Chronic venous disease: health status of a population and care impact on this health status through quality of life questionnaires.

AIM: There is growing interest for patient-reported outcomes (PROs) in clinical research. Application of quality of life (QoL) questionnaires to patients suffering from chronic venous disease (CVD) is thought to be an important improvement in the assessment of results in these complex disorders. The aims of the study were to describe the health status of female patients suffering from CVD, and to assess the care impact through QoL questionnaires. METHODS: Symptomatic female patients suffering from CVD (all CEAP clinical classes), aged over 18, newly treated by their general practitioner with a phlebotropic drug were enrolled in the study. Every patient had to complete a self-questionnaire including the SF-12, the CES-D, the Epworth and the CIVIQ scales at day 0 (D0), day 3 (D3) and day 7 (D7). The CIVIQ scale assesses pain and the psychological, physical and social consequences of CVD. The SF-12 is a generic measure of health status. The CES-D scale studies presence of depressive symptoms (DS) in the general population. The Epworth scale measures daytime sleepiness. RESULTS: A total of 765 physicians took part in the survey from April to August 2003. The results of the study concern 1 045 patients. Analyses are realized on the 399 patients who filled out all 3 questionnaires. Mean age was 45 years (SD=11), patients average height was 164.39 cm (SD=5.99) for an average weight of 65.2 kg (SD=12.5). Concerning change in QoL between inclusion and Day 7, the mean CIVIQ total scores at inclusion were 26.7 in the CEAP class 0-2 group and 36.3 in the CEAP class 3-6 group. The mean CIVIQ total scores at D7 were 18.5 in the CEAP class 0-2 group and 27.3 in the CEAP class 3-6 group. The mean CIVIQ total scores demonstrated that QoL is more impaired for patients in the CEAP class 3-6 group. In both groups, an improvement in patients' QoL was observed following patient management (P<0.001). At inclusion time, MCS-12 and PCS-12 were respectively 44.7 (SD=10.6) and 46.4 (SD=8.4): at day 3 and day 7, these dimensions were respectively: D3: 46.5 (SD=10.2) and 46.2 (SD=8) D7: 48 (SD=10.3) and 46.2 (SD=7.8). For the mental dimension, the difference was statistically significant (P=0.0001). In our study a possible DS (score ?17) was reported for 36.3%, 32.3% and 29% respectively at day 0, D3 and D7 (P<0.01, n=328). Concerning daytime sleepiness the Epworth mean total score showed a decrease in daytime sleepiness for patients with severe CVD (C3-C6) between day 0 and D 7 (P=0.02). CONCLUSIONS: Our study demonstrates the high impact of CVD on health status and the validity of QoL questionnaires in this pathology. They show a significant improvement of the QoL after one week of medical management.     

Quality of life among people with atrial fibrillation with and without diabetes: a comparison study

Quality of life (QoL) is an essential consideration when managing the wellbeing of patients and assists in interpretation of symptoms, functional status and perceptions. Atrial fibrillation (AF) and diabetes demand significant healthcare resources. Existing data demonstrate a negative impact on QoL as individual conditions, but there is less evidence relating to the impact of these disease groups in combination. This study therefore explores QoL in patients with AF and diabetes.This cross-sectional, observational study required participants to complete the short form (SF)-36 survey via an online platform and was offered to people affected by AF alone and people with AF and diabetes in combination. The SF-36 provides a prevalidated tool with eight domains relating to physical and psychological health.A total of 306 surveys were completed (231 AF group, 75 AF and diabetes group).The mean and standard deviation (SD)were calculated for each QoL domain,after re-coding in accordance with SF-36 guidance. Multi-variate analysis of variance (MANOVA) demonstrated an overall significant difference between the groups when considered jointly across all domains.There were significant differences between AF and AF with diabetes QoL responses in physical functioning, energy fatigue,emotional wellbeing, social functioning and pain. In these domains, the mean was highest in the AF group. There were no significant differences in the role physical,role emotional and general health domains.In conclusion, this study demonstrates that diabetes and AF has a more detrimental effect on QoL than AF alone, in the majority of domains. Further research into the general AF population and where chronic conditions co-exist is important to comprehend the true impact this disease combination has on QoL.Key words: atrial fibrillation, diabetes, quality of life     

Psychosocial status predicts mortality in patients with life-threatening ventricular arrhythmias

BACKGROUND: Quality-of-life (QoL) instruments evaluate various aspects of physical, mental, and emotional health, but how these psychosocial characteristics impact long-term outcome after cardiac arrest and ventricular tachycardia (VT) is unknown. OBJECTIVE: The purpose of this study was to evaluate the relationship of baseline QoL scores with long-term survival of patients enrolled in the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial. METHODS: Formal QoL measures included SF-36 mental and physical components, Patient Concerns Checklist, and Ferrans and Powers Quality-of-Life Index-Cardiac Version. Multivariate Cox regression was used to assess the association of survival and these measures, adjusting for index arrhythmia type, gender, race, age, ejection fraction, history of congestive heart failure, antiarrhythmic therapy, and beta-blocker use. RESULTS: During mean follow-up of 546 +/- 356 days, 129 deaths occurred among 740 patients. Higher baseline SF-36 physical summary scores (P <.001), higher baseline QoL Index summary scores (P = .015), and lower baseline Patient Concerns Checklist summary scores (P = .047) were associated with longer survival, even after adjustment for clinical variables. When QoL measures were examined simultaneously, only the SF-36 physical summary score remained significant (P = .002). CONCLUSION: During recovery after sustained VT or cardiac arrest, formal baseline QoL assessment provides important prognostic information independent of traditional clinical data.     

Health-related quality of life measured by the Short Form 36 in immune thrombocytopenic purpura: a cross-sectional survey in China

OBJECTIVES: The aim of this study is to assess the quality of life (QoL) of Chinese adults with idiopathic thrombocytopenic purpura (ITP). METHODS: The Chinese (mainland) version of Medical Outcome Study SF-36 form (SF-36) Health Survey was used to measure health-related QoL of 236 adults with ITP in a cross-sectional study. RESULTS: Comparison of SF-36 subscores of patients with ITP with healthy individuals revealed the reduction of QoL in all of the eight SF-36 dimensions. The difference on statistical significance presented in six of eight dimensions of SF-36 including physical functioning (PF), role limitations due to physical problems, body pain, general health perception (GH), social functioning (SF), and role limitations due to emotional problems (RE) between the patients with ITP and the normal population (P < 0.01). The acute ITP group showed better scores in three dimensions including GH, energy/vitality, and RE than chronic ITP (P < 0.01). Meanwhile through classification with platelet count, three subgroups of patients also experienced significant differences in PF, GH, and SF from the eight dimensions. Age was a significant negative predictor of all eight dimensions other than the SF while current platelet count was a significant negative predictor of GH. Moreover, the treatment cost and family income also influenced the QoL scores. The subjective feeling of fear about bleeding had a detrimental impact on QoL. CONCLUSIONS: QoL was impaired in patients with ITP, especially in the acute patients. The platelet count and the feeling of fear about bleeding had a detrimental impact on QoL.     

Construction and validation of a patient-reported outcome dedicated to chronic venous disorders: SQOR-V (specific quality of life and outcome response - venous)

BACKGROUND: Chronic venous disorders (CVD) have an impact on quality of life (QoL), both physically and psychologically. As of now, several vein specific QoL scales exist, but no patient-reported outcome (PRO) is available which takes into account altogether symptoms, impairment of activities, appearance of the legs and concerns regarding health risk. Since clinical severity and disability are mostly evaluated in severe patients, where the main outcome - namely skin changes - is obvious but rare, the authors considered that a reproducible and clinically relevant survey that could account for specific patients' complaints was needed, particularly for CEAP C0s-C3 patients. OBJECTIVES: The objective of this study was to build a specific autoquestionnaire and to establish its statistical validity and clinical relevance. METHODS: A review of existing questionnaires and an analysis of relevant literature were carried out by a committee of experts. The committee then developed a questionnaire of 46 items, with special attention to relevance for venous disorders and patients' main complaints. After construction, the French version was field-tested and results statistically analyzed. In the specific QoL & Outcome Response - Venous (SQOR-V), each item is given a value by the patient and items are grouped in five dimensions. Each dimension is weighed to a maximum value of 20, yielding an overall maximum score of 100. RESULTS: Two hundred and two questionnaires were analyzed for the initial evaluation and 152 at a second (test-retest). Determination of the Cronbach's alpha coefficient (0.96) and structural analysis demonstrated an excellent internal and structural coherence. Test-retest comparisons confirmed good reproducibility. Comparison with SF-12 and CED-D questionnaires and with CEAP classification groups verified both structural and clinical validity. CONCLUSIONS: This study demonstrates QoL impairment in patients suffering from chronic venous disorders (CVD). It also verifies the statistical validity of the SQOR-V questionnaire. More studies are needed to demonstrate the improvement in specificity and accuracy this questionnaire provides compared to existing vein-specific QoL scales, and to determine its ability to assess efficacy of any kind of treatment at any stage of the disease. Provided adequate acknowledgment of its authors, the use of SQOR-V is free. An English version is available, currently pending validation.     

The Turkish validity and reliability of the venous insufficiency epidemiological and economic study-quality of life/symptoms scales

The aim of the study was to test Turkish validity and reliability of Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms (VEINES-QoL/Sym) in patients with chronic venous insufficiency (CVI). A total of 118 patients with CVI hospitalized in 3 different hospitals were enrolled in this study. VEINES-QoL/Sym, translated to Turkish with a standard methodology, was applied to the patients and was evaluated for acceptability, reliability, validity, and responsiveness. Cronbach α (including if item deleted) values were used for the reliability analysis. Construct and criterion validity approaches were used for validity analysis. Cronbach α values are .86 for the VEINES-QOL and .81 for the VEINES-Sym. No problematic items were observed for the scale. The VEINES-QoL/Sym was significantly sensitive to clinical, etiology, anatomy, and pathophysiology (CEAP) classification, indicating good criterion validity. Significant correlation was found between scores of SF-36 and VEINESQoL (r = .43-.66). Turkish version of the VEINES-QOL/Sym was found reliable and valid for Turkish patients with CVI.     

Health-related quality of life and sense of coherence among elderly patients with severe chronic heart failure in comparison with healthy controls

OBJECTIVE: To describe health-related quality of life (QoL) and sense of coherence (SOC) in a group of elderly people with moderate to severe chronic heart failure and to make comparisons with a healthy sex- and age-matched control group. METHODS: Patients (n = 94), with a mean age of 81 years, hospitalized for chronic heart failure with New York Heart Association functional classification III to IV were age- and sex-matched to a healthy control group. The instruments used were the 36-Item Short Form Health Survey (SF-36) and SOC. RESULTS: The patients had lower levels of health-related QoL scores (SF-36) but high and similar scores of SOC compared with the controls. There were, however, significant positive correlations between the SOC scores and the emotional dimensions in the SF-36 instrument. CONCLUSION: The findings from this study indicate that old age and severe chronic heart failure were associated with limited functional abilities and impaired health-related QoL but also with internal resources such as SOC.     

The relevance of the natural history of varicose veins and refunded care

Chronic venous disease (CVD) is one of the most common diseases in our population. Aside from venous symptoms like heaviness and pain, which are present in about 50% of the general population, signs of CVD include varicose veins (VVs), oedema, eczema, venous eczema, hyperpigmentation, white atrophy, lipodermatosclerosis and venous ulcers. The aim of this paper is to review current literature for the relevance of natural history of VVs in refunded care. Available papers on VVs, progression of the disease and complications were reviewed. Prevalence of VVs is high with more than 20% in the general population. Information on progression of uncomplicated VV to chronic venous insufficiency (CVI) is rare. However, most venous ulcers have a primary venous origin. The progression rate of VV to higher clinical stages reaches 4% per year. Among the risk factors are obesity and higher age. Quality of life (QOL) is also reduced in uncomplicated VV in C2 patients. In conclusion, there is evidence from the literature that a high proportion of patients with uncomplicated VVs in the clinical, aetiological, anatomical and pathophysiological classification (CEAP Clinical Class 2) will progress to CVI if untreated. VVs have a negative impact on QOL and clinical symptoms. VV patients with CVI (C3-C6) as well as those C2 patients with severe clinical symptoms and impaired QOL due to CVD should be treated with ablation of the VVs in a refunded care system.     

Impact of musculoskeletal disorders on quality of life: an inception cohort study

OBJECTIVE: To assess longitudinally the impact of new onset musculoskeletal (MSK) disorders on quality of life (QoL). METHODS: An inception cohort of 1202 subjects in France aged 45-60 years was determined to be free of MSK problems at baseline. Over 28 months of follow up between 1996 and 1998, 310 were diagnosed with MSK disorders and matched for age and sex with 620 healthy controls. The impact of the MSK disorder onset on QoL was assessed by the change in SF-36 dimension scores over time, using a linear mixed ANOVA model to compare the groups. RESULTS: The incidence of MSK disorder was 13.6% per person-year in the spine, 4.2% per person-year in a joint, and 4.6% per person-year at an extra-articular site. The greatest change in QoL was a 10 point drop in the 100 point SF-36 bodily pain dimension scale in the MSK group. Compared with controls, subjects with an MSK disorder had significantly greater reductions in the following dimensions: bodily pain (a -7.4 point difference in change), vitality (-2.7), general health (-1.8), and physical functioning (-1.3). Within the MSK group, chronic disorders had a greater impact than acute ones on the physical functioning (-2.1), role emotional (-8.4), and social functioning (-5.9) dimensions. CONCLUSION: New onset MSK disorders have a marked deleterious effect on QoL in the physical domain, with lesser effects on social and mental functioning. This evidence of an early significant impact on their QoL reinforces recent recommendations for early treatment and primary prevention.     

Assessing the utility of five domains in SF-12 Health Status Questionnaire in an AIDS clinical trial

OBJECTIVE: To assess a shortened quality-of-life (QoL) measurement tool in a population with advanced HIV infection. DESIGN: Five domains (seven items) in a 12-item questionnaire (SF-12) were compared with those same domains in a 39-item questionnaire (SF-39). Data were collected using SF-39 in a randomized clinical trial for the prevention of cytomegalovirus disease. METHODS: The performance of SF-12 relative to SF-39 was evaluated within each domain by comparing QoL scores at baseline and over time, assessing the reliability and validity for both instruments, assessing item consistency and discrimination within instruments, and implementing event-time analyses that quantified dependence of the hazard for death and progression of disease (POD) on baseline values. RESULTS: Baseline measures are similar for both instruments, with high correlation within each domain. The slopes over time for the SF-12 and SF-39 domains are also similar. Both the SF-12 and SF-39 domains have satisfactory reliabilities and perfect discrimination. The hazard ratios for death and POD are similar for both instruments within a domain. All SF-12 and most SF-39 domains are highly predictive for death but are not highly predictive for POD. CONCLUSIONS: For the domains considered, SF-12 is a reasonable and effective replacement for SF-39 in studies of patients with advanced HIV disease. SF-12 reduces item redundancy and the burden of data requirements for both investigators and patients; consequently, it may improve compliance with form completion.     

Effect of body mass index on quality of life in allergic/asthmatic patients.

Evaluation of quality of life (QoL) is of particular interest in patients suffering from chronic diseases. Although studies have shown an association between QoL and obesity and allergy/asthma, the effect of obesity on QoL is not well known. The aim of this study was to assess the impact of body mass index (BMI) as a contributory factor on QoL in patients with a diagnostic label of allergy/asthma. We surveyed 100 patients (69 F/31 M) (age 34.15+/-13.32 years), and 65 healthy controls (42 F/23 M) (age 35.45 +/-8.96 years). QoL was determined by SF-36. BMI > or = 25 kg/m(2) was accepted as overweight/obesity. Forty-five percent of the patients had BMI > or = 25 kg/m(2) with no difference between the genders. They were significantly older and more likely to have less education level than those with BMI < 25 kg/m(2). Quality-of-life scores among patients with allergy/asthma were lower than those in the control group, irrespective of BMI. However, increased BMI was found to be related with improved quality of life among controls. Pearson's analysis showed that BMI was inversely correlated with physical functioning among patients (r = -0.229, p = 0.034), but in the control group it was positively correlated with QoL. All the domains of SF-36, except role-physical ones, among female subjects were significantly impaired more than those of male patients. It has been shown that the major determinants of impaired QoL are female sex, older age, and less educational status in patients with allergic/asthmatic symptoms. The impact of BMI on QoL could be undermined, because it seems to play a minor role.     

Chronic venous insufficiency: worldwide results of the RELIEF study. Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids

Chronic venous insufficiency (CVI) results in considerable morbidity and may seriously affect patients' quality of life. The RELIEF (Reflux assEssment and quaLity of life improvEment with micronized Flavonoids) Study was a prospective controlled study designed to assess differences in the severity and in the evolution of symptoms and signs of CVI according to presence or not of venous reflux. Patients were thus separated into 2 comparative groups: those presenting venous reflux and those without venous reflux. The design of the study was multicentric and international, carried out in 23 countries over 2 years, in which 5,052 symptomatic patients assigned to classes C0 to C4 (on the basis of CEAP clinical classification) were enrolled. Patients were treated with micronized purified flavonoid fraction (MPFF), consisting of 450 mg of micronized diosmin and 50 mg of flavonoids expressed in hesperidin over 6 months. In order to document changes in the quality of life of these patients during MPFF treatment, a new validated Quality of Life Questionnaire specific to CVI (CIVIQ) was used. The study also set out to gather epidemiologic data including the prevalence of venous reflux in symptomatic patients. The RELIEF study provided important information about the epidemiology and clinical manifestations of CVI. Of particular interest was the observation that venous reflux was found to be absent in 57% of patients diagnosed as suffering from CVI belonging to CEAP classes C0 to C4. A positive relationship between symptoms of CVI (pain, leg heaviness, sensation of swelling, and cramps) and presence of venous reflux was found in the RELIEF study: symptoms were more frequent and more severe at presentation in patients with venous reflux. Moreover, during MPFF treatment, all symptoms showed a greater decrease in the group without venous reflux compared with the other group. This difference in the evolution of symptoms between the 2 groups was significant for pain, sensation of swelling, and cramps. Regarding leg heaviness and signs such as edema (assessed by leg circumference), patients improved equally independently of the presence or not of venous reflux. The significant and progressive improvement in the signs of CVI was reflected in significant changes in the clinical class of the CEAP classification, ie, from more severe to less severe stages. Continuous clinical improvement was found throughout the study and after treatment with MPFF for 6 months, the clinical scores of all symptoms and signs had significantly decreased (p=0.0001 versus DO) in both groups. This improvement was also associated with a significant and continuous progression in the quality of life scores of all patients. Age of patients, average time since diagnosis, and presence of venous reflux increased with the severity of the disease. The relationship shown in this study between these parameters and clinical CEAP classification reflects the progressive nature of CVI. Despite obvious symptoms of CVI, a very low percentage (21.8%) of the "intention-to-treat" (ITT) population had previously been treated. This was the case whether venous reflux was present or not.     

Health-related quality of life and fatigue in patients with adrenal incidentaloma

The objective of the present study was to examine several dimensions of quality of life (QoL) and fatigue in patients with adrenal incidentaloma. This was a case-control study designed to analyze patient outcomes using three validated generic QoL questionnaires, EQ-5D, SF-36, and MFI-20, the results of which were compared to those obtained for age- and sex-matched controls. The study population comprised 139 consecutive patients with nonfunctioning adrenal masses (104 females, 35 males; age 59.1 ± 10.8) and 139 age- and sex-matched controls. Reduced QoL was found in patients with adrenal incidentaloma as compared to controls. Dimensions of QoL that were notably affected included mobility (P = 0.03), performance of usual activities (P = 0.002), and anxiety/depression (P = 0.04) as evaluated using the EQ-5D; physical functioning (P < 0.001), physical role (P < 0.001), general health (P < 0.001), vitality (P = 0.001), social functioning (P = 0.001), and emotional role (P < 0.001) as evaluated using the SF-36; and physical fatigue (P = 0.04) as assessed using the MFI-20 questionnaire. In addition, perceived health on a visual analogue scale was also significantly lower in patients than in controls (64.8 ± 19.2 vs. 77.1 ± 15.1; P < 0.001). Patients with adrenal incidentaloma reported reduced QoL and a higher level of physical fatigue compared to age- and sex-matched controls. This subject will benefit from further studies comparing QoL outcomes of laparoscopic adrenalectomy versus no treatment in patients with adrenal incidentaloma.     

Effect of elastic stockings on edema related to chronic venous insufficiency. Videocapillaroscopic assessment

AIM: To evaluate the effect of class II (23-32 mm Hg) compression stockings on the edema of the ankle in patients with chronic venous insufficiency (CVI), and to assess the relationship between the microvascular phenomenon and the volume of the leg. MATERIAL AND METHOD: 11 patients (19 limbs, 5 women and 6 men, mean age 57 years) with CVI, CEAP 2-3 were studied through physical examination, Doppler color ultrasound test, measurement of leg volume and videocapillaroscopy. Patients were evaluated before (T0), after 7 days (T1) and 14 days (T2) of daily compression therapy with elastic stockings. Statistical comparisons used the Mac Nemar test for binomial variables and Wilcoxon test for paired quantitative data. RESULTS: All patients experienced significant improvement of symptoms, the volume of the limbs on the average decreased in the first week T0-T1=284.8 cm(3) +/- 307.5 cm(3) (6.27%, p<0.001). During the second week a small increase in volume was observed T2-T1=+ 12.23 cm(3), NS, 0.29%). The width of the capillary halo of edema decreased during the first week by an average of T0-T1=5.77 microm +/- 10.99 microm. During the second week the width of the edema halo continued diminishing, although in smaller proportion (T0-T2=7.89 microm +/- 11.77 microm). CONCLUSION: Daily use of grade II compression stockings induces a reduction in leg volume in patients with CEAP grades 2-3. This improvement of edema is paralleled by a decrease in the size of the pericapillary halo.     

Acceptability and Psychometric Properties of the Minnesota Living With Heart Failure Questionnaire Among Patients Undergoing Heart Valve Surgery: Validation and Comparison With SF-36

BackgroundHealth-related quality of life (HQOL) enhancement is a major objective of valvular surgery (VS), but assessments have been limited primarily to generic measures that may not be optimally responsive to intervention. Disease-specific instruments have been used in heart failure (HF), commonly associated with valve disease, but have been neither validated nor routinely applied among patients undergoing VS.Methods and ResultsWe administered the Minnesota Living with Heart Failure (MLHFQ) and SF-36 questionnaires preoperatively (T₀) to 50 patients undergoing VS and at 1 (T₁) and 6 months (T₂) after VS. Performance of MLHFQ was evaluated and compared with SF-36. MLHFQ completion rates were >98% (NS vs. SF-36); Cronbach's α was ≥0.9 (total score, dimensions), supporting internal reliability. Confirmatory factor analysis verified good model fit for physical/emotional domain items (relative chi-squares <3.0, critical ratios >2.0, both instruments), supporting structural validity. Spearman coefficients correlating MLHFQ with parallel SF-36 domains were moderate to high (0.6-0.9; P ≤ .001: T₀-T₂), supporting convergent validity. Baseline HQOL was poorest in patients with HF (P ≤ .05 [both instruments]), supporting criterion validity. Responsiveness (proportional HQOL change scores: T₀ vs. T₂) to VS was greater with MLHFQ vs. SF-36 (P ≤ .002).ConclusionsAmong patients undergoing VS, the MLHFQ is highly acceptable and maintains good psychometric properties, comparing favorably with SF-36. These findings suggest its utility for measuring disease-specific HQOL changes after VS.     

RELIEF study: first consolidated European data. Reflux assEssment and quaLity of lIfe improvement with micronized Flavonoids

The RELIEF study (Reflux assEssment and quality of life improvement with micronized Flavonoids in chronic venous insufficiency [CVI]) is a prospective, controlled, multicenter, international study performed in patients with or without venous reflux. This study was conducted between March 1997 and December 1998 in 23 countries worldwide with the participation of more than 10,000 patients suffering from CVI. The European countries, the subject of this report, were represented by the Czech and Slovak Republics, Hungary, Poland, Russia, and Spain. The principal aims of the study were: 1. To validate the first quality-of-life scale specific to chronic venous insufficiency (CMVIQ) in different languages and to assess the evolution of quality of life in patients suffering from CVI, with or without venous reflux, treated with micronized purified flavonoid fraction (MPFF*) (1,000 mg/day). 2. To collect international epidemiologic data on venous reflux assessed with pocket Doppler and photoplethysmography. 3. To assess the evolution of symptoms and signs with a specific emphasis on edema through validated Leg-O-Meter measurement (heaviness, pain, cramps, sensation of swelling, edema) in patients suffering from CVI and treated with MPFF, 1,000 mg/day, during 6 months. The first country-by-country statistical analysis and the European consolidated analysis are now available. The CIVIQ questionnaires adapted to each participating country have been validated with highly significant validity and reproducibility (p<0.0001). All dimensions have demonstrated a highly significant and evolving improvement during the study. The results show several interesting findings concerning the epidemiologic data and, of these, two were particularly interesting: - More than 50% of patients suffering from CVI (class 0 to 4 of the CEAP classification) were reflux-free, which means that they were suffering from functional CVI. Patient distribution between the different classes of the CEAP classification changed in a statistically significant manner after 6 months' treatment with MPFF; the number of patients in the more severe classes decreased to the benefit of the less severe classes. Symptoms such as pain, leg heaviness, sensation of swelling, and cramps were significantly improved (p=0.0001). This was associated with a significant decrease in edema, when present, measured by leg circumferences with the Leg-O-Meter (p=0.0001). In conclusion, the European results of the RELIEF study showed the perfect validity and reproducibility of CIVIQ questionnaire adaptations, and the positive progression of quality-of-life scores on MPFF treatment. This progression was paralleled by clinical improvement of patients reflected not only by assessment of CVI symptoms and signs but also by evolution of the CEAP classification.     

Impact of rate versus rhythm control on quality of life in patients with persistent atrial fibrillation. Results from a prospective randomized study.

AIMS: Despite the high prevalence of atrial fibrillation (AF), there are only limited data on quality of life (QoL) stemming from prospective trials comparing rate versus rhythm control. This prospective study evaluated QoL in patients with symptomatic persistent AF randomized to therapy aiming at rate versus rhythm control. METHODS AND RESULTS: Patients with symptomatic persistent AF (7 to 360 days duration) were prospectively randomized to ventricular rate control (n=125) or to cardioversion and maintenance of sinus rhythm (n=127). QoL was assessed by the Medical Outcomes Study Short Form health survey (SF-36) at baseline and during 1 year of follow-up. Changes in QoL were compared on an intent-to-treat basis, and subsequently between patients in sinus rhythm versus AF. At baseline, all SF-36 scales were reduced compared to healthy controls. At 1 year, six of eight items had improved significantly in patients assigned to rate control, and five of eight items on rhythm control (p=ns). The physical component summary showed a comparable increase with both treatment strategies (rate control: p=0.004; rhythm control: p<0.001) whereas no significant changes were found for the mental component summary. At 1 year, 55% of patients reported a positive health transition with no inter-group differences. There were no significant differences in QoL in patients in sinus rhythm or AF at the end of the observation period. CONCLUSION: In patients with symptomatic persistent AF, the two treatment strategies of rate versus rhythm control are associated with similar improvements in QoL.     

Impact of irritable bowel syndrome on patients' lives: development and psychometric documentation of a disease-specific measure for use in clinical trials

OBJECTIVE: To develop a disease-specific questionnaire to capture the impact of irritable bowel syndrome (IBS) and its treatment on patients' lives, the Irritable Bowel Syndrome Impact Scale (IBS-IS). PATIENTS AND METHODS: One hundred and fifty-five IBS patients participated (126 (81%) female; age (mean+/-SD) 45.5+/-12.4 years). We developed the initial 39 items from the literature, available IBS-specific instruments and input from physicians, nurses and patients. We deleted IBS-IS items with a high ceiling effect, items that measured a different construct and items showing a high correlation (r>0.90) with another item and with Rasch analysis, leaving 26 items. We then applied exploratory factor analysis to examine domain groupings. Subjects completed the IBS-IS instrument, the Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS), Short Form-36 (SF-36), Visceral Sensitivity Index (VSI), and Hospital Anxiety and Depression (HAD) scale. Internal consistency, construct validity and discriminate validity were assessed. RESULTS: The 26 items represented five domains: fatigue, impact on daily activities, sleep disturbance, emotional distress and eating habits. The internal consistency reliability for the domains was 0.87 to 0.96. Most associations between similar constructs in the IBS-IS, GSRS-IBS, SF-36, VSI, and HAD were >0.40. Each IBS-IS domain score decreased with increasing IBS symptom severity (P<0.05), and the patients scored >5 score units lower than a US general population scored on all eight SF-36 dimensions. CONCLUSION: The IBS-IS is a short, user-friendly instrument with excellent psychometric properties that has potential usefulness for clinical trials.     

Health-related quality of life in multiple musculoskeletal conditions: a cross-sectional population based epidemiological study. II. The MAPPING study

OBJECTIVE: Musculoskeletal conditions are a major burden on individuals, health systems, and social care systems. The objective of the MAPPING study was to assess the impact of musculoskeletal conditions on health-related quality of life (HRQL) in an Italian population sample. METHODS: Trained rheumatologists carried out structured visits in which subjects were asked about musculoskeletal symptoms and socio-demographic characteristics, completed validated instruments for measuring HRQL, such as the Short Form 36 items status survey questionnaire (SF-36), the EUROQoL five item questionnaire (EQ-5D), and chronic pain severity (Chronic Pain Grade - CPG questionnaire), and underwent a standardized physical examination. We considered a sample size of 576 patients diagnosed as having had musculoskeletal conditions. For the purposes of this study, musculoskeletal diseases were classified into 4 diagnostic groups: inflammatory rheumatic diseases (IRD), symptomatic peripheral osteoarthritis (SPOA), low back pain (LBP), and soft tissue disorders (STD). Cases were defined by previously validated criteria. RESULTS: The 4 major musculoskeletal disease groups, compared to non-sufferers, significantly impaired all eight health concepts of the SF-36 in the following order of magnitude: IRD, SPOA, STD, and LBP. Similar results were found for EQ-5D. The most striking impact was seen for SF-36 physical measures. On multiple regression modelling the physical component (PCS) of the SF-36 was influenced by female sex, age, high BMI, and low educational level (all at a p level < 0.001), and by manual occupation (p = 0.028) and chronic co-morbidity (p = 0.035) in LBP In SPOA, factors influencing physical function were age (p = 0.0001), low educational level (p = 0.006), female sex (p = 0.028), and chronic co-morbidity (p = 0.037). Moreover, an association on chronic co-morbidity and low educational level (both at a p level < 0.001), age (p = 0.004), and manual occupation (p = 0.035) was found with IRD, as well as of chronic co-morbidity and low educational level (both at a p level < 0.001), female sex (p = 0.006) and high BMI (p = 0.036) with STD were also found. Similar results were found for EQ-5D. CONCLUSIONS: The MAPPING study indicates that musculoskeletal conditions have a clearly detrimental effect on the HRQL and one third of the adult population in Italy visited at least one physician for musculoskeletal problem in the past year. These results enable a comparison to be made of the burden of musculoskeletal conditions with that of other common chronic conditions.