Naftidrofuryl can enhance the quality of life in patients with intermittent claudication.

BACKGROUND: Using a disease specific questionnaire, the CLAU-S, we undertook a double blind, placebo controlled study in patients with intermittent claudication to determine whether the increase in the pain-free walking distance, previously demonstrated with naftidrofuryl, is reflected as an improvement in the patients' quality of life. PATIENTS AND METHODS: 287 patients, with stable intermittent claudication for at least 3 months were entered into the study. Following an initial one month placebo run-in, patients were randomised to either naftidrofuryl, at a dosage of 200 mg three times daily, or matching placebo, for 6 months. All patients completed the self-administered CLAU-S questionnaire which is divided into 6 dimensions, before the start of treatment, at 3 and 6 months. Statistical analysis was undertaken on an intention-to-treat (ITT) basis which included all patients know to have taken at least one dose of the drug and to have provided key data on at least one occasion after baseline. For each of the CLAU-S dimensions the two groups were compared with respect to difference between the initial and final values. RESULTS: 255 patients (133 naftidrofuryl, 122 placebo) were eligible for the ITT analysis. Significant improvements, in favour of the active medication, were seen for the dimensions "daily living", "pain", "disease specific anxiety" and "mood". A multivariate analysis of covariance, which took into account such factors as initial score, age and sex confirmed the global superiority of naftidrofuryl (p = 0.004). CONCLUSIONS: In this placebo controlled study, using a disease specific questionnaire, naftidrofuryl has been shown to significantly improve several aspects of the quality of life of patients with intermittent claudication.     

A new questionnaire for assessing the quality of life of patients with intermittent claudication

BACKGROUND: Quality of life assessment is becoming increasingly relevant for evaluating the impact of disease and treatments and for deciding priorities when allocating resources. This is especially true in intermittent claudication where the goal of therapy is not the cure of the disease but rather to alleviate its symptoms and improve the patient's functional capabilities. At present, however, no generic scale fits all criteria for the ideal quality of life measuring in intermittent claudication. METHODS: We developed a questionnaire aimed at evaluating the specific limitations encountered by claudicants in the physical activity and in the social and emotional functioning. The present study evaluated the questionnaire for validity, reliability, and sensitivity to change, attributes considered to be essential for a questionnaire to be useful. RESULTS: In 30 patients with intermittent claudication, the scores of the four sections of the questionnaire significantly correlated with the scores of the corresponding sections of the Nottingham Health Profile. This indicates that the questionnaire is valid. For each of the four subscales, the intraclass correlation coefficient was > 0.75, thus showing a high test re-test reliability. Also the internal consistency is strong with alpha coefficient ranging from 0.79 to 0.89. Finally, the questionnaire was administered to 9 patients before and 4 weeks after percutaneous transluminal angioplasty for claudication. After the intervention, the improvement in walking performance paralleled the improvement in quality of life. This indicates that the questionnaire is sensitive to change. CONCLUSIONS: Our questionnaire appears to be a valid and reliable quality of life measure in intermittent claudication.     

Impact of obesity on health-related quality of life in patients with chronic illness

OBJECTIVE:To determine the association between overweight and obesity and health-related quality of life (HRQOL) in patients with chronic conditions typical of those seen in general medical practice, after accounting for the effects of depression and medical comorbidities. DESIGN: Cross-sectional analysis of data from the Medical Outcomes Study. SETTING: Offices of physicians practicing family medicine, internal medicine, endocrinology, cardiology, and psychiatry in three U.S. cities. PATIENTS: We surveyed 2,931 patients with chronic medical and psychiatric conditions. The patients completed a self-administered questionnaire at enrollment and had complete data on height and weight. MEASUREMENTS AND MAIN RESULTS: Body mass index (BMI), chronic medical conditions, and depression were obtained by structured interview. Health-related quality of life was measured by the SF-36 Health Survey. Patients who were overweight (BMI 25.0-29.9 kg/m2), patients with class I obesity (BMI 30.0-34.9 kg/m2), and patients with class II-III obesity (BMI > or = 35 kg/m2) had significantly lower adjusted physical function scores (by 3.4, 7.8, and 13.8 points, respectively) compared with nonoverweight patients. Patients with class I and class II-III obesity also had significantly lower adjusted general health perceptions scores (by 2.8 and 4.4 points, respectively) and lower adjusted vitality scores (by 4.0 and 7.1 points, respectively), compared with nonoverweight patients. No significant differences between nonoverweight, overweight, and obese patients were observed for the mental health scale. Women with elevated BMI had significantly lower HRQOL scores compared with the scores of obese men in several domains. Additionally, blacks with elevated BMI had significantly lower scores than whites in several domains of HRQOL. CONCLUSIONS: Overweight and obesity have the largest association with physical function measures. Recent national standards, which have lowered the threshold for defining overweight, identify patients who are more likely to have clinically significant reductions in HRQOL and functional impairment.     

Impact of pain on health-related quality of life in patients with inflammatory bowel disease

AIM: To evaluate intensity, localization and cofactors of pain in Crohn’s disease and ulcerative colitis patients in connection with health-related quality of life (HRQOL) and disease activity. METHODS: We reviewed and analyzed the responses of 334 patients to a specifically designed questionnairebased on the short inflammatory bowel disease questionnaire (SIBDQ) and the German pain questionnaire. Pain intensity, HRQOL, Crohn’s disease activity index (CDAI) and colitis activity index (CAI) were correlated a...     

Long-term effects of supervised exercise training on walking capacity and quality of life in patients with intermittent claudication

Supervised exercise training has been shown to improve walking capacity in several studies of patients with intermittent claudication. However, data on long-term outcome are quite limited. The aim of this prospective study was to evaluate long-term effects of supervised exercise training on walking capacity and quality of life in patients with intermittent claudication. Patients and methods: Sixty-seven consecutive patients with intermittent claudication who completed a supervised 12-week exercise training program were asked for follow up evaluation 39 +/- 20 months after program completion. Pain-free walking distance (PWD) and maximum walking distances (MWD) were assessed by treadmill test and several questionnaires. Results: Forty (60%) patients agreed to participate, 22 (33%) refused participation, and 5 (7%) died during follow-up. PWD and MWD significantly improved at completion of 12-weeks supervised exercise training as compared to baseline (PWD 114 +/- 100 vs. 235 +/- 248, p = 0.002; MWD 297 +/- 273 vs. 474 +/- 359, p = 0.001). Improvement of PWD and MWD could be maintained at follow up (197 +/- 254, p = 0.014; 390 +/- 324, p = 0.035, respectively) with non-smokers showing significantly better sustained PWD and MWD improvement as compared to baseline. Overall, walking capacity correlated with functional status of quality of life. Conclusions: Major findings of this investigation were that improvement in walking capacity is sustained after completion of supervised exercise training program with best results in patients who quitted or never smoked. Improved walking capacity is associated with increased functional status of quality of life.     

The impact on health-related quality of life of treatment interruptions in HIV-1-infected patients

To examine health-related quality of life (HRQOL) before, during and after treatment interruptions (TI) in antiretroviral therapy, we analysed results from Medical Outcomes Study HIV health surveys on 50 HIV-1-infected patients. HRQOL scores decreased during a TI but increased after re-initiating treatment, although scores remained lower than those preceding the TI. The reasons for a TI differentially affected HRQOL. The findings suggest that TI should be based on medical decisions and not used to increase HRQOL.     

Impact of sleep-related breathing disorders on health-related quality of life in patients with chronic heart failure

BACKGROUND: Quality of life in patients with chronic heart failure (HF) is often severely compromised. Sleep-related breathing disorders (SRBD) like Cheyne-Stokes Respiration (CSR) or obstructive sleep apnea (OSAS) are often observed in patients with severe HF resulting in fragmentation of sleep, excessive daytime sleepiness and an increased mortality. While an apnea/hypopnea-index (AHI) >30/h represents an independent predictor of poor prognosis, clinical relevance of even minor SRBD with an AHI <30/h remains unclear with respect to quality of life, exercise capacity or depression rate. METHODS: Sixty-nine consecutive ambulatory patients with stable HF (NYHA II-III, EF 25%) underwent two night polygraphies with a six-channel ambulatory recording. Spiroergometry was performed, and patients were examined for sleep quality (PSQI), depressed mood (BDI) and health-related quality of life (SF-36). The data were compared to 10 age-matched healthy controls and 11 patients with OSAS (AHI 14-29/h) not suffering from HF. RESULTS: Fifty-one patients completed follow up. 52% were positively diagnosed for SRBD (AHI 16-30/h: 12 patients CSR, 5 patients OSAS, 9 patients mixed); 25 patients (48%) showed no relevant SRBD. Patients with HF and SRBD had lower quality of life than patients without SRBD and HF. The severity of SRBD as indicated by the AHI significantly correlated with quality of life measures: Bodily pain, physical functioning and social functioning showed largest impairment in patients with HF and SRBD. Furthermore, elevated depression rates in correlation to the AHI were only observed in patients with SRBD similar to patients with OSAS without HF. CONCLUSION: Even minor SRBD in patients with HF independently influence quality of life and correlate with estimation of depression and sleep disturbances.     

Impact of inflammatory bowel disease on health-related quality of life

Health-related quality of life (HRQOL) has a recognized importance to evaluate, manage and follow patients. Different types of instruments for measuring HRQOL have recently been introduced to evaluate HRQOL in patients with inflammatory bowel disease. Most questionnaires suggest that inflammatory bowel disease has a significant impact in HRQOL. It seems that ulcerative colitis has less profound effects on HRQOL than Crohn's disease and that some differences in HRQOL status are related to some factors such as the severity of the disease. When patients express their concerns, most important worries are related to surgery. Effective medical treatment appears to improve HRQOL. Effects of surgery on HRQOL can probably be different depending on the type of surgical technique and if it is curative or not. Recent studies suggest that inflammatory bowel disease not only impacts on patient's HRQOL but also on their caregivers. Features such as the impact on HRQOL of different disease variables, such as complications or patient personality, the role of medical or surgical treatments on different dimensions of HRQOL, the cost-utility evaluation of therapy are some of the fields that will probably focus the protagonism in the next years.     

Impact of radiofrequency ablation on health-related quality of life in patients with paroxysmal supraventricular tachycardia compared with a norm population one year after treatment

Objective

This study evaluated the impact of radiofrequency ablation (RFA) on health-related quality of life (HRQOL) in patients with paroxysmal supraventricular tachycardia (PSVT).

Methods

HRQOL was assessed with the Short Form-36 Health Survey (SF-36) and EuroQol (EQ)-5D at baseline and 3 and 12 months after RFA. At 12 months, the patients were compared with an age- and gender-matched reference group.

Results

Patients showed a marked improvement in all the SF-36’s scales at 3 months after treatment compared with baseline. Patients scored higher in all scales in the SF-36 but not in the EQ-5D’s index at 12 months compared with baseline. No further improvements were detected from 3 to 12 months follow-up. Twelve months after treatment, patients scored equal to the reference group in the SF-36 and EQ-5D index, indicating a complete restoration of the HRQOL after RFA.

Conclusion

PSVT is a condition with a pronounced impact on HRQOL. At 12 months follow-up after RFA, patients’ HRQOL scores were similar to those of the age- and gender-matched reference group.     

Impact of fibromyalgia pain on health-related quality of life before and after treatment with tramadol/acetaminophen

OBJECTIVE: To assess health-related quality of life (HRQOL) in patients with moderate-to-severe fibromyalgia pain compared with the general population, and to assess the relationship between pain severity and HRQOL before and after treatment with an analgesic. METHODS: Data were obtained from a randomized, double-blind study of patients with moderate-to-severe fibromyalgia pain. Patients received either tramadol/acetaminophen or placebo 4 times/day as needed for 91 days. HRQOL was measured with the Short Form 36 Health Survey (SF-36) and the Fibromyalgia Impact Questionnaire (FIQ). Baseline HRQOL scores were compared with a national sample of noninstitutionalized adults and a sample of patients with impaired HRQOL due to congestive heart failure. Patients with fibromyalgia were divided into tertiles by change in pain severity, and SF-36 scores were compared across the tertiles. Mean changes in SF-36 and FIQ scores were compared between treatment groups. RESULTS: Patients with fibromyalgia scored lower than the US norm on all SF-36 scales (P < 0.0001) and lower than patients with congestive heart failure on most scales. More severe pain was associated with greater impairment of HRQOL compared with less severe pain (P < 0.0001). Patients in the highest tertile for improved pain severity had greater improvement in HRQOL scores than patients in the lower tertiles. Compared with patients who received placebo (n = 157), patients treated with tramadol/acetaminophen (n = 156) showed greater improvement on SF-36 physical functioning, role physical, bodily pain, and physical summary scales, as well as FIQ scales for ability to do job, pain, and stiffness (P < 0.01). CONCLUSION: Moderate-to-severe fibromyalgia pain significantly impairs HRQOL, and effective pain relief in these patients significantly increases HRQOL.     

Impact of treatment satisfaction on quality of life of patients with acromegaly

Purpose

To evaluate satisfaction of acromegalic subjects with their medical treatment and its contribution to their quality of life.

Methods

This cross-sectional study included a total of 159 medications used in 133 subjects with acromegaly (controlled n = 84 and uncontrolled n = 49, female/male: 81/52). Subjects were asked to complete questionnaires on symptoms of depression (BDI) and satisfaction with the medical therapy they received for acromegaly (TSQM). Acromegaly cases also completed Acromegaly Quality of Life Questionnaire (AcroQoL).

Results

Subjects on pegvisomant therapy scored lower on convenience (p = 0.007). Cases on combination therapy had lower domain scores for effectiveness, convenience and global satisfaction in comparison to the cases on monotherapy (p = 0.01, p = 0.01 and p = 0.01, respectively). The time elapsed since diagnosis and the duration of medical therapy were positively correlated with effectiveness score (r = 0.2, p = 0.007 and r = 0.2, p = 0.04, respectively). The AcroQoL score was positively correlated with all domains of TSQM (for effectiveness r = 0.2, p = 0.01; for side effects r = 0.3, p = 0.001; for convenience r = 0.3, p = 0.004 and for global satisfaction r = 0.2, p = 0.01). In contrast, the BDI score was inversely correlated with all domains of TSQM (for effectiveness r = ?0.3, p = 0.001; for side effects r = ?0.2, p = 0.006; for convenience r = ?0.3, p < 0.001 and for global satisfaction r = ?0.3, p = 0.001).

Conclusion

In acromegaly, quality of life, status of depression and satisfaction of the subjects with their treatment are intercorrelated.     

Treatment of severe intermittent claudication with pentoxifylline: a 40-week, controlled, randomized trial

The efficacy, safety, and cost of pentoxifylline (PXF) in the treatment of severe intermittent claudication were studied comparing PXF and placebo in a randomized 40-week study. A treadmill test was performed at inclusion and at the end of weeks 20 and 40. A progressive training plan and the control of risk factors (with antiplatelet treatment) were used in both groups. Of the 200 included patients, 178 completed the study: 88 in the PXF group and 90 in the placebo group. There were 22 dropouts. The two groups were comparable for age, sex distribution, and for the presence of risk factors and smoking. There was a significant increase in pain-free walking distance (PFWD) in both groups. The absolute and percent increase in PFWD was significantly greater in the PXF group (p<0.05). At 20 weeks, the increase was 360.5% in the PXF vs 252% in the placebo group. At 40 weeks, the increase was 386% in the PXF and 369% in the placebo group (p<0.02). Total walking distance (TWD) increased at 20 weeks (up to 254%) and up to 329% at 40 weeks. In the placebo groups the increase was 158% at 20 weeks and 183% at 40 weeks. The excess increase produced by PXF treatment was 30% at 20 weeks and 38% at 40 weeks (p<0.02). Unwanted effects treatment was well tolerated. No serious drug-related side effects were observed. In summary, between-group analysis favors PXF considering walking distance and costs. Results indicate good efficacy and tolerability.     

Impact of surgery for Crohn's disease on health-related quality of life

OBJECTIVE: When patients with Crohn's disease (CD) express concerns about their disease, they emphasize worries about surgery. However, most studies about the impact of surgery in CD on health-related quality of life (HRQOL) have compared postsurgical changes on HRQOL relative to HRQOL before surgery, not taking into account the influence of CD activity on HRQOL. Our aim was to assess whether surgical treatment of CD modifies HRQOL, compared with inactive CD, active CD, or healthy controls. METHODS: Outcomes of 29 CD patients in remission with a previous bowel resection were compared with those from 42 clinically active CD patients and 48 patients with medically induced remission. A reference control group of 63 healthy individuals was also studied. HRQOL was measured by the Inflammatory Bowel Disease Questionnaire (IBDQ), the Psychological General Well Being Index (PGWBI), and the EuroQol. RESULTS: Active CD patients scored the lowest on the IBDQ. Both operated and nonoperated inactive CD patients had lower HRQOL scores than controls in overall IBDQ and in all five domains. However, neither global score, digestive, systemic, emotional, social, or functional dimensions differed significantly between operated and nonoperated inactive CD patients. PGWBI and the visual analog scale of the EuroQol were also similar in both groups of inactive CD patients (103 [range, 94-107] vs. 103 [97-106] and 90 [73-87] vs. 82 [76-84]), but significantly higher than in active CD. CONCLUSIONS: HRQOL is impaired in active CD, and improves during remission irrespective of whether it had been achieved medically or surgically. Our results suggest that to improve HRQOL it is more important to achieve remission than the approach, drugs or surgery, chosen.     

Impact of fatigue on health-related quality of life in rheumatoid arthritis

OBJECTIVE: To multidimensionally assess fatigue in rheumatoid arthritis (RA) and to evaluate the impact of fatigue on health-related quality of life (HRQOL). METHODS: The study was conducted in 1999 among 490 RA patients with varying disease duration. Fatigue was measured with the Multidimensional Fatigue Inventory (MFI-20) and HRQOL with a validated Dutch version of the RAND 36-Item Health Survey. We evaluated the impact of fatigue on HRQOL by multiple linear regression analyses taking into account RA-related pain and depressive symptoms. RESULTS: Different aspects of fatigue selectively explained different dimensions of HRQOL. The MFI-20 was entered last to the linear regression models, resulting in an additional increase of explained variance of 1% (mental health) to 14% (vitality). CONCLUSION: The multidimensional portrayal of RA-related fatigue can be used to develop intervention strategies targeted to specific aspects of fatigue. Fatigue, supplementary to RA-related pain and depressive symptoms, appears to be a feasible and treatable target in the clinical management of RA to increase HRQOL.