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1.
Rev Epidemiol Sante Publique ; 71(4): 102088, 2023 Aug.
Article in French | MEDLINE | ID: mdl-37352795

ABSTRACT

OBJECTIVES: Madagascar faces many difficulties in accessing diagnosis and treatment of hepatitis B. The prevalence of chronic hepatitis B infection is estimated at 6.9%. The costs associated with screening and treatment are high and not easily accessible. This article proposes a reflection on the challenges and difficulties of access to diagnosis and treatment for patients with chronic hepatitis B. METHOD: The "Neo Vac" study aimed to document the life paths of people living with chronic hepatitis B, their difficulties and their perceptions of HBV. Twenty-three semi-structured interviews were conducted in 2019 in Antananarivo with patients and gastroenterologists. RESULTS: The study describes the numerous obstacles that mark the therapeutic pathways of chronic HBV patients. The first result indicates lack of knowledge of the disease by chronic HBV patients and the varied circumstances in which the disease is discovered. None of the persons interviewed had been screened on their own initiative, the screening having taken place during prenatal consultations or emergency hospitalizations or during a morbidity episode. The care pathway was characterized by doubt and anxiety due to lack of knowledge about the possible disease outcome and concern about the costs of care. DISCUSSION: Little known by the population and health professionals, hepatitis B is rarely the subject of voluntary screening and is most often detected during an apparently unrelated health event. The exorbitant cost of treatment for patients, the cost of medical analyses and secondary costs, and the unavailability of follow-up tests outside the capital constitute barriers to access to care that are insurmountable for the majority of the Malagasy population. CONCLUSIONS: This first qualitative study on the experiences of HBV-infected persons in terms of access to care and treatment in Madagascar underlines the extent to which access to treatment remains limited, due to the absence of a national policy for the prevention, screening and management of hepatitis B, which remains a highly neglected and unrecognized disease in Madagascar as well as internationally.


Subject(s)
Hepatitis B, Chronic , Hepatitis B , Pregnancy , Female , Humans , Hepatitis B, Chronic/diagnosis , Hepatitis B, Chronic/epidemiology , Hepatitis B, Chronic/therapy , Madagascar/epidemiology , Caregivers , Hepatitis B/diagnosis , Hepatitis B/epidemiology , Hepatitis B/therapy , Qualitative Research
2.
Int J Tuberc Lung Dis ; 24(4): 428-435, 2020 04 01.
Article in English | MEDLINE | ID: mdl-32317068

ABSTRACT

SETTING: Tuberculosis (TB) incidence is declining overall in France, but not in Paris where some areas remain relative hot spots for TB.OBJECTIVES: To obtain a better knowledge of local TB epidemiology in order to facilitate control measures.DESIGN: Analysis of demographic data of TB patients diagnosed at the Bichat-Claude Bernard Hospital from 2007 to 2016, with spoligotyping of Mycobacterium tuberculosis complex isolates.RESULTS: During the study period, 1096 TB patients were analysed. The incidence of TB diagnosis was stable, averaging 115 patients per year, predominantly males (71%), foreign-born (81%), with pulmonary TB (77%) and negative HIV serology (88%). The mean age of foreign-born TB patients decreased over the study period, most significantly in recent arrivals in France, whose average age decreased by two years (P = 0.001). The time period between arrival in France and being diagnosed with active TB decreased annually significantly by 0.75 years (P = 0.02). The proportion of L4.6.2/Cameroon and L2/Beijing sub-lineages increased annually by 0.7% (P < 0.05). Multi-drug resistant strains, representing 4% of all strains, increased annually by 0.75% (P = 0.03)CONCLUSION: The number of TB patients remained high in northern Paris and the surrounding suburbs, suggesting the need for increased control measures.


Subject(s)
Mycobacterium tuberculosis , Tuberculosis, Multidrug-Resistant , Tuberculosis , Beijing , Cameroon , Child, Preschool , France/epidemiology , Humans , Male , Paris/epidemiology , Tuberculosis/diagnosis , Tuberculosis/epidemiology
3.
Epidemiol Infect ; 146(16): 2049-2055, 2018 12.
Article in English | MEDLINE | ID: mdl-30196797

ABSTRACT

Knowing the burden of influenza is helpful for policy decisions. Here we estimated the contribution of influenza-like illness (ILI) visits associated with laboratory-confirmed influenza among all clinic visits in a Senegal sentinel network. ILI data from ten sentinel sites were collected from January 2013 to December 2015. ILI was defined as an axillary measured fever of more than 37.5 °C with a cough or a sore throat. Collected nasopharyngeal swabs were tested for influenza viruses by rRT-PCR. Influenza-associated ILI was defined as ILI with laboratory-confirmed influenza. For the influenza disease burden estimation, we used all-case outpatient visits during the study period who sought care at selected sites. Of 4030 ILI outpatients tested, 1022 were influenza positive. The estimated proportional contribution of influenza-associated ILI was, per 100 outpatients, 1.2 (95% CI 1.1-1.3), 0.32 (95% CI 0.28-0.35), 1.11 (95% CI 1.05-1.16) during 2013, 2014, 2015, respectively. The age-specific outpatient visits proportions of influenza-associated ILI were higher among children under 5 years (0.68%, 95% CI: 0.62-0.70). The predominant virus during years 2013 and 2015 was influenza B while A/H3N2 subtype was predominant during 2014. Influenza viruses cause a substantial burden of outpatient visits particularly among children under 5 of age in Senegal and highlight the need of vaccination in risk groups.


Subject(s)
Ambulatory Care/statistics & numerical data , Cost of Illness , Influenza, Human/epidemiology , Orthomyxoviridae/isolation & purification , Adolescent , Adult , Aged , Aged, 80 and over , Child , Child, Preschool , Cough , Female , Fever , Humans , Infant , Infant, Newborn , Influenza, Human/pathology , Male , Middle Aged , Nasopharynx/virology , Orthomyxoviridae/classification , Orthomyxoviridae/genetics , Pharyngitis , Real-Time Polymerase Chain Reaction , Reverse Transcriptase Polymerase Chain Reaction , Senegal/epidemiology , Sentinel Surveillance , Young Adult
4.
Clin Microbiol Infect ; 22(10): 891.e1-891.e4, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27404368

ABSTRACT

The aim of this study was to estimate the prevalence of extended-spectrum ß-lactamase-producing Enterobacteriaceae (ESBL-E) in faeces of healthy children aged 0-59 months in Bangui (Central African Republic). Stool samples of 134 children, recruited for a matched case-control study, were cultured on a commercial ESBL-selective chromogenic medium (CHROMagar ESBL, France). The phenotypic resistance patterns of isolated strains were investigated, as well as the genetic basis for antibiotic resistance. The factors associated with increased risk for ESBL-E carriage were also studied. The prevalence of ESBL-E carriage was 59% (79/134), one of the highest reported worldwide. The only factor found to be associated with carriage was living in a highest-income family (p=0.03). In all, 83 ESBL-E were recovered as simultaneous carriage of two strains was detected in four children. blaCTX-M-15 was found in all strains except two, frequently associated with qnr (54/81, 66%) and aac(6')-Ib-cr (35/81, 43%) genes. Escherichia coli, the most commonly recovered species (51/83, 61%), was assigned mainly to the pandemic B2-O25b-ST131 group (39/51, 76%). Resistance transfer, which was studied in 20 randomly selected ESBL-E strains, was successful in 13 (13/20, 65%) isolates. In eight of these isolates (8/13, 62%), blaCTX-M-15 genes were found in incompatibility group FIb conjugative plasmids. We found one of the highest prevalence rates of faecal carriage of ESBL-E reported worldwide, highlighting the need to improve control of the distribution of antibiotics in limited-resource countries.


Subject(s)
Carrier State/epidemiology , Enterobacteriaceae/isolation & purification , Feces/microbiology , beta-Lactamases/genetics , Bacterial Proteins/genetics , Carrier State/microbiology , Case-Control Studies , Central African Republic/epidemiology , Child, Preschool , Drug Resistance, Bacterial , Enterobacteriaceae/enzymology , Enterobacteriaceae/genetics , Female , Humans , Infant, Newborn , Male
5.
Clin Infect Dis ; 57(3): 370-80, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23633111

ABSTRACT

BACKGROUND: Cutaneous leishmaniasis (CL) is a disfiguring but not life-threatening disease. Because antileishmanial drugs are potentially toxic, the World Health Organization (WHO) recommends simple wound care or local therapy as first-line treatment, followed or replaced by systemic therapy if local therapy fails or cannot be performed. METHODS: To determine the feasibility and impact of the recommended approach, we analyzed the results of a centralized referral treatment program in 135 patients with parasitologically proven CL. RESULTS: Infections involved 10 Leishmania species and were contracted in 29 different countries. Eighty-four of 135 patients (62%) were initially treated without systemic therapy. Of 109 patients with evaluable charts, 23 of 25 (92%) treated with simple wound care and 37 of 47 (79%) treated with local antileishmanial therapy were cured by days 42-60. In 37 patients with large or complex lesions, or preexisting morbidities, or who had not been cured with local therapy, the cure rate with systemic antileishmanial agents was 60%. Systemic adverse events were observed in 15 patients, all receiving systemic therapy. CONCLUSIONS: In this population of CL patients displaying variable degrees of complexity and severity, almost two-thirds of patients could be initially managed without systemic therapy. Of these, 60 were cured before day 60. The WHO-recommended stepwise approach favoring initial local therapy therefore resulted in at least 44% of all patients being cured without exposure to the risk of systemic adverse events. Efforts are needed to further simplify local therapy of CL and to improve the management of patients with complex lesions and/or preexisting comorbidities.


Subject(s)
Antiprotozoal Agents/therapeutic use , Bandages , Leishmaniasis, Cutaneous/therapy , Travel , Administration, Topical , Adolescent , Adult , Aged , Aged, 80 and over , Child , Child, Preschool , Female , Humans , Infant , Male , Middle Aged , Treatment Outcome , Young Adult
6.
J Viral Hepat ; 18(7): e358-65, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21692948

ABSTRACT

Elastometry has demonstrated good accuracy, but little is known about its reproducibility. The aim of this study was to assess the intra- and inter-operator reproducibility of liver stiffness measurement among hepatitis C virus (HCV)-infected patients in Egypt. The study was conducted among HCV-infected patients referred for treatment evaluation in two hepatitis treatment centres of Cairo. Two operators took liver stiffness measurement two times per patient the same day. Intra- and inter-reproducibility were estimated by different methods: Bland and Altman graphics, variation coefficient, intraclass correlation coefficient and Kappa coefficient; 7.1 kPa was used as the threshold of significant (≥F2) fibrosis whenever needed. Fifty-eight patients were included in the study, and 216 measurements were taken. Failure rate was 7% and associated with overweight. For a value of 7.1 kPa, the inter-operator 95% limits of agreement were estimated at ±2.88 kPa. Intra- and inter-operator coefficients of variation ranged between 11% and 15%, intraclass correlation coefficients [95% confidence interval] between 0.94 [0.86-0.97] and 0.97 [0.95-0.99], and Kappa coefficients between 0.65 [0.44-0.88] and 0.92 [0.81-1.00]. The reliability of liver stiffness measurement is questionable when considering the decision to initiate antiviral therapy because of the percentage of discordance between measurements is notable, especially in the intermediate fibrosis stages.


Subject(s)
Elasticity Imaging Techniques/methods , Hepatitis C/complications , Liver Cirrhosis/pathology , Liver/pathology , Adult , Egypt , Elasticity , Female , Humans , Liver Cirrhosis/etiology , Male , Middle Aged , Reproducibility of Results
7.
Rev Mal Respir ; 27(9): 1015-21, 2010 Nov.
Article in French | MEDLINE | ID: mdl-21111271

ABSTRACT

A prospective study was carried out in two tertiary hospitals in Dakar to determine the main causes of sputum acid-fast bacillus (AFB) smear-negative pneumonia in HIV-infected patients. All clinical and microbiological records were reviewed by experts. Seventy patients were finally enrolled. Most of them were hospitalized at an advanced stage of AIDS. The median CD4 cell count was 62/mm(3) and the median body mass index (BMC) was 18 kg/m(2). Thirty-one patients (44 %) were known as seropositive for HIV infection prior to admission. Radiological opacities were localized in 70 % of patients and diffuse in 21 %. Fiberoptic bronchoscopy was performed in 50 patients (71 %). A definite or probable diagnosis was obtained in 55 patients (79 %). Bacterial pneumonia (usually due to Enterobacteriaceae and Pseudomonas aeruginosa), tuberculosis, Pneumocystis pneumoniae and other causes (Kaposi's sarcoma, atypical mycobacteria) were diagnosed in 67 %, 24 %, 5 %, and 13 % of these patients respectively. In conclusion, pneumonia of bacterial origin and tuberculosis can be incriminated in the majority of cases of AFB negative pneumonia observed in HIV patients in Dakar.


Subject(s)
HIV Infections/complications , Hospitalization , Pneumonia, Bacterial/microbiology , Decision Trees , Humans , Pneumonia, Bacterial/diagnosis , Pneumonia, Bacterial/etiology , Pneumonia, Bacterial/therapy , Prospective Studies , Senegal
8.
HIV Med ; 8(7): 439-50, 2007 Oct.
Article in English | MEDLINE | ID: mdl-17760736

ABSTRACT

OBJECTIVES: Resistance testing in HIV disease may provide long-term benefits that are not evident from short-term data. Our objectives were to estimate the long-term effectiveness, cost and cost-effectiveness of genotype testing in patients with extensive antiretroviral exposure. METHODS: We used an HIV simulation model to estimate the long-term effectiveness and cost-effectiveness of genotype testing. Clinical data incorporated into the model were from NARVAL, a randomized trial of resistance testing in patients with extensive antiretroviral exposure, and other randomized trials. Each simulated patient was eligible for up to three sequential regimens of antiretroviral therapy (i.e. two additional regimens beyond the trial-based regimen) using drugs not available at the time of the study, such as lopinavir/ritonavir, darunavir/ritonavir and enfuvirtide. RESULTS: In the long term, projected undiscounted life expectancy increased from 132.2 months with clinical judgement alone to 147.9 months with genotype testing. Median survival was estimated at 11.9 years in the resistance testing arm vs 10.4 years in the clinical judgement alone arm. Because of increased survival, the projected lifetime discounted cost of genotype testing was greater than for clinical judgement alone (euro313,900 vs euro263,100; US$399,000 vs US$334,400). Genotype testing cost euro69,600 (US$88,500) per quality-adjusted life year gained compared with clinical judgement alone. CONCLUSIONS: In patients with extensive prior antiretroviral exposure, genotype testing is likely to increase life expectancy in the long term as a result of the increased likelihood of receiving two active new drugs. Genotype testing is associated with cost-effectiveness comparable to that of strategies accepted in patients with advanced HIV disease, such as enfuvirtide use.


Subject(s)
Anti-HIV Agents/therapeutic use , Drug Resistance, Viral/genetics , Genotype , HIV Infections/drug therapy , HIV-1/drug effects , Anti-HIV Agents/economics , Cost-Benefit Analysis , Disease Progression , HIV Infections/economics , HIV-1/genetics , Humans , Models, Statistical , Quality of Life , Quality-Adjusted Life Years , Time Factors
9.
Cephalalgia ; 24(4): 262-70, 2004 Apr.
Article in English | MEDLINE | ID: mdl-15030534

ABSTRACT

We have recently developed an instrument to describe and categorize severity of migraine attacks from patient self-report, the MIGSEV questionnaire. We have now performed a large prospective survey using this tool to evaluate migraine severity in 2979 patients consulting for headache in France, included by 1164 general practitioners, 174 neurologists and 82 gynaecologists. The objective of the study was to determine the prevalence of severity grades in a large population who consults for migraine, to test the concordance between severity calculated from physician-derived and patient-derived data, and to test the relevance of the concept of severity as applied to diagnosis, other measures of the burden of migraine, and to health-related quality of life. Severe attacks were reported in around one-fifth of the sample. Physician- and patient-derived data provided concordant estimates of severity in 71% of cases, the discordant cases representing principally an underestimate by the physician of headache severity. Migraine severity was associated with frequent, long-lasting and treatment-resistant attacks, and with poor quality of life. The MIGSEV questionnaire is proposed as a simple measure of severity for the diagnosis and management of migraineurs, suitable for use both by physicians and patients.


Subject(s)
Migraine Disorders/diagnosis , Migraine Disorders/physiopathology , Severity of Illness Index , Surveys and Questionnaires , Adolescent , Adult , Aged , Aged, 80 and over , Female , France , Humans , Male , Middle Aged , Migraine Disorders/epidemiology , Prospective Studies , Quality of Life , Reproducibility of Results
10.
Therapie ; 56(4): 349-53, 2001.
Article in French | MEDLINE | ID: mdl-11677851

ABSTRACT

Reference data on pathologies, their management, risk factors and the use of drugs in real life is necessary. In France, there are no existing databases of a set of systematically recorded data which associate information on drugs and morbidity/mortality. In contrast, there are a great number of studies focused on pathologies, their management or on drugs. A directory that could identify these databases and a means of accessing them would be desirable. Pharmaco-epidemiology studies must answer epidemiologically specific quality criteria, which must be planned at study conception. The protocol must be developed with a scientific committee on which there are epidemiologically experienced people. It is a prerequisite that a committee of experts with epidemiological competence should give advice on the 'acceptability' of the protocol, that is on the aim and the methodology. Data collection must be the subject of specific quality control of both the study and its aims. Cross-checking with other sources of data is recommended when possible. The coordinator of each study must send a final report to investigators and publish the results.


Subject(s)
Databases, Factual , Drug Evaluation , Epidemiology , Health Services Needs and Demand , Pharmacology , Research Design/standards , Clinical Protocols/standards , Drug Evaluation/methods , Drug Evaluation/standards , Epidemiologic Methods , France , Humans , Motivation , Quality Assurance, Health Care/methods , Quality Control , Research Personnel/psychology
11.
Clin Cardiol ; 24(1): 73-9, 2001 Jan.
Article in English | MEDLINE | ID: mdl-11195610

ABSTRACT

BACKGROUND: Epidemiologic evidence suggests that an elevated heart rate (HR) is an adverse and independent prognostic factor in arterial hypertension and other cardiovascular diseases. Although diltiazem is characterized as an HR-lowering calcium antagonist, no studies have quantified the magnitude of HR changes in patients with angina or hypertension. HYPOTHESIS: The study was undertaken to explore the magnitude of proportional HR reduction at varying levels of resting HR with the sustained-release formulation of diltiazem (SR diltiazem) at the usual clinical doses of 200 or 300 mg once daily. METHODS: This meta-analysis was conducted on six comparative double-blind studies including 771 patients with angina or hypertension in which SR diltiazem 200-300 mg once daily was compared either with placebo or with other agents known not to influence HR (angiotensin-converting enzyme inhibitors, diuretics). Sustained-release diltiazem decreases elevated baseline HR, with an increasing effect at higher initial rates. RESULTS: Multiple comparisons by baseline HR category showed a significant difference between both groups for baseline HR of 74-84 beats/min and > or = 85 beats/min (p = 0.001). Sustained-release diltiazem had no significant HR-decreasing effect on baseline HR < or =74 beats/min but appears to have a genuine regulating effect on HR: it reduces tachycardia without inducing excessive bradycardia. These findings are in contrast to those with dihydropyridine calcium antagonists, which tend to increase HR and have been associated with an adverse outcome in acute cardiovascular conditions. At the same time, there is evidence to suggest that HR-lowering calcium-channel blockers decrease cardiovascular event rates following myocardial infarction. CONCLUSION: When calcium antagonists are indicated for use in patients with angina or hypertension, an HR-lowering agent, that is, diltiazem rather than dihydropyridine, should be recommended.


Subject(s)
Angina Pectoris/drug therapy , Antihypertensive Agents/administration & dosage , Calcium Channel Blockers/administration & dosage , Diltiazem/administration & dosage , Heart Rate/drug effects , Hypertension/drug therapy , Angina Pectoris/physiopathology , Antihypertensive Agents/therapeutic use , Blood Pressure , Calcium Channel Blockers/therapeutic use , Delayed-Action Preparations , Diltiazem/therapeutic use , Double-Blind Method , Drug Administration Schedule , Exercise Test , Female , Humans , Hypertension/physiopathology , Male , Meta-Analysis as Topic , Middle Aged
12.
Int J Obes Relat Metab Disord ; 24(12): 1608-17, 2000 Dec.
Article in English | MEDLINE | ID: mdl-11126213

ABSTRACT

OBJECTIVE: To investigate associations between adiposity indices and food intake in nonobese prepubertal free-living children. SUBJECTS: Five-hundred and one children, 280 boys and 221 girls aged 5-11 y in two little towns in northern France. DESIGN: Cross-sectional survey. MAIN OUTCOME MEASURES: Height and weight, four skinfolds (biceps, triceps, subscapular, suprailiac), waist and hip girths, were measured. Sum of skinfolds (SSF), body mass index (BMI), and relative weight (RW) were calculated. Energy intake (EI), percentage of energy intake ascribed to carbohydrates (%EIC), complex carbohydrates (%EICC), fats (%EIF), saturated fats (%EISF) and proteins (%EIP) were assessed by a single 24 h record. Basal metabolic rate (BMRI was estimated according to Schofield's equations. Obese (RW > or = 120%), and underreporting children according to Goldberg's and Black's equations were excluded. RESULTS: In multiple linear regressions analyses performed with hierarchical mixed models, adiposity indices were significantly and inversely associated in girls with %EIC (all P-values < 0.02), and positively with %EIF (all P-values < 0.05, waist girth and BMI excepted). Similar but non-significant trends were observed in boys. The relationships were not linear, and thresholds close to current dietary recommendations were highlighted. When %EIF was low, a lower percentage of energy intake ascribed to %EISF was associated with thinness. These associations remained after the exclusion of children who had an EI/BMR > or = 1.50. CONCLUSIONS: In nonobese prepubertal children aged 5-11 y, a high %EIC, close to dietary recommendations (> or = 55%), was associated with thinness. A high %EIF, over the upper dietary recommendation (< or = 35%), was associated with a greater adiposity thickness. There was no further increase in adiposity beyond this threshold. Reasons for the absence of a linear relationship pattern between adiposity and macronutrient intake remain to be determined.


Subject(s)
Adipose Tissue , Body Composition , Energy Intake , Body Constitution , Body Height , Body Mass Index , Body Weight , Child , Child, Preschool , Cross-Sectional Studies , Diet , Diet Records , Dietary Carbohydrates/administration & dosage , Dietary Fats/administration & dosage , Dietary Proteins/administration & dosage , Eating , Female , France , Humans , Linear Models , Male , Nutrition Policy , Nutrition Surveys , Skinfold Thickness
13.
Rev Epidemiol Sante Publique ; 46(4): 263-75, 1998 Sep.
Article in English | MEDLINE | ID: mdl-9805731

ABSTRACT

BACKGROUND: This paper describes nutritional characteristics and eating habits of the participants of the Fleurbaix Laventie Ville Santé study. METHODS: One-day dietary records for children (under 14 years of age) and three-day records for adolescents and adults provided nutritional data for 2,364 people between the ages of 2 and 70. RESULTS: Daily energy intake increased up to the age of 18 (9038 +/- 2620 kJ in women and 11,659 +/- 2146 kJ in men) and decreased thereafter. In parallel, the contribution of fat and protein to energy intake increased with age (respectively 42% and 18% in people older than 40) whereas the contribution of carbohydrates decreased (40% in people older than 40). The daily distribution of energy intake indicated increased contributions of lunch and dinner with age, and decreased contributions of breakfast and of afternoon snacks. Consumption of potatoes and processed meat far exceeded that of fruit, bread and fish. In comparison to recommended intakes and to other French nutritional studies, total energy intake in our study was similar, whatever the sex and age range. In contrast, the contribution of fat and protein to energy intake was always higher while that of carbohydrates was lower. This was especially true for the adults. CONCLUSIONS: These differences cannot be entirely explained by the differences in methodologies used and are undoubtedly due to the regional eating habits in the area studied.


Subject(s)
Feeding Behavior , Nutrition Surveys , Adolescent , Adult , Age Factors , Child , Child, Preschool , Female , France , Humans , Male
14.
Int J Obes Relat Metab Disord ; 21(7): 567-73, 1997 Jul.
Article in English | MEDLINE | ID: mdl-9226487

ABSTRACT

OBJECTIVE: To study the determinants and nature of dietary underreporting in a free-living population. DESIGN: Cross-sectional study of nutritional and behavioural characteristics. SUBJECTS: 1030 weight-stable subjects, 501 women and 529 men older than 15 y, included in the Fleurbaix Laventie Ville Santé study. MEASUREMENTS: Dietary intake was assessed using a 3 dy dietary record. Self assessed body weight and height were also recorded. Behavioural and socio-economic data were obtained from a questionnaire. Underreporters were defined as people with a reported ratio of energy intake to estimated basal metabolic rate lower than 1.05. RESULTS: Underreporting concerned 16% of the population and was significantly more frequent in obese than in non obese subjects (P < 0.001). Underreporting was significantly associated with a high socio-professional class (P < 0.05), having dieted at least once (P < 0.01) and to be in dietary restraint (P < 0.05). Furthermore, the contribution of protein to energy intake was significantly higher in underreporters than in non underreporters, independently of weight status. CONCLUSIONS: These data underline that underreporting may bias the assessment of energy and macronutrient intake, particularly in studies on obesity and dietary restraint. Questions about weight concern, dieting and dietary restraint may be useful to identify subjects who underestimate their food intake.


Subject(s)
Diet Records , Energy Intake , Feeding Behavior , Self Disclosure , Adolescent , Adult , Basal Metabolism , Body Height , Body Weight , Cross-Sectional Studies , Diet Surveys , Female , France , Humans , Male , Obesity , Reproducibility of Results
15.
Therapie ; 52(4): 281-5, 1997.
Article in French | MEDLINE | ID: mdl-9437878

ABSTRACT

The development and evaluation of new drugs often rely on surrogacy. An intermediate outcome becomes a surrogate outcome if it fulfils certain criteria, it should be easier to measure compared with the clinical outcome, a statistical relationship should exist between the clinical outcome and the surrogate outcome, a relation should exist allowing prediction of the degree of clinical effect based on the measured effect on the surrogate outcome. Development and authorization of drugs today often rely on so-called surrogate outcomes. Is this use sound? The validity of such outcomes has been reviewed in different therapeutic areas: hypertension, venous thromboembolism, AIDS, osteoporosis, hepatitis C. Based on this review, a pragmatic strategy is proposed which allows for the validation and proper use of surrogate outcomes.


Subject(s)
Drug Evaluation , Acquired Immunodeficiency Syndrome/drug therapy , Hepatitis C/drug therapy , Hypertension/drug therapy , Osteoporosis/drug therapy , Reproducibility of Results , Terminology as Topic , Thromboembolism/drug therapy
16.
Health Econ ; 6(3): 217-27, 1997.
Article in English | MEDLINE | ID: mdl-9226140

ABSTRACT

The role of modelling in economic evaluation is explored by discussing, with examples, the uses of models. The expanded use of pragmatic clinical trials as an alternative to models is discussed. Some suggestions for good modelling practice are made.


Subject(s)
Clinical Trials as Topic , Decision Support Techniques , Models, Economic , Clinical Trials as Topic/methods , Clinical Trials as Topic/standards , Cost-Benefit Analysis/methods , Databases, Factual/standards , Databases, Factual/supply & distribution , Forecasting/methods , Humans
18.
Diabete Metab ; 21(6): 433-9, 1995 Dec.
Article in English | MEDLINE | ID: mdl-8593925

ABSTRACT

The purpose of this study was to evaluate the efficacy of a traditional Chinese treatment (TCT) based on three plants in association with a sulfonylurea, glibenclamide (2.5 mg X 3/d). A 2 X 2 factorial design was adopted for this multicentre randomized double-blind trial involving 4 groups [A = placebo (P) TCT + P glibenclamide; B = P TCT + verum glibenclamide; C = verum TCT + P glibenclamide; D = verum TCT + verum glibenclamide]. Patients included were type 2 diabetic outpatients, 40-70 years of age, treated by diet alone or oral anti-diabetic drugs. Endpoint criteria evaluated were HbA1, blood glucose and plasma insulin (at fasting, and 1 and 2 h after a test meal). At each visit, a clinical examination was performed, and a questionnaire on side effects and associated symptoms was completed. The dose was reduced by half in the case of hypoglycaemia. The 216 patients were recruited in 5 centres [Shanghai (1) = 48, Shanghai (2) = 40, Beijing = 40, Canton = 42, Chengdu = 46 and randomized into treatment groups A, B, C, D (56, 56, 50 and 54 respectively). Eleven patients were withdrawn for administrative reasons. In patients treated with glibenclamide, a significant increase in weight and insulinaemia was observed, together with a significant decrease in blood glucose values; in those receiving TCT, blood glucose values were significantly decreased only 2 h after the test meal. A synergistic effect on blood glucose was observed when both treatments were given. Hypoglycaemia occurred in 19 patients (all in the two verum glibenclamide groups). This first multicentre controlled trial showed that the 3 Chinese plants tested were well-tolerated and effective in Type 2 diabetes as indicated by a significant synergistic effect in association with a sulfonylurea.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Glyburide/therapeutic use , Medicine, Chinese Traditional , Adult , Aged , Analysis of Variance , Blood Glucose/metabolism , Diabetes Mellitus, Type 2/metabolism , Double-Blind Method , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies
19.
J Cardiovasc Pharmacol ; 25 Suppl 2: S51-7, 1995.
Article in English | MEDLINE | ID: mdl-8699862

ABSTRACT

A national survey was performed in France from May to June, 1993. The aim of this study was to evaluate general practitioners' attitudes and behaviors when diagnosing and managing patients with lower extremity arterial disease (LEAD). One thousand general practitioners, randomly drawn from an exhaustive list, were contacted to participate in a telephone interview concerning the last patient with intermittent claudication seen in their practice. Four hundred seventy-six general practitioners participated. Risk factors noted for these 476 patients with intermittent claudication were in agreement with the literature: 86% were men aged 64 +/- 10 years (mean +/- SD) and 14% were women aged 73 +/- 8 years. Sixty-two percent had a pain-free walking distance of between 100 and 500 meters at diagnosis. Forty-five percent were former smokers and 37% currently smoked; 55% had hypertension, 14% diabetes, and 56% disturbances of lipid metabolism. A majority of them were hypercholesterolemic. The diagnosis of the disease was based primarily on a clinical assessment, confirmed for 33% by Doppler or echo Doppler. The mean duration of diagnosis was 4.4 +/- 4.1 years. Management of the disease was mainly by prescription of vasodilators (91%), antiplatelet agents (59%), and anticoagulants (8%). Use of Doppler or echo Doppler was recommended once a year. Infection was observed in 27% of patients. Thirty-eight percent had had a cardiac incident (angina pectoris or myocardial infarction) and 10% a cerebrovascular accident. They differed significantly from those with LEAD alone for the following parameters: age (68.5 +/- 9.2 vs. 63.2 +/- 10.3 years; p < 0.001); duration of LEAD (5.6 +/- 4.6 vs. 3.6 +/- 3.5 years; p < 0.001); hypertension (65% vs. 50%; p < 0.01); and current smoking (29% vs. 43%; p < 0.01). This survey confirmed the feasibility of telephone interviewing, on a large sample of general practitioners in France. The high level of association with other cardiac incidents was, for these patients, a much higher risk of mortality and morbidity than LEAD alone. It would be interesting to validate the associations observed with a prospective study of comorbidity.


Subject(s)
Arteriosclerosis Obliterans/therapy , Family Practice , Adult , Aged , Arteriosclerosis Obliterans/complications , Arteriosclerosis Obliterans/diagnosis , Attitude of Health Personnel , Cardiovascular Diseases/complications , Female , France , Humans , Intermittent Claudication/complications , Intermittent Claudication/diagnosis , Intermittent Claudication/therapy , Interviews as Topic , Leg/blood supply , Male , Middle Aged , Regional Blood Flow/physiology , Risk Factors , Ultrasonics
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