Psychosocial and socioeconomic factors are most predictive of health status in patients with claudication.

BACKGROUND: As a key treatment goal for patients with symptomatic peripheral artery disease (PAD), improving health status has also become an important end point for clinical trials and performance-based care. An understanding of patient factors associated with 1-year PAD health status is lacking in patients with PAD. METHODS: The health status of 1073 consecutive patients with symptomatic PAD in the international multicenter PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry was measured at baseline and 1 year with the Peripheral Artery Questionnaire (PAQ). The association of 47 patient characteristics with 1-year PAQ scores was assessed using a random forest algorithm. Variables of clinical significance were retained and included in a hierarchical multivariable linear regression model predicting 1-year PAQ summary scores. RESULTS: The mean age of patients was 67.7 ± 9.3 years, and 37% were female. Variables with the highest importance ranking in predicting 1-year PAQ summary score were baseline PAQ summary score, Patient Health Questionnaire-8 depression score, Generalized Anxiety Disorder-2 anxiety score, new onset symptom presentation, insurance status, current or prior diagnosis of depression, low social support, initial invasive treatment, duration of symptoms, and race. The addition of 19 clinical variables in an extended model marginally improved the explained variance in 1-year health status (from R2 0.312 to 0.335). CONCLUSIONS: Patients' 1-year PAD-specific health status, as measured by the PAQ, can be predicted from 10 mostly psychosocial and socioeconomic patient characteristics including depression, anxiety, insurance status, social support, and symptoms. These characteristics should be validated and tested in other PAD cohorts so that this model can inform risk adjustment and prediction of PAD health status in comparative effectiveness research and performance-based care.

[The quality of life of patients with atherosclerosis of lower extremities - 15-year observation]. / Jakosc zycia chorych z miazdzyca zarostowa tetnic konczyn dolnych ­ obserwacja 15-letnia.

An improving quality of life of a patient seems to be the primary goal of contemporary medicine facing the controversies arising over the duration of persistent therapy, on the one hand, and mounting costs of health care, on the other. AIM: The aim of the study was to assess the applicability of the SF-36 (Short Form Health Survey) quality-of-life scale to the evaluation of patients with lower-extremity atherosclerosis and to find a link with the new composite endpoint of the study which the quality of life predisposes to. MATERIALS AND METHODS: The patients operated on for lower-extremity atherosclerosis (y-graft) in one centre in the years 1999-2004 were invited to take part in the study. 64 out of 172 patients joined the study. The study participants were assessed for the quality of life, distance intermittent claudication and lower-extremity pulse presence. Information was also collected on their past medical history and life style. The works of the study group undertaken in 2021 thanks to cooperation with the Ministry of Digitalization allowed to determine deaths among the study participants and link them to the information collected earlier, including the quality of life. RESULTS: It was confirmed that the SF-36 scale, a tool from the group of general tools, i.e. a tool not dedicated to any particular disease, allows to perfectly assess the quality of life in the studied group of patients. The assessments obtained in the SF-36 subscales were higher for patients with an at least 10-year post-surgery survival. Yet, it is the differences observed in the analysis of the three variables, namely, social functioning (t=3.825, p<0.001), limitations due to emotional problems (t=3.496, p=0.001) and emotional well-being (t+2.179, p=0.033) that are statistically significant. CONCLUSIONS: The results of the study indicate that the main factors differentiating patients who die within 10 years from the surgery and those with an over-10 survival are primarily emotional well-being related issues.

Clinical Benefit, Harm, and Cost Effectiveness of Screening Men for Peripheral Artery Disease: A Markov Model Based on the VIVA Trial.

OBJECTIVE: Although screening for peripheral arterial disease (PAD) seems obvious due to its two to three times increased mortality, high prevalence in the elderly, ease of detection, and relatively harmless prevention, the evidence is sparse. METHODS: A Markov decision model was created to model the lifetime effectiveness and cost effectiveness of general population PAD screening and relevant intervention in 65 year old men. The model was informed by original estimates from the VIVA trial data except for ankle brachial systolic blood pressure index test accuracy, quality of life, and background mortality, which were adopted from the literature. A Markov model was designed for 65 year old men, who were distributed in the starting states of no/detected/undetected PAD. The main outcomes were life years, quality adjusted life years, and costs of healthcare. RESULTS: Screening for PAD reduced the rates of amputations and stroke by 10.9% and 2.4%, respectively, while it increased the rates of revascularisation, acute myocardial infarction, and major bleeding by 5.5%, 7.1%, and 4.3% respectively. The overall life expectancy was increased by 14 days per invited subject. The cost per life year/quality adjusted life year was estimated at €16 717/€20 673. On the addition of low dose rivaroxaban reduced the costs per life year gained by 40%. If the model ran for only five follow up years, screening reduced relative mortality by 1.71%, suggesting PAD screening accounts for one fourth of the reported overall 7% relative mortality risk reduction of combined abdominal aortic aneurysm, PAD, and hypertension screening. CONCLUSION: Screening of men for PAD is likely to be both clinically effective and cost effective in a lifetime perspective.

Delayed gratification and adherence to exercise among patients with claudication.

Few studies have explicitly identified factors that explain an individual's willingness to engage in community-based exercise for claudication. Identifying the unique characteristics of those inclined toward physical activity would inform interventions that encourage walking. We examined the utility of behavioral economics-related concepts in understanding walking among Veterans with claudication. Patients who received care at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas, were surveyed on symptom severity, behavioral economics, stress, and depression. The primary outcome was a binary variable measuring current walking for exercise and defined as walking for at least 30 minutes every day. Multivariable logistic regression models were used to identify variables, both clinically and statistically significant, at a p-value < 0.05. Between April 2017 and March 2018, we received 148 (30%) responses. A total of 35% (n = 51) of respondents indicated that they walked recreationally for exercise compared to 65% (n = 94) who did not. Characteristics that were significantly associated with walking included regularly saving money (adjusted odds ratio (aOR) = 10.7, p = 0.001), seeking complex problem-solving (aOR = 0.12, p = 0.002), and severe symptoms (aOR = 0.24, p = 0.017). Individuals describing a preference for the future rather than immediate benefit also reported currently walking for exercise. Defining the characteristics of those who exercise may help inform strategies designed to increase walking among those who do not adhere to recommendations.

The role of psychopathology in perceiving, reporting and treating intermittent claudication: a systematic review.

INTRODUCTION: The aim of this systematic review is to investigate the association between mental health and intermittent claudication (IC) perception, reporting and treatment in subjects with peripheral artery disease (PAD). EVIDENCE ACQUISITION: Literature searches of experimental and observational studies published until February 1st, 2016 were conducted using the following electronic databases: Medline/PubMed and Embase. The selection criteria for the studies included a population of patients diagnosed with peripheral artery disease who reported symptoms of intermittent claudication and were assessed for any psychopathological states (depression, anxiety, mood and personality disorders), which in turn were analyzed with regard to the following: IC severity, symptom perception and reporting, patients' quality of life, treatment compliance and its effectiveness. The risk of bias was assessed using Cochrane Collaboration's tool and the Newcastle Ottawa Scales. The strength of recommendations was graded according to GRADE system. EVIDENCE SYNTHESIS: The literature search identified 1598 citations, of which 13 studies with varying risk of bias were included in the review. Depression, anxiety, and personality types were described in more than 800 patients with peripheral arterial disease who suffered from intermittent claudication. With regard to IC perception and reporting, individuals with higher levels of depression had lower levels of pain acceptance, were more dissatisfied with their function and control over function and had a poorer quality of life. In the case of the type D personality, the results were not consistent. Studies assessing the influence of psychopathology on IC severity and treatment also showed discrepant results. Some studies indicated no differences between type D and non-type D patients with regard to the Ankle Brachial Index as well as pain free (PFWD) and maximal walking distances (MWD). On the other hand, others revealed that type D and depressed patients terminated 6MWT prematurely due to the onset of symptoms and experienced a greater annual decline in 6-minute walk distance, fast walking velocity and short physical performance battery. With regard to treatment adherence, patients with no mental problems made the best recoveries. Hostility, aggressiveness and affect-liability were the greatest obstacles to compliance. CONCLUSIONS: Mental disorders might influence the way in which the symptoms of the disease are reported, coped with, and treated. However, the results of the review preclude recommending a routine psychological examination as one of basic diagnostic procedures in patients with peripheral artery disease suffering from IC.

Patient Experience of Recovery After Major Leg Amputation for Arterial Disease.

OBJECTIVES: To date, studies of vascular amputees primarily examine quantitative outcomes following limb loss. Less is known about the patient's perspective after major lower limb amputation. Here, we define and describe the postamputation recovery period. METHODS: Qualitative study using purposive, maximum variation sampling on the variables of amputation level and times since surgery. We first conducted structured interviews with 20 participants (median age: 65 years, range: 45-88 years; 85% male; below knee amputation n = 14; above knee amputation n = 6; median time from amputation to interview = 16 months, range: 4-51 months). Findings were validated via a focus group with 5 amputees. Data were coded, analyzed, and interpreted by 2 reviewers. RESULTS: All participants expressed the desire to have an active role in the decision to undergo amputation, even while acknowledging that limb salvage options were exhausted. Following amputation, participants described a 6-month recovery period when they learned to modify daily activities to accommodate their new functional and psychological needs. Participants defined recovery as when they had regained functional independence, which was described as a level of mobility that allowed them to perform daily activities with minimal assistance. Concerns that participants felt were poorly addressed included uncontrolled pain, feeling unprepared to live with an amputation, and questions about prosthetics. Two of the 5 focus group participants stated a preference for amputation earlier in the treatment course. CONCLUSIONS: Postamputation recovery has an early (up to 6 months) and late phase (after 6 months) and concludes when amputees regain what they perceive as independence. Patients desire to participate in amputation decision-making; in this study, some would have preferred amputation earlier in their clinical course. Attention to the domains that impact quality of life, and fostering a shared decision-making process, are opportunities to enhance postamputation recovery.

PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories): Overview of Design and Rationale of an International Prospective Peripheral Arterial Disease Study.

BACKGROUND: Health status outcomes, including symptoms, functional status, and quality of life, are critically important outcomes from patients' perspectives. The PORTRAIT study (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) was designed to prospectively define health status outcomes and examine associations between patients' characteristics and care to these outcomes among those presenting with new-onset or worsened claudication. METHODS AND RESULTS: PORTRAIT screened 3637 patients with an abnormal ankle-brachial index and new, or worsened, claudication symptoms from 16 peripheral arterial disease (PAD) specialty clinics in the United States, the Netherlands, and Australia between June 2, 2011, and December 3, 2015. Of the 1608 eligible patients, 1275 (79%) were enrolled. Before treatment, patients were interviewed to obtain their demographics, PAD symptoms and health status, psychosocial characteristics, preferences for shared decision-making, socioeconomic, and cardiovascular risk factors. Patients' medical history, comorbidities, and PAD diagnostic information were abstracted from patients' medical records. Serial information about patients' health status, psychosocial, and lifestyle factors was collected at 3, 6, and 12 months by a core laboratory. Follow-up rates ranged from 84.2% to 91%. Clinical follow-up for PAD-related hospitalizations and major cardiovascular events is ongoing. CONCLUSIONS: PORTRAIT systematically collected serial PAD-specific health status data as a foundation for risk stratification, comparative effectiveness studies, and clinicians' adherence to quality-based performance measures. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01419080.

Assessment of Minimum Important Difference and Substantial Clinical Benefit with the Vascular Quality of Life Questionnaire-6 when Evaluating Revascularisation Procedures in Peripheral Arterial Disease.

OBJECTIVES: Patient reported outcomes are increasingly used to assess outcomes after peripheral arterial disease (PAD) interventions. VascuQoL-6 (VQ-6) is a PAD specific health-related quality of life (HRQoL) instrument for routine clinical practice and clinical research. This study assessed the minimum important difference for the VQ-6 and determined thresholds for the minimum important difference and substantial clinical benefit following PAD revascularisation. MATERIALS AND METHODS: This was a population-based observational cohort study. VQ-6 data from the Swedvasc Registry (January 2014 to September 2016) was analysed for revascularised PAD patients. The minimum important difference was determined using a combination of a distribution based and an anchor-based method, while receiver operating characteristic curve analysis (ROC) was used to determine optimal thresholds for a substantial clinical benefit following revascularisation. RESULTS: A total of 3194 revascularised PAD patients with complete VQ-6 baseline recordings (intermittent claudication (IC) n = 1622 and critical limb ischaemia (CLI) n = 1572) were studied, of which 2996 had complete VQ-6 recordings 30 days and 1092 a year after the vascular intervention. The minimum important difference 1 year after revascularisation for IC patients ranged from 1.7 to 2.2 scale steps, depending on the method of analysis. Among CLI patients, the minimum important difference after 1 year was 1.9 scale steps. ROC analyses demonstrated that the VQ-6 discriminative properties for a substantial clinical benefit was excellent for IC patients (area under curve (AUC) 0.87, sensitivity 0.81, specificity 0.76) and acceptable in CLI (AUC 0.736, sensitivity 0.63, specificity 0.72). An optimal VQ-6 threshold for a substantial clinical benefit was determined at 3.5 scale steps among IC patients and 4.5 in CLI patients. CONCLUSIONS: The suggested thresholds for minimum important difference and substantial clinical benefit could be used when evaluating VQ-6 outcomes following different interventions in PAD and in the design of clinical trials.

The influence of pain-related beliefs on physical activity and health attitudes in patients with claudication: A pilot study.

We examined how pain beliefs are related to symptom severity, expectations of risk/benefits, and baseline physical activity among claudicants. Eligible patients at the Michael E DeBakey Veterans Affairs Medical Center were administered questionnaires that measured: fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire [FABQ]), walking impairment, baseline physical activity, claudication type, and risk/benefit attitudes. Among 20 participants, the median age was 69 years (IQR: 66-75). In our efforts to understand how fear-avoidance beliefs influenced physical activity among people with claudication, we found that 12 out of 19 participants (63%) thought that the primary etiology of their pain was walking, while 18 (out of 20) (90%) people thought that walking would exacerbate their leg symptoms - suggesting that there was some confusion regarding the effects of walking on claudication. Those who expected that walking would benefit their symptoms more than surgery reported fewer fear-avoidance beliefs ( p=0.01), but those who believed that walking would make their leg pain worse expected greater benefit from surgery ( p=0.02). As symptom severity increased, fear-avoidance beliefs also increased ( p=0.001). The association between symptom severity and fear-avoidance beliefs indicates that as pain or impairment increases, the likelihood of avoiding behaviors that are thought to cause pain might also increase. Accounting for pain-related beliefs when recommending physical activity for claudication should be considered.

Clinimetric Evaluation of the Vascular Quality of Life Questionnaire in Patients with Lower Limb Ischaemia.

OBJECTIVES: Although commonly used to measure health related quality of life in patients with lower limb ischaemia, the measurement properties of the VascuQol and its assumed underlying health dimensions have not been studied in depth. The objective of this study was therefore to evaluate aspects of reliability and validity of the Dutch version of the VascuQol in patients with intermittent claudication (IC) and critical limb ischaemia (CLI). METHODS: Two datasets containing 195 patients with IC and 150 patients with CLI were used. Face validity of the VascuQol was examined in interviews with patients and a survey among health professionals. Homogeneity and structural validity of the VascuQol were assessed using Cronbach's α coefficients and explanatory factor analysis. Furthermore, convergent validity and known group validity were assessed. RESULTS: During the face validity interviews, three items were indicated as less relevant. Homogeneity analysis showed that the α coefficient of the VascuQol was .93, while the symptoms and social domains had α coefficients below the threshold of .70. The original five domains of the VascuQol could not be reproduced. Instead, factor analysis yielded a three factor solution. Moderate correlations were found for the activities, social and emotional VascuQol domains and matching health domains of other patient reported outcome measures (PROMs). Lower convergent correlations were observed for the pain domain and the sumscore of the VascuQol. The VascuQol was able to distinguish between patients' level of HRQL in relation to their disease severity (IC versus CLI patients). CONCLUSIONS: There is room for improvement of the VascuQol questionnaire. Further clinimetric studies should be performed to strengthen clinically relevant findings based on this instrument.

Revascularization of smokers with claudication is not predicted to limit quality of life despite a higher risk of late failure.

OBJECTIVE: Tobacco smoking after lower extremity revascularization for claudication has repeatedly been shown to increase the risk of adverse events, such that many vascular specialists consider that refusal to abstain from smoking constitutes a major contraindication to open surgical bypass or endovascular intervention. METHODS: A Markov decision analysis (DA) model was used to compare the options of direct revascularization vs medical therapy only in smokers with claudication. The primary outcome was calculated quality of life (cQoL), determined for each patient at follow-up based on the outcomes of the treatment received. Markov DA software was used to predict the QoL for each treatment option preoperatively based on smoking status. RESULTS: Among patients referred during a recent 64-month period with vasculogenic claudication, 94 were actively smoking compared with 217 who were not. The DA model predicted that if the patients who smoked were to discontinue smoking, the best therapy would be bypass surgery for 77% and endovascular intervention for 17%. However, despite at least doubling the risks with intervention in the patients who continue to smoke, the DA model still predicted that 78% and 9% would fare better with open surgical or endovascular intervention, respectively. Among actively smoking patients, open surgical (3%) or endovascular (4%) therapies were initially performed in few patients, whereas 93% were offered only medical therapy. Among initial nonsmokers, revascularization was performed by open (27%) or endovascular (42%) means. At 3 years, the median (interquartile range [IQR]) cQoL was lower in initial smokers than in nonsmokers (0.73 [IQR, 0.73-0.77] vs 0.82 [IQR, 0.75-0.86]; P < .0001), primarily because of a lack of revascularization for smokers. Among initial smokers who did undergo revascularization initially, because of progression of symptoms, or after smoking cessation, cQoL was similar to initial nonsmokers (0.77 [IQR, 0.73-0.84] vs 0.73 [IQR, 0.73-0.73]; P = .37). Although 26% of initial smokers had stopped by the time of their last follow-up, 10% of initially nonsmoking patients were smoking at follow-up. However, among all patients undergoing intervention, the cQoL of patients smoking at the time of last their follow-up was similar to nonsmokers (0.82 [IQR, 0.82-0.86] vs 0.83 [IQR, 0.73-0.86]; P = .99). CONCLUSIONS: Patients with claudication who smoke may be denied the symptom improvement associated with revascularization, yet recidivism for smoking also occurs among patients who have stopped smoking in order to receive revascularization. The strategy not to directly revascularize patients with claudication who continue to smoke does not appear to maximize patient midterm QoL.

Quality-of-life assessment as an outcomes measure in critical limb ischemia.

Critical limb ischemia (CLI) is a diagnosis plagued by significant comorbidity and high mortality rates. Overall survival remains poor in this population regardless of the procedure-related success as demonstrated by freedom from amputation, intervention, and patency. The literature has traditionally focused on physician-centered and lesion-centered outcomes with regards to limb salvage procedures, but there remains a relative paucity of studies of CLI patients describing patient-centered outcomes such as quality of life (QoL), independent living, and ambulation status. Review of the available literature indicates patients do not always experience significant gains in their QoL after limb salvage interventions, despite reasonable graft patency, amputation-free survival, and limb salvage rates. Further research is required using QoL tools in a measurable and clinically relevant fashion to guide optimal quality care that maximizes patient-centered outcomes.

Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial.

BACKGROUND: Physical activity is recommended for people with peripheral arterial disease (PAD), and can improve walking capacity and quality of life; and reduce pain, requirement for surgery and cardiovascular events. This trial will assess the efficacy of a brief behavioral counselling intervention delivered by allied health professionals to improve physical activity in people with PAD. METHODS: This is a multi-center randomised controlled trial in four cities across Australia. Participants (N = 200) will be recruited from specialist vascular clinics, general practitioners and research databases and randomised to either the control or intervention group. Both groups will receive usual medical care, a written PAD management information sheet including advice to walk, and four individualised contacts from a protocol-trained allied health professional over 3 months (weeks 1, 2, 6, 12). The control group will receive four 15-min telephone calls with general discussion about PAD symptoms and health and wellbeing. The intervention group will receive behavioral counselling via two 1-h face-to-face sessions and two 15-min telephone calls. The counselling is based on the 5A framework and will promote interval walking for 3 × 40 min/week. Assessments will be conducted at baseline, and 4, 12 and 24 months by staff blinded to participant allocation. Objectively assessed outcomes include physical activity (primary), sedentary behavior, lower limb body function, walking capacity, cardiorespiratory fitness, event-based claudication index, vascular interventions, clinical events, cardiovascular function, circulating markers, and anthropometric measures. Self-reported outcomes include physical activity and sedentary behavior, walking ability, pain severity, and health-related quality of life. Data will be analysed using an intention-to-treat approach. An economic evaluation will assess whether embedding the intervention into routine care would likely be value for money. A cost-effectiveness analysis will estimate change in cost per change in activity indicators due to the intervention, and a cost-utility analysis will assess change in cost per quality-adjusted life year. A full uncertainty analysis will be undertaken, including a value of information analysis, to evaluate the economic case for further research. DISCUSSION: This trial will evaluate the efficacy and cost-effectiveness of a brief behavioral counselling intervention for a common cardiovascular disease with significant burden. TRIAL REGISTRATION: ACTRN 12614000592640 Australian New Zealand Clinical Trials Registry. Registration Date 4 June 2014.

Quality of Life in Patients Suffering from Critical Limb Ischemia.

BACKGROUND: Various treatment options exist for patients suffering from critical limb ischemia (CLI). These options consist of endovascular procedures, surgical revascularization, primary amputation, or conservative therapy. The effect of the treatment is traditionally focused on outcomes, such as primary patency and limb salvage, though quality of life (QoL) is considered an important additional primary end point in a more patient-oriented healthcare system. The aim of this systematic review is to explore the best clinical decision making possible, to increase QoL in CLI patients. METHODS: This review is based on a systematic electronic literature search using the PubMed and EMBASE databases. Articles evaluating QoL in patients with CLI were selected for further analysis. Only prospective studies, written in English, describing QoL and health status (HS) after endovascular or surgical revascularization, amputation or conservative therapy were considered for inclusion. Treatment results were divided into short-term (≤3-month follow-up) and long-term results (≥1-year follow-up) to achieve a clear view of the QoL in patients suffering for CLI patients. RESULTS: Twenty-five articles describing HS in patients suffering from CLI were included. It was found that while most of these articles reported HS of patients, rarely did they report on QoL. As a result, it is difficult to determine the best treatment to increase HS as studies that focus on the comparison of treatment modalities are lacking. All 4 treatment modalities can raise HS in the short and the long terms; however, endovascular and surgical revascularization seem to positively effect HS the most. QoL results are lacking in both the short and long terms. CONCLUSIONS: All treatment methods included in the study resulted in an increase in patients' HS in both short and long terms. More comparative studies with inclusion of all different treatments of CLI are needed to assist in clinical decision making and perform tailored interventions for the individual patient. QoL and HS are confusingly used in current international literature with abundant HS research. To take patients individual opinions more into account, focus on QoL research is needed to designate the superior treatment in patients suffering from CLI.

One year health status benefits following treatment for new onset or exacerbation of peripheral arterial disease symptoms: the importance of patients' baseline health status.

OBJECTIVE/BACKGROUND: Limited information is available on expected health status gains following invasive treatment in peripheral arterial disease (PAD). One year health status outcomes following invasive treatment for PAD were compared, and whether pre-procedural health status was indicative of 1 year health status gains was evaluated. METHODS: Pre-procedural and 1 year health status (Short Form-12, Physical Component Score [PCS]) was prospectively assessed in a cohort of 474 patients, enrolled from 2 Dutch vascular clinics (March 2006-August 2011), with new or exacerbation of PAD symptoms. One year treatment strategy (invasive vs. non-invasive) and clinical information was abstracted. Quartiles of baseline health status scores and mean 1 year health status change scores were compared by invasive treatment for PAD. The numbers needed to treat (NNT) to obtain clinically relevant changes in 1 year health status were calculated. A propensity weight adjusted linear regression analysis was constructed to predict 1 year PCS scores. RESULTS: Invasive treatment was performed in 39% of patients. Patients with baseline health status scores in the lowest quartile undergoing invasive treatment had the greatest improvement (mean invasive 11.3 ± 10.3 vs. mean non-invasive 5.3 ± 8.5 [p = .001, NNT = 3]), whereas those in the highest quartile improved less (.8 ± 6.3 vs. -3.0 ± 8.2 [p = .025, NNT = 90]). Undergoing invasive treatment (p < .0001) and lower baseline health status scores (p < .0001) were independently associated with greater 1 year health status gains. CONCLUSION: Substantial improvements were found in patients presenting with lower pre-procedural health status scores, whereas patients with higher starting health status levels had less to gain by an invasive strategy.

Failure of patients with peripheral arterial disease to accept the recommended treatment results in worse outcomes.

BACKGROUND: Strategies available to facilitate decision making for patients with peripheral arterial disease (PAD) include a Markov-based decision analysis (DA) model and the Lower Extremity Grading System (LEGS) score. Both have suggested inferior outcomes when the actual treatment received (ATX) differs from that predicted. This study focuses on patient outcomes when such discordance exists. METHODS: All patients referred for symptomatic lower extremity PAD over a 3-year period were evaluated using the DA model and the LEGS score. Calculated quality of life (cQOL) values were assigned before treatment based on patient symptom, perfusion, and amputation status and at follow-up (range 1.000 [perfect health] to .000 [death]). The primary outcome of cQOL was compared according to whether the ATX matched that proposed by the surgeon or predicted by the DA model or LEGS score. Secondary outcomes for revascularized patients included major adverse limb event with perioperative death (MALE + POD) and amputation-free survival (AFS). RESULTS: Among 375 procedures in 345 consecutive patients, the greatest improvement in cQOL at last follow-up (median 16 months) was observed with endovascular (0.23 ± 0.16, n = 93) or open (0.21 ± 0.17, n = 137) revascularization compared with primary amputation (0.10 ± 0.07, n = 23) or medical therapy (0.04 ± 0.09, n = 122). Multivariate regression showed discordance with the surgeon's recommendation (P < 0.05) and/or the DA model (P < 0.05) to be independent predictors of improvement failure. ATX did not always agree with that proposed by the surgeon (89% agree, κ = 0.84), the DA model (68% agree, κ = 0.53), or the LEGS score (53% agree, κ = 0.32). Improvement in cQOL was greatest when ATX was concordant with treatment proposed by the surgeon (0.18 vs. 0.08, P < 0.01), the DA model (0.19 vs. 0.13, P < 0.01), or the LEGS score (0.23 vs. 0.10, P < 0.01). Patient refusal to follow the surgeon's recommendations and continued smoking were associated with minimal improvement (cQOL ranges 0.05-0.07 and 0.00-0.02, respectively), while pursuing a less morbid procedure was associated with greater improvement (cQOL range 0.28-0.38). Among revascularized patients, MALE + POD was lower at 36 months after endovascular than open surgery (21% ± 5% vs. 36% ± 4%, P < 0.05), while AFS was not significantly different. Only discordance with the surgeon's recommendation was an independent predictor of MALE + POD, possibly because of limitations in sample subset size. CONCLUSIONS: Mean cQOL improved most with direct revascularization, especially when the treatment received matched that predicted by the models or proposed by the surgeon. Type of treatment received was an independent predictor of agreement of treatment with recommendations. Patient refusal to follow the recommended treatment as well as the strategy not to revascularize claudicants who persist in smoking were associated with much less patient benefit from treatment.

A systematic review of functional and quality of life assessment after major lower extremity amputation.

BACKGROUND: When judging the success or failure of major lower extremity (MLE) amputation, the assessment of appropriate functional and quality of life (QOL) outcomes is paramount. The heterogeneity of the scales and tests in the current literature is confusing and makes it difficult to compare results. We provide a primer for outcome assessment after amputation and assess the need for the additional development of novel instruments. METHODS: MEDLINE, EMBASE, and Google Scholar were searched for all studies using functional and QOL instruments after MLE amputation. Assessment instruments were divided into functional and QOL categories. Within each category, they were subdivided into global and amputation-specific instruments. An overall assessment of instrument quality was obtained. RESULTS: The initial search revealed 746 potential studies. After a review of abstracts, 102 were selected for full review, and 40 studies were then included in this review. From the studies, 21 different assessment instruments were used 63 times. There were 14 (67%) functional measures and 7 (33%) QOL measures identified. Five (36%) of the functional instruments and 3 (43%) of the QOL measures were specific for MLE amputees. Sixteen instruments were used >1 time, but only 5 instruments were used >3 times. An additional 5 instruments were included that were deemed important by expert opinion. The 26 assessment instruments were rated. Fourteen of the best-rated instruments were then described. CONCLUSIONS: The heterogeneity of instruments used to measure both functional and QOL outcomes make it difficult to compare MLE amputation outcome studies. Future researchers should seek to use high-quality instruments. Clinical and research societies should endorse the best validated instruments for future use in order to strengthen overall research in the field.

Vascular Quality of Life Questionnaire-6 facilitates health-related quality of life assessment in peripheral arterial disease.

BACKGROUND: Most commonly used outcome measures in peripheral arterial disease (PAD) provide scarce information about achieved patient benefit. Therefore, patient-reported outcome measures have become increasingly important as complementary outcome measures. The abundance of items in most health-related quality of life instruments makes everyday clinical use difficult. This study aimed to develop a short version of the 25-item Vascular Quality of Life Questionnaire (VascuQoL-25), a PAD-specific health-related quality of life instrument. METHODS: The study recruited 129 individuals with intermittent claudication and 71 with critical limb ischemia from two university hospitals. Participants were a mean age of 70 ± 9 years, and 57% were men. All patients completed the original VascuQoL when evaluated for treatment, and 127 also completed the questionnaire 6 months after a vascular procedure. The VascuQoL-25 was reduced based on cognitive interviews and psychometric testing. The short instrument, the VascuQoL-6, was tested using item-response theory, exploring structure, precision, item fit, and targeting. A subgroup of 21 individuals with intermittent claudication was also tested correlating the results of VascuQoL-6 to the actual walking capacity, as measured using global positioning system technology. RESULTS: On the basis of structured psychometric testing, the six most informative items were selected (VascuQoL-6) and tested vs the original VascuQoL-25. The correlation between VascuQoL-25 and VascuQoL-6 was r = 0.88 before intervention, r = 0.96 after intervention, and the difference was r = 0.91 (P < .001). The Cronbach α for the VascuQoL-6 was .85 before and .94 after intervention. Cognitive interviews indicated that the responders considered all six items to be relevant and comprehensible. Rasch analysis was used to reduce response options from seven (VascuQoL-25) to four (VascuQoL-6). VascuQol-6 was shown to have high precision and discriminative properties. Item fit was excellent, with both "infit" and "outfit" between 0.7 and 1.3 for all six items. The standardized response mean after intervention was 1.15, indicating good responsiveness to clinical change. VascuQoL-6 results correlated strongly (r = 0.72; P < .001) with the actual measured walking ability (n = 21). CONCLUSIONS: VascuQoL-6 is a valid and responsive instrument for the assessment of health-related quality of life in PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings.

Burden of peripheral arterial disease in Europe and the United States: a patient survey.

BACKGROUND: The aim of the current study was to quantify the burden of peripheral arterial disease (PAD) with respect to health-related quality of life, work productivity and activity impairment, and healthcare resource utilization. METHODS: Data were obtained from the 2010 EU National Health and Wellness Survey (NHWS), which included participants from France, Germany, Italy, Spain, and the UK (5 EU, N = 57,805) as well as the 2010 US NHWS (N = 75,000). The NHWS is an annual, cross-sectional, self-administered Internet survey which employs a stratified random sampling frame to match the age and gender characteristics of the NHWS sample with known population statistics. Participants who self-reported a diagnosis of PAD were compared with participants who did not self-report a diagnosis of PAD on health-related quality of life (mental and physical component summary scores and health utilities from the Short Form-12v2), work productivity and activity impairment (Work Productivity and Activity Impairment questionnaire), and healthcare resource use in terms of the number of physician visits, emergency room visits, and hospitalizations in the past six months through regression modeling adjusting for demographics and health characteristics. RESULTS: A total of 743 (1.29%) and 777 (1.04%) participants self-reported a diagnosis of PAD in the 5 EU and US, respectively. After adjusting for demographics and health characteristics, patients with PAD reported worse health-related quality of life, as measured by health utilities (5 EU: 0.66 vs. 0.70; US: 0.66 vs. 0.72; all p < .05), greater overall work impairment percentage (5 EU: 38.27% vs. 27.48%; US: 23.89% vs. 14.26%) and greater healthcare resource use compared to participants without PAD (all p < .05). CONCLUSIONS: These results suggest a significant burden for patients with PAD in both the 5 EU countries and the US with respect to both quality of life and economic outcomes. Improved management of these patients may have profound effects from both patient and societal perspectives.

[Quality of life and burden of disease in peripheral arterial disease: a study among Hungarian patients]. / Magyarországi perifériás veroérbetegek életminoség és betegségteher vizsgálatának eredményei.

INTRODUCTION: Peripheral arterial disease may occur in about of 14% of patients with high blood pressure, of which 1-3% suffer from chronic critical limb ischemia. Literature data on the quality of life according to the Fontaine stages are very limited. AIM: The aim of this study was to assess the quality of life of Hungarian patients with peripheral arterial disease regarding Fontaine stages II, III and IV. METHODS: The study was based on a cross-sectional survey, which was carried out in four angiologic centres. One hundred and two respondents with peripheral arterial disease (43% woman) were evaluated. The average age of the patients was 70 years (SD-10). RESULTS: Based on the EQ-5D index, the results of the quality of life assessment with respect to Fontaine stages II, III and IV were 0.66, 0.35 and 0.18, respectively. In each stage the EQ-5D values were lower than the values of the age-matched average population. The results of the Pain Visual Analogue Scale (0-100 mm) were 38, 65 and 71 mm in Fontaine stages II, III and IV, respectively, and this showed a strong correlation with the EQ-5D (R = -0.68). In stage Fontaine IV the quality of life of the patients was significantly lower among those who had pain at rest and ALSO ulcer on the leg. CONCLUSIONS: Peripheral disease with clinical symptoms causes significant reduction in quality of life which can be measured with EQ-5D. It becomes worse as we move along the Fontaine stages. While measuring the health gain in stage Fontaine IV, the health gain from the reduction of pain in rest and partial recovery from ulcer should be taken into account.