Leg symptoms, the ankle-brachial index, and walking ability in patients with peripheral arterial disease

OBJECTIVE: To determine how functional status and walking ability are related to both severity of lower extremity peripheral arterial disease (PAD) and PAD-related leg symptoms. DESIGN: Cross-sectional study. SETTING: Academic medical center. PARTICIPANTS: Patients aged 55 years and older diagnosed with PAD in a blood flow laboratory or general medicine practice (n = 147). Randomly selected control patients without PAD were identified in a general medicine practice (n = 67). MEASUREMENTS: Severity of PAD was measured with the ankle-brachial index (ABI). All patients were categorized according to whether they had (1) no exertional leg symptoms; (2) classic intermittent claudication; (3) exertional leg symptoms that also begin at rest (pain at rest), or (4) exertional leg symptoms other than intermittent claudication or pain at rest (atypical exertional leg symptoms). Participants completed the 36-Item Short-Form Health Survey (SF-36) and the Walking Impairment Questionnaire (WIQ). The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 to 100 (100 = best). MAIN RESULTS: In multivariate analyses patients with atypical exertional leg symptoms, intermittent claudication, and pain at rest, respectively, had progressively poorer scores for walking distance, walking speed, and stair climbing. The ABI was measurably and independently associated with walking distance (regression coefficient = 2.87/0.1 ABI unit, p =.002) and walking speed (regression coefficient = 2.09/0.1 ABI unit, p =.015) scores. Among PAD patients only, pain at rest was associated independently with all WIQ scores and six SF-36 domains, while ABI was an independent predictor of WIQ distance score. CONCLUSIONS: Both PAD-related leg symptoms and ABI predict patient-perceived walking ability in PAD.     

Associations of calf skeletal muscle characteristics and peripheral nerve function with self-perceived physical functioning and walking ability in persons with peripheral artery disease

We determined whether more adverse calf muscle characteristics and poorer peripheral nerve function were associated with impairments in self-perceived physical functioning and walking ability in persons with lower extremity peripheral artery disease (PAD). Participants included 462 persons with PAD; measures included the ankle-brachial index (ABI), medical history, electrophysiologic characteristics of nerves, and computed tomography of calf muscle. Self-perceived physical functioning and walking ability were assessed using the 36-Item Short Form Health Survey (SF-36) and the Walking Impairment Questionnaire (WIQ). Results were adjusted for age, sex, race, ABI, body mass index, comorbidities, and other confounders. Lower calf muscle area was associated with a poorer SF-36 physical function (PF) score (overall p-trend < 0.001, 33.76 PF score for the lowest quartile versus 59.74 for the highest, pairwise p < 0.001) and a poorer WIQ walking distance score (p-trend = 0.001, 29.71 WIQ score for the lowest quartile versus 48.43 for the highest, pairwise p < 0.001). Higher calf muscle percent fat was associated with a poorer SF-36 PF score (p-trend < 0.001, 53.76 PF score for the lowest quartile versus 40.28 for the highest, pairwise p = 0.009). Slower peroneal nerve conduction velocity was associated with a poorer WIQ speed score ( p-trend = 0.023, 30.49 WIQ score for the lowest quartile versus 40.48 for the highest, pairwise p = 0.031). In summary, adverse calf muscle characteristics and poorer peripheral nerve function are associated significantly and independently with impairments in self-perceived physical functioning and walking ability in PAD persons.     

Effect of cilostazol on treadmill walking,community-based walking ability,and health-related quality of life in patients with intermittent claudication due to peripheral arterial disease: meta-analysis of six randomized controlled trials

OBJECTIVES: To assess whether cilostazol, a phosphodiesterase III inhibitor, improves treadmill and community-based walking ability and health-related quality of life (HQL) in patients with intermittent claudication resulting from peripheral arterial disease (PAD). DESIGN: Retrospective meta-analysis of data pooled from six Phase 3, multicenter, double-blind, placebo-controlled, parallel-group, randomized studies. SETTING: Patients were recruited from outpatient ambulatory medical care facilities. PARTICIPANTS: Patients' (n = 1,751) mean age +/- standard deviation was 65 +/- 9, and they had a history of PAD for 6 months or longer and an ankle brachial index (ABI) of 0.90 or less. INTERVENTION: Cilostazol 50 mg bid or 100 mg bid for 12, 16, or 24 weeks. MEASUREMENTS: ABI; maximal walking distance (MWD); pain-free walking distance on a graded and constant-load treadmill; and HQL, measured using the Walking Impairment Questionnaire (WIQ) and the Medical Outcomes Study Short Form-36 (SF-36). RESULTS: Maximal treadmill walking distance improved more in both cilostazol groups than in the placebo group (both P <.0001). WIQ and SF-36 physical summary scores improved significantly more with cilostazol than with placebo (for instance, WIQ distance score, P <.0001 and SF-36 physical summary score, P <.0001, comparing persons taking cilostazol with controls). Improved MWD correlated with improvements in WIQ (correlation with distance score, r = 0.34, P <.0001) and SF-36 physical summary scores (r = 0.29, P <.0001). CONCLUSIONS: Treatment with cilostazol was associated with greater improvements in community-based walking ability and HQL in patients with intermittent claudication than treatment with placebo. These improvements correlated with increased MWD. This analysis of effects of cilostazol on improving walking ability in persons with claudication is the first cilostazol study focused on community-based measures of functional status and HQL. Questionnaires assessing walking ability and HQL provide important patient-based information about clinical outcomes of claudication therapy.     

Functional decline in patients with and without peripheral arterial disease: predictive value of annual changes in levels of C-reactive protein and D-dimer

BACKGROUND: Inflammation may be a potential mechanism of aging-related functional decline. We determined whether greater annual increases in levels of high sensitivity C-reactive protein (hsCRP) and D-dimer predicted greater decline in functioning among persons with and without lower extremity peripheral arterial disease (PAD). METHODS: We prospectively studied 296 men and women with PAD and 191 without PAD. Objective measures of functioning, hsCRP, and D-dimer were obtained at baseline and annually for 3 years (mean follow-up = 36.3 +/- 6.4 months). RESULTS: Among PAD participants, greater annual increases in hsCRP were associated with greater annual declines in 6-minute walk performance (-2.63 ft/mg/L, p =.039) but not in other functional outcomes. Higher prior year absolute hsCRP levels were associated with greater declines in 6-minute walk (-2.93 ft/mg/L, p =.022), summary performance score (-0.038/mg/L, p =.017), and rapid paced 4-meter walk (-0.29 cm/s/mg/L, p =.026) during the subsequent year. Among participants without PAD, greater annual increases in hsCRP were associated with greater annual declines in 6-minute walk (-7.47 ft/mg/L, p =.002), usual-pace 4-meter walk (-0.33 cm/s/mg/L, p <.001), fast paced 4-meter walk (-0.56 cm/s/mg/L, p =.003), and the summary performance score (-0.029 mg/L, p <.001). There were no consistent associations between D-dimer levels and functional decline. CONCLUSION: These findings suggest that inflammation may play a role in functional decline in persons with and without PAD.     

The impact of peripheral arterial disease on health-related quality of life in the Peripheral Arterial Disease Awareness, Risk, and Treatment: New Resources for Survival (PARTNERS) Program

This study tested the hypothesis that patients with PAD have impaired health-related quality of life (HRQoL) to a degree similar to that of patients with other types of cardiovascular disease (other-CVD), and also evaluated the clinical features of PAD associated with impaired HRQoL. This was a cross-sectional study in 350 primary care practice sites nationwide with 6,499 participants. The reference group had no clinical or hemodynamic evidence of PAD or other-CVD; the PAD group had an ankle-brachial index < 0.90 or a prior history of PAD; the other-CVD group had a clinical history of cardiac or cerebral vascular disease (but no PAD), and the combined PAD-other-CVD group included both diagnoses. Individuals were assessed using four HRQoL questionnaires including the Walking Impairment Questionnaire (WIQ), Medical Outcomes Study SF-36 (SF-36), Cantril Ladder of Life and the PAD Quality of Life questionnaire. PAD patients had lower WIQ distance scores than the other-CVD group. Both the PAD and other-CVD groups had significantly lower SF-36 Physical Function scores compared with the reference group. The WIQ revealed that PAD patients were more limited by calf pain, whereas other-CVD patients were more limited by chest pain, shortness of breath and palpitations. In conclusion, in this nationwide study, one of the first to directly compare the HRQoL burden of CVD with that of PAD, the evaluation of PAD in office practice revealed a HRQoL burden as great in magnitude as in patients with other forms of CVD.     

Peripheral arterial disease and depressed mood in older men and women

The objective of this study was to determine whether lower extremity peripheral arterial disease (PAD) is associated with depressive symptoms and whether PAD-related disability mediates the association between PAD and depressive symptoms. The study used a cross-sectional design set in an academic medical center. A cohort of men and women aged 55 years and older with (n = 93) or without (n = 74) PAD was recruited. PAD subjects were identified from a blood flow laboratory and a general medicine practice. Non-PAD subjects were identified from the same general medicine practice. PAD was diagnosed and quantified using the ankle-brachial index (ABI). Depressive symptoms were assessed by the 15-item short version of the Geriatric Depression Scale (GDS-S; score range 0-15, 0 = no depressive symptoms). The six-minute walk test and the Walking Impairment Questionnaire (WIQ) distance score (score range 0-100, 100 = better walking ability) were measures of walking impairment. PAD subjects had depressive mood (DM) (defined by GDS-S score >5) twice as often as controls (24% vs 12%, p = 0.06). After adjustment for age, education, and number of comorbidities, the prevalence of depressive mood among PAD subjects was increased, but this association was not significant (OR = 1.8, 95% CI 0.7-4.4). The WIQ distance score weakened the association between PAD and DM, and higher distance scores were associated with a lower likelihood of DM (OR = 0.98 per one unit of the WIQ, 95% CI 0.96-0.99). Among PAD subjects, severe PAD (ABI <0.5) was not significantly associated with DM (OR = 1.4, 95% CI 0.5-4.1), but a greater 6-min walk distance was associated with a lower likelihood of DM (OR = 0.8 per 100 feet, 95% CI 0.70-0.97). Substituting the WIQ scores for six-min walk distance in the model showed that higher WIQ scores were associated with lower likelihood of DM among PAD subjects (OR= 0.98 per one unit of the WIQ, 95% CI 0.95-1.0), though the association did not achieve statistical significance. In conclusion, these data suggest that PAD may be associated with an increased risk of DM and that this relationship may be related to PAD-associated disability. An evaluation for depression may be appropriate in men and women with PAD. Findings should be evaluated in a larger study cohort.     

Functional status measured by walking impairment questionnaire and cardiovascular risk prediction in peripheral arterial disease: results of the Peripheral Arteriopathy and Cardiovascular Events (PACE) study

The prognostic impact of the functional status of patients with intermittent claudication is still obscure. From the lists of seven general practitioners, we identified all subjects aged 40-80 years (n = 4352). Of those reporting leg symptoms while walking on the Rose questionnaire (n = 760), 60 had a qualifying diagnosis of peripheral arterial disease (PAD). All of them received the Walking Impairment Questionnaire (WIQ). For each patient affected by PAD, three sex- and age-matched controls were selected randomly. After a 24-month follow-up, survival curves showed that PAD patients with WIQ scores > median had a higher cardiovascular risk than controls, and patients with WIQ scores < median had an even poorer prognosis (p < 0.001 for all WIQ domains). In PAD, after adjustment for age, sex, ankle-brachial index and comorbidity, two WIQ domains (ie walking speed and stair-climbing) were associated with cardiovascular events. The cardiovascular risk of claudicants who had a score > median for at least three WIQ domains was intermediate versus the risk of controls and PAD patients with a WIQ score < median, also when adjusted for the covariates indicated above (RR = 3.26, p = 0.019). In intermittent claudication, a worse functional status entails a greater risk of ischemic events versus low functional impairment.     

Lower extremity performance is associated with daily life physical activity in individuals with and without peripheral arterial disease

OBJECTIVES: To determine whether persons with poorer lower extremity functioning have reduced physical activity levels. DESIGN: Cross-sectional. SETTING: Three Chicago-area medical centers. PARTICIPANTS: Two hundred twenty-five people with lower extremity peripheral arterial disease (PAD) and 121 individuals without PAD. MEASUREMENTS: The summary performance score (SPS) was determined for all participants. The SPS combines data on walking velocity, time for five repeated chair rises, and standing balance. Each test is scored on a 0 to 4 scale (4 = best). Scores are summed to create the SPS (0-12 scale, 12 = best). All participants wore a vertical accelerometer for 7 days to measure physical activity. RESULTS: The SPS was associated linearly with 7-day physical activity levels of participants with (P< .0001) and without PAD (P< .0001). This relationship was maintained even after restricting analyses to subsets of participants who reported that they could walk a quarter of a mile and up and down stairs without difficulty (P< .001) and were able to walk for 6-minutes without stopping (P< .001). In multiple linear regression analyses, the SPS was associated with physical activity in participants with (P< .01) and without PAD (P< .001), adjusting for age, sex, race, comorbidities, ankle brachial index, neuropathy, and leg symptoms.CONCLUSION: In people with and without PAD who have impaired lower extremity performance, reduced physical activity levels may contribute to subsequent disability. Future study is needed to determine whether interventions to increase physical activity can prevent functional decline in persons with a low SPS.     

Measuring health status in Israeli patients with fibromyalgia syndrome and widespread pain and healthy individuals: utility of the short form 36-item health survey (SF-36)

OBJECTIVES: To examine the usefulness of the Medical Outcomes Study Short Form-36 (MOS SF-36) in measuring health-related quality of life (QOL) in fibromyalgia syndrome (FMS) patients, and to determine whether subscale scores of SF-36 could distinguish patients with FMS from patients with widespread pain alone, and from healthy individuals. METHODS: The study population included three groups of women: 90 patients with FMS, 96 patients with widespread pain, and 50 healthy controls. In all subjects, health-related QOL was assessed by SF-36. The Health Assessment Questionnaire was used to evaluate functional disability, helplessness and psychological status. FMS-related symptoms and tenderness also were assessed. RESULTS: The 8 subscales of SF-36 showed a consistent pattern for physical function, physical role functioning, body pain, general health, vitality, and social function, with the lowest scores in patients with FMS, intermediate scores in patients with widespread pain alone, and the highest scores in healthy subjects. Emotional role functioning and mental health scores were significantly higher among healthy controls than among patients. The SF-36 subscales of physical functioning, bodily pain, and social functioning were highly correlated with another measure of functional disability (from the Health Assessment Questionnaire) in all patient groups. Most of the subscales were associated with psychological variables (helplessness, depression, and anxiety). All eight subscales of SF-36 were strongly correlated with the mean score of another measure of quality of life, QOL-16. CONCLUSIONS: Most of the SF-36 subscales represent health dimensions relevant to patients with FMS and widespread pain alone. The severity of functional impairment as assessed by the SF-36, distinguishes patients with FMS and widespread pain alone from healthy individuals, and also discriminates between patients with widespread pain alone and FMS patients.     

Health-related quality of life in Moroccan patients with rheumatoid arthritis

We aimed to assess the aspects of health-related quality of life (HRQoL) in Moroccan patients with rheumatoid arthritis (RA) and to evaluate the disease-related parameters influencing it. Two hundred fifty-five patients with RA were consecutively included. We assessed sociodemographic characteristics, cigarette smoking status, disease duration, diagnosis delay, joint pain intensity (on a 0–100-mm visual analogue scale), disease activity (by the disease activity score (DAS 28) and biological tests), structural damage (by radiographs scored using the Sharp’s method as modified by Van der Heijde), functional disability (by the Health Assessment Questionnaire), extra-articular manifestations, immunological status, and treatments. The Arabic version of the Medical Outcomes Study Short Form 36 Health Survey (SF-36) was applied to assess HRQoL. All domains of SF-36 were deteriorated in a significant way comparing to the general population. The most affected subgroups of SF-36 were role limitation, role emotional, vitality, and social functioning. Women had significantly lower scores of SF-36 compared to men. Patients with decreased levels of education and low socioeconomic status had significantly lower scores of SF-36 (for all p?≤?0.01). Current and ex-smokers had lower scores in physical domains of quality of life. Patients treated with methotrexate had better scores of mental health. Furthermore, patients receiving biologic agents had better scores of physical and social domains. Decreased scores of SF-36 were significantly correlated with disease duration, joint pain intensity, clinical and biological disease activity, functional disability, and radiographic damage. The level of antibodies against citrullinated peptides had significant correlations with the impairment of physical domains of SF-36. Physical as well as mental aspects of HRQoL in our RA patients were significantly deteriorated. Recognizing complicated relationships between HRQoL and disease-related variables among our RA patients can help to develop further management strategies to improve patients’ daily living particularly with the advent of new treatments.     

Secondhand smoke and health-related quality of life in never smokers: results from the SAPALDIA cohort study 2

BACKGROUND: Although secondhand smoke (SHS) has been linked with various respiratory conditions and symptoms, its association with health-related quality of life (HRQOL) is unknown. METHODS: A cross-sectional study was performed of 2500 never smokers in Switzerland who participated in the Swiss Cohort Study on Air Pollution and Lung Diseases in Adults and completed a 36-Item Short Form Health Survey (SF-36) in 2002. Using linear regression models adjusting for confounders, we measured the association between HRQOL and moderate or high SHS exposure (< or =3 h/d or >3 h/d) compared with no SHS exposure. Data from men and women were analyzed separately and further stratified by source of SHS (home, workplace, and public spaces). RESULTS: After adjustments, SHS was associated with reduced scores in all SF-36 domains. High SHS exposure predicted a greater reduction in HRQOL. Compared with nonexposed women, those with high SHS exposure at home had significantly lower scores on the physical functioning (-7.8, P < .001), role physical (-10.5, P = .02), bodily pain (-9.2, P = .01), and social functioning (-8.1, P = .007) domains. Exposed men had lower scores for the role physical domain (-20.0, P < .001) and a trend toward lower scores in other domains. In women, exposure to SHS at home was associated with a stronger negative effect on HRQOL than at work and in public spaces. CONCLUSIONS: Secondhand smoke is associated with reduced HRQOL, more significantly so in women. Exposure to SHS at home and high levels of exposure are associated with lower SF-36 scores, suggesting a dose-response relationship.     

Influence of clinical and immunological parameters on the health-related quality of life of patients with primary Sjögren's syndrome

OBJECTIVE: To evaluate health-related quality of life (HR-QoL) in patients with primary SS patients using the SF-36 questionnaire and to analyse the association between the main clinical features and the SF-36 scales. METHODS: We studied 110 patients (105 women and 5 men, mean age of 56 years) with primary SS seen consecutively in the outpatient clinic of our Department. We used the population-based reference values for the Spanish version of the SF-36 health survey as control values for a healthy population. RESULTS: Comparison between patients with primary SS and the control population showed lower scores in all SF-36 scales (p < 0.001). Analysis of the SF-36 scales by gender showed a significant correlation between age and the values for physical functioning (p = 0.013) and bodily pain (p = 0.016) scores. No significant differences in SF-36 scores were found when comparing patients according to the presence or absence of sicca features. Women with vaginal dryness had lower scores for social functioning (61.9 vs. 74.4) and general health (37.2 vs. 44.7) than those without, although the differences were not statistically significant (p > 0.05). Patients with extraglandular involvement had lower scores for the vitality scale (40.8 vs. 54.5 p = 0.007), social functioning (67.0 vs. 79.8, p = 0.010), bodily pain (49.5 vs. 62.5, p = 0.018) and general health (38.6 vs. 49.4 p = 0.001) than those without. CONCLUSION: Patients with primary SS had clearly lower HR-QoL scores than the healthy population; with significantly lower scores in all SF-36 scales and in both summary measures. We identified several epidemiological and clinical SS features related to these lower SF-36 scores. Age at protocol correlated with physical functioning and bodily pain. Vaginal dryness was the sicca feature that most affected the HR-QoL of female SS patients, and a poor HR-QoL was also observed in those patients with a systemic expression of the disease, with pulmonary involvement being the extraglandular manifestation that most contributed to a poor HR-QoL. Our results highlight the importance of earlier diagnostic and therapeutic management of patients with primary SS, which, together with a close follow-up, may contribute to a significant improvement in their HR-QoL.     

Health-related quality of life in primary antibody deficiency

Patients with primary antibody deficiencies (PAD) are susceptible to recurrent and chronic infections and a variety of complications. This study was performed to assess quality of life (QoL) of PAD patients who were under long term treatment and regular follow-up.Thirty six adults with proved diagnosis of PAD, who had received regular intravenous immunoglobulin replacement therapy, were enrolled in this study. The QoL of selected PAD patients was measured by Medical Outcomes Study 36-item Short-Form (SF-36) Health Survey questionnaire.The patients with PAD showed significantly reduced scores in physical component in comparison with healthy age-sex matched control subjects (60.2±20.1 vs. 85.5±4.7, P<0.001). Mental component score was also significantly decreased in the patient's group (59.8±19.5 vs. 72.3±3.4, P=0.002). There was a reverse association between SF-36 scores and number of infections episodes (r=-0.73 P=0.003). The patients with long delay diagnosis showed significantly lower SF-36 scores (r=-0.62, P=0.003).The patients with PAD who were diagnosed timely and managed appropriately seem to have lower complications and better QoL. However, the patients with severe phenotypes and long delay in diagnosis showed lower QoL, even in medical management.     

Are fitness,activity, and fatness associated with health-related quality of life and mood in older persons?

PURPOSE: This study sought to determine whether levels of fitness, habitual physical activity, and fatness are associated health-related quality of life and mood in older persons. METHODS: The subjects were men (n = 38) and women (n = 44), ages 55 to 75 years, who had milder forms of hypertension, but who were otherwise healthy and not engaged in a regular exercise or diet program. Aerobic fitness was assessed by maximal oxygen uptake during treadmill testing, muscle strength by a one-repetition maximum, habitual activity by questionnaire, fatness by dual-energy x-ray absorptiometry, and body mass index. Health-related quality of life was assessed by the Medical Outcomes Study SF-36, and mood by the Profile of Mood States (POMS). Correlations were determined by bivariate and multivariate regression. RESULTS: Higher aerobic fitness was associated with more desirable outcomes, as indicated by the POMS anger and total mood disturbance scores and by the SF-36 bodily pain, physical functioning, vitality, and physical component scores. Increased fatness was associated with less desirable outcomes, as indicated by the POMS anger, depression, and total mood disturbance scores and by the SF-36 bodily pain, physical functioning, role-emotional, role-physical, social functioning, vitality, and physical component scores. Higher physical activity was associated with an increased POMS score for vigor and a decreased SF-36 score for bodily pain. Strength was not related to health-related quality of life or mood. Aerobic fitness was the strongest predictor of the SF-36 score for vitality and the POMS score for total mood disturbance, whereas fatness was the strongest predictor of the POMS anger score and the SF-36 bodily pain, physical functioning, and physical component scores. CONCLUSIONS: Even in the absence of regular exercise and a weight-loss diet, relatively small amounts of routine physical activity within a normal lifestyle, slight increases in fitness, and less body fatness are associated with a better health-related quality of life and mood.     

The ICIDH-2 as a framework for the assessment of functioning and disability in rheumatoid arthritis

OBJECTIVE: To investigate by a cross sectional study in patients with rheumatoid arthritis (RA) the relationship between measures of impairment, activity limitation, and participation of the model of functioning and disability (ICIDH-2). METHODS: Inclusion data of patients with RA (n=803) from the Swiss Clinical Quality Management Group were used. Impairments were measured by the Short Form-36 (SF-36) bodily pain scale, rheumatoid arthritis disease activity index (RADAI), disease activity score (DAS28), and radiographic scoring (x ray). Activity limitation was measured with the Health Assessment Questionnaire (HAQ) and the SF-36 physical functioning scale. Participation was measured with the SF-36 role and social functioning scales. Spearman (partial) correlations were used for analysis. RESULTS: Impairment and activity limitation dimensions of the ICIDH-2 model are related; correlations with the HAQ were: SF-36 bodily pain (r(s)=-0.61), RADAI (r(s)=0.58), DAS28 (r(s)=0.49), and x ray (r(s)=0.35). Similar correlations were found for SF-36 physical functioning. Activity limitation and participation restriction dimensions are also related: the HAQ correlates well with SF-36 role-physical (r(s)=-0.53) and SF-36 social functioning (r(s)=-0.43); SF-36 physical functioning correlates similarly. For impairment and participation restriction dimensions only SF-36 bodily pain is substantially correlated (r(s)=0.47 and 0.48) with SF-36 role-physical, after correcting for the influence of the activity limitation dimension (HAQ and SF-36 physical functioning). CONCLUSIONS: In this cross sectional study of patients with RA, impairments are associated with activity limitations, and activity limitations are associated with participation restrictions. Pain is the only impairment directly associated with participation restrictions. Based on the results of this study, it is strongly recommended that the ICIDH-2 framework is used in clinical trials and observational studies including the assessment of disease consequences in RA.     

Circulating blood markers and functional impairment in peripheral arterial disease

OBJECTIVES: To determine whether higher levels of inflammatory blood markers, D‐dimer, and homocysteine were associated with greater impairment in lower extremity functioning in persons with peripheral arterial disease (PAD). DESIGN: Cross‐sectional. SETTING: Three Chicago‐area medical centers. PARTICIPANTS: Four hundred twenty‐three persons with PAD (ankle–brachial index (ABI) <0.90). MEASUREMENTS: Lower extremity performance was assessed using the 6‐minute walk and with usual‐ and fast‐paced 4‐m walking speed. Blood markers were D‐dimer, C‐reactive protein (CRP), interleukin‐6 (IL‐6), soluble vascular cellular adhesion molecule‐1 (sVCAM‐1), soluble intracellular adhesion molecule‐1 (sICAM‐1), and homocysteine. Calf muscle area was measured using computed tomography. RESULTS: Adjusting for confounders, higher levels of D‐dimer (P<.001), IL‐6 (P<.001), sVCAM‐1 (P=.006), CRP (P=.01), homocysteine (P=.004), and sICAM‐1 (P=.046) were associated with poorer 6‐minute walk performance. Higher levels of D‐dimer (P<.001), IL‐6 (P=.003), sVCAM‐1 (P=.001), and homocysteine (P=.005) were associated with slower usual‐paced 4‐m walking speed. Higher levels of D‐dimer, sVCAM‐1, sICAM‐1, IL‐6, and homocysteine were associated with slower fast‐paced walking speed. Results were attenuated after additional adjustment for calf muscle area. CONCLUSION: Higher levels of inflammation and D‐dimer were associated with poorer lower extremity performance in participants with PAD, independent of confounders including ABI.     

Health-related quality of life and impact of antiviral treatment in Chinese patients with chronic hepatitis C in Taiwan

AIM: To evaluate health-related quality of life (HRQOL) in Chinese patients with chronic hepatitis C (CH-C), and the impact of antiviral treatment. METHODS: Short Form 36 (SF-36) Health-related Quality of Life Questionnaires to interview CH-C patients, and age- and sex-matched control subjects at outpatient clinics of a medical center in Taiwan were used. Data were transformed to scores for comparisons of eight major SF-36 domains. We also enrolled consecutive CH-C patients who completed one course of antiviral treatment (interferon α with ribavirin), and measured the HRQOL before, at the 12th wk of treatment, at the end of treatment, and at mo 6, after stopping the treatment to evaluate the impact of antiviral treatment. RESULTS: A total of 371 outpatients were enrolled, including 182 with CH-C and 189 age- and sex-matched subjects without CH-C. CH-C subjects had obviously lower educational status (P<0.01). Mean scores of domains in general health, physical functioning, role-physical, role-emotional, vitality, and mental health of the SF-36 were significantly lower in subjects with CH-C than those without CH-C (P<0.05). In an analysis of 47 CH-C patients who received and completed the whole course of antiviral treatment, mean scores of all domains were significantly lower at wk 12 of treatment compared to baseline. The scores returned to pretreatment values by the end of treatment, but were significantly increased at mo 6 after stopping the treatment. Among the 47 CH-C patients, 21 had sustained responses and 26 had non-sustained responses to antiviral treatment. Compared to pretreatment values, subjects with sustained responses had significantly lower social functioning scores at wk 12 of treatment, and scores for all SF-36 domains returned to pretreatment values, and increased significantly at mo 6 after stopping the treatment. For non-sustained virological responders, scores of all SF-36 domains significantly decreased at wk 12 of treatment, and did not increase significantly by the end of treatment, or at mo 6 after stopping the treatment when compared to the pretreatment values. CONCLUSION: HRQOL in CH-C patients is significantly impaired in most SF-36 domains. Antiviral treatment impaired HRQOL of CH-C subjects during early treatment, mainly in non-sustained virological responders, and improved at mo 6 after stopping the treatment, mainly in sustained virological responders.     

Disability and poor quality of life associated with comorbid anxiety disorders and physical conditions

BACKGROUND: Evidence has been emerging that anxiety disorders are associated with several physical health conditions. We used the first community survey, which assessed physical conditions based on physician assessment and included standardized diagnostic assessment of mental disorders by trained health professionals, to examine the relationship between anxiety disorders and physical conditions. METHODS: The German Health Survey (N = 4181; response rate, 87.6%; ages 18-65 years) used the Composite International Diagnostic Interview to assess Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition mood, substance use, and anxiety disorders (panic disorder, social phobia, specific phobia, generalized anxiety disorder, agoraphobia, obsessive-compulsive disorder) and a standardized medical interview supplemented by laboratory data to assess a broad range of physical conditions. The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) was used to measure health-related quality of life. Number of days of role impairment was used to measure past 30-day disability. RESULTS: After adjusting for sociodemographic factors and other common mental disorders, the presence of an anxiety disorder was significantly associated with thyroid disease, respiratory disease, gastrointestinal disease, arthritis, migraine headaches, and allergic conditions (adjusted odds ratios between 1.39 and 2.12; P<.05). Compared with physical disorders alone, the presence of comorbid anxiety disorder with 1 or more physical disorders was associated with poorer physical component scores on the SF-36 (adjusted mean scores for physical condition alone and physical condition with anxiety disorder, 48.50 and 45.86, respectively; P<.001) and past 30-day disability due to physical problems (adjusted odds ratio, 1.69; 95% confidence interval, 1.20-2.37). CONCLUSION: Anxiety disorders are independently associated with several physical conditions in the community, and this comorbidity is significantly associated with poor quality of life and disability.     

The effects of oral amino acid intake on ambulatory capacity in elderly subjects

BACKGROUND AND AIMS: The combination of high prevalence of inactivity in the older population, and high risk of ill-health and disability associated with inactivity, suggests that interventions that are successful in increasing levels of activity may have a great impact on population health in later life. With advancing age, the risk of developing serious nutritional deficiencies also increases. This study was designed to assess the effects of dietary amino acid supplementation on effort tolerance in healthy elderly subjects with reduced physical activity. METHODS: Forty-four subjects (age > 65 years) with sedentary life-style and lower health-related quality of life were studied. Subjects, in an open-label fashion, received an oral amino acid mixture (AAM, 12 g/day) containing essential and non-essential amino acids for a 3-month period. Ambulatory dysfunction resulting in sedentary life-style was assessed by a 6-min walk test. A walking impairment questionnaire (WIQ) was used to evaluate self-perceived ambulatory dysfunction. Maximal isometric muscular strength of the right hand was measured during isometric exercise by a handgrip dynamometer. RESULTS: The 6-min walk distance increased from 214.5 +/- 32 to 262.8 +/- 34.8 m (p < 0.001) after AAM treatment. The baseline scores on the three subscales of WIQ changed significantly during treatment: WIQ distance increased from 56.2 +/- 12.9 to 66.3 +/- 12.8% (p < 0.001); WIQ speed from 52 +/- 12.6 to 69.2 +/- 14.8% (p < 0.001) and WIQ stairs from 74.4 +/- 22.6 to 94.2 +/- 25% (p < 0.001), as did maximal isometric muscular strength (16.6 +/- 2.4 vs 19.2 +/- 2.2 kg, p < 0.001). Changes in plasma glucose (+11 +/- 11 mg/dL), total cholesterol (0 +/- 39 mg/dL), HDL cholesterol (0 +/- 17 mg/dL), and triglycerides (-11 +/- 58 mg/dL) were not significant between baseline and AAM. CONCLUSIONS: An oral amino acid supplement, as used in this pilot study, improves ambulatory capacity and maximal isometric muscle strength in elderly subjects without affecting the main metabolic parameters. Amino acid supplementation may thus represent useful non-pharmacological intervention to maintain physical fitness in these subjects.     

Function and health-related quality of life: results from a randomized controlled trial of leflunomide versus methotrexate or placebo in patients with active rheumatoid arthritis. Leflunomide Rheumatoid Arthritis Investigators Group.

OBJECTIVE: To assess the efficacy of leflunomide or methotrexate compared with placebo in improving function and health-related quality of life in patients with active rheumatoid arthritis (RA), and to examine correlations between response status (as defined by the American College of Rheumatology [ACR] response criteria) and improvement in these measures. METHODS: This 52-week, multicenter, doubleblind, controlled trial compared responses to the Health Assessment Questionnaire (HAQ), modified Health Assessment Questionnaire (MHAQ), Problem Elicitation Technique (PET), Medical Outcomes Study Short Form 36 (SF-36), and questions regarding work productivity among 3 treatment groups (leflunomide, methotrexate, and placebo). Improvement in the PET top 5 and SF-36 scales and component scores were compared with ACR response rates. RESULTS: Clinically meaningful and statistically significant (P<0.0001) improvement in measures of function and heath-related quality of life (MHAQ scores, all scales and disability index of the HAQ, weighted top 5 score of the PET, 5 of 8 scales and physical component score of the SF-36, and work productivity) was seen during treatment with leflunomide in comparison with placebo. Methotrexate administration resulted in significant improvements (P<0.05) in comparison with placebo in the MHAQ scores, HAQ disability index, weighted top 5 score of the PET, physical component score of the SF-36, and bodily pain scale. Compared with methotrexate, leflunomide administration resulted in significantly (P<0.01) more improvement in the MHAQ scores, 5 of 8 scales and disability index of the HAQ, weighted top 5 score of the PET, and 2 of 8 scales and physical component score of the SF-36. Improvements in the PET score, SF-36 physical component score, and work productivity correlated with the ACR responder rates of > or =20% and > or =50% improvement. CONCLUSION: Significant improvements in function and health-related quality of life occurred in patients with RA during treatment with leflunomide or methotrexate. These findings were clinically meaningful and correlated with the ACR response status.