Revisión sistemática: costo-efectividad, acceso y adherencia a programas de ejercicio supervisado en pacientes con claudicación intermitente / Systematic review: cost-effectiveness, access and adherence to supervised exercise programs in patients with intermittent claudication

OBJETIVO: Determinar las razones de la escasa derivación, acceso, y adherencia a programas de ejercicio supervisado (PES) en pacientes con claudicación intermitente (CI) y la costo-efectividad de estos programas a nivel Internacional. MÉTODOS: Se utilizaron las fuentes de datos de PubMed y ScienceDirect. Se incluyeron revisiones con acceso completo, publicados desde el año 2010, que incluían como mínimo 3 artículos de tipo cuantitativo. RESULTADOS: Se incluyeron 5 Revisiones asociadas a los resultados del ejercicio supervisado, su costo-efectividad, la baja derivación y adherencia a PES de los pacientes con CI. En cuanto a la costo-efectividad los resultados indican que los PES fueron rentables con un ICER de £711 a £1.608 por QALY ganado al compararlos con ejercicio no supervisado, y al compararlos con la cirugía de revascularización (CR) no hay diferencia significativa en QALY ganados, sin embargo, el costo por QALY fue €381.694 más alto para la CR. Por otro lado, las principales razones de la subutilización de los PES, es que los pacientes se resisten a asistir, ya que involucra un esfuerzo y responsabilidad, además de tener problemas de reembolso, teniendo baja adherencia. Sumado a esto, el interés personal de los médicos por realizar intervenciones que involucran pago por servicio produce una baja derivación (45% de cirujanos en Europa refieren menos del 50% de sus pacientes). CONCLUSIÓN: Las principales dificultades para adoptar los PES serían una carencia en la destinación de recursos, falta de centros, dificultad de traslado, falta de tiempo, o de interés por parte de los pacientes, además de incentivos financieros a otras alternativas de tratamiento por sobre PES lo que limita su derivación.

OBJECTIVE: To determine the reasons for the limited derivation, access and adherence to supervised exercise programs (SEP) in patients with intermittent claudication (IC) and the cost-effectiveness of these programs internationally. METHODS: PubMed and ScienceDirect databases were searched. Revisions with full access, published since 2010, which included at least 3 quantitative type articles. RESULTS: 5 reviews were included, these were associated with the results of the supervised exercise, its cost-effectiveness, the low referral and adherence to programs of patients with IC. Regarding cost-effectiveness, the results indicated that SEP were more cost-effective with an ICER of £711 to £1.608 per QALY gained when compared with unsupervised exercise, and that when compared with revascularization surgery (RC) there was no significant difference in QALYs, however the cost per QALY was € 381.694 higher for the RC. On the other hand, the main reasons for the underutilization of SEP are that patients are reluctant to attend, since it involves effort and responsibility, in addition to having reimbursement problems, therefore having low adherence. Added to this, the personal interest of doctors in performing interventions that involve payment for service produce a low referral (45% of surgeons in Europe refer less than 50% of their patients) CONCLUSION: The main difficulties in adopting the SEP would be a lack in the allocation of resources, lack of centers, difficulty of transportation, lack of time or lack of interest from patients, in addition to financial incentives to other treatment alternatives over SEP, which limits their referral.

Supervised Exercise Therapy for Intermittent Claudication Is Increasingly Endorsed by Dutch Vascular Surgeons.

BACKGROUND: Although supervised exercise therapy (SET) is generally accepted as an effective noninvasive treatment for intermittent claudication (IC), Dutch vascular surgeons were initially somewhat hesitant as reported by a 2011 questionnaire study. Later on, a nationwide multidisciplinary network for SET was introduced in the Netherlands. The aim of this questionnaire study was to determine possible trends in conceptions among Dutch vascular surgeons regarding the prescription of SET. METHODS: In the year of 2015, Dutch vascular surgeons, fellows, and senior residents were asked to complete a 26-item questionnaire including issues that were considered relevant for prescribing SET such as patient selection criteria and comorbidity. Outcome was compared to the 2011 survey. RESULTS: Data of 124 respondents (82% males; mean age 46 years; 64% response rate) were analyzed. SET referral rate of new IC patients was not different over time (2015: 81% vs. 2011: 75%; P = 0.295). However, respondents were more willing to prescribe SET in IC patients with chronic obstructive pulmonary disease (2015: 86% vs. 2011: 69%; P = 0.002). Nevertheless, a smaller portion of respondents found that SET was also indicated for aortoiliac disease (2015: 63% vs. 2011: 76%; P = 0.049). Insufficient health insurance coverage and/or personal financial resources were the most important presumed barriers preventing patients from initiating SET (80% of respondents). Moreover, 94% of respondents judged that SET should be fully reimbursed by all Dutch basic health insurances. CONCLUSIONS: The concept of SET for IC is nowadays generally embraced by the vast majority of Dutch vascular surgeons. SET may have gained in popularity in IC patients with cardiopulmonary comorbidity. However, SET remains underutilized for aortoiliac disease. Reimbursement is considered crucial for a successful SET implementation.

Exercise rehabilitation for peripheral artery disease: An exercise physiology perspective with special emphasis on the emerging trend of home-based exercise.

Peripheral artery disease (PAD) is a significant medical concern that is highly prevalent, costly, and deadly. Additionally, patients with PAD have significant impairments in functional independence and health-related quality of life due to leg symptoms and ambulatory dysfunction. Exercise therapy is a primary treatment for patients with PAD, as ambulatory outcome measures improve following a program of exercise rehabilitation. This review describes the outcomes that improve with exercise, the potential mechanisms for improved leg symptoms, key exercise program considerations for training patients with PAD with walking-based exercise, other exercise modalities that have been utilised, the use of on-site supervised exercise programs, and a major focus on historical and contemporary trials on conducting home-based, minimally supervised exercise program to treat PAD. The review concludes with recommendations for future exercise trials, with particular emphasis on reported greater details of the exercise prescription to more accurately quantify the total exercise dose of the program.

Near-infrared spectroscopy assessment following exercise training in patients with intermittent claudication and in untrained healthy participants.

Selected near-infrared spectroscopy (NIRS) parameters were assessed in healthy untrained participants and in peripheral arterial disease (PAD) trained patients to evaluate their usefulness in rehabilitative outcome. Forty-five PAD and 15 healthy participants were studied at entry and at 34 ± 2 weeks. Healthy participants performed their usual activities. Patients with PAD performed 2 home-based programs: structured at prescribed pace (S-pre, n = 31) and unstructured at free pace (U-free, n = 14). We measured ankle-brachial index (ABI), NIRS calf oxygen consumption at rest, NIRS dynamic muscle perfusion during an incremental test, and walking capacity. In all patients with PAD the NIRS parameters significantly increased approaching the stable values of untrained healthy participants. Among PAD, only S-pre group showed significant improvements in hemodynamic, functional, and NIRS parameters with selective adaptations in the worse legs. The assessment of NIRS parameters, that were found stable without training in healthy and modified in PAD only following structured training, might outline the local exercise-induced adaptations.

Evaluation of patient compliance, quality of life impact and cost-effectiveness of a "test in-train out" exercise-based rehabilitation program for patients with intermittent claudication.

BACKGROUND: Patients with intermittent claudication (IC) could benefit from low-cost, effective rehabilitative programs. This retrospective study evaluates compliance, impact on Quality of Life (QoL) and cost-effectiveness of a hospital prescribed, at-home performed (Test-in/Train-out) rehabilitative program for patients with IC. METHODS AND RESULTS: Two-hundred and eighty-nine patients with IC (71 ± 10.1 years, M = 210) were enrolled for a 2-year period. Two daily 10-min home walking sessions at maximal asymptomatic speed were prescribed, with serial check-ups at the hospital. Compliance with the program was assessed by assigning a score of 1 (lowest compliance) to 4 (highest compliance). The SF-36 questionnaire and a constant-load treadmill test were used to evaluate QoL and Initial/Absolute Claudication Distance, respectively. Both direct and indirect costs of the program were considered for cost-effectiveness analysis. Two-hundred and fifty patients (70.5 ± 9.2 years, M = 191), at Fontaine's II-B stage (86%), were included in the study. No adverse events were reported. The average compliance score was 3.1. At discharge, both SF-36 domains and walking performance significantly increased (P < 0.0001). A total of 1,839 in-hospital check-ups (7.36 /patient) were performed. Direct and indirect costs represented 93% and 7% of the total costs, respectively. The average costs of a visit and of a therapy cycle were C68.93 and C507.20, respectively. The cost to walk an additional meter before stopping was C9.22. CONCLUSIONS: A Test-in/Train-out program provided favourable patient compliance, QoL impact and cost-effectiveness in patients with IC.

Claudication: exercise vs endoluminal revascularization (CLEVER) study update.

The Claudication: Exercise vs Endoluminal Revascularization (CLEVER) Study is a prospective multicenter randomized clinical trial designed to compare the relative clinical and cost-effectiveness of invasive revascularization with stents to supervised exercise rehabilitation in a cohort with moderate to severe claudication due to aortoiliac insufficiency. The study is currently enrolling at twenty-eight sites in the US and Canada. Enrollment of 217 participants is planned, with data collected at baseline, six months, and 18 months. The primary study endpoint is maximum walking duration (MWD) on a graded treadmill test; secondary endpoints include community-based walking, markers of cardiovascular disease risk (body mass index, waist circumference, blood pressure, lipid profile, glucose tolerance, and plasma fibrinogen), health-related quality of life, and cost effectiveness. There are currently sixty randomized participants; recruitment is projected to end in July 2010 and final study results reported in June 2012.

Supervised exercise for intermittent claudication - an under-utilised tool.

INTRODUCTION: The use of supervised exercise in the management of intermittent claudication is well supported by level I evidence upon which are based grade A recommendations by the TASC II Inter-Society Consensus for the Management of Peripheral Arterial Disease and the Scottish Intercollegiate Guidelines Network (SIGN). These include that supervised exercise should be made available as part of the initial treatment for all peripheral arteriopaths. SUBJECTS AND METHODS: A questionnaire, comprising 10 questions, was drawn up to address the issues pertinent to supervised exercise in intermittent claudication. This was distributed by post, along with a pre-stamped return envelope, to all ordinary members of the Vascular Society of Great Britain and Ireland (VSGBI). All returned and received questionnaires had their responses entered onto a pre-prepared spreadsheet. RESULTS: Of the 186 questionnaires posted to UK resident surgeons, 84 were returned. This equates to a response rate of 45%. Of the responders, only 24% had access to supervised exercise. There was a large spread in the proportion of eligible patients which were referred to a programme, with only 14% of VSGBI members recommending 100% of eligible patients. Rates of non-compliance varied greatly. Contra-indications to supervised exercise included cardiac (27%), and vascular, musculoskeletal, geographic, and respiratory (8% each). Most supervised exercise sessions (85%) were 1 h in duration. The majority (65%) of programmes comprised one session per week. With regards the duration of programme, 55% were 3 months. Almost all classes were led by either a physiotherapist (41%) or a nurse (48%). In centres where no supervised exercise programme was available, verbal advice was given by 63%, with 34% offering leaflets. A supervised exercise set up has not been achieved due to lack of resource in 72%. CONCLUSIONS: These results are contrary to the recommendations offered by the TASC II Inter-Society Consensus and SIGN, in particular in terms of availability and referral to supervised exercise, as well as frequency of the classes where programmes were in place. The offer of information either verbally or via leaflet is commended; however, this has been shown as inferior to supervised exercise. Quoting resource as the reason for non-implementation goes against the published quality-of-life and pharmaco-economic data, which promote supervised exercise as both functionally and financially effective. This work highlights the importance of translating the results of research into evidence-based clinical practice.

Effectiveness and costs of a short-course supervised training program in claudicants: proposal for a shared protocol with aerobic working load.

AIM: The purpose of this study was to assess the costs and effectiveness of a short-course physical training program, consisting of an aerobic protocol with clearly defined working loads in each single training session, in patients with intermittent claudication (IC). METHODS: Initial (ICD), absolute (ACD) claudication distance, and recovery time (RT) have been measured by maximal treadmill exercise in 74 claudicants. Ankle brachial index (ABI) has been measured too. Measurements have been repeated after 18 days of supervised physical training consisting of a daily walk reaching either a distance goal of 1-2 km or a time goal of at least 30 min. The working load of each single training session has been tailored at 60-70% of the ACD measured by a non-maximal treadmill exercise. RESULTS: ICD increased from 56.2 (+/- standard deviation/+/- standard error: 35.3/4.1) to 123.9 (66.5/7.7); ACD increased from 104.8 (49.8/5.8) to 195.1 (81.7/9.5) and RT reduced from 201.2 (98.3/11.4) to 85.8 (43.6/5.1), with P<0.0001 for all parameters. We analyzed separately patients with moderate (M-CL) and severe (S-CL) claudication, and found significant improvements in both groups. The Ds (post-training value minus pretraining value) were: ICD 89.6 (59.9/10.9) in M-CL and 50.2 (29.9/4.6) in S-CL; ACD 102.8 (66.8/11.6) in M-CL and 80.1 (41.5/6.4) in S-CL; RT -98.7 (86.9/15.1) in M-CL and -128.5 (88.1/13.7) in S-CL, with P<0.0001 for all parameters. The differences between M-CL and S-CL were significant only for ICD (P=0.0003) and ACD (P<0.05). ABI showed an increasing trend, which was statistically significant (P<0.001), but clinically irrelevant. The protocol cost was 4179 Euro (average cost 46.30 Euro to walk one additional meter). CONCLUSION: Supervised physical training is confirmed to be an effective tool for the treatment of IC, and the proposed short-course protocol gave the same improvements as the longer ones while reducing the costs. The proposed procedure for tailoring the working load of a single session identifies clearly the working load, near maximal pain but avoiding the risk of inflammatory activation.

Economic evaluation of a short-course intensive rehabilitation program in patients with intermittent claudication.

AIM: The aim of this study was to provide cost-description and cost-effectiveness of a short-course intensive in-hospital rehabilitation program in patients with intermittent claudication. METHODS: Costs per case treated were calculated according to a local standard protocol including diagnostic evaluation of peripheral arterial disease and other related cardiovascular conditions, physical training, and secondary prevention. Three additional less structured scenarios were also evaluated. RESULTS: All 107 enrolled patients (males 91%, mean age 65+/-8 years) completed the program (4-week duration; twice a day walking exercise) and showed significant increases in walking performance, as evaluated by constant treadmill-test. At admission, the mean values of initial claudication distance (ICD) and absolute claudication distance (ACD) were 150+/-111 and 432+/-327 m, respectively. At the end of the program, 12 (11%) patients completed the treadmill test without pain, while 31 (29%) completed the test without stopping due to maximal pain. Among the remaining 64 (60%) patients, the ICD and ACD increased by 137% and 112%, respectively. The cost per case treated ranged from Euro 1733.2 (standard protocol) to Euro 918.9 (physical training only). By adding the cost of hospitalization and indirect costs, the same costs ranged from Euro 4626.2 to Euro 3811.9. The average cost to walk one additional meter without pain as a result of the rehabilitation program was Euro 57.5, while the cost to walk one additional meter before stopping was Euro 27. As showed by sensitivity analysis, the maintenance of the expected level of treatment success was crucial for program's cost-effectiveness. CONCLUSION: From the societal viewpoint, short-course intensive rehabilitation may be cost-effective in patients with stable intermittent claudication and could be considered in decision models evaluating different therapeutic options.

The role of pedometers in the assessment of intermittent claudication.

OBJECTIVES: to evaluate the role of pedometers in the assessment of patients with intermittent claudication by comparing them with treadmill testing, post-exercise ankle brachial pressure index (ABPI) and physical function questionnaires. PATIENTS AND METHODS: fifty patients with intermittent claudication were prospectively assessed by treadmill examination measuring maximum walking distance (MWD) and post-exercise ABPI. Three physical function questionnaires: (1) Medical Outcome Study Short Form-36 (MOS SF-36), Physical Function (PF). (2) MOS SF-36 Role limitation due to Physical Problems (RP). (3) Walking Impairment Questionnaire (WIQ) were completed. Pedometers were used for one week and the daily average number of steps taken by each patient recorded. Pedometers scores were compared with MWD, post-exercise ABPI and physical function questionnaires scores using Spearman correlation test. RESULTS: pedometers estimation of daily physical activity moderately correlated with MWD (Rho=0.35, p=0.01), post-exercise ABPI (Rho=0.35, p=0.01), MOS-SF 36 PF (Rho=0.31, p=0.02), MOS-SF RP (Rho=0.28, p=0.05) and with WIQ (Rho=0.42, p=0.003). CONCLUSIONS: they moderately correlate with treadmill testing, post-exercise ABPI, and with physical function questionnaires. Pedometers may provide a simple and cheap alternative for the assessment of physical and functional disability in intermittent claudication.

Intermittent claudication: pharmacoeconomic and quality-of-life aspects of treatment.

The purpose of this article is to review the literature on the pharmacoeconomics of treatment for intermittent claudication and to discuss the importance of quality-of-life assessment for evaluating treatment strategies. Systemic risk reduction is the primary objective in the treatment of patients with intermittent claudication, as these patients have a high future risk of cardiovascular morbidity and mortality. Modification of cardiovascular risk factors accompanied by antiplatelet therapy is likely to improve overall survival, reduce myocardial infarction and stroke, and will, perhaps, also reduce the risk of ulcers and amputation at acceptable cost-effectiveness ratios. The second goal in the treatment of patients with intermittent claudication is to improve their walking capacity and community-based functional status. Supervised exercise training is the most effective noninvasive intervention to improve walking capacity, but may have elevated indirect costs. Among patients with disabling claudication who are candidates for invasive therapeutic procedures, angioplasty is cost effective in those with femoropopliteal stenosis or occlusion and in those with critical limb ischaemia and a stenosis. For all these therapeutic strategies there is a need to relate the costs to a relevant and comprehensive measure of effectiveness. Quality-of-life evaluation by using questionnaires exploring the specific problems encountered by patients with intermittent claudication in their daily life appear to be the most appropriate tool to evaluate the net result of a treatment. Cost-utility studies by combining pecuniary and quality-of-life evaluations provide information that is extremely useful to patients with intermittent claudication, regulatory authorities, the pharmaceutical industry and healthcare providers.

PGE(1) treatment of severe intermittent claudication (short-term versus long-term, associated with exercise)--efficacy and costs in a 20-week, randomized trial.

The efficacy, safety, and cost of prostaglandin E1 (PGE1) in the treatment of severe intermittent claudication was studied comparing a long-term treatment protocol (LTP) with a short-term treatment protocol (STP) in a randomized 20-week study. The study included 980 patients (883 completed the study) with an average total walking distance of 85.5 +/-10 m (range 22-119). Phase 1 was a 2-week run-in phase (no treatment) for both protocols. In LTP, phase 2 was the main treatment phase. In the LTP, treatment was performed with 2-hour infusions (60 microg PGE1, 5 days each week for 4 weeks. In phase 3 (4-week interval period) PGE1 was administered twice a week (same dosage). In phase 4 (monitoring lasting 3 months, from week 9 to 20) no drugs were used. In STP phase 2 treatment was performed in 2 days by a 2-hour infusion (first day: morning 20 microg, afternoon 40 microg; second day morning and afternoon 60 microg). The reduced dosage was used only at the first cycle (week 0) to evaluate tolerability or side effects. Full dosage (60 microg bid) was used for all other cycles. The same cycle was repeated at the beginning of weeks 4, 8, and 12. The observation period was between weeks 12 and 20. A treadmill test was performed at inclusion, at the beginning of each phase, and at the end of 20th week. A similar progressive physical training plan (based on walking) and a reduction in risk factors levels plan was used in both groups. Intention-to-treat analysis indicated an increase in walking distance, which improved at 4 weeks and at 20 weeks in the STP more than in the LTP group. At 4 weeks the variation (increase) in pain-free walking (PFWD) was 167.8% (of the initial value) in the LTP group and 185% in the STP group (p<0.05). At 4 weeks the variation (increase) in total walking distance (TWD) was 227.6% of the initial value in the LTP group and 289% in the STP group (p<0.05). At 20 weeks the increase in PFWD was 496% of the initial value in the LTP group vs 643% in the STP group (147% difference; p<0.02). The increase in TWD was 368% in the LTP group and 529% in the STP group (161% difference; p<0.02). In both groups there was a significant increase in PFWD and TWD at 4 and 20 weeks, but results obtained with STP are better considering both walking distances. No serious drug-related side effects were observed. Local, mild adverse reactions were seen in 6.3% of the treated subjects in the LTP and 3% in the STP. Average cost of LTP was 6,664 Euro; for STP the average costs was approximately 1,820 E. The cost to achieve an improvement in walking distance of 1 m was 45.8 E with the LTP and 8.5 E with the STP (18% of the LTP cost; p<0.02). For an average 100% increase in walking distance the LTP cost was 1,989 E vs. 421 E with STP (p<0.02). Between-group analysis favors STP considering walking distance and costs. Results indicate good efficacy and tolerability of PGE, treatment. With STP less time is spent in infusion and more in the exercise program. STP reduces costs, speeds rehabilitation, and may be easily used in a larger number of nonspecialized units.

Improved walking economy in patients with peripheral arterial occlusive disease.

The effect of exercise rehabilitation on the oxygen cost of ambulation in patients with peripheral arterial occlusive disease (PAOD) was evaluated with specific emphasis on the effects of exercise rehabilitation on the slow component of VO2. Because the slow component of VO2 represents an increase in VO2 despite constant-intensity exercise, it can profoundly affect the relative energy cost of exercise in individuals with a low functional capacity. Twenty-six patients with intermittent claudication performed treadmill walking at 2.0 mph/0% grade for 20 min or until maximal claudication pain before and after 4 months of rehabilitation. The slow component of VO2 during the treadmill test was defined as the difference between the end-exercise VO2 and the VO2 observed at minute 3. Ankle/brachial systolic pressure index (ABI) was measured before and immediately following the exercise test. Rehabilitation consisted of 3 d x wk(-1) of treadmill walking for 15-30 min at 60-70% of VO2peak. The slow component of VO2 and end-exercise VO2 at pretraining (0.75 +/- 0.90 and 11.12 +/- 2.10 mL x kg[-1] x min[-1]) were significantly reduced after 4 months of exercise rehabilitation (-0.07 +/- 1.11 and 10.07 +/- 1.80 mL x kg[-1] x min[-1]; P < 0.05). Exercise rehabilitation also significantly (P < 0.05) increased the post-exercise ABI (pre-rehabilitation = 0.36 +/- 0.26, post-rehabilitation = 0.43 +/- 0.25). These data suggest that 4 months of exercise rehabilitation: 1) improves walking economy in PAOD patients because of a decreased slow component of VO2, and 2) increases post-exercise ABI.

Exercise in the treatment of claudication: assessment and treatment of functional impairment.

Claudication is an important cause of impaired exercise capacity, which limits a patient's ability to walk and thus to meet the personal, social and occupational demands of daily life. Given that improvement of the walking impairment is the primary goal of treating claudication, exercise performance and functional status of patients with claudication should be measured before and after any intervention. Assessment of functional status in both the laboratory and community settings is important so that the various treatments can be judged as to relative efficacy. Studies have shown that exercise training programs have a clinically important impact on functional capacity in persons with claudication. A meta-analysis showed that pain-free walking time increased 180% and maximal walking time increased 120% in claudicants who participated in an exercise program. Substantial improvements have been found in walking speeds and distances (65% and 44%, respectively), caloric expenditure (31%) and physical functioning (67%).