[Perceptions of patients and physicians involved in clinical trials: an overview of the literature]. / Perception des essais cliniques par les patients et les investigateurs: revue bibliographique (1re partie).

UNLABELLED: OBJECTIVE - METHOD: The purpose of this review is to explore the expectations of patients and physicians prior to participate to a clinical trial and their positive or negative experiences after participating. A systematic review of Medline database from 1966 to 2005 identified 79 papers reported patients and physicians perceptions of clinical trials (only 3 in French), whom 27 English surveys conducted on patients and physicians. RESULTS: If primary patients' motivation for enrolment was altruistic, physicians wish to help their patient. After enrolment, the most perceived positive benefit for patients and physicians are, respectively, the emotional improvement and the greater opportunity for personal benefit offered to enrolled patients. Most physicians' negative experience included logistical difficulties while patients are unease with randomisation and often uncomfortable with medical procedures. Unlike patients, all physicians' expectations seem to be fulfilled. CONCLUSION: The knowledge of patients' and physicians' perception of participation may improve recruitment in clinical trials.

[Patients' and physicians' perceptions on participation in a clinical trial: results on a survey in a French hospital]. / Perception des essais cliniques par les patients et les investigateurs : enquête à l'hôpital Neuro-Cardiologique de Lyon.

OBJECTIVES: We report the first survey on French physicians and patients participating to assess motivations prior enrolment and benefits and constraints perceived after participation. METHOD: Twenty physicians were interviewed and 37 patients completed a questionnaire during clinical study participation. RESULTS: If the main patient's motivation is altruistic, physician wish their own patient feel better. After participation, patient is satisfied with being part of a research effort and contributing to medical science. Effect of trial treatment on physical well-being seems less pronounced. Main constraint is the randomisation to placebo group. For physicians, the main benefit is getting research experience and training. Main constraints are logistical. Otherwise, perceptions on the same clinical trial depend on participant. In fact, physician usually overestimates constraints of clinical trial for patient. CONCLUSION: The knowledge of patients and physicians perceptions of clinical trials and its taking into account should probably reduce difficulties in the recruitment in France.

Incremental predictive value of carotid ultrasonography in the assessment of coronary risk in a cohort of asymptomatic type 2 diabetic subjects.

OBJECTIVE: Consensus guidelines recommend cardiovascular risk assessment as the initial step of primary prevention. The aim of this study was to evaluate the incremental predictive value for coronary events conferred by carotid ultrasonography in addition to risk assessment by Framingham score and screening for silent myocardial ischemia in a cohort of type 2 diabetic patients. RESEARCH DESIGN AND METHODS: We prospectively studied 229 patients free of any cardiovascular complication with at least one additional cardiovascular risk factor. At baseline, all patients had an exercise treadmill test, carotid intima-media thickness (IMT) measurement, and coronary risk assessment by Framingham score. Cardiovascular events were registered during a 5-year follow-up period. RESULTS: Age, carotid IMT, carotid plaques, number of risk factors, Framingham score, and suboptimal exercise electrocardiogram were associated with incident cardiovascular events (P < 0.05). Carotid IMT was an independent predictor of cardiovascular events (P = 0.045). The predictive value for coronary events was similar for carotid IMT and Framingham score as assessed by area under the receiver operating characteristic curves. An improvement in risk prediction was conferred by addition of carotid IMT in a Cox model (global chi(2) increased from 14.1 to 18.1, P = 0.035). CONCLUSIONS: This prospective study confirms that carotid IMT is a marker of cardiovascular risk in this type 2 diabetic cohort, establishes that carotid IMT provides a similar predictive value for coronary events than Framingham score, and suggests that the combination of these two indexes significantly improves risk prediction for these patients.

Anxiety and depression are associated with unhealthy lifestyle in patients at risk of cardiovascular disease.

Adherence to lifestyle recommendations for prevention of cardiovascular disease remains a critical issue. We examined the association of anxiety and depression with healthy behaviors in a large population of subjects at risk of cardiovascular disease. We studied 1612 consecutive subjects referred for evaluation of cardiovascular risk factors. Separated scores reflecting unhealthy behaviors (physical inactivity, smoking and poor diet) were combined to produce a global unhealthy lifestyle score. The Hospital Anxiety and Depression scale (HAD) was used to assess both anxiety and depression. Both anxiety and depression were significantly associated with physical inactivity in both sexes and with an unhealthy diet in men but not in women. Anxiety and depression were both significantly correlated to smoking habits in men whereas only depression was related to smoking in women. In both sexes, the global score reflecting unhealthy lifestyles was positively associated with the degree of anxiety and depression. In multivariate analysis, both anxiety and depression appeared as independent determinant of unhealthy lifestyle in both sexes, with a stronger influence for depression. Depression and to a lesser extent anxiety are associated with a cluster of unhealthy behaviors in subjects at risk of cardiovascular disease, suggesting the difficulty of modifying lifestyle in patients with anxious-depressive disorders.

Depressive symptoms are associated with unhealthy lifestyles in hypertensive patients with the metabolic syndrome.

OBJECTIVE: Metabolic syndrome results from a complex interaction between lifestyle and genetic factors. Among this population, adhesion to healthy recommendations is a cornerstone of cardiovascular disease prevention. We examined the association between depression and multiple unhealthy behaviours in hypertensive patients with the metabolic syndrome. RESEARCH DESIGN AND METHODS: Eight hundred and forty consecutive hypertensive subjects with the metabolic syndrome were studied in our secondary-care centre. Separated scores reflecting unhealthy behaviours (physical inactivity, smoking and unhealthy diet) were combined to produce a global unhealthy lifestyle score. The Hospital Anxiety and Depression scale was used to assess and quantify depression. We performed a separate analysis for each sex. RESULTS: The prevalence of depression (13.0 versus 7.3%, P < 0.001) was greater in women than in men. Presence of depression was significantly associated in both men and women with unhealthy diet (in particular, excessive cholesterol and total caloric intake) but also with decreased physical activity in men and with smoking habits in women. In both sexes, the global unhealthy lifestyle score, reflecting a cluster of unhealthy behaviours, was positively correlated with the depression score. In multivariate analysis, the depression score appeared in both sexes as an independent determinant of unhealthy lifestyle. CONCLUSIONS: Among hypertensive subjects with the metabolic syndrome, depressive symptoms along a continuum of severity are independently associated with multiple unhealthy lifestyles. This suggests that even minor forms of depression may impact on adhesion to health behaviours beyond major depressive symptoms and/or psychiatric condition.

Relation between XbA1 apolipoprotein B gene polymorphism and cardiovascular risk in a type 2 diabetic cohort.

AIM: To evaluate in a prospective study the association of XbA1 apolipoprotein B (apoB) gene polymorphism with lipid parameters and cardiovascular (CV) events in a type 2 diabetic cohort. METHODS AND RESULTS: A cohort of 212 type 2 diabetic patients, free of any cardiovascular complication, was studied. Cardiovascular events were registered for all the patients for 5 years. XbA1 apolipoprotein B gene polymorphism was analysed by PCR-RFLP method. A mild increase in HbA1c was found in X+X+ carriers (P = 0.014). Despite this lower glycemic control, there were no differences between genotype subgroups for lipid parameters except for apoB, significantly higher in X+X+ than in X-X- subjects. In univariate analysis, the cardiovascular events rate was higher in X-X- but did not reach statistical significance (P =0.07). In stepwise multivariate regression analysis, cardiovascular events risk was significantly higher in X- carriers (P = 0.014) and also in smokers, microalbuminuric and older patients. CONCLUSIONS: We report for the first time in a prospective study the association of XbA1 apolipoprotein B gene polymorphism and cardiovascular events in a diabetic population. The mechanism underlying the excess of cardiovascular risk in X- carriers, despite a better metabolic profile, is likely to involve a linkage disequilibrium between apolipoprotein B gene locus and another gene locus related to cardiovascular risk.

Alteration in lipoprotein lipase activity bound to triglyceride-rich lipoproteins in the postprandial state in type 2 diabetes.

Postprandial lipid metabolism is largely dependent upon lipoprotein lipase (LPL), which hydrolyses triglycerides (TGs). The time course of LPL activity in the postprandial state following a single meal has never been studied, because its determination required heparin injection. Recently, we have shown that LPL activity could be accurately measured in nonheparinized VLDL using a new assay aiming to determine the LPL-dependent VLDL-TG hydrolysis. Based on the same principle, we used in this study TG-rich lipoprotein (TRL)-bound LPL-dependent TRL-TG hydrolysis (LTTH) to compare the time course of LPL activity of 10 type 2 diabetics to that of 10 controls, following the ingestion of a lipid-rich meal. The peak TG concentration, reached after 4 h, was 67% higher in diabetics than in controls (P < 0.005). Fasting LTTHs were 91.3 +/- 15.6 in controls versus 70.1 +/- 4.8 nmol NEFA/ml/h in diabetics (P < 0.001). LTTH was increased 2 h postprandially by 190% in controls and by only 89% in diabetics, resulting in a 35% lowering of the LTTH area under the curve in diabetics. Postprandial LTTH was inversely correlated with TG or remnant concentrations in controls but not in diabetics, and with insulin resistance in both groups. These data show that TRL-bound LPL activity increases in the postprandial state and is strongly reduced in type 2 diabetes, contributing to postprandial hypertriglyceridemia.

Balance lipídico: sus indicaciones y su importancia práctica / Lipidic balance: indications and pratical usefulness

Los gastos en salud han aumentado progresivamente lo que impone la obligación de precisar frente a cada tipo de patología los exámenes de mayor rendimiento y de menores costos. Las indicaciones del estudio lipídico se dividen en discutibles y formales. Entre estas últimas se consignan: -Cuadros sugerentes de dislipidemias (pancreatitis, xantomas, ateromatosis, etc.) -Encuesta familiar de portadores de hiperlipidemias primitivas. -Pacientes con otros factores de riesgo cardiovascular obesidad diabetes, tabaquismo, hipertensión, etc.) -Control de evolución y tratamiento de hiperlipidemias secundarias (diabetes, hipotiroidismo, ictericia obstructiva, síndrome nefrótico, alcoholismo, etc). En el estudio lipídico se distinguen tres etapas: 1. Diagnóstico de hiper o dislipidemia. 2. Diagnóstico etiológico de la hiperlipidemia. 3. Búsqueda de posibles elementos de valor pronóstico