The cumulative effect of small dietary changes may significantly improve nutritional intakes in free-living children and adults.

BACKGROUND/OBJECTIVES: The ELPAS (Etude Longitudinale Prospective Alimentation et Santé) study was an 8-month randomized controlled dietary modification trial designed to test the hypothesis that family dietary coaching would improve nutritional intakes and weight control in 2026 free-living children and parents. It resulted in significant nutritional changes, with beneficial effects on body mass index in adults. In these ancillary analyses, we investigated dietary changes throughout the intervention. SUBJECTS/METHODS: Before the study, modeling analyses were carried out on the French Association Sucre Produits Sucrés Consommation et Communication (ASPCC) food-consumption database to identify the most efficient dietary intervention strategy. During the study, all participants performed monthly three nonconsecutive 24-h dietary recalls: this allowed for measuring changes in the number of servings per day and serving size for each targeted food category throughout the intervention. RESULTS: Modeling analyses showed that targeting only the 10 main foods contributing to fat and carbohydrate intakes did not allow for reaching the ELPAS nutritional goals. As a result, it was decided to target more foods and to propose several types of dietary advice (such as change in serving size, change in cooking method, food substitution). This strategy led to many appropriate dietary changes during the intervention, but only a few of them reached significance. The mean number of servings per day was indeed significantly modified for only 7% of the targeted food categories in children and 17% in parents. The mean serving size was modified for only 12% of targeted food categories in children and 9% in parents. CONCLUSIONS: The cumulative effect of small dietary changes may induce significant nutritional improvements, with limited burden for populations.

Prevention of recurrent depressive episodes with milnacipran: consequences on quality of life.

BACKGROUND: Depression is now seen as a chronic disabling condition that spans the patient's lifetime and creates significant medical, economic and quality of life consequences. METHODS: 500 depressed patients were treated with milnacipran for 6 months. A total of 214 recovered patients were randomised to receive either milnacipran (50 mg bid) or a matching placebo for a 1-year recurrence prevention phase. Recurrence rate was the primary criteria; quality of life (QoL) consequences were evaluated through a shortened version of the French Sickness Impact Profile (SIP), the Depression Impact Profile (DIP). RESULTS: Milnacipran demonstrated its ability to reduce recurrences (Odds-Ratio=1.5; P<0.05), with a more marked effect in recovered patients with few residual symptoms (Odds-Ratio=3.0). Responders who continued treatment with milnacipran had a dramatic improvement in their quality of life, although patients with residual symptoms still experienced some deterioration in their QoL (recreation, emotional, social, alertness and home assistance scores). Even recovered patients having zero scores on the Hamilton Depression Rating Scale-21 items (HDRS) had some QoL deterioration. The DIP emotional score was found to be more predictive of recurrence than the HDRS. Overall, the QoL was improved for those in the milnacipran group in comparison to placebo on the mobility, communication, psycho-social and total scores. LIMITATIONS: The QoL evaluation was a secondary criteria; no a priori sample size estimate was performed. The choice of a generic QoL instrument might have reduced the sensitivity to clinical changes in depression. CONCLUSIONS: Prevention of recurrence in MDD with milnacipran contributes to an improvement in the QoL.

The association of poor adherence and acute metabolic disorders with low levels of cohesion and adaptability in families with diabetic children. The PEDIAB Collaborative Group.

A cross-sectional multicentre study was conducted in 165 French diabetic children aged 7-13 y and their parents. A standardized scale (FACES III) was used to determine if family cohesion and adaptability (i) differed in diabetic children's families, as compared to other families; (ii) were related to an adherence measure; or (iii) were related to metabolic control. More diabetic families than comparison families fell into the categories of disengaged with low levels of cohesion, and rigid with low levels of adaptability. Scores of cohesion and adaptability were significantly and positively correlated with both children's and parents' adherence scores, but not with HbA1c levels. Children whose families were characterized as rigidly disengaged had a significantly greater number of hypoglycaemias and six times as many episodes of ketoacidosis than the other diabetic children. Not only in adolescents, but also in families of diabetic children, family-centred interventions are needed to improve compliance and to prevent acute metabolic complications.

French cross-cultural adaptation of the Health Utilities Indexes Mark 2 (HUI2) and 3 (HUI3) classification systems. Clinical and Economic Working Groups.

The McMaster Health Utilities Indexes Mark 2 (HUI2) and 3 (HUI3) are multiattribute health classification systems, for which multiattribute preference functions have been developed in Canada. They provide a comprehensive instrument for use in economic evaluations and population health survey studies. This paper reports on the first results on the adaptation of the HUI2 and HUI3 systems cross-culturally and the assessment of the validity and reliability of the French self-report questionnaire in different patient populations. The cross-cultural adaptation included translation, backtranslations, an expert consensus meeting and pre-test with a few patients and healthy subjects in order to produce a conceptually equivalent French version of the 15 question self-report questionnaire and the HUI2 and HUI3 classification systems. Different groups of patients attending specialized clinics (n = 709) completed the questionnaire and another generic questionnaire (the Sickness Impact Profile (SIP)) for validity assessment. Physicians and patients were also asked for a global subjective assessment of the patient's health status. The French questionnaire was well received by the patients. The criterion and convergent validities of both classification systems (correlations with the patients' and physicians' assessments and with the responses to the SIP questionnaire) were satisfactory. The internal consistency was acceptable too (Cronbach's alpha = 0.81), as was the 3 day test-retest reproducibility. These first results authorize careful use of the 15 question self-report questionnaire in French. An assessment of the multiattribute preference function for the HUI3 system in France will be the study's next objective.

Validity of subjective assessment of changes in respiratory health status: a 30 year epidemiological study of workers in Paris.

The validity of scales used for subjective assessment of health, particularly transitional indices, is under discussion. The aim of the present study was to assess the concurrent and predictive validity of a simple estimate of long-term subjective assessment of respiratory health changes. A longitudinal study of 915 workers was conducted over 30 yrs, with both retrospective self-assessment of respiratory health changes and objective measurements of spirometric values 12 yrs apart. An assessment of the reason for death during the subsequent 20 yrs was performed. Subjective assessment of respiratory deterioration over 12 yrs was significantly related to both cross-sectional lung function values and longitudinal lung function changes (forced expiratory volume in one second (FEV1) decline), an association which remained after adjustment for FEV1 level. It was also related to the same risk factors as decline in FEV1 (smoking, occupational exposure). Self-evaluation of respiratory deterioration was significantly predictive of death from all causes, with the highest (but nonsignificant) rate ratio for respiratory causes. Asthmatics exhibited greater long-term variability (objective and subjective) than nonasthmatics. Independent of dyspnoea, self-assessment of respiratory health deterioration was significantly related to FEV1. Subjective assessment of long-term changes in respiratory health provides valid information.

The Asthma Impact Record (AIR) index: a rating scale to evaluate the quality of life of asthmatic patients in France.

Asthma is a chronic disease, which affects patients' daily lives. The goal of this study was the development of a disease-specific scale to evaluate quality of life in asthmatic patients in France: The Asthma Impact Record Index (AIR Index). The study was conducted with the participation of 486 asthmatic patients using the following steps: 1) selection of dichotomous items; 2) reduction of the number of items; 3) study of reproducibility of the questionnaire; 4) weighting of items; 5) study of the reliability and validity of the final version of the AIR Index. The final version of the AIR Index contains 63 unweighted items. The items were classified into subscales representing the main dimensions of quality of life: 1) physical, which was itself split into two subscales: a) physical activities; and b) symptoms; 2) psychological; and 3) social or relational. The internal consistency, measured by Cronbach's alpha coefficients, was found to be high, for the global scale and all subscales (range 0.79-0.94). The concurrent validity, evaluated by studying the relationship between the score values on the global scale and the subscales, and the parameters reflecting disease severity, was also high. We conclude that the AIR Index might represent a useful evaluative and discriminant instrument in studying quality of life in asthma in French populations.

Risk factors for poor glycemic control in diabetic children in France.

OBJECTIVE: To test whether immigrant versus nonimmigrant origin, among other factors, is associated with differences in glycemic control in diabetic children. RESEARCH DESIGN AND METHODS: A cross-sectional multicenter survey was performed in 165 French diabetic children aged 7-13 years and their parents. HbA1c was measured by high-performance liquid chromatography in a single laboratory (reference value: 5.1 +/- 0.6%). Standardized questionnaires were used to evaluate cognitive, familial, and socioeconomic factors and adherence to diabetes regimen. RESULTS: The mother's place of birth was found to account for 6.6% of the HbA1c variance. Two groups of children were identified with French-speaking immigrant (n = 27) and native French mothers (n = 138) who had significantly different HbA1c values of 9.1 +/- 8% vs. 8.1 +/- 1.4%, respectively (P < 0.001). Adherence to diabetes treatment was significantly lower in immigrant mothers for diet and insulin changes (P < 0.01), as well as their level of diabetes knowledge (P < 0.01). This immigrant group had no significant differences in parents' socioeconomic status, educational background, family status, family functioning, diabetes education background, and social support compared with the native French mothers' group. CONCLUSIONS: Despite no differences in socioeconomic status, a group of children with less well-controlled diabetes was identified by the mother's place of birth. Cultural factors have a crucial importance in glycemic control in diabetic children and in parents' adherence to treatment and must be taken into account in the development of educational programs.

Change in alcohol, tobacco and coffee consumption in pregnant women: evolution between 1988 and 1992 in an area of high consumption.

OBJECTIVE: Analyse the evolution of alcohol, tobacco and coffee consumption during pregnancy in a population characterized by a high level of consumption and a low socioeconomic situation. STUDY DESIGN: Data were obtained from two studies done with the same protocol and questionnaire in the Roubaix Public Maternity Hospital in 1988 (176 women) and 1992 (235 women); the two periods were compared using univariate tests and multiple logistic regression to control for social factors. RESULTS: Between 1988 and 1992, there was a clear decrease in alcohol consumption, a slight decrease in coffee consumption and an increase in tobacco use. These changes affected usual consumption as well as consumption during pregnancy. The increase in tobacco use was no longer significant after controlling for social factors. However, the decrease in alcohol consumption affected all women regardless of sociodemographic characteristics, and remained significant after controlling for these characteristics. CONCLUSION: Several factors support the hypothesis that the decrease in the reported alcohol consumption is real, for consumptions in the low to moderate range. However, it is difficult to identify the role of the several factors involved in this evolution: behaviour of the general population, attitude among pregnant women, information and sensitization of prenatal care providers. Besides, one negative aspect needs to be considered: the stability of the incidence of fetal alcohol syndrome, probably reflecting the stability of the proportion of very heavy consumers.

Attitudes and behavior of pregnant women and health professionals towards alcohol and tobacco consumption.

The objective of this study was to identify those factors that influence pregnant women's behavior towards alcohol consumption, so that they could be taken into account when developing alcohol prevention programs in prenatal care. Tobacco use was also studied to identify similarities and differences in attitudes and behavior. A sample of 176 women was interviewed using a structured questionnaire in the prenatal clinics or post-partum wards. Most women were aware that alcohol and tobacco could be harmful to their babies; however heavy drinkers recognized the influence of alcohol in pregnancy less often than the others. Sixty percent of the women, even among the light drinkers, thought that two drinks per day was a reasonable level of consumption during pregnancy. When asked who could be helpful in decreasing their alcohol consumption, most women mentioned their husband, and the doctor or midwife. This is in contrast to our finding that less than 20% of heavy drinkers were advised to reduce alcohol consumption, as compared to 70% of heavy smokers. The results point to the potential for more active interventions on alcohol reduction by health personnel during prenatal care.

[French version and validation of a scale evaluating compliance in diabetic children]. / Adaptation en langue française et validation d'une échelle mesurant l'adhésion au traitement des enfants diabétiques.

In order to evaluate the educational needs of diabetic children, a study was performed to validate a scale for adherence to treatment (compliance) by diabetic children. The lack of such scales in France, led us to validate an existing American scale. After a classic linguistic translation, back-translation, and a pilot study, 165 diabetic children aged 7 to 13 years filled out a 25 item questionnaire that assessed four areas: glucose testing, diet, hypoglycemia, insulin adjustment. Face validity as measured by response rates was excellent and the reliability as measured by Cronbach's alpha was good (alpha = 0.65) as in the American scale. Concordant validity was studied: the insulin adjustment score was inversely correlated with hypoglycemia (r = -0.23, p < 0.01); age (r = 0.28, p < 0.001), age at diagnosis (r = 0.18, p < 0.05), and diabete knowledge (r = 0.47, p < 0.001) were all correlated with adherence. The French version of the adherence to treatment scale is valid and reliable for the study of adherence to treatment in diabetic children. This scale provides an evaluative tool that will facilitate the performance of an educational diagnosis.

National study of obliterative arterial disease of the lower limbs involving general practitioners in France: Artemio study.

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.

[Health and factors associated with glycemic control in 165 children with insulin-dependent diabetes, aged 7-23 year]. / Etat de santé et facteurs liés au contrôle glycémique chez 165 enfants atteints de diabète insulinodépendant âgés de 7 à 13 ans.

BACKGROUND: A multicenter cross-sectional study was the first step of a project aimed at performing an educational diagnosis for IDDM children in France. POPULATION AND METHODS: Inclusion criteria were age 7 to 13 years, IDDM duration > 6 months and to be followed in a university pediatric department. One hundred and seventy-three children, followed in six centers, were eligible. One hundred and sixty-five of them (age 10.2 +/- 1.9 years and IDDM duration 3.1 +/- 2.7 years) agreed to participate. Standardized questionnaires were completed by the parents and children. Clinical examination was performed and a medical questionnaire was completed by the usual diabetologist of children. HbA1c was measured using a single HPLC method (normal levels +/- 2 sd = 4.5 to 5.7%). RESULTS: Mean HbA1c was 8.3 +/- 1.6% (range 5-13.2%) and values were distributed as follows: < or = 7% for 24.5%, < or = 8% for 46.6% and > 10% for 14% of the children. Age (r = 0.33, P < 0.001), duration of diabetes (r = 0.29, P < 0.001), number of biochemical hypoglycemias (r = -0.21, P < 0.01) and cholesterol level (r = 0.31, P < 0.001) were correlated with HbA1c levels and accounted for 30% of the variance in predicting HbA1c. The difference of HbA1c levels between prepubertal and pubertal children was significant (P < 0.02). Other usual clinical parameters as well as indexes for diabetes monitoring were not significantly correlated with HbA1c. In addition, four subgroups were associated with a significant deterioration (delta > or = 1%) in mean HbA1c levels: 1) age > 10 years (n = 82, P < 0.01); 2) pubertal stage in girls (Tanner stages III vs I, P < 0.05); 3) IDDM duration > or = 2 years (n = 106, P < 0.001); 4) a non French native mother (n = 27, P < 0.001). CONCLUSIONS: Only 50% of this group under specialized care had an acceptable level of glycemic control (HbA1c < or = 8%). Factors related to glycemic control were identified, as well as subgroups of children at particular risk for bad glycemic control which requires specifically targeted interventions. The analyse of sociodemographic, psychological, familial and cognitive factors is currently being conducted in this population, in order to find other explicative variables of glycemic control and to develop specifically targeted educational programs.

[Internal validation of a measurement scale: relation between principal component analysis, Cronbach's alpha coefficient and intra-class correlation coefficient]. / Validation interne d'une échelle de mesure: relation entre analyse en composantes principales, coefficient alpha de Cronbach et coefficient de corrélation intra-classe.

The objective is to establish a simple relationship between two frequently used validation techniques which have been developed in the literature along the same lines: Principal Component Analysis and Cronbach's alpha. We have shown that under certain conditions, it is possible to estimate the reliability by using the results of a Principal Component Analysis only. Moreover, we report the relation between Cronbach's alpha and intraclass correlation coefficient, which are both used to estimate the reliability of continuous measures.

[Evaluation of quality of life: construction of a scale]. / Evaluer la qualité de la vie: construction d'une échelle.

Research in public health has recently tended to take a more global perspective when considering the individual patient. In addition to a measure of functional status, the integration of the disease into the daily life of the individual, or his quality of life is what is being evaluated. This concept, while relatively recent (10-15 yrs), is the result, in part, of changes in the diagnosis and treatment of patients, particularly those with chronic and severe diseases. In clinical trials, what is sought is a measurement of change in the level of well being during the evolution of an illness or of the different levels that exist between two groups. The validation of a scale of this type requires both a qualitative and a quantitative phase with attention being paid to the methodological issues in scale development Specific statistical techniques are used to modify evolving versions. The adaptation of an existing scale into another language requires a rigorous qualitative phase before the quantitative phase is begun.

Methods for clinical assessment of expectorants: a critical review.

The purpose of the paper is to discuss some aspects of the methods that are most appropriate for the clinical assessment of new expectorants. Expectorants are drugs devised to help in the removal of bronchial secretions. The evaluation of these drugs is aimed at demonstrating, in controlled trials, their efficacy, safety and, if possible, mechanism of action. Unfortunately, there is no universally accepted assessment technique available. Evaluation of symptoms with the use of self-reported measures is imprecise. Studies of quality of life can assist as a means of assessing the usefulness of this class of drug for patients. Lung function tests evaluate only the possible indirect effects of expectorants; the changes observed are often minor and they do not correlate with other methods of evaluation. Mucociliary clearance studies evaluate bronchial drainage by mucociliary transport and cough. They are a useful pharmacological approach but they cannot replace therapeutic trials. In vitro and ex vivo studies of bronchial secretion, while improving knowledge of the mechanisms of bronchial secretion, fail to predict the modifications of bronchial drainage produced in vivo by cough or mucociliary transport. To be considered efficient, expectorants should not only ease the removal of bronchial secretions, but also improve the patient's condition for the duration of treatment.

[Psychological and social evaluation]. / Evaluation psychologique et sociale.

The purpose of psychological and social assessment of health programs is the measurement of psychological well-being and lifestyle in targeted populations (i.e. pregnant women, mothers, children or teenagers) and interactive effects on other family members. A psychological and social evaluation should contain the following elements: social and/or cultural factors that facilitate participation in a health program, the opinion of and satisfaction with the program, the psychological and social consequences of the program. Three types of tools can be utilized to measure psychological and social indicators: standardized questionnaires, questionnaires designed specifically for the study in question, and interviews. Study protocols, data collection and analyses must be done using the same methods as those used in any other type of medical evaluation. The investigator must be particularly sensitive to the quality of the measurement tools, the size of the sample and the effects of confounding factors. Social and psychological aspects are essential in the evaluation of a health program. On the one hand, they allow for an understanding of how a health program is accepted and applied within a population. On the other hand, they enable the verification of whether or not there has been any change in the quality of life among individuals and their families.

[Evaluation of health education programs]. / Evaluation des programmes d'éducation pour la santé.

Health education may be defined as a process that seeks to achieve voluntary changes in behavior conducive to health. Systematic program planning, based on an extensive investigation of the needs of a specific population is essential if health education is to attain validity in the eyes of the public, health professionals and policy makers who assess its value. In addition, unless educational programs have clearly defined and measurable objectives, health education will continue to be an area that uses the measurement of activities, rather than the measurement of changes in behavior and health status, as its ultimate goal. The PRECEDE model, presented here, offers a quantifiable means of conducting an educational diagnosis in health, behavioral and cognitive, attitudinal and organizational terms before the development of an educational program. The process allows the practitioner to define objectives, which form the basis for subsequent analyses of the effectiveness of the program.

Health education for hypertensive patients.

Three educational interventions for the control of essential hypertension in ambulatory patients were based on analyses of the educational needs of patients and providers. The educational program increased reported compliance with medication, improved the proportion of patients losing weight, and improved appointment keeping. Most important, there was a favorable effect on blood pressure (BP) control. The proportion of patients with BP under control in the group assigned to all three interventions increased by 28% (from 38% to 66%), while the proportion in the control group receiving standard medical therapy with no educational interventions remained unchanged at 42%.