[Acute lymphoblastic leukemia in children]. / Quel espoir pour les LLA de l'enfant? Bilan du CHR de la Citadelle.

We report our experience over the last seventeen years (1985-2002) of the treatment of acute lymphoblastic leukemia (ALL) in children at the University of Liege Pediatric Department of Hematogy-Oncology (CHU-Sart Tilman and CHR-Citadelle). Seventy seven children are enrolled in our study; the mean follow-up is 6.7 years. The 5 years over all survival and the disease free survival for the entire group are respectively 83% and 79%. Prognostic factors shown in our study are sex, high white blood cells counts at diagnosis and immunophenotypes.

The influence of venous thromboembolism on quality of life and severity of chronic venous disease.

BACKGROUND: It is not known whether burden-of-illness differs in chronic venous disease patients with prior venous thromboembolism compared with patients with other forms of chronic venous disease. OBJECTIVE: To compare severity of disease and quality of life in chronic venous disease patients with and without prior venous thromboembolism. PATIENTS AND METHODS: The VEINES Study population is an international cohort of 1531 outpatients with chronic venous disease in Belgium, France, Italy and Canada. Clinical severity of chronic venous disease graded using the seven-category 'CEAP' scale, and quality of life using standardized generic (SF-36) and venous disease-specific (VEINES-QOL/Sym) questionnaires were compared in patients with and without venous thromboembolism. Multivariable analyses with adjustment for known confounders were used to examine associations between venous thromboembolism and quality of life. RESULTS: One hundred and fifty-one (10%) patients had prior venous thromboembolism. These patients had more severe chronic venous disease than those without venous thromboembolism (P <0.0001), including a higher frequency of healed or active ulcers (29% vs. 7%, respectively). Multivariable analyses controlling for age, sex, country, education, body mass index, years of chronic venous disease and comorbid conditions demonstrated that prior venous thromboembolism was an independent predictor of poorer generic quality of life (SF-36 Mental Component Summary score, P=0.047; SF-36 Physical Component Summary score, P=0.012) and venous disease-specific quality of life (VEINES-QOL, P = 0.0002; VEINES-Sym, P=0.009). CONCLUSIONS: Disease severity is worse and quality of life poorer in chronic venous disease patients with prior venous thromboembolism compared with patients with other forms of chronic venous disease. Our findings support the need for further research of interventions to prevent and treat the long-term complications of venous thromboembolism.

A new approach to the qualitative evaluation of functional disability in dementia.

BACKGROUND: Dementia patients suffer from the progressive deterioration of cognitive and functional abilities. Instrumental disabilities usually appear in the earlier stages of the disease while basic disabilities appear in the more advanced stages. In order to differentiate between mild, moderate and severe patients both instrumental and basic functional disabilities should be taken into account simultaneously. OBJECTIVES: The objective of this study was to find a new method for classifying dementia patients based on their disabilities by using a basic and an instrumental Activities of Daily Living (ADL) scale. METHODS: Functional disability was assessed in a Belgian cohort of dementia patients using the Katz and Lawton Instrumental Activities of Daily Living (IADL) scales. A k-means derived clustering method allocated patients to disability clusters according to their Katz and Lawton scores. In order to validate the classification, we compared socio-demographic, clinical and costs parameters between the groups. RESULTS: The clustering method allocated patients between three clusters: dependent, non-dependent with instrumental functional disability (ND-IFD) and non-dependent. Dependence, as defined by these clusters, significantly correlates with age, residential setting, MMSE, patient's quality of life and costs. CONCLUSION: This new classification of patients suffering from dementia will provide better understanding of functional disabilities and will complement the evaluation of disease severity based on cognitive function.

[The measurement of sense of competence in caregivers of patients with dementia]. / La mesure du sentiment de compétence chez les aidants de patients déments.

BACKGROUND: In the context of a cohort study on the socio-economic consequences of dementia in Belgium, we evaluated the validity, reliability and feasibility of the French version of the Dutch Sense of Competence questionnaire (SCQ), and of its short version (the SSCQ), in caregivers of demented patients The questionnaire was based on Zarit's burden interview and on a theoretical family-crisis model. METHODS: Construct validity was evaluated by factor analysis and by comparison of the results with those of the original SCQ study. Reliability was evaluated by Cronbach's alpha and by item-total correlations. Feasibility was assessed by a standardized index of missing values. RESULTS: The three domains found in the original SCQ were identified by factor analysis: consequences of involvement in care for the personal life of the caregiver, satisfaction with one's own performance as a caregiver and satisfaction with the elderly person as a recipient of care. The mean scores were similar to those in the original study, except for the consequences for personal life. Cronbach's alpha for both the SCQ and the SSCQ exceeded the 0.70 criterion. Two of the 27 items did not meet the item-total correlation criterion; the SSCQ items all met the criterion. The standardised index of missing values was deemed acceptable. CONCLUSIONS: The French versions of the SCQ and the SSCQ are valid and reliable. Like the Dutch version, the French version of the SCQ can be a useful outcome measure for the evaluation of intervention studies and the SSCQ is suitable for the daily practice.

Cognitive impairment, dementia and quality of life in patients and caregivers.

OBJECTIVE: To study the impact of cognitive impairment and severity of dementia on the quality of life (QoL) of patients and their caregivers. DESIGN: Descriptive cross-sectional study within the NAtional Dementia Economic Study. SETTING: 231 general practices and 15 specialist clinics in Belgium. SUBJECTS: 605 patients aged > or = 65 years: 106 referent subjects without cognitive impairment (R), 113 subjects with cognitive impairment and no dementia (CIND), 386 subjects with mild (83), mild/moderate (108), moderate (62) or severe (133) dementia (D1 to D4). OUTCOME MEASURES: QoL of patients: COOP/WONCA charts, Katz's Activities of Daily Living (ADL) scale, Lawton's Instrumental Activities of Daily Living (IADL) scale. QoL of caregivers: COOP/WONCA charts, SF-36 questionnaire, short-form Beck Depression Inventory, Sense of Competence questionnaire (SCQ). MAIN RESULTS: QoL of patients: For R, CIND and D1 to D4 patients, dependence for ADL reached 5%, 6%, 16%, 20%, 48% and 79%, respectively, and mean IADL scores were 5.6, 5.0, 3.4, 2.0, 0.6 and 0.1, respectively. QoL of caregivers: The main impact of caregiving was on mental health, with SF-36 MCS scores of 51.3, 47.7 and 45.4 for R, CIND and all D patients and respectively 32.6%, 31.3% and 42.5% depression prevalence. Sense of competence decreased with severity of patient's cognitive impairment. Caregivers of CIND patients always rated intermediate between R and D1 patients. Caregivers of D3 patients were the most affected ones. CONCLUSION: The data suggest that improving the cognitive status of patients and providing assistance to caregivers would be complementary ways of action to support caregiving of patients living at home.

The economic impact of dementia in Belgium: results of the National Dementia Economic Study (NADES).

OBJECTIVES: To estimate costs associated with dementia and its severity and to identify main cost determinants. DESIGN: One-year prospective cohort study. SETTING: 231 general practitioners (GPs) and 15 specialist clinics throughout Belgium. SUBJECTS: 605 patients aged > or = 65 years (219 referent patients, 218 demented patients at home and 168 demented patients in institution). OUTCOME MEASURES: Medical costs (visits to GPs/specialists, physiotherapy, hospitalisation, nursing, incontinence, medication) and non-medical costs (special equipment, services, professional help and caregiving). RESULTS: Total monthly costs amounted to 368.50 Euro dollar for referent patients, 445.56 Euro dollar for demented patients at home and 2301.7 Euro dollar for demented patients in institutions. Highest costs were measured in patients with severe dementia (556.88 Euro dollar at home, 2465.28 Euro dollar in institutions). In demented patients at home, 60% of costs were accounted for by the health system, with hospitalisation and medication being the main cost components (36% and 20%). In demented patients in institution, 46% of the costs were accounted for by the health system, with residential costs and nursing being the main cost components (42% and 32%). In multivariate covariance analysis, the main determinants of costs for demented patients at home were physical dependence and co-morbidity (neoplasm, cardiovascular disease). The adjusted difference between demented and referent patients was 25 Euro dollar per month. CONCLUSIONS: A large fraction of the costs observed in dementia is explained by the association of dementia with physical dependence, co-morbidity and need for caregiving. From an economic point of view, the results support the caring for patients at home.

Do varicose veins affect quality of life? Results of an international population-based study.

PURPOSE: This study assessed the impact of varicose veins (VV) on quality of life (QOL) and patient-reported symptoms. METHODS: A cross-sectional population-based study was held in 166 general practices and 116 specialist clinics for venous disorders of the leg in Belgium, Canada (Quebec), France, and Italy. Study subjects included a sample of 259 reference patients without VV (CEAP class 0 or 1) and 1054 patients with VV who were classified as having VV alone (367; 34.8%), VV with edema (125; 11.9%), VV with skin changes (431; 40.9%), VV with healed ulcer (100; 9.5%), and VV with active ulcer (31; 2.9%). The main outcome measure was generic and disease-specific QOL, as measured by means of the Short-Form Health Survey-36 (SF-36) and the VEINES-QOL scale, and patient-reported symptoms as measured by the VEINES-SYM scale. RESULTS: In patients with VV, age-standardized mean SF-36 physical (PCS) and mental (MCS) scores were 45.6 and 46.1 in men and 44.2 and 43.2 in women, respectively, compared with population norms of 50. PCS scores decreased according to increasing severity of concomitant venous disease, with the lowest mean scores of 37.3 and 35.5 found in patients with VV and active ulcer. However, adjusted analyses showed no statistically significant differences between patients with VV alone and patients without VV for PCS (0.0), MCS (1.0), VEINES-QOL (-0.1), or VEINES-SYM (0.0) scores. In comparison with patients without VV, the largest differences were seen in patients with VV and edema (PCS, VEINES-QOL, and VEINES-SYM score differences of -1.8, -2.5, and -2.9, respectively) and in patients with VV and ulceration (differences of -3.3, -3.4, and -2.7, respectively). The high prevalence of major symptoms of venous disorders in patients in CEAP class 0 or 1 being treated for venous disorders (76.1% of patients had heaviness, aching legs, or swelling) might have contributed to the impairment of QOL in the reference group. CONCLUSION: Results indicate that impairment in physical QOL in patients with VV is associated with concomitant venous disease, rather than the presence of VV per se. Findings concerning QOL in patients with VV can only be reliably interpreted when concomitant venous disease is taken into account. In patients with VV alone, the objectives of cosmetic improvement and the improvement of QOL should be considered separately.

[Dementia in Belgium: prevalence in aged patients consulting in general practice]. / La démence en Belgique: taux de prévalence chez les sujets âgés consultant en médecine générale.

Early detection of dementia is an important element for the efficacy of therapies currently proposed to slow down disease progression. This detection mainly relies on general practitioners. In order to estimate the impact of dementia on health services, we have estimated from the data of the NAtional Dementia Economic Study (NADES) the prevalence rate of dementia in patients aged > or = 65 years living at home and consulting in general practice. The study population was based on the sampling of consecutive patients consulting a general practitioner, irrespective of the reason and location of the consultation. The diagnosis of dementia was based on the CAMDEX performed at home in patients presenting > or = 3 warning signs of dementia. The prevalence rate of dementia among 2.234 registered patients living at home was 14.3% (CI95: 12.6-16.0). In age groups 65-74, 75-84 and > or = 85 years, it was 7.0%, 17.5% and 18.5%, respectively, in men, and 6.1%, 15.8% and 25.2%, respectively, in women. The percentage of demented with mild, mild to moderate, moderate and severe dementia was 35.0%, 38.8%, 13.1% and 13.1%, respectively. After adjusting for the age and sex distribution of the Belgian population, the prevalence rate in patients aged > or = 65 years was estimated at 11.3%. A diagnosis of dementia had already been made by a specialist in 41.5% of patients with dementia, with figures of 19.3%, 34.3%, 41.9% and 60.9% according to the severity of disease (mild, mild to moderate, moderate, severe). The onset of first symptoms had preceded the diagnosis by an average of 1 year. Our results show a high prevalence rate of dementia in the elderly living at home consulting in general practice, and less than half of the patients had previously been diagnosed. It is possible that a systematic detection will not be performed as long as specific treatments are not made widely available.

Methodological issues in a cost-of-dementia study in Belgium: the NAtional Dementia Economic Study (NADES).

The NAtional Dementia Economic Study (NADES) is an on-going prospective, one-year cohort study developed in Belgium to assess the socio-economic consequences of dementia in a group of patients and their caregivers (n = 400). Comparison is made with a group of subjects with cognitive impairment and no dementia (n = 100) and a group of subjects without any cognitive impairment (n = 100). Recruitment of subjects is based on screening of warning signs of dementia by general practitioners, followed by a Cambridge Mental Disorders of the Elderly Examination (CAMDEX) performed at home. This paper presents an overview of the study protocol and the rationale for basic design options, such as the choice of study population, screening strategy, and methods used for the case validation. It also presents preliminary results on the prevalence of dementia in general practice, the sensitivity and specificity of the warning signs as a screening test of dementia, and the validity of a computerised case ascertainment algorithm based on DSM-III-R criteria.

Chronic venous disorders of the leg: epidemiology, outcomes, diagnosis and management. Summary of an evidence-based report of the VEINES task force. Venous Insufficiency Epidemiologic and Economic Studies.

BACKGROUND: To critically review the classification, epidemiology, outcomes, diagnosis and treatment of chronic venous disorders of the leg (CVDL), to issue evidence-based recommendations, and to identify areas requiring further research. METHODS: Articles identified by an extensive literature search were scored by members of an international task force. Only those articles with a moderate or strong rating for internal validity were retained. RESULTS: A scoring system weighing CVDL severity according to the probability of ulcer occurrence is proposed. Epidemiological data on the frequency of CVDL and its risk factors are reviewed. The following items are evaluated: costs associated with treatment; clinical outcomes related to CVDL and its treatment; available generic and disease-specific measures of quality of life; diagnostic procedures used to detect venous reflux; and efficacy of available treatments. CONCLUSIONS: CVDL is an important public health problem, based on its prevalence, cost and impact on quality of life. High-priority areas for research on CVDL are identified.

[Multiple benefits of antenatal corticotherapy. Current status in th Belgian French community]. / Bénéfices multiples de la corticothérapie anténatale. Etat de la question en communauté Française de Belgique.

The benefit of antenatal administration of corticosteroids (betamethasone or dexamethasone) in the newborn prematured babies before the 34 week of gestation has been well demonstrated: reduction of respiratory distress syndrome but also a decrease in the incidence of severe intraventricular hemorrhages, episodes of necrotising enterocolitis and neonatal mortality. In this article, we report the impact of this treatment in the Belgian French Community in the population of infants with a birth weight below 1,500 g, born between 1990 and 1994 in the seven neonatal intensive care units. Based on this epidemiological study (compared with international publications) we propose the routine use of corticosteroids during the antenatal period, with the aim of seeing an increase in the use of this treatment, which, although costing little, produces clinical benefit.

High incidence of primary pulmonary hypertension associated with appetite suppressants in Belgium.

Primary pulmonary hypertension is a rare, progressive and incurable disease, which has been associated with the intake of appetite suppressant drugs. The importance of this association was evaluated in Belgium while this country still had no restriction on the prescription of appetite suppressants. Thirty-five patients with primary pulmonary hypertension and 85 matched controls were recruited over 32 months (1992-1994) in Belgium. Exposure to appetite-suppressants was assessed on the basis of hospital records and standardized interview. Twenty-three of the patients had previously taken appetite suppressants, mainly fenfluramines, as compared with only 5 of the controls (66 versus 6%, p<0.0001). Five patients died before the interview, all of them had taken appetite suppressants. In 8 patients the diagnosis of primary pulmonary hypertension was uncertain, 5 of them had taken appetite suppressants. The patients who had been exposed to appetite suppressants tended to be on average more severely ill, and to have a shorter median delay between onset of symptoms and diagnosis. A policy of unrestricted prescription of appetite suppressants may lead to a high incidence of associated primary pulmonary hypertension. Intake of appetite suppressants may accelerate the progression of the disease.

[Introduction to the theory of pharmaco-economics]. / Introduction théorique à la pharmaco-économie.

This article presents an overview of the principles of pharmaco-economic evaluation. A pharmaco-economic evaluation is a comparison of the costs and effects of at least two therapeutic strategies, including at least one drug. It is mostly useful if a new treatment is more effective and more costly than a reference one. The way the effects of treatments are expressed defines several types of analyses: cost minimisation, cost-effectiveness, cost-utility and cost-benefit. The costs measured can be direct (medical and non-medical) and indirect (tangible and intangible). The principle of decision analysis is illustrated.

[An acetylsalicylic acid-dypiridamole combination (Asasantine) in the prevention of the recurrence of cerebrovascular accidents (a cost-effectiveness analysis)]. / Association AAS-dypiridamole (Asasantine) dans la prévention des récidives d'AVC (analyse coût-efficacité).

On the basis of the results of the European stroke Prevention Study (ESPS 2) obtained on 6,602 patients, we used a Markov model to perform a cost-effectiveness analysis of a combination of a low-dose of acetylsalicylic acid (ASA) (25 mg b.i.d.) and sustained-release dipyridamole (DP) (200 mg b.i.d.) versus a low-dose of acetylsalicylic acid alone in the prevention of recurrent stroke in Belgium. The perspective was that of the Social Security. Total costs per patient over 5 years amounted to 1,317,718 FB for placebo, 1,312,015 FB for ASA and 1,326,526 FB for ASA-DP, with respectively 3.16, 3.25 and 3.33 stroke-free life years (SFLY). For 1,000 patients followed over 5 years, the number of SFLYs gained by ASA-DP is 170 when compared to placebo and 100 when compared to ASA. As compared to placebo, ASA is a dominant strategy and the combination AAS-DP has a cost-effectiveness ratio of 50,569 FB per SFLY gained. The cost-effectiveness ratio of ASA-DP vs. ASA was 176,963 FB per SFLY gained and was not substantially modified in sensitivity analyses. The favourable cost-effectiveness ratio for ASA-DP is mainly explained by the reduction of costs associated with the acute treatment of stroke.

[Mortality and morbidity of low birth weight premature newborns in a French community from 1990 to 1994]. / Mortalité et morbidité des prématurés de faible poids de naissance en communauté Française de 1990 à 1994. "Cercle de Néonatologie de la Communauté Française de Belgique".

The development of new technologies in neonatal intensive care which appeared this last decade increased the viability of premature newborns and contributed to the increase in the number of admissions of very low birth weight (VLBW) newborns in the intensive neonatal care services (12.6% of admissions in 1987, 15.2% in 1996). In a retrospective epidemiology survey in French speaking Belgian Community, we collected the data of 1521 newborns whose birth weight was under 1500 g, from January 1990 to December 1994, in order to improve our knowledge or regional mortality and morbidity rates and to estimate the impact of new procedures. We do not notice any variation of annual mortality (+/- 20%), nor of morbidity (sequelae risks to survivors at the departure of the hospital +/- 23%) on the global population during the survey period. However the mortality of infants born between 30 and 33 weeks drops dramatically (17% in 1990, 3.6% in 1994). As it has been demonstrated in randomised surveys, we recover the beneficial effect of antenatal corticotherapy which allows us to reduce to more than 50% the mortality of newborns from treated mothers (11% mortality versus 24%). In comparison to figures of international literature, our survival rate without sequelae is at least 10% lower than Américan results for infants whose birth weight is < 1000 g and at least 5% lower for infants between 1000 and 1500 g. In conclusion, although the introduction of surfactant and high frequency ventilation during this period, mortality rate of VLBW infants doesn't seem to decrease significantly from 1990 to 1994. However, multivariate statistical study of predictable mortality and morbidity factors need to be performed in order to define or promote preventive strategy.

Reliability study of the Leg-O-Meter, an improved tape measure device, in patients with chronic venous insufficiency of the leg. VEINES Group.(Venous Insufficiency Epidemiologic and Economic Study).

The objective of this study was to evaluate the inter-rater reliability of the Leg-O-Meter, an instrument designed to measure the ankle or calf circumference. The Leg-O-Meter consists of a tape measure fixed to a stand attached to a small board on which the patient is in standing position. For this study the tape measure of the Leg-O-Meter was fixed at 10 cm from the board in order to standardize all measurements. Informed consent to participate in the study was obtained from 39 patients consulting the phlebology clinic of Hôpital St-Michel, Paris, France. Participants were asked to enter a closed room where four independent and blinded observers consecutively took measurements of both legs with the Leg-O-Meter. The order of the observers was randomized between patients. Under the assumption of a two-way random effects model an intraclass correlation coefficient (ICC) was used to determine the reliability or reproducibility of a measure with the Leg-O-Meter. The overall reliability coefficient calculated by the ICC for the right and left leg were estimated at 97.09% [95.52%;100%]95% and 97.08% [95.86%;100%]95%, respectively. The authors conclude that the Leg-O-Meter gives a standardized and reliable measure of the circumference of the ankle. Furthermore, it is not invasive or costly.

The VEINES study (VEnous Insufficiency Epidemiologic and Economic Study): an international cohort study on chronic venous disorders of the leg. VEINES Group.

The aim of the VEINES study is to address some gaps in knowledge regarding the multidimensional repercussions of venous disorders and the measurement of outcomes. Its objectives are to describe and compare defined clinical presentations of venous-related leg disorders with regard to natural history, clinical outcome, functional capacity, quality of life, and economic impact. A secondary objective is to develop or identify and test standardized instruments for the evaluation of therapeutic effectiveness. This paper presents an overview of the design of the study and of the options chosen for the recruitment process and the outcome measures.

[Reports of suspected side effects of selective serotonin reuptake inhibitors in Belgium and The Netherlands]. / Meldingen van vermoedelijke bijwerkingen van selectieve serotonine-heropnameremmers in België en Nederland.

OBJECTIVE: To study the adverse drug reaction (ADR) profile of selective serotonin re-uptake inhibitors (SSRI) in Belgium and the Netherlands. DESIGN: Descriptive study. SETTING: The Belgian Pharmacovigilance Centre and the Dutch Drug Safety Unit. METHOD: All adverse reactions of fluoxetine, fluvoxamine, paroxetine and sertraline, reported between the moment of registration of these drugs and January 1st 1995, were assessed for causality. Possible, probable and certain adverse reactions were counted per drug and per country. RESULTS: At the national monitoring centres of Belgium and of the Netherlands adverse reactions were reported 78 and 537 times, respectively. Approximately 30% of the adverse reactions were well-established. Approximately 60% of the reactions were poorly documented or not serious. Less than 1% of the adverse reactions reported in Belgium and approximately 13% of the reactions reported in the Netherlands, were less established and/or serious. These reactions were: movement disorders and extrapyramidal reactions, convulsions, galactorrhoea, hyponatraemia and syndrome of inappropriate antidiuretic hormone secretion, and purpura. CONCLUSION: The ADR profile was compatible with the ADR profile in the medical literature, but not all ADR were similarly represented in the product information of the different SSRI. More adverse reactions were reported in the Netherlands than in Belgium.