Comparative evaluation of socioeconomic insecurity in peripheral and coronary artery disease patients.

BACKGROUND: Cardiovascular disease represents the leading cause of death worldwide. Socioeconomic deprivation is a risk factor for cardiovascular disease. We have previously shown that precariousness was more frequent in symptomatic peripheral artery disease (PAD) patients than in the general population. According to a previous study, coronary artery disease (CAD) patients have a higher level of education than CAD with PAD, but no study directly compared the level of precariousness in PAD and CAD patients. AIM: To measure and compare the level of socioeconomic insecurity in patients suffering from symptomatic PAD with those suffering from isolated CAD, i.e without symptomatic PAD. METHODS: We conducted an observational, cohort, prospective, multicenter study. Patients suffering from symptomatic PAD or CAD were recruited through the medical or surgical vascular or cardiology departments, or the vascular rehabilitation center. The EPICES score and the INSEE parameters were used for analysis. The individual is considered precarious when his or her score is greater than or equal to 30. Cardiovascular risk factors and peripheral arterial disease stages were also collected. RESULTS: In total, 230 patients were included. According to the EPICES score, 47.8% [95%CI, 38.7-56.7] of patients with symptomatic PAD were in a precarious situation compared to 17.4% [95%CI, 10.5-24.3] of patients suffering from isolated CAD (P<0.001). The mean EPICES score was 33.3 (SD 22.5) in the PAD and 16.9 (SD 17.02) in the CAD population, respectively (P<0.001). In the PAD population, the level of education was low, with an under-representation of patients with a baccalaureate or higher education degree: 21.7% [95%CI, 14.2-29.3] vs. 41.7% [95%CI, 32.7-50.7] in the PAD and CAD populations, respectively. There was also an under-representation of executives and intellectual and intermediate professions in the PAD population, 18.3% [95%CI, 11.2-25.3], compared to the CAD population, 31.3% [95%CI, 22.8-39.8]. CONCLUSION: PAD patients are more precarious than patients suffering from CAD. A better detection of socioeconomic deprivation in patients suffering from peripheral arterial disease could allow comprehensive care and thus hope for an improvement in terms of morbidity and mortality.

Patient Education in Spa Resorts: Experience from a French National Program for Patients with Chronic Venous Insufficiency.

The prognosis of chronic venous insufficiency (CVI) is greatly depending upon the ability of the patients to optimize their health-related behaviors (mainly compliance to compression stockings, physical activity and diet). As this is usually challenging for the patients, we developed a therapeutic education program (TEP) aiming at helping them to achieve these optimizations. We report here the preliminary results obtained with this program. This structured TEP was developed by a working group of 15 health professionals to be used during the regular French spa 3-week treatment course for CVI patients. The program included three interactive workshops aiming at improving the patients' knowledge, skills and motivation, two educational consultations allowing to set and follow-up their personal action plans and a built-in evaluation. It was implemented in spa resorts specialized in CVI. Among the first 150 patients (116 women and 34 men, mean age 69 years old (SD 8 years), 49% had post-thrombotic disease. Compliance to the education workshops was 98%. After a 3-month follow-up, 83% of the patients fully achieved at least one behavioral objective. Quality of life, as assessed by the CIVIQ 2 auto-questionnaire, improved at 3 months (p = 0.0024) and 9 months (p = 0.018). These results demonstrate the feasibility of a TEP for CVI patients and its ability to improve their health-related behaviors, opening the way for the development of similar programs for other chronic diseases in the setting of spa resorts.

Impact of an educational program on the quality of life of patients with lymphedema: A preliminary evaluation.

OBJECTIVE: We report on the preliminary evaluation of a well-designed program, Living with Lymphedema. This longitudinal cohort study assessed patients' quality of life using questionnaires. Our main objective was to evaluate the satisfaction of the patients and their adherence to the program. This was done using a specific questionnaire of satisfaction as well as by noting patients' adherence to the program (number of patients attending all three consultations). The secondary objective was to assess the effect of the program on the patient's quality of life. The assessment criteria were the evolution of the Medical Outcomes Study 36-Item Short Form Health Survey and EuroQol questionnaire scores between the first (C1) and third (C3) consultations. METHODS: The Living with Lymphedema program targeted all patients with lymphedema in the Grenoble (France) conurbation and within the GRANTED health care network that includes vascular medicine specialists, primary care physicians, physical therapists, and dietitians in the Alpine region of France. All studied patients were ambulatory patients. The GRANTED network took care only of the educational aspect of the disease. All patients with primary or secondary lymphedema were offered the Living with Lymphedema program, whatever their age and the location of the lymphedema (upper or lower limbs). The collection of patient data conformed to the ethical and administrative regulations of the regional health authority. Grenoble Institutional Review Board (CPP Sud-Est V; No. 5891) approval for the study was specifically obtained for this evaluation on December 24, 2012. The program was built around one-to-one consultations, group workshops, and more specialized appointments. It was complementary to the routine medical care received by the patient (not evaluated in this study). It proposed three individual "educational" consultations, seven group workshops, and two specialized consultations with a dietitian. All the consultations or workshops were led by certified professionals trained in therapeutic education. RESULTS: The cohort was the 34 patients included in the program. We found a significant improvement in the physical dimension of the Medical Outcomes Study 36-Item Short Form Health Survey score (P = .01) between C1 and C3 but not for the psychic dimension. Visual analog scale scores of the ability to cope with the lymphedema showed a statistically significant improvement between C1 and C3 (P = .05). No difference was observed in adherence to compression therapy. CONCLUSIONS: This therapeutic educational program showed a significant improvement in several criteria of quality of life and in the autonomy of patients with lymphedema.

A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency.

BACKGROUND: Apart from compression therapy, physical therapy has scarcely been evaluated in the treatment of chronic venous disorders (CVDs). Spa treatment is a popular way to administer physical therapy for CVDs in France, but its efficacy has not yet been assessed in a large trial. The objective was to assess the efficacy of spa therapy for patients with advanced CVD (CEAP clinical classes C4-C5). METHODS: This was a single-blind (treatment concealed to the investigators) randomized, multicenter, controlled trial (French spa resorts). Inclusion criteria were primary or post-thrombotic CVD with skin changes but no active ulcer (C4a, C4b, or C5). The treated group had the usual 3-week spa treatment course soon after randomization; the control group had spa treatment after the 1-year comparison period. All patients continued their usual medical care including wearing compression stockings. Treatment consisted of four balneotherapy sessions per day for 6 days a week. Follow-up was performed at 6, 12 and 18 months by independent blinded investigators. The main outcome criterion was the incidence of leg ulcers at 12 months. Secondary criteria were a modified version of the Venous Clinical Severity Score, a visual analog scale for leg symptoms, and the Chronic Venous Insufficiency Questionnaire 2 and EuroQol 5D quality-of-life autoquestionnaires. RESULTS: Four hundred twenty-five subjects were enrolled: 214 in the treatment group (Spa) and 211 in the control group (Ctr); they were similar at baseline regarding their demographic characteristics, the severity of the CVD, and the outcome variables. At 1 year, the incidence of leg ulcers was not statistically different (Spa: +9.3%; 95% confidence interval [CI], +5.6 - +14.3; Ctr: +6.1%; 95% CI, +3.2 - +10.4), whereas the Venous Clinical Severity Score improved significantly in the treatment group (Spa: -1.2; 95% CI, -1.6 - -0.8; Ctr: -0.6; 95% CI, -1.0 - -0.2; P = .04). A significant difference favoring spa treatment was found regarding symptoms after 1 year (Spa: -0.03; 95% CI, -0.57 - +0.51; Ctr: +0.87; 95% CI,+0.46 - +1.26; P = .009). EuroQol 5D improved in the treatment group (Spa: +0.01; 95% CI, -0.02 - +0.04) while it worsened (Ctr: -0.07; 95% CI, -0.10 - -0.04) in the control group (P < .001). A similar pattern was found for the Chronic Venous Insufficiency Questionnaire 2 scale (Spa: -2.0; 95% CI, -4.4 - +0.4; Ctr: +2.4; 95% CI, +0.2 - +4.7; P = .008). The control patients showed similar improvements in clinical severity, symptoms, and quality of life after their own spa treatment (day 547). CONCLUSIONS: In this study, the incidence of leg ulcers was not reduced after a 3-week spa therapy course. Nevertheless, our study demonstrates that spa therapy provides a significant and substantial improvement in clinical status, symptoms, and quality of life of patients with advanced venous insufficiency for at least 1 year.

Clinical analysis of the corona phlebectatica.

BACKGROUND: The corona phlebectatica (CP) is classically described as the presence of abnormally visible cutaneous blood vessels at the ankle with four components: "venous cups," blue and red telangiectases, and capillary "stasis spots." Previous studies showed that the presence of CP is strongly related to the clinical severity of chronic venous disorders (CVD) and the presence of incompetent leg perforators. The aim of this study was to select the most informative components of the CP in the assessment of the clinical severity of CVD patients. METHODS: A multicentric series of 262 unselected patients (524 limbs) consulted for CVD were clinically evaluated using a standardized form to record the CEAP "C" items and the presence of the four CP components. Standard categorical and ordinal statistics were used to describe the external validity of the CP components as severity indexes, taking the "C" classes as reference. RESULTS: "Stasis spots" (P < .001; r = .44) and blue telangiectases (P < .01; r = .32) were linearly associated with the ascending order of "C" classes, whereas the relationship is less clear for the red telangiectases and the "venous cups." The association pattern of the four components showed that only the blue telangiectases and the "stasis spots" were consistent with each other. Blue telangiectases were found more sensitive (0.91 vs 0.75) but less specific (0.52 vs 0.80) than "stasis spots" for advanced venous insufficiency (CEAP "C4-6"). CONCLUSION: This study shows that only blue telangiectases and "stasis spots" provide valuable information in patients with CVD and deserve to be taken into account in the evaluation of such patients. Further studies are needed to show the reproducibility of this data, which we regard as essential for clinical use.

[Therapy education for patients receiving oral anti-coagulants vitamin K antagonists]. / Education thérapeutique des patients traités par anticoagulants oraux antivitamines K.

The vitamin K antagonists (VKA) remain to this day the only oral form of therapeutic anticoagulation. Approximately 1% of the French population, mainly elderly, is treated with these anticoagulants. Oral anticoagulants have significant risks of iatrogenic complications; indeed they are the leading cause of such drug-induced complications, predominantly hemorrhages. AFSSAPS (French Drug and Medical Products Agency) clinical practice recommendations, repeatedly disseminated, emphasize the education of patients receiving VKAs. Managing oral anticoagulant treatment is challenging, with a significant risk of under- or overdosing and consequently, thrombosis or hemorrhage. The therapeutic window is narrow, multiple drug-interactions are possible, and the specific dose required for a particular individual to achieve appropriate International Normalized Ratio (INR) levels is unpredictable. The literature contains few randomized controlled trials about the efficacy of education for patients treated with oral anticoagulants. These education programs are not standardized and are therefore varied and difficult to compare. Nevertheless, studies demonstrate the importance of patient education programs in reducing the risk of hemorrhage and achieving better treatment stability. The Grenoble region hospital-community network for vascular diseases (GRANTED) has developed an education program for these patients, consisting of individual sessions for the patient and/or a friend or family member (either at a health care facility or at the patient's home), telephone support and group sessions, and using educational tools and supports. There is also a link with the general practitioner who receives a report. This approach makes it possible to adapt the educational message to individual patients and their daily lives, as well as directly involving them in the management of their treatment.

Randomized trial of balneotherapy associated with patient education in patients with advanced chronic venous insufficiency.

OBJECTIVES: Except for compression therapy, physical therapy has scarcely been evaluated in the treatment of chronic venous disorders (CVD). Spa treatment is a popular way to administer physical therapy for CVD in France, but its efficacy has not been evaluated yet. This study aimed to assess the efficacy of balneotherapy associated with patient education, as performed in the spa resort of La Léchère, in patients with advanced chronic venous insufficiency (CEAP clinical classes C4/C5). METHODS: The study was a randomized controlled trial, spa therapy being administered on top of the usual medical care. Evaluation was by a blinded independent investigator. Subjects were patients with primary or post-thrombotic CVD with skin changes but no active ulcer (C4a, C4b, or C5), living in Grenoble area, and willing to undergo a spa treatment course in La Léchère. The treated group had the three week spa treatment course in La Léchère, soon after randomization; the control group also had a spa treatment, but starting at day 365. The treatment consisted of four balneology sessions per day, six days a week during three weeks, and three educational workshops. An independent follow-up was performed in Grenoble hospital every three months for 15 months. The main outcome criterion was the severity of the skin changes, as evaluated by means of malleolar chromametry. Quality of life, as measured by the Chronic Venous Insufficiency Questionnaire 2 scale, a visual analog scale (VAS) for leg symptoms, and the occurrence of leg ulcers were used as secondary criteria. The year after spa treatment in the treated group was compared with the year before spa treatment in the control group. RESULTS: Fifty-nine subjects were enrolled (29 in the treatment group and 30 in the control group). No statistically significant difference between groups was found at study onset regarding age, sex, etiology, CEAP "C" class, and the outcome variables. After treatment, chromametry showed significantly decreased pigmentation and erythema in the treatment group compared with the controls (P < .01). Quality of life (P < .01) and symptoms (P < .001) also improved significantly. These differences remained significant after one year follow-up. The control patients improved similarly after their own spa treatment (day 450). CONCLUSION: This study shows that spa therapy, associating balneotherapy and patient education, is able to improve significantly the skin trophic changes of the CVD patients and their CVD related quality of life and symptoms. This effect is of large magnitude and remains significant one year after the treatment course.

EDUC'AVK: reduction of oral anticoagulant-related adverse events after patient education: a prospective multicenter open randomized study.

BACKGROUND: Long-term oral anticoagulation treatment is associated with potential morbidity. Insufficient patient education is linked to poorly controlled anticoagulation. However the impact of a specific educational program on anticoagulation related morbidity remains unknown. OBJECTIVE: To evaluate the effect of an oral anticoagulation patient education program in reducing both hemorrhagic and recurrent thrombotic complications. DESIGN/PARTICIPANTS: We conducted a prospective, multicenter open randomized study, comparing an interventional group who received a specific oral anticoagulation treatment educational program with a control group. Eligible patients were older than 18 and diagnosed as having deep vein thrombosis or pulmonary embolism requiring therapy with a vitamin K antagonist for 3 months or more. Our primary outcome was the occurrence of hemorrhagic or thromboembolic events. RESULTS: During the 3-month follow-up the main outcome criteria were observed 20 times (6.6% of patients), 5 (3.1%) in the experimental and 15 (10.6%) in the control group. Consequently, in multivariate analysis, the cumulative risk reduction in the experimental group was statistically significant (OR 0.25, 95% CI 0.1-0.7, p < 0.01). CONCLUSIONS: Patient education using an educational program reduced VKA-related adverse event rates.

[Partnering with patients to reflect on the conceptual design of a therapeutic patient education programme]. / Associer des patients à la conception d'un programme d'éducation thérapeutique.

Within the framework of a patient education training programme, a group of health sector professionals comprised of hospital doctors, general practitioners, nurses, physiotherapists and dieticians created a programme intended for people with peripheral vascular disease (intermittent claudication). A study was carried out simultaneously utilising a questionnaire and a series of four interviews which permitted professionals to collect data on the patients' expectations regarding such a programme and their points of view at each specific stage of its development. This article analyses the contribution of the patients to the therapeutic patient education programme design, namely with respect to their influence on the programme's content, on the educational process and approach as well as on the professionals' perspectives on disease, various treatments and people with this particular illness. The discussion highlights the range of goals and objectives that can potentially be met through dialogue and exchange between people suffering from the same disease.

Incidence and natural history of Raynaud phenomenon: A long-term follow-up (14 years) of a random sample from the general population.

BACKGROUND: Because the natural history of primary Raynaud phenomenon (RP) is unclear, we undertook this long-term (14 years) follow-up of an epidemiologic study on RP to investigate the incidence, remittance rate, and transition rate toward systemic sclerosis and other scleroderma spectrum disorders in a population-based sample of subjects. METHODS: In 1988 and 1989, 296 subjects obtained from a random sample of the general population of the Alpine valley of Tarentaise (southeast France) completed a cross-sectional study on RP. Of these, 78 met the diagnostic criteria for RP (RP+). From April 2002 to March 2003, we were able to get follow-up information on 292 people (dropout rate, 1.4%). Eighteen subjects (6.1%) had died, and the remaining 274 were successfully contacted. They were first evaluated by a standardized phone interview regarding their cold sensitivity, digital color changes, and RP. If any significant medical changes related to RP and/or suggesting scleroderma were reported, these subjects were invited for a medical evaluation. RESULTS: Mortality was similar in RP+ and RP- subjects, and no death was due to an RP-related condition. Seven cases of new RP were diagnosed in the RP- group, which corresponds to an annual incidence rate of 0.25%. Among the 72 RP+ subjects and the 7 subjects with a new RP available for follow-up, none developed clinical features of scleroderma. A disappearance of RP attacks for 2 winters or more was reported by 24 RP+ subjects (33%). CONCLUSIONS: These results show that, in the general population, RP is most often a benign condition and may disappear in a substantial proportion of subjects.