Cost-effectiveness of supervised exercise therapy compared with endovascular revascularization for intermittent claudication.

BACKGROUND: Current guidelines recommend supervised exercise therapy (SET) as the preferred initial treatment for patients with intermittent claudication. The availability of SET programmes is, however, limited and such programmes are often not reimbursed. Evidence for the long-term cost-effectiveness of SET compared with endovascular revascularization (ER) as primary treatment for intermittent claudication might aid widespread adoption in clinical practice. METHODS: A Markov model was constructed to determine the incremental costs, incremental quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio of SET versus ER for a hypothetical cohort of patients with newly diagnosed intermittent claudication, from the Dutch healthcare payer's perspective. In the event of primary treatment failure, possible secondary interventions were repeat ER, open revascularization or major amputation. Data sources for model parameters included original data from two RCTs, as well as evidence from the medical literature. The robustness of the results was tested with probabilistic and one-way sensitivity analysis. RESULTS: Considering a 5-year time horizon, probabilistic sensitivity analysis revealed that SET was associated with cost savings compared with ER (-€6412, 95 per cent credibility interval (CrI) -€11 874 to -€1939). The mean difference in effectiveness was -0·07 (95 per cent CrI -0·27 to 0·16) QALYs. ER was associated with an additional €91 600 per QALY gained compared with SET. One-way sensitivity analysis indicated more favourable cost-effectiveness for ER in subsets of patients with low quality-of-life scores at baseline. CONCLUSION: SET is a more cost-effective primary treatment for intermittent claudication than ER. These results support implementation of supervised exercise programmes in clinical practice.

Development of quality indicators for physiotherapy for patients with PAOD in the Netherlands: a Delphi study.

OBJECTIVES: The aim of the study was to develop quality indicators (QIs) for physiotherapy management of patients with intermittent claudication (IC) in the Netherlands. DESIGN: As part of an international six-step method to develop QIs, an online survey Delphi-procedure was completed. After two Delphi-rounds a validation round was performed. PARTICIPANTS: Twenty-six experts were recruited to participate in this study. Twenty-four experts completed two Delphi-rounds. A third round was conducted inviting 1200 qualified and registered physiotherapists of the Dutch integrated care network 'Claudicationet' to validate a draft set of quality indicators. RESULTS: Out of 83 potential QIs in the Dutch physiotherapy guideline on 'Intermittent claudication', consensus among the experts selected nine indicators. All nine quality indicators were validated by 300 physiotherapists. CONCLUSION: A final set of nine indicators was derived from (1) a Dutch evidence-based physiotherapy guideline, (2) an expert Delphi procedure and (3) a validation by 300 physiotherapists. This set of indicators should be validated in clinical practice.

The effect of supervised exercise therapy on physical activity and ambulatory activities in patients with intermittent claudication.

OBJECTIVE/BACKGROUND: Intermittent claudication (IC) is associated with a reduction in physical activity (PA) and a more rapid functional decline leading to a higher mortality rate compared with healthy individuals. Supervised exercise therapy (SET) is known to increase the walking capacity of patients with IC. However, it is unclear whether SET increases PA. The aim of this study was to investigate the effect of SET on PA levels and ambulatory activities in patients with IC. METHODS: Patients newly diagnosed with IC were requested to wear an activity monitor 1 week prior to and 1 week immediately after 3 months of SET. The primary outcome was the percentage of patients meeting the minimum recommendations of PA (American College of Sports Medicine [ACSM]/American Heart Association [AHA] recommendation for public health of ≥ 67 metabolic equivalents [METs]/min/day, in bouts of ≥ 10 min) at baseline and after 3 months of SET. Additionally, daily PA level (METs/min), duration of ambulatory activities, daily number of steps, pain free walking distance (PFWD), maximal walking distance (MWD), and Short Form Health Survey (SF-36) health surveys were compared before and after SET. RESULTS: Data from 41 participants were available for analysis. A higher number of participants met the ACSM minimum recommendation for PA at the 3 month follow up (baseline: 43%; 3 months: 63%; p = .003). Despite significant increases in PFWD (baseline: 210 m; 3 months: 390 m; p = .001), MWD (baseline: 373 m; 3 months: 555 m; p = .002) and physical functioning score (SF-36) following SET, no increase in the mean daily PA level was found (395 ± 220 vs. 411 ± 228 METs/min; p = .43). Furthermore, the total number of steps and time spent in ambulatory activities did not change following SET. CONCLUSION: Three months of SET for IC leads to more patients meeting the ACSM/AHA public health minimum recommendations for PA. Assessment of PA could be incorporated as an outcome parameter in future research comparing different treatment modalities for peripheral arterial disease.

Physical activity monitoring in patients with peripheral arterial disease: validation of an activity monitor.

OBJECTIVES: The daily life physical activity (PA) of patients with peripheral arterial disease (PAD) may be severely hampered by intermittent claudication (IC). From a therapeutic, as well as research, point of view, it may be more relevant to determine improvement in PA as an outcome measure in IC. The aim of this study was to validate daily activities using a novel type of tri-axial accelerometer (Dynaport MoveMonitor) in patients with IC. METHODS: Patients with IC were studied during a hospital visit. Standard activities (locomotion, lying, sitting, standing, shuffling, number of steps and "not worn" detection) were video recorded and compared with activities scored by the MoveMonitor. Inter-rater reliability (expressed in intraclass correlation coefficients [ICC]), sensitivity, specificity, and positive predictive values (PPV) were calculated for each activity. RESULTS: Twenty-eight hours of video observation were analysed (n = 21). Our video annotation method (the gold standard method) appeared to be accurate for most postures (ICC > 0.97), except for shuffling (ICC = 0.38). The MoveMonitor showed a high sensitivity (>86%), specificity (>91%), and PPV (>88%) for locomotion, lying, sitting, and "not worn" detection. Moderate accuracy was found for standing (46%), while shuffling appeared to be undetectable (18%). A strong correlation was found between video recordings and the MoveMonitor with regard to the calculation of the "number of steps" (ICC = 0.90). CONCLUSIONS: The MoveMonitor provides accurate information on a diverse set of postures, daily activities, and number of steps in IC patients. However, the detection of low amplitude movements, such as shuffling and "sitting to standing" transfers, is a matter of concern. This tool is useful in assessing the role of PA as a novel, clinically relevant outcome parameter in IC.

Physical activity monitoring in patients with intermittent claudication.

OBJECTIVES: Reduced physical activity (PA) is associated with a higher mortality rate and more rapid functional decline in patients with intermittent claudication (IC). The newest generation of accelerometers can assess both direction and intensity of activities three-dimensionally and may also adequately calculate energy expenditure in daily life. The aim of this study was to quantify daily PA level and energy expenditure of newly diagnosed patients with IC and healthy controls. PA outcomes are compared with contemporary public health physical activity guidelines. METHODS: Before initiating treatment, 94 patients with newly diagnosed IC and 36 healthy controls were instructed to wear a tri-axial seismic accelerometer for 1 week. Daily PA levels (in metabolic equivalents, METs) were compared with the ACSM/AHA public health PA minimum recommendations (≥64 METs·min·day, in bouts of ≥10 minutes). A subgroup analysis assessed the effect of functional impairment on daily PA levels. RESULTS: Data from 56 IC patients and 27 healthy controls were available for analysis. Patients with IC demonstrated significantly lower mean daily PA levels (±SD) than controls (387 ± 198 METs·min vs. 500 ± 156 METs·min, p = .02). This difference was solely attributable to a subgroup of IC patients with the largest functional impairment (WIQ-score < 0.4). Only 45% of IC patients met the public health physical activity guidelines compared with 74% of the healthy controls (p = .01). CONCLUSIONS: More than half of patients with IC do not meet recommended standards of PA. Considering the serious health risks associated with low PA levels, these findings underscore the need for more awareness to improve physical exercise in patients with IC.

When is supervised exercise therapy considered useful in peripheral arterial occlusive disease? A nationwide survey among vascular surgeons.

OBJECTIVES: Although international guidelines state that supervised exercise therapy (SET) should be offered to all patients with intermittent claudication (IC), SET appears to be underutilised in clinical practice. The aim of this study was to document current opinions of Dutch vascular surgeons on SET as treatment option for peripheral arterial occlusive disease (PAOD). MATERIALS AND METHODS: Vascular surgeons and fellows in vascular surgery were asked to complete a 24-question survey either at the 2011 Annual Meeting of the Dutch Society for Vascular Surgery or online. RESULTS: Ninety-one participants, including 83 vascular surgeons (51% of all Dutch vascular surgeons), completed the survey. The respondents would refer 75.4% of newly diagnosed patients with IC for SET. SET was considered less useful in patients with IC and major (cardiopulmonary) co-morbidity or a significant iliac artery stenosis. In critical limb ischaemia, the combination of SET and angioplasty was considered useful in 71.9%. Respondents regarded patient satisfaction (63.3%) and improvement in pain-free or maximal walking ability (26.6%) as clinically most relevant goals of SET. Most (84.4%) agreed that SET should also include lifestyle management. CONCLUSION: Although the vast majority of Dutch vascular surgeons consider SET as an important treatment option for PAOD, SET should receive more emphasis in clinical practice since arguments not to refer for SET are outdated. Furthermore, vascular surgeons agree that lifestyle management should be integrated in SET.