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.

Cardiovascular Rehabilitation Increases Walking Distance in Patients With Intermittent Claudication. Results of the CIPIC Rehab Study: A Randomised Controlled Trial.

OBJECTIVE: To examine whether a cardiac rehabilitation programme in a community based setting for patients with intermittent claudication (IC) affects walking ability, quality of life, and changes in health behaviour. The trial investigated a cross sector cardiovascular rehabilitation programme compared with usual care for patients having non-operative management. METHODS: The trial allocated 118 patients, with 1:1 individual randomisation to either an intervention or control group. Data were collected at a department of vascular surgery and at a healthcare centre in Denmark. The rehabilitation intervention consisted of usual care plus 12 weeks of exercise training, pedometer, health education, and text messages. The primary outcome was maximum walking distance at six months measured by treadmill walking test. The secondary outcomes were maximum walking distance at 12 months and pain free walking distance measured by treadmill walking test, healthy diet, level of physical activity, and quality of life (QoL) at six and 12 months. RESULTS: In the intervention group, 46 participants were analysed, with 47 in the control group. Following three months of rehabilitation, a 37% difference (95% CI 1.10 - 1.70; p = .005) was found between groups in maximum walking distance at six and 12 months, in favour of the intervention group. The same positive effect was found in physical activity, QoL, and healthy diet, but was not statistically significant in pain free walking distance and smoking. CONCLUSION: A specialised community based cardiac rehabilitation programme for patients with IC showed statistically and clinically significant effects on maximum walking distance, physical activity, quality of life, and healthy diet, but not on pain free walking distance and smoking, compared with usual care without rehabilitation.

Better Outcomes for Older people with Spinal Trouble (BOOST) trial: statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication.

BACKGROUND: Neurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence. The effectiveness of conservative interventions in this population is not known. We describe the statistical analysis plan for the Better Outcomes for Older people with Spinal trouble (BOOST) randomised controlled trial. METHODS/DESIGN: BOOST is a pragmatic, multicentre, parallel, two-arm, randomised controlled trial. Participants are community-dwelling adults, 65 years or older, with neurogenic claudication, registered prospectively, and randomised 2:1 (intervention to control) to the combined physical and psychological BOOST group physiotherapy programme or best practice advice. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the Short Physical Performance Battery, Swiss Spinal Stenosis Scale, 6 Minute Walk Test, Fear Avoidance Beliefs Questionnaire, and Tilburg Frailty Indicator. Outcomes are measured at 6 and 12 months by researchers blinded to treatment allocation. The primary statistical analysis is by intention to treat. Further study design details are published in the BOOST protocol. DISCUSSION: The planned statistical analyses for the BOOST trial aim to reduce the risk of outcome reporting bias from prior data knowledge. Any changes or deviations from this statistical analysis plan will be described and justified in the final study report. TRIAL REGISTRATION: This study has been registered in the International Standard Randomised Controlled Trial Number registry, reference number ISRCTN12698674 . Registered on 10 November 2015.

A Comparison of Quality of Life in Elderly Patients with Intermittent Claudication and Chronic Limb-Threatening Ischemia.

BACKGROUND: Intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI) are both associated with a decreased health status and possibly quality of life (QOL). A better understanding of the differences in QOL between patients with IC and CLTI could be of additional value in shared decision-making. The aim of this study was to compare the QOL at baseline between patients with IC and patients with CLTI. METHODS: The study population was based on 2 study cohorts, 1 cohort consisted of patients with IC (ELECT registry) and the other cohort of patients with CLTI (KOP-study). Patients with an age of ≥70 years were included. QOL at baseline was measured by the WHOQOL-BREF questionnaire. Nonresponders were excluded from data analyses. Student's t-tests and analysis of covariance (ANCOVA) analyses were used to compare QOL between the 2 groups. Outcomes of the ANCOVA analyses were expressed as estimated marginal means. RESULTS: In total, 308 patients were included, 115 patients with IC and 193 patients with CLTI. Patients with CLTI were older (median age 80 years vs. 75 years, P < 0.001) and had more comorbidities. Patients with IC had a statistically significant higher QOL regarding physical health (mean 13.7 [standard deviation (SD) 2.3] vs. 10.8 [SD 2.8], P < 0.001), psychological health (mean 15.3 [SD 2.1] vs. 14.1 [SD 2.4], P < 0.001), environment (mean 16.3 [SD 2.4] vs. 15.5 [SD 2.0], P < 0.002), and the overall domain (mean 3.5 [SD 0.7] vs. 3.1 [SD 0.9], P < 0.001). After correcting for the confounding effect of age and sex, patients with IC still had a statistically significant higher QOL in the physical, psychological, environment, and overall domain. CONCLUSIONS: Patients with IC had a significantly higher QOL in the physical, psychological, environment, and overall domains of the WHOQOL-BREF questionnaire compared with patients with CLTI. This underlines the importance of strategies that reduce disease progression as disease progression is associated with a decrease in QOL.

Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial.

BACKGROUND: Supervised exercise programmes for intermittent claudication have poor access and limited compliance. Neuromuscular electrical stimulation (NMES) may be an effective alternative. A proof-of-concept study and RCT were conducted. METHODS: In study 1, eligible patients underwent baseline assessment; treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five-level instrument (EQ-5D-5L™) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery. After familiarization with the NMES device, participants underwent a 30-min session of stimulation with concomitant recording of haemodynamic measures at 15 min, and after device cessation. Measurements were repeated after 6 weeks of daily use of NMES. In study 2, consecutive patients underwent baseline assessment before online randomization to a supervised exercise programme only, or adjunctive NMES treatment for 6 weeks, followed by repeat measurements. RESULTS: Study 1 (20 patients) showed a significant improvement in MCD (46 per cent; P < 0·001) and ICD (71 per cent; P < 0·001). The RCT (42 patients) showed a significant adjunctive benefit of NMES in ICD (46 per cent; P = 0·014). Improvements were seen in the ICQ (9 points; P = 0·009) and EQ-5D-5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031). Blood volume flow and time-adjusted mean velocity increased significantly with the device on (P < 0·050). Overall, NMES compliance exceeded 95 per cent. CONCLUSION: Footplate NMES significantly improved walking distance in patients with intermittent claudication when used independently and also as an adjunct to supervised exercise. Registration number: trial 1, NCT02436200; trial 2, NCT02429310 (http://www.clinicaltrials.gov).

ANTECEDENTES: Los programas de ejercicio supervisado (supervised exercise programmes, SEP) para la claudicación intermitente (intermittent claudication, IC) tienen un acceso y un cumplimiento deficientes. La estimulación eléctrica neuromuscular (neuromuscular electrical stimulation, NMES) puede ser una alternativa clínicamente efectiva. Se realizó un estudio de prueba de concepto y un ensayo controlado aleatorizado. MÉTODOS: Estudio 1: Veinte pacientes elegibles se sometieron a una evaluación inicial que incluía una prueba en la cinta de correr para la distancia inicial de claudicación (initial claudication distance, ICD) y la distancia máxima de claudicación (maximum claudication distance, MCD), EuroQoL-5D (EQ-5D), valoración mediante el cuestionario de claudicación intermitente (intermittent claudication questionnaire, ICQ), y hemodinámica por ecografía de la arteria femoral superficial. Después de familiarizarse con el dispositivo NMES, los participantes se sometieron a una sesión de estimulación de 30 minutos con el registro concomitante de medidas hemodinámicas a los 15 minutos y después del cese del dispositivo. Se realizaron mediciones repetidas después de 6 semanas de uso diario de NMES. Estudio 2: Se reclutaron 42 pacientes que tras una evaluación inicial y posterior aleatorización al azar en línea, se asignaron al Grupo A, utilizando SEP solamente; o al el Grupo B, con tratamiento NMES complementario durante 6 semanas seguido de medidas repetidas. RESULTADOS: El estudio 1 mostró una mejoría significativa de la MCD (46%, P < 0,0001) y de la ICD (71%, P < 0.004). El ensayo clínico mostró un beneficio coadyuvante significativo de NMES en la ICD (46%, P = 0,014). Se observaron mejorías en la puntuación del ICQ (9 puntos, P < 0,01) y del EQ-5D (P < 0,05) en el estudio 1, con un beneficio coadyuvante significativo de NMES en la puntuación del ICQ (11 puntos, P < 0,05). El flujo de volumen de sangre (CC/min) y TAMV (cm/s) aumentaron significativamente con el dispositivo en funcionamiento (P < 0,05). El cumplimiento global de la NMES superó el 95%. CONCLUSIÓN: La plataforma de NMES para el pie mejora significativamente las distancias de caminar en la claudicación intermitente cuando se usa de forma independiente y también proporciona un beneficio complementario al ejercicio supervisado en la distancia caminada sin dolor. La mejora del flujo sanguíneo puede ser un mecanismo para explicar estos resultados.

Treadmill Measured vs. Questionnaire Estimated Changes in Walking Ability in Patients With Peripheral Artery Disease.

OBJECTIVE: Determining the maximum walking time (MWT) using the treadmill test is the gold standard method for evaluating walking capacity and treatment effect in patients with peripheral arterial disease (PAD). However, self reported functional disability is important when assessing quality of life. Changes in the Walking Estimated Limitation Calculated by History (WELCH) questionnaire scores were compared with the MWT. METHODS: A cross sectional study was performed in patients with intermittent claudication. The treadmill test (3.2 km/h; 10% gradient) and WELCH questionnaire were administered to all patients for objective evaluation of walking capacity. Given the log normal distribution of these parameters in patients with PAD, a log transformation was applied to the WELCH score (LnW) and maximum walking time (LnT). The responsiveness of the WELCH score was determined using mean changes and correlation coefficients of LnW and LnT changes. The effect of time on the "estimated minus real" (E - R) changes (LnW - change minus LnT - change) was assessed after categorisation of patients into various test-retest intervals. Patients who underwent lower limb revascularisation between the two tests and those who underwent medical treatment only were analysed. RESULTS: Correlation coefficients between LnW and LnT for tests 1 and 2 were r = 0.514 and r = 0.503, respectively (p < .001, for both). Correlation for LnW change vs. LnT change was 0.384 (p < .001). E - R was positive only early after surgery. E - R was negative for all test-retest intervals >1 year in revascularised and non-revascularised patients. CONCLUSION: Changes in WELCH scores correlated with changes observed on the treadmill in patients with intermittent claudication. For long test-retest intervals, WELCH changes tended to overestimate the worsening of walking impairment as compared with the measured difference observed in both revascularised and non-revascularised patients. A shortlived "honeymoon" (overestimation of the benefit for the shortest test-retest interval) was observed only in revascularised patients.

Quantification of Daily Physical Activity and Sedentary Behavior of Claudicating Patients.

BACKGROUND: Claudication is the most common manifestation of peripheral artery disease (PAD), producing significant ambulatory compromise. Limited information exists on the routine physical activity of claudicating patients. Our objective was to record the intensity/time profiles of physical activity and the timing and duration of sedentary behavior of a sample of community-dwelling claudicating patients. METHODS: Forty-four claudicating patients referred to our vascular clinic were recruited. Physical activity was recorded using the ActiGraph GT1M activity monitor. The Actigraph monitor is a lightweight instrument designed to measure human movement through changes in acceleration, measured as counts over 1-minute time periods. Data from 7 consecutive days were used for the calculations. We processed the data using the ActiLife software program. RESULTS: The average daily activity of the claudicating patients shows a steady increase beginning approximately 05:30 AM until a peak plateau from approximately 10:00 AM to 01:30 PM followed by a steady decrease until approximately 09:30 PM, when a sustained period of inactivity begins. The average claudicating patient takes 3586 steps per day at an average intensity of 1.77 metabolic equivalents of task (METs, a physiological measure expressing the energy cost of physical activities). Average physical activity intensity and peak intensity fluctuate very little during the day, and they rarely exceed the level of light activity (light = <3 METs maximum effort, such as casual walking or light housework). During awake time, approximately 7 hours are spent in sedentary behaviors (<1.5 METs), and sedentary time is spread throughout the day mostly in short intervals between periods of low-energy activity. CONCLUSIONS: Our study objectively demonstrates the reduced physical activity of claudicating patients and documents physical activity/duration profiles throughout the day. The intensity of the physical activity of the average claudicating patient fluctuates very little during the day and rarely exceeds a light intensity level. Claudicating patients spend approximately half of their awake time in sedentary behavior and when they walk they do it in short bursts followed by several minutes of rest. We anticipate that changes in routine physical activity/duration profiles of patients with PAD will provide relevant, sensitive, and direct measures of the effectiveness of therapeutic interventions.

Successful Smoking Cessation Associated with Walking Behavior in Patients with Claudication.

BACKGROUND: Behavioral economics theories suggest that a preference for delayed benefits promotes positive behavioral change, a concept relevant to both smoking cessation and community-based exercise regimens for claudication. Given the high rate of smoking among older veterans, we were interested in examining the association between smoking cessation, exercise regimen adherence, and preferences for delayed versus immediate benefits. METHODS: Between April 2017 and March 2018, patients with claudication at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas, received questionnaires collecting information on social, behavioral, and psychological characteristics. A dual validation system, via the electronic medical record and survey data, measured the primary outcome-smoking cessation versus current smoking. Self-reported physical activity was measured through the validated Ainsworth's compendium of Physical Activities and binary survey questions. The Walking Impairment and Barratt's Impulsivity Questionnaires measured subjective symptom severity and behavioral economics factors, respectively. Multivariable, logistic regression models identified significant associations. RESULTS: The survey was mailed to 500 patients who met the eligibility criteria. We received responses from 148 individuals (30%), and 67 of 141 (48%) indicated that they had successfully quit smoking. In unadjusted comparisons, the median cognitive complexity score in the smoking cessation group was higher than that in the current smoking group. A greater proportion of patients who reported walking for exercise (n = 46) also reported successful smoking cessation (28/46, 61%). Among those who were not walking for exercise (n = 88), more individuals reported current smoking (49/88, 56%). In the multivariable model, individuals who had successfully stopped smoking were older (odds ratio [OR]: 7.59, P < 0.001), more likely to walk for exercise (OR: 3.94, P = 0.009), more interested in the future than in the present (OR: 1.73, P = 0.030), and more likely to regularly save money (OR: 3.49, P = 0.046). CONCLUSIONS: We found that participants who reported successful smoking cessation were more likely to report walking for exercise. Our findings suggest that adherence to walking may be less challenging for patients who have already successfully implemented and continue to implement another beneficial health behavior (smoking cessation). Patients with claudication who are current smokers may be less likely to adopt exercise recommendations.

Translation and Validation of the Brazilian-Portuguese Short Version of Vascular Quality of Life Questionnaire in Peripheral Artery Disease Patients with Intermittent Claudication Symptoms.

BACKGROUND: The Vascular Quality of Life Questionnaire (VascuQoL-6) was proposed to evaluate specific quality of life of peripheral artery disease (PAD) patients. However, there is no Brazilian-Portuguese version available, blunting its use in Brazilian patients. The objective of the study was to analyze the psychometric properties of a translated Brazilian-Portuguese version of VascuQoL-6 in Brazilian patients with PAD with intermittent claudication symptoms. METHODS: One hundred eleven patients with PAD participated in the study. After translation and retranslation, construct validity was analyzed by identifying correlation between VascuQoL-6 scores, general World Health Organization qualify of life (WHOQOL) score, and subjective and objective functional capacity tests. To determine the reliability, internal consistency and test-retest reliability with at least 7 days interval between 2 questionnaire applications were calculated. RESULTS: Significant correlations between the VascuQoL-6 score and total WHOQOL score (r = 0.44; P < 0.05) were observed. Moreover, we observed negative correlations between the VascuQoL-6 score and 4-meter usual pace (r = -0.33; P < 0.05) and 4-meter fast pace (r = -0.34; P < 0.05) and positive correlation with onset claudication distance (r = 0.39; P < 0.05) and total walking distance (r = 0.29; P ≤ 0.05). Internal consistency was 0.84, whereas the intraclass coefficient correlation was 0.84, with no differences in VascuQoL-6 scores between the 2 applications days. CONCLUSIONS: The Brazilian-Portuguese version of the VascuQoL-6 presents adequate valid and reliability indicators, allowing its use in patients with PAD with intermittent claudication symptoms.

Supervised exercise therapy versus home-based exercise therapy versus walking advice for intermittent claudication.

BACKGROUND: Although supervised exercise therapy (SET) provides significant symptomatic benefit for patients with intermittent claudication (IC), it remains an underutilized tool. Widespread implementation of SET is restricted by lack of facilities and funding. Structured home-based exercise therapy (HBET) with an observation component (e.g., exercise logbooks, pedometers) and just walking advice (WA) are alternatives to SET. This is the second update of a review first published in 2006. OBJECTIVES: The primary objective was to provide an accurate overview of studies evaluating effects of SET programs, HBET programs, and WA on maximal treadmill walking distance or time (MWD/T) for patients with IC. Secondary objectives were to evaluate effects of SET, HBET, and WA on pain-free treadmill walking distance or time (PFWD/T), quality of life, and self-reported functional impairment. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (December 16, 2016) and the Cochrane Central Register of Controlled Trials (2016, Issue 11). We searched the reference lists of relevant studies identified through searches for other potential trials. We applied no restriction on language of publication. SELECTION CRITERIA: We included parallel-group randomized controlled trials comparing SET programs with HBET programs and WA in participants with IC. We excluded studies in which control groups did not receive exercise or walking advice (maintained normal physical activity). We also excluded studies comparing exercise with percutaneous transluminal angioplasty, bypass surgery, or drug therapy. DATA COLLECTION AND ANALYSIS: Three review authors (DH, HF, and LG) independently selected trials, extracted data, and assessed trials for risk of bias. Two other review authors (MvdH and JT) confirmed the suitability and methodological quality of trials. For all continuous outcomes, we extracted the number of participants, mean outcome, and standard deviation for each treatment group through the follow-up period, if available. We extracted Medical Outcomes Study Short Form 36 outcomes to assess quality of life, and Walking Impairment Questionnaire outcomes to assess self-reported functional impairment. As investigators used different scales to present results of walking distance and time, we standardized reported data to effect sizes to enable calculation of an overall standardized mean difference (SMD). We obtained summary estimates for all outcome measures using a random-effects model. We assessed the quality of evidence using the GRADE approach. MAIN RESULTS: For this update, we included seven additional studies, making a total of 21 included studies, which involved a total of 1400 participants: 635 received SET, 320 received HBET, and 445 received WA. In general, SET and HBET programs consisted of three exercise sessions per week. Follow-up ranged from six weeks to two years. Most trials used a treadmill walking test to investigate effects of exercise therapy on walking capacity. However, two trials assessed only quality of life, functional impairment, and/or walking behavior (i.e., daily steps measured by pedometer). The overall methodological quality of included trials was moderate to good. However, some trials were small with respect to numbers of participants, ranging from 20 to 304.SET groups showed clear improvement in MWD/T compared with HBET and WA groups, with overall SMDs at three months of 0.37 (95% confidence interval [CI] 0.12 to 0.62; P = 0.004; moderate-quality evidence) and 0.80 (95% CI 0.53 to 1.07; P < 0.00001; high-quality evidence), respectively. This translates to differences in increased MWD of approximately 120 and 210 meters in favor of SET groups. Data show improvements for up to six and 12 months, respectively. The HBET group did not show improvement in MWD/T compared with the WA group (SMD 0.30, 95% CI -0.45 to 1.05; P = 0.43; moderate-quality evidence).Compared with HBET, SET was more beneficial for PFWD/T but had no effect on quality of life parameters nor on self-reported functional impairment. Compared with WA, SET was more beneficial for PFWD/T and self-reported functional impairment, as well as for some quality of life parameters (e.g., physical functioning, pain, and physical component summary after 12 months), and HBET had no effect.Data show no obvious effects on mortality rates. Thirteen of the 1400 participants died, but no deaths were related to exercise therapy. Overall, adherence to SET was approximately 80%, which was similar to that reported with HBET. Only limited adherence data were available for WA groups. AUTHORS' CONCLUSIONS: Evidence of moderate and high quality shows that SET provides an important benefit for treadmill-measured walking distance (MWD and PFWD) compared with HBET and WA, respectively. Although its clinical relevance has not been definitively demonstrated, this benefit translates to increased MWD of 120 and 210 meters after three months in SET groups. These increased walking distances are likely to have a positive impact on the lives of patients with IC. Data provide no clear evidence of a difference between HBET and WA. Trials show no clear differences in quality of life parameters nor in self-reported functional impairment between SET and HBET. However, evidence is of low and very low quality, respectively. Investigators detected some improvements in quality of life favoring SET over WA, but analyses were limited by small numbers of studies and participants. Future studies should focus on disease-specific quality of life and other functional outcomes, such as walking behavior and physical activity, as well as on long-term follow-up.

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.

User Preferences for Mobile Health Interventions: A Survey among Intermittent Claudication Patients and Their Physical Therapists.

BACKGROUND: Smartphone apps provide novel ways for triggering lifestyle change by coupling objective measurements of health behavior with tailored feedback. Little is known about end-user preferences regarding the content of mobile health (mHealth) interventions. The aim of this study was to assess smartphone use and preferences regarding app content among intermittent claudication patients and their treating physical therapists. METHODS: A cross-sectional survey was sent via an internal email system to 1,514 physical therapists specialized in treating patients with intermittent claudication. They were asked to complete one questionnaire themselves and administer a second to their intermittent claudication patients currently under treatment. Data on participant characteristics and smartphone use were collected from all respondents. The preferred app components were obtained from participants owning a smartphone. Binary logistic regression analysis was used to explore the adjusted association between age and attained educational level, and smartphone use. RESULTS: The response rate of therapists was 40.8% (617/1,514), and a total of 488 patients completed the survey. After excluding incomplete forms, a total of 615 physical therapist forms and 483 patient forms were analyzed. Overall, 40.6% of patients and 95% of therapists owned a smartphone. Higher educational level was associated with smartphone ownership (adjusted odds ratio = 2.46, 95% confidence interval (CI) = 1.41-4.27, P = 0.001). Compared to patients aged ≥75 years, lower age was associated with higher odds of owning a smartphone (adjusted odds ratios for patients aged ≤54 years = 21.27, 95% CI = 6.82-66.30, P < 0.001; aged 55-64 years = 4.76, 95% CI = 2.52-9.00, P < 0.001; and aged 65-74 years = 2.58, 95% CI = 1.54-4.33, P < 0.001). The most preferred app components for intermittent claudication patients in possession of a smartphone included monitoring treadmill-measured walking distances (71%), global positioning system tracking of walks (50%), and daily physical activity monitoring (49%). Physical therapists were most interested in global positioning system tracking of walks (89%), daily physical activity monitoring (82%), keeping track of treadmill-measured walking distance (79%), help with smoking cessation (65%). CONCLUSIONS: Smartphone ownership is associated with younger age and a higher educational level in patients with intermittent claudication. This study provides a framework of end-user preferences regarding desired features to guide the development of an app to potentiate health outcomes of intermittent claudication treatment.

Identifying content gaps in health status measures for intermittent claudication using the International Classification of Functioning, Disability and Health.

OBJECTIVE: The Walking Impairment Questionnaire (WIQ) and Intermittent Claudication Questionnaire (ICQ) are commonly used patient-reported functional outcome measures for intermittent claudication, but their functional representation has not been characterized. The World Health Organization's International Classification of Functioning, Disability and Health (ICF) framework comprehensively describes health-related function and has been used to evaluate health status and quality of life (QOL) measures. We applied a content analysis technique commonly used in functional rehabilitation research to evaluate ICF domains represented by WIQ and ICQ to characterize their health status and functional representation. METHODS: The overall perspective of each question was assigned as health status-function, health status-disability, Environment-facilitator, Environment-barrier, or QOL. All meaningful concepts in each question were identified and linked to the most appropriate and precise ICF code from the hierarchy of component, chapter, or category using the validated technique. A 20% random sample of questions was secondarily coded with disagreements resolved by discussion. RESULTS: Codability was agreed upon for 87% of questions; agreement was 100% on component and chapter and 88% on category. WIQ contains 18 concepts among 14 questions (1.3 concepts per question); all questions are from the health status-disability perspective. All WIQ concepts are from the "Activities/Participation-d" ICF component, "Mobility-d4" chapter. "Walking long distances" (d4501, >1 km) is omitted. ICQ contains 37 codable concepts among 16 questions (2.3 concepts per question). Thirteen questions are from health status-disability perspective, three from QOL. Sox of the nine chapters of the "Activities/Participation-d" ICF component are represented by 20 of 37 concepts; 11 of 20 in the "Mobility-d4" chapter. The other "Activities/Participation-d" chapters and categories in ICQ are "Learning/applying knowledge" ("thinking-d163"), "General tasks/demands" ("carrying out daily routine-d230"), "Domestic life" ("shopping-d6200," "doing housework-d640"), "Major life areas" ("Maintaining a job-d8451"), and "Community life" ("socializing-d9205," "hobbies-d9204"). "Body Functions-b" ICF component is represented 11 times, covering pain, numbness, emotion, mood, and cardiovascular functions. "Body Structures-s" is represented three times as lower extremity. Neither WIQ nor ICQ specifically addresses "Walking on different surfaces," (64,502) "Walking around obstacles" (d4503), or "Moving around using equipment" (d465), which includes assistive devices. Walking on an incline is not addressed in WIQ, ICQ, or the ICF. CONCLUSIONS: Applying this ICF-based content assessment methodology to patient-reported vascular disease outcome measures is feasible, representing a novel method of assessing such instruments. WIQ's scope is limited; it does not address functional capacity and covers only health status pertaining to walking disability. The ICQ is more inclusive, but concept density may obscure meaning. Neither instrument is functionally comprehensive and both have significant omissions that should be considered for inclusion.

[Quality of life in patients with lower extremity atherosclerosis during standard treatment and therapeutic angiogenesis]. / Kachestvo zhizni u patsientov s aterosklerozom nizhnikh konechnostei pri ispol'zovanii standartnogo lecheniia i terapevticheskogo angiogeneza.

AIM: To compare the impact of standard conservative treatment (SCT) and its combination with therapeutic angiogenesis for 3 to 5 years on quality of life in patients with Stage II (according to the classification developed by A.V. Pokrovsky-Fontaine) lower extremity atherosclerosis. SUBJECTS AND METHODS: 92 patients (69 men and 23 women) (mean age 65.2±7.7 years) were examined and divided into 2 groups of 46 people each. Only SCT (statins at an individually adjusted dose, antiaggregants, and graded exercise walking 3 to 5 km daily were used in Group 1; while Group 2 received SCT in combination with double injection of a plasmid-based VEGF165 gene drug (1.2 mg) into the ischemic limb muscles. The Russian version of the standard SF-36 questionnaire was applied; pain-free walking distances were measured before treatment and then every year; limb preservation and survival rates were determined in the patients. RESULTS: It was determined that standard treatment did not significantly affect patients' quality of life throughout the follow-up period. Addition of gene therapy leads to a significant improvement in both physical (p=0.00001) and psychological (p=0.00002) health components just in the first year of the follow-up. This is achieved through a significant (500%) increase in the average leg pain-free walking distance; p=0.007). CONCLUSION: The obtained result is consistently high throughout the subsequent period. There was no statistically significant difference in survival rates between the groups; limb preservation remained comparable.

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 Effect of Structured Patient Education on Physical Activity in Patients with Peripheral Arterial Disease and Intermittent Claudication: A Systematic Review.

OBJECTIVES: The aim was review the components and effects of patient education interventions to improve physical activity (PA) in patients with peripheral arterial disease (PAD) and intermittent claudication (IC), and patients' experiences of these interventions. DATA SOURCES: CINAHL, Cochrane Library, Ovid, ProQuest, AMED, MEDLINE, PsycINFO, Web of Science Core Collection, and PEDRO, and Trial registers and directory of Open Access repository websites and Web of science conference proceedings were searched. Hand searching of reference lists of identified studies was also performed to identify studies that reported the effect of patient education interventions on daily PA and/or walking capacity in individuals with PAD and IC, or studies investigating patients' experiences of such interventions. METHODS: A systematic search was conducted in June 2016 (updated in March 2017). Primary outcomes were daily step count and self reported PA; the secondary outcome was absolute claudication distance. There was substantial heterogeneity in terms of modalities of patient education in the included studies; hence a narrative synthesis was implemented. RESULTS: Six studies (1087 participants) were included in the review. Findings from a small number of high quality trials demonstrated potential for PA improvement with structured education interventions. Nevertheless, evidence is currently inconclusive regarding the effect on daily PA and walking capacity of patients with IC. Patients reported that they valued the interventions studied, finding them acceptable and important in improving their PA, motivating and empowering them to self manage their condition. CONCLUSIONS: The evidence from the review is limited and inconclusive regarding the effectiveness of structured education for increasing PA in patients with PAD and IC. More rigorous trials are needed before recommendations can be made. Future interventions should consider the key criteria for a structured patient education programme, and also report patients' experiences and perceptions.

Patient-perceived health-related quality of life before and after laparoscopic aortobifemoral bypass.

BACKGROUND: In patients operated with laparoscopic aortobifemoral bypass (LABFB) for atherosclerotic obstruction in aortoiliac segment, the main focus of the reports published during the last two decades has been morbidity and mortality. The primary objective of this study was to examine the health-related quality of life (HRQL) in these patients before and after LABFB. PATIENTS AND METHODS: Fifty consecutive patients (27 females) with Trans-Atlantic Inter-Society Consensus II, type D lesions were prospectively included. Short-Form 36 (SF-36) questionnaire was used to get information about the HRQL before LABFB and at 1, 3 and 6 months after the operation. Main indication for LABFB was intermittent claudication. Linear mixed-effect models were used to assess changes in HRQL over time. Age, gender, smoking, blood loss, operation time, concomitant operation, the American Society of Anesthesiologists category, length of hospital stay, previous vascular procedures and aorta cross-clamping were used as fixed factors and their impact on the physical components of the SF-36, as well as the summary scores were determined with univariate analysis. Variables with P<0.2 were included in the multivariate regression analysis. P<0.05 was considered statistically significant. RESULTS: Statistically significant improvement was found in all SF-36 domains as well as in the summary scores after LABFB compared to the preoperative scores. The improvement in scores was substantial already at 1 month and the effect was maintained at 3 and 6 months survey time points. Concomitant operations had a statistically significant negative impact on the physical components of SF-36. Data completeness of item questionnaires was 93% in the whole material. Reliability scale and homogeneity estimates for the eight domains had high internal consistency. CONCLUSION: Patients operated with LABFB for Trans-Atlantic Inter-Society Consensus II, type D lesions have reduced HRQL. LABFB leads to substantial and statistically significant improvement in the patients' HRQL, when examined with SF-36. These results need to be replicated by a randomized clinical trial.

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.

Primary Stenting of the Superficial Femoral Artery in Intermittent Claudication Improves Health Related Quality of Life, ABI and Walking Distance: 12 Month Results of a Controlled Randomised Multicentre Trial.

BACKGROUND: Invasive treatment of intermittent claudication (IC) because of severe atherosclerotic stenosis or occlusion in the superficial femoral artery (SFA) is controversial. This prospective randomised trial was performed to assess the impact on health related quality of life (HRQoL) of primary stenting with nitinol self expanding stents compared with best medical treatment alone in patients suffering from stable IC due to SFA disease. METHODS: One hundred patients with stable IC caused by SFA disease from seven Swedish hospitals treated with best medical treatment (BMT) were randomised to either the stent (n = 48) or the control (n = 52) group. Change in HRQoL assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 12 months after treatment was the primary outcome measure. Improvement in the Walking Impairment Questionnaire (WIQ), ankle brachial index (ABI), and walking distance were secondary outcomes. RESULTS: HRQoL improved significantly. In the stent group the following SF-36 domains improved: Physical Function, 19 points (p < .001); Bodily Pain, 14 points (p = .001); General Health, 6 points (p = .019); Vitality, 10 points (p = .004); Physical Component Summary, 6.5 points (p < .001); EQ5D, 0.14 points (p = .008); and WIQ 22 points (p < .001). They were unchanged in the control group. Both ABI (from 0.58 ± 0.11 to 0.86 ± 0.19, p < .001, in the stent group and from 0.63 ± 0.17 to 0.70 ± 0.20, p = .005, in the control group) and walking distance (WD) (from 171 ± 90 meters to 613 ± 381 meters, p < .001, in the stent group and from 209 ± 106 m to 335 ± 321 meters, p = .012, in the control group) improved, and at 12 months both the ABI (p < .001) and the WD (p = .001) were higher in the stent group. CONCLUSIONS: In patients with IC caused by lesions in the SFA, the addition of primary stenting to BMT was associated with significant improvement in HRQoL, ABI, and walking distance after 12 months follow-up compared with BMT alone.

A Three Month Home Exercise Programme Augmented with Nordic Poles for Patients with Intermittent Claudication Enhances Quality of Life and Continues to Improve Walking Distance and Compliance After One Year.

OBJECTIVE/BACKGROUND: The objective of this study was to collect 1 year follow-up information on walking distance, speed, compliance, and cost in patients with intermittent claudication who took part in a previously reported 12 week randomised clinical trial of a home exercise programme augmented with Nordic pole walking versus controls who walked normally. A second objective was to look at quality of life and ankle brachial pressure indices (ABPIs) after a 12 week augmented home exercise programme. METHODS: Thirty-two of the 38 patients who completed the original trial were followed-up after 6 and 12 months. Frequency, duration, speed, and distance of walking were recorded using diaries and pedometers. A new observational cohort of 29 patients was recruited to the same augmented home exercise programme. ABPIs, walking improvement, and quality of life questionnaire were recorded at baseline and 12 weeks (end of the programme). RESULTS: Both groups in the follow-up study continued to improve their walking distance and speed over the following year. Compliance was excellent: 98% of the augmented group were still walking with poles at both 6 and 12 months, while 74% of the control group were still walking at the same point. The augmented group increased their mean walking distance to 17.5 km by 12 months, with a mean speed of 4.2 km/hour. The control group only increased their mean walking distance from 4.2 km to 5.6 km, and speed to 3.3 km/hour. Repeated ANOVA showed the results to be highly significant (p = .002). The 21/29 patients who completed the observational study showed a statistically significant increase in resting ABPIs from baseline (mean ± SD 0.75 ± 0.12) to week 12 (mean ± SD 0.85 ± 0.12) (t = (20) -8.89, p = .000 [two-tailed]). All their walking improvement and quality of life parameters improved significantly (p = .002 or less in the six categories) over the same period and their mean health scores improved by 79%. CONCLUSIONS: Following a 12 week augmented home exercise programme, most patients with intermittent claudication continued to significantly improve their walking distance and walking speed at 1 year compared with normal walking. Quality of life and ABPIs improved significantly after only 12 weeks and it is postulated that the improvement in ABPI was due to collateral development. These results justify the belief that an augmented home exercise programme will be as clinically effective as existing supervised exercise programmes, with the added benefits of lower cost and better compliance. Funding for a multicentre trial comparing an augmented home exercise programme with existing supervised exercise programme is now urgently required.