Assessment of disease impact in patients with intermittent claudication: discrepancy between health status and quality of life

OBJECTIVE: To describe similarities and differences between health status and quality of life in patients with intermittent claudication. METHODS: This was an observational study in the vascular outpatient department of a teaching hospital; it concerned 200 consecutive patients with intermittent claudication. Health status was assessed with the RAND-36, and quality of life was assessed with a reduced version of the World Health Organization Quality of Life assessment instrument-100. Scores were compared with those of sex- and age-matched healthy controls. Mann-Whitney U tests were used to detect statistically significant differences ( P < .01) between patients and healthy controls. Pearson correlations were calculated between health status and quality-of-life scores. Differences between correlations were examined by using Fisher z statistics. The upper and lower 10% of quality-of-life scores were compared with the response quartiles of the health status scores. RESULTS: Health status was significantly impaired in all domains. Quality of life was significantly worse with respect to aspects of physical health and level of independence and one global evaluative facets overall quality of life and general health. Quality-of-life assessment with the World Health Organization Quality of Life instrument disclosed patient-reported problems that had not been identified in health status. Conversely, patients did not regard all objective functional impairments as a problem. Pearson correlations ranged from 0.20 to 0.74. There were patients with excellent and very poor quality-of-life scores in nearly all the quartiles of the corresponding health status domains. CONCLUSIONS: Health status and quality of life represent different outcomes in patients with intermittent claudication. In addition to functional restrictions as measured in health status, quality of life also permits a personal evaluation of these restrictions. Objective functioning and subjective appraisal of functioning are complementary and not identical. Combining these measures should direct treatment in a way that meets patients' needs.     

Poor health-related quality of life in patients with peripheral arterial disease: type D personality and severity of peripheral arterial disease as independent predictors

BACKGROUND: Peripheral arterial disease (PAD) is associated with poor health-related quality of life (HRQOL), but individual differences in this patient-based outcome are not fully understood. We examined the impact of PAD severity, invasive treatment, and type D personality, defined as tendencies to experience negative emotions and be socially inhibited, on HRQOL in a 1-year follow-up study. METHOD: At their first visit to the department of surgery at the St. Elisabeth Hospital in Tilburg, The Netherlands, 203 consecutive PAD patients completed the DS14 type D personality and RAND-36 questionnaires (all self-report). Clinical data were derived from patients' medical files and included ankle-brachial index (ABI), initial and absolute claudication distance (ICD, ACD), and invasive treatment. The main outcome was HRQOL at 1-year follow-up. RESULTS: HRQOL improved between baseline and follow-up, and invasive treatment led to significant improvements in the subscales Physical Functioning (P = .005) and Pain (P = .003). Type D patients were severely impaired in their HRQOL compared with other patients at baseline (P < .01) and at follow-up (P < .05). ABI and ACD also predicted HRQOL at follow-up. After adjusting for ABI and ACD, invasive treatment and type D personality independently predicted all HRQOL domains, except for Physical Functioning. Overall, type D personality predicted increased risk for both poor General Health (odds ratio [OR], 3.70; 95% confidence interval [CI], 1.69 to 8.08; P = .001) and poor Mental Health (OR, 6.01; 95% CI, 2.44 to 14.79, P < .0001) at 1 year after the PAD diagnosis. CONCLUSION: Despite an overall improvement, type D patients remained more impaired in 1-year HRQOL than other patients, adjusting for ABI and ACD. Type D personality is a psychologic risk factor that predicts poor patient-based outcomes in PAD and should be taken into account when HRQOL in PAD is evaluated.     

The effect of peripheral percutaneous transluminal angioplasty on quality of life in patients with intermittent claudication.

BACKGROUND AND OBJECTIVE: intermittent claudication is associated with a significant reduction in quality of life. Treatment of claudicants aims to reduce mortality from cardio- and cerebro-vascular events and to improve quality of life. Quality of life assessment should be used to guide and evaluate treatment in this group of patients. Peripheral percutaneous transluminal angioplasty (PTA) is now widely used in the treatment of intermittent claudication. The aim of this review is to examine the effect of PTA on quality of life (QOL) in patients with intermittent claudication. METHODS: a review was conducted of prospective clinical trials assessing the effect of peripheral PTA on QOL. Publications were retrieved by searching Medline and PreMedline, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Database of systematic reviews, AMED and CINAHL. The reference lists of the relevant publications were also searched. RESULTS: seven prospective studies (10 publications) on the effect of PTA on QOL in claudicants were identified. Several different questionnaires were used to measure quality of life (Nottingham Health Profiile, SF-36, EuroQol) none of which were disease specific. All the studies showed some improvement in QOL after PTA at follow-up periods of between 6 weeks and 24 months, except for one which showed some improvement at 6 months but not at 24 months. CONCLUSIONS: despite the fact that studies on the effect of PTA on QOL in claudicants have used generic QOL questionnaires which are relatively insensitive, the findings suggest that PTA may result in some improvement in QOL in these patients, although level I evidence to support this is lacking. The availability of disease-specific questionnaires should enable a more accurate assessment of PTA on QOL in these patients.     

Assessment of generic health-related quality of life in patients with intermittent claudication.

OBJECTIVES: to measure quality of life in patients with intermittent claudication and evaluate the ability of patients and vascular surgeons to make a similar assessment. DESIGN, MATERIALS AND METHODS: in this prospective study patients with intermittent claudication attending two vascular clinics were asked to complete a generic health-related quality of life instrument (MOS SF-36). Patient quality of life and vascular surgeons' assessment of patient quality of life were further evaluated using a single question/adjectival scale response combination. RESULTS: patients' self-assessment of their quality of life correlated better with the SF-36 score than did the surgeons' assessment. There was little correlation between the surgeons' and patients' own assessment of quality of life. The surgeons differed significantly from each other in their assessments. Claudicants had lower SF-36 scores than population norms in pain and physical aspects of quality of life. CONCLUSIONS: claudicants have worse quality of life than the general population, with pain and physical limitations being the most important domains. Surgeons predict the quality of life of claudicating patients less accurately than patients do themselves, and may differ from their colleagues in such assessments. Objective quality of life assessment in claudicants should be undertaken before treatment is decided.     

Metabolic syndrome impairs physical function, health-related quality of life, and peripheral circulation in patients with intermittent claudication

PURPOSE: This study was conducted to (1) examine the effect of metabolic syndrome on intermittent claudication, physical function, health-related quality of life, and peripheral circulation in patients with peripheral arterial disease (PAD), and (2) determine whether peripheral vascular function was predictive of intermittent claudication and physical function in patients with metabolic syndrome. METHODS: Patients limited by intermittent claudication and who had metabolic syndrome (n = 133) were compared with those without metabolic syndrome (n = 201). Patients were assessed on metabolic syndrome characteristics, PAD-specific measures consisting of ankle/brachial index and claudication distances, physical function measures, health-related quality of life, and calf blood flow and transcutaneous oxygen tension responses after 3 minutes of vascular occlusion. RESULTS: Initial claudication distance (mean +/- SD) was 29% shorter (P = .018) in patients with metabolic syndrome than in the controls (128 +/- 121 meters vs 180 +/- 166 meters), and absolute claudication distance was 22% shorter (P = .025) in those with metabolic syndrome (319 +/- 195 meters vs 409 +/- 255 meters). Furthermore, patients with metabolic syndrome had lower peak oxygen uptake (P = .037), a shorter 6-minute walk distance (P = .027), lower values on six domains of health-related quality of life (P < .05), reduced calf hyperemia (P = .028), and greater calf ischemia (P < .001) after vascular occlusion. In the group with metabolic syndrome, calf ischemia was correlated with initial claudication distance (r = 0.30, P = .004), absolute claudication distance (r = 0.40, P < .001), and peak oxygen uptake (r = 0.52, P < .001). CONCLUSION: Metabolic syndrome worsens intermittent claudication, physical function, health-related quality of life, and peripheral circulation in patients with PAD. Calf ischemia in those with metabolic syndrome was predictive of intermittent claudication and physical function. The additive burden of metabolic syndrome thus places patients who are limited by intermittent claudication at an even greater risk for living a functionally dependent lifestyle. Aggressive risk-factor modification designed to treat components of metabolic syndrome should be evaluated for efficacy in modifying physical and vascular function in patients with intermittent claudication.     

Disease-specific quality of life assessment in intermittent claudication: review.

OBJECTIVES: intermittent claudication (IC) is a common condition that has a major impact on the patients' quality of life (QoL). Generic QoL instruments often lack sensitivity to detect small but clinically significant variation in QoL. Disease-specific instruments may overcome this problem. This study aims to review various disease-specific QoL instruments available for use in IC and make recommendations for clinical utilization based on validity, reliability and responsiveness. METHODS: a detailed literature search and extensive bibliography review of all papers relating to disease-specific QoL and IC. RESULTS: several disease-specific QoL instruments are available for use in patients with IC. The most notable of these are the Claudication Scale (CLAU-S), Sickness Impact Profile - Intermittent Claudication (SIP(IC)) and the VascuQoL. The Walking Impairment Questionnaire (WIQ) is an objective measure of the patient's walking ability and not a QoL instrument. CONCLUSION: many of the questionnaires are new and have undergone only a limited validation process. More work is required in this field before any one disease-specific QoL instrument can be recommended for use in patients with IC.     

Impact of obstructive airways disease on quality of life in older adults.

BACKGROUND: Obstructive airways disease adversely affects quality of life, although relationships between quality of life and lung function have been shown to be weak. The relationships between the results of a quality of life questionnaire, spirometric tests, and methacholine bronchial challenge were investigated in a population sample of middle aged and elderly people. METHODS: A random population sample of the white population of Central Manchester, UK were contacted by post. Respondents were invited to undergo bronchial challenge with methacholine (Newcastle dosimeter method) and to complete the St George's Respiratory Questionnaire. This self-completed questionnaire quantifies quality of life as three component scores, with higher scores indicating greater impairment of quality of life. RESULTS: Two hundred and twenty seven subjects aged 45-86 years completed the St George's Questionnaire and performed spirometric tests; 190 completed the methacholine challenge. All quality of life scores were higher in subjects with a forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) of < 65%, indicating impaired quality of life in subjects with airways obstruction. There was no relationship between quality of life and age. Multiple regression analysis showed independent relationships between quality of life scores and both baseline FEV1 and bronchial responsiveness. However, the amount of variation in quality of life attributable to variation in FEV1 or bronchial responsiveness was less than 10%. Subgroup analysis indicated that the quality of life score was independently associated with bronchial responsiveness and not FEV1 in subjects aged < 65 years, but with baseline FEV1 and not bronchial responsiveness in older subjects. CONCLUSIONS: Obstructive airways disease significantly impairs quality of life in adults. The reduction in quality of life in these patients is related to both baseline pulmonary function and non-specific bronchial responsiveness. The impact of airways obstruction on quality of life does not decrease with advancing age.     

Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease

Purpose: This study evaluated the effects of cilostazol on walking distances in patients with intermittent claudication (IC) caused by peripheral arterial occlusive disease. Methods: The study was a multicenter, randomized, double-blind, placebo-controlled trial. Two hundred thirty-nine patients with IC were randomly assigned to receive cilostazol (100 mg b.i.d.) or a placebo for 16 weeks. All patients underwent serial, variable-grade, constant-speed treadmill testing. Absolute claudication distance (ACD), assessed at the end of the 12-hour dosing interval (trough), was the primary end point. Secondary end points included ACD assessed 3 to 4 hours after dosing (peak) and initial claudication distances (trough and peak). Functional status measures, including the Medical Outcomes Scale (SF-36) and Walking Impairment Questionnaire, were used to assess subjective changes over the 16-week treatment period. Ankle-brachial indexes were calculated from Doppler-measured systolic pressures at every visit with treadmill testing. Results: Patients treated with cilostazol demonstrated significant improvements over the placebo patients in ACD at all three time points tested after baseline (weeks 8, 12, and 16). Peak treadmill testing at weeks 8 and 12 also showed significant improvement in walking distances for cilostazol-treated patients over placebo-treated patients. At week 16, patients in the cilostazol group had a 96.4-meter (47%) increase in ACD compared with 31.4 meters (12.9%) for the placebo group (p < 0.001). In the SF-36, significant improvement was observed in the physical component subscale and the composite physical component score. In the Walking Impairment Questionnaire, improvements were significant in patient reports of walking speed and specific measures of walking difficulty. Ankle-brachial indexes improved in the cilostazol group (0.64 ± 0.02 to 0.70 ± 0.02) compared with the placebo group (0.68 ± 0.02 to 0.69 ± 0.02) (p < 0.0125). The most frequent adverse events were headache, abnormal stools (e.g. loose stools), diarrhea, and dizziness. Conclusions: Cilostazol significantly increased ACD at all measured time points and initial claudication distances at most time points. This agent may represent a new treatment option for patients with intermittent claudication. (J Vasc Surg 1998;27:267-75.)     

Computerized dynamic posturography in the objective assessment of balance in patients with intermittent claudication

One-third of all elderly patients fall each year and impaired balance has been recognized as a specific risk factor. Intermittent claudication is common among the elderly population, affecting approximately 5% of the population over the age of 50. The aim of this proof-of-concept study was to assess the prevalence of impaired balance among elderly claudicants and to assess each patient's insight into their own risk of falling. A total of 58 claudicants (45 men), median age of 70 (interquartile range = 65-73) years, underwent objective balance assessment by using computerized dynamic posturography. As compared with 195 (5%) historic controls, 24 (41%) of the claudicants demonstrated abnormal balance when the Sensory Organization Test (SOT) was used. Vestibular dysfunction occurred in 52% of the claudicants. Abnormalities including somatosensory (22%), visual function (17%), and preferential reliance on inaccurate visual cues (17%) occurred less often. Prolonged Motor Control Test latency times were uncommon (n = 13) and were in most cases evenly distributed between those with normal (n?= 7) and abnormal (n = 6) composite SOT scores. There was a significant difference in history of falling between claudicants with abnormal and normal SOT scores (p = 0.003), with a higher number of patients with abnormal SOT having experienced falling in the past year. However, no correlation between fear of falling and composite SOT score was found (Spearman rank correlation, r?= 0.124; p = 0.381). Impaired balance, particularly secondary to vestibular problems, is very common among claudicants and may predispose to a high incidence of falls. Claudicants with abnormal balance are more likely to have a history of falls but not a fear of falling, thus potentially rendering these patients to be at a greater risk.     

Quality of life and peripheral arterial disease

Peripheral arterial disease (PAD) is a common disease entity with the potential to cause considerable impairment in the quality of life (QoL) of millions of Americans. As there is no exact cure for PAD, thus representing a chronic illness, the goal of treatment is disease management including the prevention of cardiovascular events, and improving QoL by helping people with PAD live productive and satisfying lives. Disagreement exists between patients' clinically inferred QoL status and their perceptions of QoL exist concerning PAD. Whereas a clinician may be concerned with a physiological or anatomical abnormality that may ultimately lead to disease and discomfort, a patient may be more concerned with their overall sense of QoL, which is only in part related to their clinical health status. Thus, to truly understand the outcomes of PAD and its treatment, it is necessary to supplement the traditional clinical outcome measures with information from the patient point of view. In this article, we review measurement instruments available to assess patient-reported QoL, and discuss the potential these tools have for providing accurate and meaningful information to complement traditional clinical outcome data.