized to receive either our intensified schedule (group A, n = 71) of epirubicin 50 mg/m2 on days 1 and 8 (every 3 weeks), or a non-intensified program (group B, n = 70) in which epirubicin was only administered on day 1. Both groups also received fluorouracil (5 FU) and cyclophosphamide 500 mg/m2 on day 1 of each course. RESULTS A statistically significant difference in response rate was observed (69% in group A v 41% in group B, P < .001) for both locally advanced (LA) and recurrent metastatic (RM) disease. Response duration (22 v 14 months, P < .01) and time to progression (TTP; 19 v 8 months, P < .02) were also significantly improved. Overall survival was similar in both groups. However, univariate and/or multivariate analyses showed a meaningful relationship between type of treatment allocated, dose-intensity (DI) of epirubicin, and response rate, as well as between TTP and survival. Ultimately, TTP and survival were also influenced by further treatment modalities, namely, hormonotherapy and chemotherapy. CONCLUSION This study validates prospectively the concept of a dose-response relationship for an anthracycline-based chemotherapy in previously untreated advanced breast cancer.

In the current context, the assessment of the quality of care in daily clinical practice becomes essential. The aim of this study was to use medical basic datasets associated with information on pharmacological treatments to assess the quality of care of a prophylaxis treatment after major orthopaedic surgery and to compare hospitals' clinical practices.The study was performed in 20 Belgian hospitals. Patients who underwent total hip replacement (THR), total knee replacement (TKR), or hip fracture surgery (HFS) were selected retrospectively from the hospitals' 2002 and 2003 administrative databases (n = 14,991). Quality indicators assessed were incidence of venous thromboembolism, major bleeding and death. Prophylaxis analysed were enoxaparin, nadroparin and fondaparinux.Venous thromboembolism and major bleeding events were rare (1.9% and 1.1% respectively). Patients who underwent HFS were at greater risk of having pulmonary embolism [OR = 2.01; confidence interval (CI) = 1.38-2.92; P = 0.0002], major bleeding (OR = 4.00; CI = 2.93-5.46; P0.0001) or death from any cause (OR = 8.86; CI = 6.85-11.45; P0.0001) than patients who underwent THR or TKR. Multivariate analyses showed that the hospital variable had a significant impact on the probability to have adverse events and that patients who received enoxaparin were at greater risk of death than patients who received nadroparin (OR(enoxaparin vs fraxiparin) = 1.59; 95% CI = 1.04-2.44; P = 0.033).Results indicate that differences in thromboembolism prophylaxis practices among hospitals have a significant impact on adverse events. This reinforces the need to develop data-processing tools that enable better monitoring of quality of care.

The efficacy of combination therapy with vinorelbine, cyclophosphamide, and 5-fluorouracil was assessed in women who had received no prior therapy for locally advanced or metastatic breast cancer. Sixty patients with metastatic breast cancer who had finished any adjuvant therapy at least 6 months previously and who had not received treatment for advanced disease were entered onto the study. The schedule consisted of vinorelbine (Navelbine, Pierre Fabre Medicament) 25 mg/m 2 on days 1 and 8, cyclophosphamide 500 mg/m 2 on day I, and 5-fluorouracil 500 mg/m 2 followed by folinic acid 200 mg/m 2 on days I and 8. Treatment was repeated every 21 days up to a maximum of 8 cycles. Objective responses were observed in 27 of 60 patients (45%; CI 95 32.4-57.6) including 4 complete responses (6.7%; CI 95 0-13) and 23 partial responses (38.3%; CI 95 22.5-54.1). The responses were achieved in both visceral and nonvisceral sites and at the same rate for patients with multiple sites of disease. Neutropenia was dose limiting, with 40% of patients affected at grade 3 or 4, while other hematologic and nonhematologic toxicity was very mild. This schedule achieves good levels of response without the use of an anthracycline, so it is suitable either for patients who have been extensively exposed to anthracyclines during adjuvant therapy or for those who have other contraindications to their use.

Gliomas are the most common CNS tumours in children and present either as circumscribed tumours or diffusely infiltrative neoplasms. Diffuse gliomas develop both in the cerebral hemispheres and the brainstem and have a poor prognosis. Guidelines for the therapy of these tumours are still debated. In this study, we reviewed the clinical features of 27 consecutive patients with diffuse gliomas admitted to the Department of Paediatrics of CHR Citadelle, University of Liège, between 1985 and 2005. We review their clinical presentation, diagnosis, treatment and outcome with reference to the published literature.

We present the experience of the Citadelle Hospital (Liege, B) in the diagnosis, treatment and follow-up of medulloblastoma in children. A retrospective study of 10 cases of medulloblastoma was performed. Five years after diagnosis, the event-free survival was 77%.

The imperfect risk adjustment of prospective payment for hospitals may have dramatic consequences on equity. If the hospital is able to distinguish subgroups of patients with different expected costs within a group for which the risk-adjusted payment per admission is the same, it is likely to select the most profitable cases and deny care to the others. Meanwhile, hospitals refusing to practice patients' selection may experience solvency problems. In the long term, either those hospitals fail and access to care is at risk, or they decrease the quality of treatments and access to quality is at risk. In Belgium, since 1995, a prospective payment per case has replaced the traditional per diem payments for non-medical expenditures. A fixed number of days are paid to each admission, based on the patient's characteristics, namely diagnosis, age and geriatric profile. In this paper, we examine the imperfect risk adjustment related to the non-inclusion of socio-economic factors in the hospital financing formula. Using data from 61 Belgian hospitals from 1995, we observe that socio-economic status, which is currently not accounted for as risk adjuster, has a significant impact on length of stay (LOS). We estimate that patients in the upper-income categories, patients with a self-employed status and patients with an employee status are beneficial for hospitals' financial results, due to their shorter stays. On the contrary, the non-active, the low-income patients and patients benefiting from an insurance preferential regime represent, on average, a financial loss for hospitals. Finally, we find that financial results under the current financing scheme are biased due to the non-inclusion of SES risk-adjustors. Hospitals with the most beneficial social case-mix are shown to experience a shift from a positive to a negative financial outcome when SES risk adjustors are included, while the reverse is observed for hospitals with the worst social case-mix.

In this retrospective study, we analyse epidemiology, clinical symptoms and therapeutic results in a group of 23 children with neuroblastoma. Half of them were less than 2 years of age; in 19 of 23, the primitive tumour was abdominal; 35% of them were initially metastatic. The overall survival was 83% at 5 years and the event free survival, 75% at 5 years. Pronostic factors are age, extension of the disease at diagnosis, biologic parameters and genetic study of the neuroblast cells (amplification of N-myc oncogen). Our study shows the deleterious effect of bone lesions.

Purpose: To evaluate the feasibility and tolerance of a postoperative course of gemcitabine (GEM) combined with continuous radiation after curative resection of pancreatic adenocarcinoma. Methods and Materials: Thirty patients (median age, 61 years; performance status, 0 to 1) with Stage II and III curatively resected pancreatic head adenocarcinoma were included. Gemcitabine 1000 mg/m 2 (3 out of 4 weeks, two cycles) was given within 8 weeks of surgery and followed by GEM 300 mg/m 2 weekly combined with continuous radiation (45 Gy in 25 fractions, 1.8 Gy per fraction). Results: For GEM alone, all patients received the two courses with dose reductions in 14 of 30 patients (46%). All but 3 patients completed full chemoradiation; 1 stopped radiation because of subocclusion of a gastroenterostomy, and 2 did not start owing to disease progression. Reduction in GEM during radiation was necessary in 12 of 30 patients (40%). No toxic death was noted; World Health Organization Grade 3/4 hematologic and nonhematologic toxicities were seen in 10 of 30 patients (33%) and 3 of 30 patients (10%), respectively. After a median follow-up of 19 months, no late toxicity was reported. Eleven patients died from progressive disease; median disease-free survival and overall survival were 14.5 and 19 months, respectively. Conclusion: This adjuvant combination is well tolerated and can be safely administered after curative surgery for pancreatic cancer. Further evaluation of this regimen is ongoing.

This paper presents an overview of the use of a French-speaking battery for the assessment of a central auditory processing disorder (CAPD) in a variety of clinical populations: prematurely born children; 8 years old children who had otitis media with effusion in early infancy; children with learning problems and dyslexia; French-speaking children attending Dutch and English schools; adults with King-Kopetzky syndrome and elderly hearing aids users. Population characteristics of each of these groups are presented and discussed.

Based on the American Speech-Language-Hearing Association (ASHA) Consensus Statement on central auditory processing and models for their exploration, a battery of audiological tests (Bilan Auditif Central--BAC) has been designed in French. The BAC consists of four types of psycho-acoustic tests: a speech-in-noise test, a dichotic test, a temporal processing test and a binaural interaction test. We briefly describe the rationale of these tests. The BAC is available in digital format. Descriptive statistics were computed on data obtained from 668 subjects divided into 15 age-groups ranging from 5 to 85 years old or over. All subjects had no complaints regarding hearing loss, normal tonal audiometry, and normal intelligence. Tests scores of the speech-in-noise test, the dichotic test and the binaural interaction test showed a normal distribution. Test scores of the temporal processing test did not follow a normal distribution. Effects of maturation and involution were clearly visible for all tests. The low correlation between scores obtained from the four tests pointed to the need for a battery of several tests to assess central auditory processing. We claim that the reported scores represent standard norms for the normal French-speaking population, and believe that the tests will be useful for evaluation of central auditory processing.

We seek to investigate socio-economic differences in psychiatric in-patient care regarding admission, treatment and outcome.This study is undertaken on a comprehensive and exhaustive psychiatric case register of all psychiatric in-patient care carried out in Belgium in 1997 and 1998 (n=144 754).Lower socio-economic groups were more likely to be compulsorily admitted, to be cared for in a non-teaching or psychiatric hospital, to be admitted in a hospital with unexpectedly long average length of stay and to be admitted to a ward with a more severe case-mix. They were less likely to receive antidepressants and psychotherapies. The improvements in functioning and in symptoms were also less favourable for these groups. The lowest group had a higher risk of dying in the hospital.Psychiatric in-patient care is associated with moderate socio-economic differences in access, treatment and outcome. Further research is needed to clarify the causes of such disparities.

This case report of a young man with a testicular germ cell-teratoma tumor illustrates the necessity of a multidisciplinary sequential approach to ensure chance of cure. The outcome of patients with advanced germ cell tumor depends on the optimal clinical management. Residual masses are frequent, and their histology can be different than the initial one (i.e., only residual mature teratoma cells or necrosis-fibrosis). Therefore a second surgery on residual masses with curative intent, may be important to optimalize the treatment and follow up.

PURPOSE: To compare a full-dose epirubicin-cyclophosphamide (HEC) regimen with classical cyclophosphamide, methotrexate, and fluorouracil (CMF) therapy and with a moderate-dose epirubicin-cyclophosphamide regimen (EC) in the adjuvant therapy of node-positive breast cancer. PATIENTS AND METHODS: Node-positive breast cancer patients who were aged 70 years or younger were randomly allocated to one of the following treatments: CMF for six cycles (oral cyclophosphamide); EC for eight cycles (epirubicin 60 mg/m2, cyclophosphamide 500 mg/m2; day 1 every 3 weeks); and HEC for eight cycles (epirubicin 100 mg/m2, cyclophosphamide 830 mg/m2; day 1 every 3 weeks). RESULTS: Two hundred fifty-five, 267, and 255 eligible patients were treated with CMF, EC, and HEC, respectively. Patient characteristics were well balanced among the three arms. One and three cases of congestive heart failure were reported in the EC and HEC arms, respectively. Three cases of acute myeloid leukemia were reported in the HEC arm. After 4 years of median follow-up, no statistically significant differences were observed between HEC and CMF (event-free survival [EFS]: hazards ratio [HR] = 0.96, 95% confidence interval [CI], 0.70 to 1.31, P = .80; distant-EFS: HR = 0.97, 95% CI, 0.70 to 1.34, P = .87; overall survival [OS]: HR = 0.97, 95% CI, 0.65 to 1.44, P = .87). HEC is more effective than EC (EFS: HR = 0.73, 95% CI, 0.54 to 0.99, P = .04; distant-EFS: HR = 0.75, 95% CI, 0.55 to 1.02, P = .06; OS HR = 0.69, 95% CI, 0.47 to 1.00, P = .05). CONCLUSION: This three-arm study does not show an advantage in favor of an adequately dosed epirubicin-based regimen over classical CMF in the adjuvant therapy of node-positive pre- and postmenopausal women with breast cancer. Moreover, this study confirms that there is a dose-response curve for epirubicin in breast cancer adjuvant therapy.

As the West of Scotland Coronary Prevention Study (WOSCOPS) was conducted in Scotland, a country well-known for its high cardiovascular risk, the generalizability of its findings on pravastatin's clinical and economic effects has been questioned. This study examines the legitimacy of this concern, using Belgium as a case study.Local information on the prevalence and clustering of risk factors in individual patients was used in a risk equation to estimate the reference risk in Belgium. In contrast to prevailing beliefs, this risk was shown to coincide with the trial population's risk. As the relative risk reduction documented in a trial should apply across populations, the health benefits observed in WOSCOPS can clearly be extrapolated. This information in combination with local costs was then used to assess the economic efficiency of primary prevention with pravastatin in Belgium by means of a previously developed model. In parallel with the original estimates for the United Kingdom, the cost-effectiveness ratios remain well within the range of what is considered strong to moderate evidence for adoption and appropriate utilization, over a wide range of input values.This study demonstrates that the clinical and economic findings from WOSCOPS can indeed be generalized to other populations.

The economic burden of hip fractures is thought to be important, but the excess medical costs they induce remain largely unknown. We assessed the direct medical costs induced by hip fractures during and after hospitalization. Hospital costs of 170 consecutive Belgian women with hip fracture were gathered. During the year following discharge, all medical costs were collected for the 159 hip fracture women who survived the acute hospitalization stay. A similar collection of data was performed on a comparison group of 159 age-and residence-matched women without a history of hip fracture. The mean cost of the acute hospital stay was 8,667 Belgian francs and the mean 1-year hip-fracture-related extra costs after hospitalization was 6,636 Belgian francs. During the year following the acute hospital stay, 19% of the hip fracture women and 4% of the comparison women were newly admitted to nursing homes (p0.001). Although health care costs increased with age, hip-fracture-related extra costs after hospitalization seemed similar in those below or above 81 years old. These extra costs amounted to 7,710 Belgian francs in women not living in nursing homes at the time of fracture, and to 3,479 Belgian francs in women who lived in nursing homes. Health or mental status before hip fracture seemed not to affect extra costs. Taking into account the higher mortality of women with hip fracture, the extra costs during the acute hospital stay and during the 1-year follow-up amounted to a mean 15,151 Belgian francs. In conclusion, both acute hospital stays and subsequent medical care contribute significantly to medical costs induced by hip fractures.

The authors first analyzed the potential interest of the delivery of anticancer agents according to chronobiological concepts for human pancreatic cancer. They report their experience on 41 patients treated in adjuvant (12 cases) or palliative (29 cases) situations. The excellent therapeutic index observed warrants further evaluations of this concept in randomized trials.

Making an effort to control health expenditure's escalation, especially in hospital, the Belgian government is planning and experimenting with prospective budgeting. A research financed by the Ministry of Public Health allows us to point out the structure of the pathologies treated as well as other variables included in the medical MBDS like urgency, number of diseased systems, ... and explains a high percentage of the variance (62%) in drugs expenditures of the surgical cases. These variables have to be used in order to calibrate hospital drugs budgets. The Interdisciplinary Centre in Health Economics has developed tools to compare drugs prescriptions by type of surgical procedures in order to help hospitals to evaluate their performance should such drugs budgets be progressively introduced.

In an ongoing phase II trial conducted in advanced breast cancer, we tested a therapy schedule consisting of continuous, 24-h infusion of 5 g/m2 ifosfamide (IFO) in 3 1 dextrose saline with mesna (MSN), repeated every 3 weeks until disease progression. Since September 1988, 16 heavily pretreated patients with advanced disease (11 with visceral lesions) considered refractory to standard chemotherapy (regimens always including cyclophosphamide) have been included. Objective partial remissions were observed in two cases (one in liver and one in soft-tissue and pleural lesions), and disease stabilization for at least 3 months occurred in four cases. No treatment-related death was recorded and tolerance was judged to be excellent (six cases) or acceptable in all instances. The haematological toxicity consisted mainly of transient leucopenia (nadirs evaluated by WHO scale as grade 3 in 43% and grade 4 in 29%), sometimes associated with thrombocytopenia (grade 3 in 7% and grade 4 in 7%). Other side effects included nausea and/or vomiting (grade 3-4 in 33%); worsening of preexisting alopecia (five cases); haemorrhagic cystitis (one case); mild, transient somnolence (two cases); and moderate fluid retention (two cases). We concluded that infusion of 5 g/m2 IFO over 24 h with MSN rescue might represent an acceptable second- or third-line salvage regimen. Close monitoring of haematological and renal function parameters is recommended. A larger number of patients will be treated in a continuation of this study to evaluate the true response rate within narrower confidence limits.

Methodological differences and variations in health care regulations among countries often preclude direct comparisons of cost-effectiveness studies. A projected risk model was applied, designed to determine the economic value in the United States of pravastatin in the secondary prevention of coronary heart disease (CHD), to Belgium using local health care costs. A Markov process was used to model the effectiveness of treatment for 3 years with pravastatin versus placebo in 1000 male CHD patients aged 60 years and clinically similar to those in the pravastatin limitation of atherosclerosis in the coronary arteries (PLAC I) and pravastatin, lipids and atherosclerosis in the carotid arteries (PLAC II) studies. The PLAC I and II trials have shown that pravastatin treatment for 3 years at a weighted mean dose of 36.64 mg daily significantly reduced the incidence of non-fatal myocardial infarction in patients with CHD. Framingham data were used to project the risk of mortality 10 years post-myocardial infarction. The incremental cost per life year gained (LYG), after discounting costs and benefits by 5% annually, in the setting of Belgian health care regulations, was Belgian francs (BEF) 720 794 (US$ 24 359) for CHD patients with one additional risk factor; BEF 526 464 (US$ 17 792) for those with two additional risk factors; and BEF 392 765 (US$ 13 274) for those with three or more additional risk factors. The cost per LYG in Belgium appeared to be more sensitive to drug acquisition cost than to costs of medical interventions. The cost-effectiveness ratios of pravastatin monotherapy for 3 years in secondary prevention of CHD, obtained with the same projected risk model, are from 86 to 92% higher in Belgium than in the United States, due to differences in medical patterns of practice and in intervention costs. (C) 1998 Elsevier Science Ireland Ltd. All rights reserved.

We report a heterosexual patient with HIV infection and a CD4 T-cell count of 0.45 x 10(9)/L who developed mild ulcerative proctitis, sacroileitis and oligoarthiritis. While he was treated with 5-aminosalicylic enemas, the patient rapidly developed severe pancolitis. An emergency colectomy without procetectomy was performed. A few months later, he suffered recurrence of ulcerative proctitis, aggravation of arthritic pain and developed anterior uveitis. All symptoms disappeared after proctectomy. There was no evidence for opportunistic infection or Kaposi's sarcoma. Antineutrophil cytoplasmic antibodies were positive and the HLA-B27 antigen was present. CD4 counts were lower during the phases of active disease than during remission. This case demonstrates that severe ulcerative colitis can occur in the presence of moderate T-cell defects. In view of a recent report of remission of Crohn's disease under comparable circumstances, it is possible that the extent of T-cell involvement in both diseases is radically different.

PURPOSE This study investigated the therapeutic effects of single-agent intravenous (IV) weekly Navelbine (vinorelbine or 5'-nor-anhydro-vinblastine; Pierre Fabre Médicament, Boulogne, France), a semisynthetic vinca alkaloid, in women who had received no prior chemotherapy for locally advanced or metastatic breast cancer. PATIENTS AND METHODS One hundred fifty-seven patients with assessable advanced or metastatic breast cancer who had received no prior chemotherapy were entered onto the study. They were stratified into five groups according to the main assessable tumor target: lung, liver, lymph nodes, skin, and others. One hundred forty-five patients were assessable for toxicity and response using World Health Organization (WHO) criteria; the 12 patients who were not evaluated were excluded because they were found not to meet the eligibility criteria. Navelbine was administered as a weekly 30-mg/m2 short IV infusion, and treatment was continued until disease progression. RESULTS The overall response rate (WHO criteria) was 41% (complete response [CR], 7%; partial response [PR], 34%; 95% confidence interval [CI], 33% to 49%). In addition, 30% of the patients had stable disease. The response rate according to target was lymph nodes (28 of 42), 67%; liver (nine of 39), 23%; lung (10 of 30), 33%; skin (21 of 30), 70%; primary tumor (10 of 16), 56%; and bone (three of 10), 30%. The median time to treatment failure was 6 months and the median survival was 18 months. A total of 1,673 cycles were given to 145 eligible patients. At least one episode of WHO grade 3 or 4 granulocytopenia was seen in 72% of the patients. Nausea and/or vomiting, anemia, and/or thrombocytopenia were seen in less than 1% of cycles. Other side effects were rare, and additional toxicities were documented in the following proportions of patients: grade 2 to 3 alopecia, 8%; infectious episodes, 6%; and peripheral neuropathy, 3%. CONCLUSION Our data confirm that Navelbine has major single-agent antitumor activity as front-line therapy in advanced breast cancer. Given its excellent tolerance profile and low toxicity, it should be considered for inclusion in first-line combination chemotherapy regimens.

Forty patients with intermediate stage (T23 cm-T3, N0-N1) operable breast cancer received neoadjuvant chemotherapy by MCF (mitoxantrone, cyclophosphamide, 5-fluorouracil). Four cycles were administered at 3-week intervals. The obvious hematological toxicity (64% of grade III for the leucocytes and up to 34% of grade IV for the granulocytes) was rapidly reversible and did not hinder completion of the treatment. Ten patients showed a complete remission and a tumor volume regression of more than 50% was observed in 12 other patients. Tumor shrinkage allowed breast-saving surgery in 50% of the cases. A complete sterilisation of the surgical specimen was found in only two of the 40 patients and a few persisting neoplastic cells were found in ten other cases. A positive response at the level of the axillary lymph nodes was also obtained in more than 50% of the cases. In 25 of the 36 cases examined, the primary chemotherapy induced cellular lesions (fibrosis, necrosis) at the tumor level. A feasibility study was undertaken in order to determine quantitatively several biochemical parameters (steroid hormone receptors, cathepsin D, c-erbB-2 oncoprotein) in very small tumor samples obtained by Tru-Cut before any treatment and in surgical specimens. In the future, these micromethods will be used systematically with the aim of estimating the value of these potential prognostic factors for therapeutic follow-up of the patients.

Background Previous research has provided evidence that socioeconomic status has an impact on invasive treatments use after acute myocardial infarction. In this paper, we compare the socioeconomic inequality in the use of high-technology diagnosis and treatment after acute myocardial infarction between the US, Quebec and Belgium paying special attention to financial incentives and regulations as explanatory factors. Methods We examined hospital-discharge abstracts for all patients older than 65 who were admitted to hospitals during the 1993–1998 period in the US, Quebec and Belgium with a primary diagnosis of acute myocardial infarction. Patients' income data were imputed from the median incomes of their residential area. For each country, we compared the risk-adjusted probability of undergoing each procedure between socioeconomic categories measured by the patient's area median income. Results Our findings indicate that income-related inequality exists in the use of high-technology treatment and diagnosis techniques that is not justified by differences in patients' health characteristics. Those inequalities are largely explained, in the US and Quebec, by inequalities in distances to hospitals with on-site cardiac facilities. However, in both Belgium and the US, inequalities persist among patients admitted to hospitals with on-site cardiac facilities, rejecting the hospital location effect as the single explanation for inequalities. Meanwhile, inequality levels diverge across countries (higher in the US and in Belgium, extremely low in Quebec). Conclusion The findings support the hypothesis that income-related inequality in treatment for AMI exists and is likely to be affected by a country's system of health care.

Summary Eighty one patients with inoperable non-small cell lung carcinoma (NSCLC) were entered in a randomized phase IT trial comparing split-dose irradiation alone to combined treatment radiotherapy and polychemoth-erapy (C.A.P. + V.D.S.). The quality of life and the survival of the patients were studied. We have defined three classes of quality of life responses based on the time elapsed before the performance status index drops. A higher quality of life failure rate was observed in the combined treatment group ( p non-significant) but the time elapsed before the Karnofsky index drops is longer in the combined treatment group for the quality of life "no change" subgroup ( p = 0.15). Survival and quality adjusted survival are similar in both treatment groups. The same conclusion holds for retrospective stratified treatment groups. The results of the study are presented according to the decision tree theory. We conclude that as far as the quality of life is concerned, polychemotherapy combined with the particular split-dose irradiation schedule used is an effective treatment of inoperable NSCLC. Its efficiency is comparable to, but not better than, the same radiotherapy schedule alone taken as a reference baseline.