Prospective evaluation of health-related quality of life in patients with deep venous thrombosis

BACKGROUND: To our knowledge, the burden of deep venous thrombosis from the patient's perspective has not been quantified. We evaluated health-related quality of life (QOL) after deep vein thrombosis and compared results with general population norms. METHODS: This was a multicenter prospective cohort study of 359 consecutive eligible patients with deep vein thrombosis recruited at 7 Canadian hospital centers. Quality of life was assessed at baseline and at 1 and 4 months after diagnosis using generic (36-Item Short-Form Health Survey) and disease-specific (Venous Insufficiency Epidemiological and Economic Study [VEINES]-QOL and VEINES symptom [VEINES-Sym] questionnaires) measures. Changes in QOL scores during the 4-month period were calculated, and determinants of lack of improvement in QOL were evaluated. RESULTS: During the 4 months, mean 36-Item Short-Form Health Survey physical and mental component summary scores improved by 5.1 and 4.6 points, respectively, and VEINES-QOL and VEINES-Sym scores improved by 3.1 and 2.2 points, respectively (P < .001 for time trend for all measures). However, about one third of patients had worsening of QOL during follow-up. Multivariate analyses showed that worsening of the postthrombotic syndrome score was an independent predictor of worsening of 36-Item Short-Form Health Survey physical component summary (P = .04), VEINES-QOL (P < .001), and VEINES-Sym (P < .001) scores. The 36-Item Short-Form Health Survey physical component summary scores were lower than population norms at all points assessed. CONCLUSIONS: On average, QOL improves during the 4 months following deep vein thrombosis. However, in about one third of patients, QOL deteriorates, and at 4 months, average QOL remains poorer than population norms. Worsening of the postthrombotic syndrome score is associated with worsening of QOL.     

Villalta scale: goals and limitations

The post-thrombotic syndrome (PTS) is a common, debilitating complication following deep venous thrombosis. PTS is a syndrome for which it has been difficult to provide a clear definition. PTS was defined as chronic venous signs/symptoms after a deep venous thrombosis. A number of scales are available to diagnose PTS, but there is a strong need for standardization. The Villalta scale was chosen as the standardized PTS scale. The Villalta scale has been validated in several studies and shows good correlation with generic and disease-specific quality of life scales. The inter-observer rate between study nurses and physicians was shown to be very good. Furthermore, the scale shows good discriminative properties among the different severity groups of PTS. The Villalta scale is useful for use in randomized controlled trials and it allows pooling of data from different studies. The Villalta scale should undergo further validation on intra-rater reliability. Ongoing randomized controlled trials will further validate the Villalta scale for use in PTS.     

Frequency and determinants of the postthrombotic syndrome after venous thromboembolism

PURPOSE OF REVIEW: Postthrombotic syndrome (PTS) is the most common complication of deep venous thrombosis (DVT). Identifying which patients are at high risk of developing PTS would help improve the management of patients with DVT and allow physicians to provide patients with individualized information on their expected prognosis. This review discusses the knowledge gained from key studies over the last decade on the incidence and determinants of PTS, with special emphasis on published studies from the last 2 years. RECENT FINDINGS: About a third to half of DVT patients will develop PTS, in most cases within 1-2 years of acute DVT. Important risk factors for PTS appear to be ipsilateral recurrence of DVT, poor quality of initial anticoagulation for the treatment of DVT and increased body mass index. SUMMARY: Preventing DVT recurrence by providing adequate intensity and duration of anticoagulation for the initial DVT and using effective thromboprophylaxis in high-risk settings is likely to reduce the frequency of PTS. Despite some advances in identifying risk factors for PTS, however, it is still not possible to reliably predict an individual patient's risk of developing PTS after an episode of DVT. Further studies of clinical determinants and biological markers of increased risk of PTS are needed to ultimately improve long-term prognosis after DVT.     

The role of comorbidity burden for patients with symptomatic peripheral arterial disease (PAD). A quantitative approach.

AIM: Comorbidity will play an increasingly important role in PAD management. Therefore, we aimed 1) to address the comorbidity load of PAD patients quantitatively and comprehensively, 2) to delineate the effects of composite comorbidity measures on general and disease-specific aspects of quality of life and on crude markers of resource allocation. METHODS: One hundred and one consecutive symptomatic PAD patients (80 males, 21 females; mean age: 66.4 +/- 9.1 years) were assessed by means of a cumulative illness rating scale (CIRS: 14 items; individual item rating from 1 for no through 5 for life-threatening impairment). Outcome measures were the illness severity score (CIRS-IS, mean of all single item scores) and the comorbidity index (CIRS-CI, number of single items with a score of 3, 4 or 5). These comorbidity indices of the PAD patients were compared with those of both 89 elderly community-dwelling volunteers (44 males, 45 females, mean age 77.4 +/- 5.3 years) we had investigated previously and 439 geriatric residents (121 males, 318 females; mean age 84.1 +/- 5.7 years) reported by Parmelee et al. in 1995. Furthermore, the PAD patients estimated their quality of life (LQ), subjective health status (HS), leg pains during either rest or walking on rating scales (ranging from 0 for the best to 10 for the worst result). RESULTS: PAD patients showed very high comorbidity indices and illness severity scores (CIRS-CI: 3.98 +/- 1.60; CIRS-IS: 1.86 +/- 0.29). These proved to be greater than those of both fit community-dwelling elderly subjects (CIRS-CI: 1.82 +/- 1.46; CIRS-IS: 1.62 +/- 0.22) and older institution residents (CIRS-CI: 2.17 +/- 1.85; CIRS-IS: 1.64 +/- 0.34). Furthermore, both CIRS-CI and CIRS-IS were significantly greater in patients with more advanced PAD stage. These indices of comorbidity load were also associated with quality-of-life impairments (r=0.253, p=0.0186), degree of ischemic rest pain (r=0.251, p=0.0196), extent of medication usage (r=0.511, p<0.0001) as well as duration of in-hospital stay (r=0.271, p=0.0084). CONCLUSION: PAD patients have a markedly increased comorbidity burden. This was greater in the more advanced PAD stages and significantly associated with quality-of-life reductions and the extent of resource allocation. A quantitative approach to the comorbidity load in PAD patients appears to be possible by means of such a scale and useful for both clinical and socioeconomic purposes.     

Long-term follow-up of patients with suspected deep vein thrombosis of the upper extremity: survival, risk factors and post-thrombotic syndrome

BACKGROUND: The outcome of upper extremity thrombosis in terms of morbidity, mortality and arm functionality is virtually unknown. We investigated mortality, risk factors, recurrent thrombosis and post-thrombotic syndrome (PTS) in patients with suspected upper extremity thrombosis. METHODS: Consecutive patients suspected of having deep vein thrombosis (DVT) of the upper extremity were followed for up to 53 months (mean 21 months). Venography and/or ultrasonography was used for diagnosis. Risk factors were identified from history and thrombophilia laboratory screening. PTS was assessed using a scoring system. Death, recurrent thrombosis and PTS were primary outcome measures. RESULTS: DVT of the upper extremity was diagnosed in 50 of 116 consecutive patients (43%). Malignancy and/or central venous lines were present in 37 of 50 (74%) patients with thrombosis. Inherited thrombophilia was diagnosed in 6 of 30 (20%) and 4 of 33 (12%) of the investigated patients with and without thrombosis, respectively (not significant). Twenty-five patients (50%) with thrombosis died during the follow-up period; this was associated with cancer in 84% of the deaths. Recurrent thrombosis was observed in four patients (8%) during follow-up. Symptoms of PTS were present in 4 of 22 patients (18%) with thrombosis and in 14 of 36 patients (39%) in whom thrombosis was excluded. CONCLUSIONS: Malignancy and central venous lines are major risk factors of upper extremity thrombosis. Thrombophilia seems to be unrelated to the presence or absence of upper extremity thrombosis. Thrombosis in combination with malignancy predicts poor survival. A scoring system can be used to assess the severity of PTS, but it does not discriminate PTS from other causes of arm complaints.     

Acute effects of exercise in patients with previous deep venous thrombosis: impact of the postthrombotic syndrome

BACKGROUND: The postthrombotic syndrome (PTS) occurs frequently after deep venous thrombosis (DVT) and is believed to worsen with upright posture and physical activity. However, the effects of exercise in patients with previous DVT have not been studied. STUDY OBJECTIVES: To determine whether previous DVT and PTS limit the ability to exercise, and whether exercise increases the severity of venous symptoms and signs. DESIGN AND SETTING: A repeated-measures cohort study that was conducted at a university-affiliated teaching hospital, 1999-2000. PARTICIPANTS: Subjects with a first episode of unilateral DVT at least 1 year earlier were recruited from the Thrombosis Clinic (total, 41 subjects; with PTS, 19 subjects). INTERVENTION: Treadmill exercise session. Measurements and results: Venous symptoms, calf muscle fatigability, flexibility, and leg volume before and after treadmill exercise were measured and compared. Exercise did not worsen venous symptoms, despite a higher gain in affected leg volume in subjects with PTS vs subjects without PTS (mean difference: affected leg, 53 mL; unaffected leg, -15 mL; p = 0.018). Calf flexibility significantly improved after exercise in subjects with PTS (gastrocnemius: affected-unaffected, PTS vs no PTS + 4.5 degrees, p = 0.0029; soleus: affected-unaffected, PTS vs no PTS + 5.7 degrees, p = 0.0011). CONCLUSIONS: Exercise did not acutely exacerbate symptoms and, in subjects with PTS, resulted in improved flexibility in the affected leg. Our findings suggest that treadmill or similar exercise is unlikely to make symptoms of PTS worse, and may improve flexibility. Further study is indicated to determine whether a regular exercise-training program might have a role in the management of patients with PTS, since, to date, the treatment options for this condition are limited.     

Minimal clinically important difference for the UCSD Shortness of Breath Questionnaire

PURPOSE: A minimal clinically important difference (MCID) is important in evaluating clinical measures such as health-related quality of life (HRQOL) instruments. The purpose of this analysis is to evaluate MCID for the UCSD Shortness of Breath Questionnaire (SOBQ). METHODS: We examined measures of disease-specific and generic HRQOL in 164 subjects with chronic lung disease before and after pulmonary rehabilitation. Subjects completed 2 disease-specific [SOBQ, Chronic Respiratory Questionnaire (CRQ)], and 2 generic HRQOL measures [RAND-36 and Quality of Well-Being Scale (QWB)]. The MCID was calculated using 3 methods: effect size, standard error of the measurement (SEM), and comparison between the SOBQ and CRQ Dyspnea scores. RESULTS: HRQOL measures correlated moderately with measures of maximum exercise tolerance but not with lung function (FEV1, FVC). HRQOL and exercise capacity improved significantly after pulmonary rehabilitation. A change of 5 units for the SOBQ appears to be a reasonable MCID for this instrument. The calculated MCIDs for the CRQ (0.47/item) and QWB (0.031) were consistent with established change scores. CONCLUSIONS: The MCID calculated using an SEM approach for the SOBQ, CRQ, and QWB meets clinical expectations for these instruments. HRQOL measures provide information that is complementary and distinct from physiological measures.     

Dyspnea as clinical indicator in patients with chronic obstructive pulmonary disease

The aim of this study was to evaluate the relationship between dyspnea and functional, psychosocial and quality of life parameters among persons with chronic obstructive pulmonary disease (COPD). We conducted a cross-sectional study of 90 stable COPD patients recruited from a specialized respiratory clinic. Dyspnea was measured using the ATS-DLD-78 questionnaire modified dyspnea scale (1-5 scale). Physical and functional evaluation included spirometry and six minute walking tests. Subjects then completed five psychological questionnaires: the Coping Inventory for Stressful Situations, the State/Trait Anxiety Inventory, the Beck Depression Index, the NEO-Five Factor Personality Inventory, and the Interpersonal Relationships Inventory. Patients also completed two disease-specific health-related quality of life (HRQL) questionnaires: St. George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Questionnaire (CRQ). Subjects were predominantly male (n = 65) with a mean age of 68 years (+/- standard deviation 7.6). Over half (54%) the patients reported severe dyspnea (grade 5), and a quarter (24%) reported moderate dyspnea (grade 3-4). Mean FEV1 was 37.8 +/- 14.8% predicted. The mean total SGRQ score was 49 +/- 16 and the CRQ total score was 4.2 +/- 0.9. Dyspnea severity was associated with poorer HRQL scores and decreased physical performance. Based on linear regression, dyspnea scores--but not spirometric values--also correlated with indices of anxiety, depression, and neuroticism. Dyspnea correlated more strongly with HRQL and with indices of anxiety and depression than spirometric values. Although spirometry is often used to evaluate disease severity, dyspnea which is a patient centered outcome better reflect overall disease impact among COPD patients.     

Effect of pulmonary rehabilitation on quality of life in patients with COPD: the use of SF-36 summary scores as outcomes measures

PURPOSE: Pulmonary rehabilitation (PR) is an accepted therapy for patients with chronic obstructive pulmonary disease (COPD), improving both exercise capacity and quality of life (QOL). Generic measures of QOL have been criticized as being insensitive to detecting the improvement in QOL after PR in contrast to disease-specific instruments. The authors looked at the Medical Outcomes Survey Short Form 36-item questionnaire (SF-36), a generic QOL measure, to detect changes in QOL in COPD patients after completion of PR. METHODS: Patients with COPD who participated in a PR program completed the QOL questionnaire before and after completion of PR. Exercise tolerance was assessed by the 6-minute walking test. Quality of life was assessed by the SF-36; the authors calculated its eight dimensions as well as mental (MCS) and physical (PCS) component summary scores. RESULTS: The patients realized a significant improvement in exercise tolerance; 6-minute walking test distance increased from 470 +/- 104 m (mean +/- standard deviation) to 536 +/- 133 m (P = 0.0006) after PR. Quality of life also improved in nearly all dimensions and in both summary scores; PCS improved from 26.1 +/- 8.0 before PR to 30.5 +/- 9.0 after PR (P = 0.008) and MCS improved from 27.9 +/- 7.0 before PR to 34.1 +/- 5.0 after PR (P = 0.0002). CONCLUSION: The SF-36 and its summary scores are sensitive instruments to detect improvement in QOL in COPD patients after PR.     

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.     

Estimated annual costs of prophylaxis and treatment of venous thromboembolic events associated with major orthopedic surgery in France.

Venous Thromboembolism (VTE) remains a major complication following orthopedic surgery despite heparin prophylaxis. Clinical consequences associated with this complication are deep vein thrombosis (DVT), pulmonary embolism, and long-term consequences of DVT, especially Postthrombotic syndrome (PTS). The purpose of the present study was to estimate the annual direct costs of VTE following major orthopedic surgery of the lower limb in France. This cost of illness study was performed by using available information from health system databases (1999) and literature and specific surveys (2002). Direct costs were calculated by using estimates of the number of patients with major orthopedic surgery in France during one year. Patients presenting with VTE were identified from the national disease-related group inpatient database. Additional resource consumption was identified by comparison with disease-related groups without the VTE complications. Ambulatory care costs after hospitalization, for recurrences and PTS, were estimated from specific surveys of general practitioners and venous disease specialists. Total annual costs of VTE associated with major orthopedic surgery for the French Sickness Fund were estimated to be approximately 60 million euros over 1 year with 28 million euros for inpatient care and 30 million euros for recurrences and PTS.     

The Post-thrombotic Syndrome: The Forgotten Morbidity of Deep Venous Thrombosis

The postthrombotic syndrome (PTS) is the most common complication of deep venous thrombosis (DVT) yet has received little attention from clinicians and researchers. Clinically, PTS is characterized by chronic pain, swelling, heaviness and other signs in the affected limb. In severe cases, venous ulcers may develop. PTS is burdensome and costly to patients and society because of its high prevalence, severity and chronicity. Preventing DVT with the use of effective thromboprophylaxis in high-risk patients and settings and minimizing the risk of ipsilateral DVT recurrence are likely to reduce the frequency of PTS. Compression stockings worn daily after DVT appear to reduce the incidence and severity of PTS but questions regarding their use and effectiveness remain. Future research should focus on identifying patients at high risk for PTS, assessing the role of thrombolysis in preventing PTS and evaluating the optimal use of compression stockings in preventing and treating PTS. In addition, new therapies to treat PTS should be sought and evaluated.     

Prevalence of the post-thrombotic syndrome in young women with previous venous thromboembolism

The prevalence of mild, moderate and severe post-thrombotic syndrome (PTS) among 43 young women with a previous single episode of deep vein thrombosis (DVT) was 67%, 7% and 0% respectively. Subjects were assessed at a mean 51 months after the event. Moderate PTS was more common in women with recurrent (n = 9) DVT (44%, P < 0.001). Chronic venous insufficiency, assessed by light reflection rheography (LRR), was significantly (P < 0.05) more prevalent in women with single previous DVT (n = 40), recurrent DVT (n = 9) and isolated pulmonary embolism (PE) (n = 19) compared with healthy age-matched controls (odds ratios 10.9, 52.4 and 3.8 respectively). LRR findings correlated with moderate, but not mild, PTS. There was no correlation between development of PTS and body mass index.     

Quality of Life Variables in the Selection of Rate Versus Rhythm Control in Patients with Atrial Fibrillation: Observations from the Canadian Trial of Atrial Fibrillation

Many patients with atrial fibrillation develop symptoms attributable to the cardiac arrhythmia itself. These symptoms may be improved either by restoring sinus rhythm or by controlling the rapid and irregular ventricular response that often accompanies this arrhythmia. One of the principal goals of therapy of atrial fibrillation management is improvement of patient symptoms; it is important to quantify these symptoms by some form of quality of life analysis. The Canadian Trial of Atrial Fibrillation (CTAF) was a multi-centre randomized clinical trial of amiodarone compared with either propafenone or sotalol in patients with recent atrial fibrillation. The quality of life (QOL) substudy of CTAF was a prospective, comprehensive assessment of quality of life of patients enrolled in CTAF. Summary measures of physical and mental health on the generic QOL scale (SF-36) improved significantly with treatment from baseline to 3 months (41.9 +/- 9.6 to 43.7 +/- 9.2, p = 0.001 for the physical component and 47.5 +/- 10.4 to 49.0 +/- 9.8, p = 0.023 for the mental component). On an arrhythmia specific scale (SCL), a significant and larger improvement was noted from baseline to 3 months in both arrhythmia symptom frequency and severity (symptom frequency from 20.4 +/- 9.4 to 16.2 +/- 9.5, symptom severity from 16.7 +/- 8.2 to 12.9 +/- 7.6, both p < 0.001). The quality of life improvements were similar in the amiodarone group compared to the sotalol or propafenone groups, both for the SF-36 and the disease-specific symptom checklist (SCL) measures. In contrast, an atrial fibrillation severity scale (AFSS) did show differences between the assigned drug therapies, which were associated with different rates of arrhythmia recurrence in the parent study. By 3 months global well-being was significantly worse for patients who had recurrent atrial fibrillation compared to those who did not (6.9 +/- 1.8 versus 7.4 +/- 1.8, p = 0.04). Similarly, symptom severity at 3 months was 11.8 +/- 7.4 for patients without recurrence, compared to 14.8 +/- 7.4 for those with recurrence ( p = 0.001). Interestingly, none of the usual clinical variables that might be perceived to be associated with quality of life, e.g., male versus female sex, age, NYHA class, beta blocker use, and ejection fraction, had much impact on subjective quality of life measures. Quality of life improves with treatment atrial fibrillation and at least some of these improvements are related to the restoration and maintenance of sinus rhythm.     

Health values of patients with chronic hepatitis C infection

BACKGROUND: Patients with hepatitis C virus (HCV) infection report a reduction in health status, but it is not known how they value their state of health. We assessed health utilities directly from patients with HCV infection. METHODS: One hundred twenty-four patients with chronic HCV infection representing a cross section of disease severity were administered a disease-specific version of the Medical Outcomes Study 36-Item Short-Form Health Survey, the Beck Depression Inventory, and 3 direct health value measures, including the Rating Scale, Time Trade-off (TTO), and Standard Gamble (SG). Correlation among measures and factor analysis was performed. RESULTS: The mean modified Medical Outcomes Study 36-Item Short-Form Health Survey scores were lower than normative population values, particularly on the Physical Component Summary scale. This scale was poorly correlated with the Rating Scale, TTO, and SG scores among HCV-infected subjects. The mean +/- SE TTO score was 0.83 +/- 0.02, and the mean +/- SE SG score was 0.79 +/- 0.02. The TTO and SG scores failed to show significant variability in relation to disease activity as determined by serum alanine aminotransferase level, histologic stage, and presence of decompensated liver disease. The Beck Depression Inventory was significantly inversely correlated with the TTO and SG. CONCLUSIONS: Although quality of life is compromised in patients with chronic HCV infection, patient-derived health utilities are not strongly associated with health status or clinical measures. Utility measures obtained from patients with HCV differ significantly from previous surrogate measures of health values. Such differences in utilities could affect decision analyses and cost-effectiveness analyses of treatment interventions for individuals with HCV infection.     

Comparison of four clinical prediction scores for the diagnosis of lower limb deep venous thrombosis in outpatients

PURPOSE: We compared three scores for the prediction of deep venous thrombosis with a new score designed specifically for outpatients. METHODS: Patients referred for evaluation because of suspected deep venous thrombosis were examined by ultrasonography. Sensitivity and specificity were calculated for three clinical scores (Wells [nine components], Kahn [four components], and St. André [six components]). We developed a new score by multivariate analysis, and then compared this score with the others in a new sample. RESULTS: Four hundred and forty-four outpatients were included in the first sample, of whom 126 (28%) had deep venous thrombosis. The Wells score was a better predictor of deep venous thrombosis than the Kahn and St. André scores. According to the Wells score, 73 patients had a high probability of deep venous thrombosis (of whom 51 [70%] actually had a thrombosis) and 178 had a low probability of deep venous thrombosis (of whom 19 [11%] had a thrombosis). A new score was developed as follows: male sex (+1), lower limb palsy or immobilization (+1), confinement to bed >3 days (+1), lower limb enlargement (+1), unilateral lower limb pain (+1), and other plausible diagnosis (-1). In a validation sample of 282 outpatients, this score identified 31 patients who had a high probability of deep venous thrombosis (score > or =3), of whom 18 (58%) had a thrombosis, and 70 patients who had a low probability (score < or =0), of whom 3 (4%) had a thrombosis. The Wells score and this ambulatory score had similar test operating characteristics in the validation sample. CONCLUSION: Our new six-component score had similar diagnostic utility as the nine-component Wells score among outpatients being evaluated for deep venous thrombosis.     

Clinical course of postthrombotic syndrome in children with history of venous thromboembolism

Postthrombotic syndrome (PTS) is a chronic morbidity of venous thromboembolism (VTE) in children. Information about the evolution of PTS is lacking in children. Present study was aimed to evaluate the time-course of extremity PTS in children who were serially followed in a hematology clinic. This retrospective cohort study included 69 consecutive children with documented VTEs that presented with symptoms of extremity VTE: 67 extremity VTEs with or without extension to vena cava, 2 inferior vena cava VTEs. Severity of PTS was assessed using modified Villalta scale. Median age of the cohort was 12.6 years (interquartile range 1.6-15 years) while median follow-up was 28.7 months (interquartile range 13.3-33.4 months. PTS prevalence was 46.8% [95% confidence interval (CI) 37.9-57.7%]. Lower extremity VTE was associated with development of PTS compared to upper extremity VTE regardless of catheter use (P = 0.002). The time-course of PTS fluctuated in 11 of 33 children (33%; 95% CI 20-47%) at a median interval of 12 months from diagnosis of VTE (range 4-14 months): three progressed from mild/moderate to severe, one improved from moderate to mild, seven fluctuated between mild and moderate. Recurrence and incomplete resolution of VTE were associated with variability in PTS severity (P < 0.05). In summary, this study suggested that almost 50% of study cohort developed PTS, and the time-course of PTS was not static in one third of children. Future research should focus on identifying the predictors contributing to the worsening of PTS and developing risk-stratified treatment interventions so as to improve the outcome of children with VTE.     

Anomalies of the inferior vena cava in patients with iliac venous thrombosis

BACKGROUND: Cases of deep venous thrombosis in the lower extremities triggered by abnormalities of the vena cava have been reported. OBJECTIVE: To describe anomalies of the inferior vena cava in patients with deep venous thrombosis. DESIGN: Prospective, consecutive case series. SETTING: University Hospital, Graz, Austria. PATIENTS: 97 patients with deep venous thrombosis. INTERVENTION: Sonography, venography, or both to diagnose deep venous thrombosis; magnetic resonance angiography to image the inferior vena cava. MEASUREMENTS: Anomalies of the inferior vena cava imaged by magnetic resonance angiography. RESULTS: 31 of 97 patients showed thrombotic occlusion of iliac veins (common and external iliac vein [ n = 29] or external iliac vein [ n = 2]). Five of 31 patients (3 men, 2 women) had an anomaly of the inferior vena cava. Anomalies were missing inferior vena cava, hypoplastic hepatic segment, and missing renal or postrenal segments. Patients with anomalies were significantly younger than the 92 patients without (mean age+/-SD, 25+/-6 years vs. 53+/-19 years; P = 0.002). In 2 patients with anomalies, the thrombotic occlusion was recurrent. CONCLUSIONS: An anomaly of the inferior vena cava should be suspected if thrombosis involving the iliac veins is seen in patients 30 years of age or younger. Patients with both an anomaly and thrombosis may be at higher risk for thrombotic recurrence.     

Impact of rate-modulated pacing on quality of life and exercise capacity—Evidence from the Advanced Elements of Pacing Randomized Controlled Trial (ADEPT)

BACKGROUND: Ninety-nine percent of pacemakers implanted in the United States include an option for rate modulation. OBJECTIVE: The purpose of this study was to determine whether dual-chamber rate-modulated pacing, when compared with dual-chamber pacing alone, improved quality of life. METHODS: This was a single-blind randomized controlled trial comparing dual-chamber with rate-modulated dual-chamber pacing. Patients were enrolled between January 12, 2000, and January 10, 2002, with 1-year follow-up ending December 19, 2002. The study was a U.S. multicenter trial, with 95 sites participating. All patients received a rate modulation-capable dual-chamber pacemaker for standard indications. Patients were screened with an exercise test (Chronotropic Assessment Exercise Protocol) 1 month later. One thousand two hundred seventy-three patients were enrolled; 401 proved ineligible, and 872 (68%) made up the randomized patient cohort. Randomized patients had a mean age of 71 years, 64% were men, and 64% had sinus node dysfunction. Randomization was in a factorial design to (1) dual-chamber rate-modulated pacing versus dual-chamber pacing and (2) automatic mode switching versus no automatic mode switching. The present report is limited to the comparison of rate modulation with no rate modulation (DDDR vs. DDD). The primary endpoint was the score on the Specific Activity Scale, an activity-based cardiovascular disease-specific instrument at 1 year. Secondary endpoints included 6-month treadmill time and additional cardiovascular disease-specific, and generic health-related quality-of-life instruments at 1 year. RESULTS: At 6 months, patients with rate modulation had a higher peak exercise heart rate (rate modulation 113.3 +/- 19.6, no rate modulation 101.1 +/- 21.1; P <.0001). Total exercise time was not different between groups. At 1 year, there were no significant differences between groups with respect to Specific Activity Scale or the secondary quality-of-life endpoints. CONCLUSIONS: We conclude that rate modulation is ineffective in improving the functional status or quality of life of patients with a bradycardia indication for dual-chamber pacing.     

Effects of depressive symptoms on health-related quality of life in asthma patients

OBJECTIVE: To assess the effects of depressive symptoms on asthma patients’ reports of functional status and health-related quality of life. DESIGN: Cross-sectional study. SETTING: Primary care internal medicine practice at a tertiary care center in New York City. PATIENTS: We studied 230 outpatients between the ages of 18 and 62 years with moderate asthma. MEASUREMENTS AND MAIN RESULTS: Patients were interviewed in person in English or Spanish with two health-related quality-of-life measures, the disease-specific Asthma Quality of Life Questionnaire (AQLQ) (possible score range, 1 to 7; higher scores reflect better function) and the generic Medical Outcomes Study SF-36 (general population mean is 50 for both the Physical Component Summary [PCS] score and Mental Component Summary [MCS] score). Patients also completed a screen for depressive symptoms, the Geriatric Depression Scale (GDS), and a global question regarding current disease activity. Stepwise multivariate analyses were conducted with the AQLQ and SF-36 scores as the dependent variables and depressive symptoms, comorbidity, asthma, and demographic characteristics as independent variables. The mean age of patients was 41 ± SD 11 years and 83% were women. The mean GDS score was 11 ± SD 8 (possible range, 0 to 30; higher scores reflect more depressive symptoms), and a large percentage of patients, 45%, scored above the threshold considered positive for depression screening. Compared with patients with a negative screen for depressive symptoms, patients with a positive screen had worse composite AQLQ scores (3.9±SD 1.3 vs 2.8±SD 0.8, P<.0001) and worse PCS scores (40±SD 11 vs 34±SD 8, P<.0001) and worse MCS scores (48±SD 11 vs 32±SD 10, P<.0001) scores. In stepwise analyses, current asthma activity and GDS scores had the greatest effects on patient-reported health-related quality of life, accounting for 36% and 11% of the variance, respectively, for the composite AQLQ, and 11% and 38% of the variance, respectively, for the MCS in multivariate analyses. CONCLUSIONS: Nearly half of asthma patients in this study had a positive screen for depressive symptoms. Asthma patients with more depressive symptoms reported worse health-related quality of life than asthma patients with similar disease activity but fewer depressive symptoms. Given the new emphasis on functional status and health-related quality of life measured by disease-specific and general health scales, we conclude that psychological status indicators should also be considered when patient-derived measures are used to assess outcomes in asthma. This project was supported by a Robert Wood Johnson Foundation Generalist Physician Faculty Scholar’s Award to Dr. Mancuso.