Endovascular Revascularization Plus Supervised Exercise Versus Supervised Exercise Only for Intermittent Claudication: A Cost-Effectiveness Analysis.

[Figure: see text].

Validation of the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale Dutch language version in patients with hindfoot fractures.

OBJECTIVES: The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale is among the most used questionnaires for measuring functional recovery after a hindfoot injury. Recently, this instrument was translated and culturally adapted into a Dutch version. In this study, the measurement properties of the Dutch language version (DLV) were investigated in patients with a unilateral hindfoot fracture. DESIGN: Multicentre, prospective observational study. SETTING: This multicentre study was conducted in three Dutch hospitals. PARTICIPANTS: In total, 118 patients with a unilateral hindfoot fracture were included. Three patients were lost to follow-up. PRIMARY AND SECONDARY OUTCOME MEASURES: Patients were asked to complete the AOFAS-DLV, the Foot Function Index and the Short Form-36 on three occasions. Descriptive statistics (including floor and ceiling effects), reliability (ie, internal consistency), construct validity, reproducibility (ie, test-retest reliability, agreement and smallest detectable change (SDC)) and responsiveness were determined. RESULTS: Internal consistency was inadequate for the AOFAS-DLV total scale (α=0.585), but adequate for the function subscale (α=0.863). The questionnaire had adequate construct validity (82.4% of predefined hypotheses were confirmed), but inadequate longitudinal validity (70.6%). No floor effects were found, but ceiling effects were present in all AOFAS-DLV (sub)scales, most pronounced from 6 to 24 months after trauma onwards. Responsiveness was only adequate for the pain and alignment subscales, with a SDC of 1.7 points. CONCLUSIONS: The AOFAS Ankle-Hindfoot Scale DLV has adequate construct validity and is reliable, making it a suitable instrument for cross-sectional studies investigating functional outcome in patients with a hindfoot fracture. The inadequate longitudinal validity and responsiveness, however, hamper the use of the questionnaire in longitudinal studies and for assessing long-term functional outcome. TRIAL REGISTRATION NUMBER: NTR5613; Post-results.

American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score: a study protocol for the translation and validation of the Dutch language version.

INTRODUCTION: The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score is among the most commonly used instruments for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. A valid Dutch version of this instrument is currently not available. Such a translated and validated instrument would allow objective comparison across hospitals or between patient groups, and with shown validity and reliability it may become a quality of care indicator in future. The main aims of this study are to translate and culturally adapt the AOFAS Ankle-Hindfoot Score questionnaire into Dutch according to international guidelines, and to evaluate the measurement properties of the AOFAS Ankle-Hindfoot Score-Dutch language version (DLV) in patients with a unilateral ankle or hindfoot fracture. METHODS AND ANALYSIS: The design of the study will be a multicentre prospective observational study (case series) in patients who presented to the emergency department with a unilateral ankle or hindfoot fracture or (fracture) dislocation. A research physician or research assistant will complete the AOFAS Ankle-Hindfoot Score-DLV based on interview for the subjective part and a physical examination for the objective part. In addition, patients will be asked to complete the Foot Function Index (FFI) and the Short Form-36 (SF-36). Descriptive statistics (including floor and ceiling effects), internal consistency, construct validity, reproducibility (ie, test-retest reliability, agreement and smallest detectable change) and responsiveness will be assessed for the AOFAS DLV. ETHICS AND DISSEMINATION: This study has been exempted by the Medical Research Ethics Committee (MREC) Erasmus MC (Rotterdam, the Netherlands). Each participant will provide written consent to participate and remain anonymised during the study. The results of the study are planned to be published in an international, peer-reviewed journal. TRIAL REGISTRATION NUMBER: NTR5613. pre-result.

Endovascular Revascularization and Supervised Exercise for Peripheral Artery Disease and Intermittent Claudication: A Randomized Clinical Trial.

IMPORTANCE: Supervised exercise is recommended as a first-line treatment for intermittent claudication. Combination therapy of endovascular revascularization plus supervised exercise may be more promising but few data comparing the 2 therapies are available. OBJECTIVE: To assess the effectiveness of endovascular revascularization plus supervised exercise for intermittent claudication compared with supervised exercise only. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of 212 patients allocated to either endovascular revascularization plus supervised exercise or supervised exercise only. Data were collected between May 17, 2010, and February 16, 2013, in the Netherlands at 10 sites. Patients were followed up for 12 months and the data were analyzed according to the intention-to-treat principle. INTERVENTIONS: A combination of endovascular revascularization (selective stenting) plus supervised exercise (n = 106) or supervised exercise only (n = 106). MAIN OUTCOMES AND MEASURES: The primary end point was the difference in maximum treadmill walking distance at 12 months between the groups. Secondary end points included treadmill pain-free walking distance, vascular quality of life (VascuQol) score (1 [worst outcome] to 7 [best outcome]), and 36-item Short-Form Health Survey (SF-36) domain scores for physical functioning, physical role functioning, bodily pain, and general health perceptions (0 [severe limitation] to 100 [no limitation]). RESULTS: Endovascular revascularization plus supervised exercise (combination therapy) was associated with significantly greater improvement in maximum walking distance (from 264 m to 1501 m for an improvement of 1237 m) compared with the supervised exercise only group (from 285 m to 1240 m for improvement of 955 m) (mean difference between groups, 282 m; 99% CI, 60-505 m) and in pain-free walking distance (from 117 m to 1237 m for an improvement of 1120 m vs from 135 m to 847 m for improvement of 712 m, respectively) (mean difference, 408 m; 99% CI, 195-622 m). Similarly, the combination therapy group demonstrated significantly greater improvement in the disease-specific VascuQol score (1.34 [99% CI, 1.04-1.64] in the combination therapy group vs 0.73 [99% CI, 0.43-1.03] in the exercise group; mean difference, 0.62 [99% CI, 0.20-1.03]) and in the score for the SF-36 physical functioning (22.4 [99% CI, 16.3-28.5] vs 12.6 [99% CI, 6.3-18.9], respectively; mean difference, 9.8 [99% CI, 1.4-18.2]). No significant differences were found for the SF-36 domains of physical role functioning, bodily pain, and general health perceptions. CONCLUSIONS AND RELEVANCE: Among patients with intermittent claudication after 1 year of follow-up, a combination therapy of endovascular revascularization followed by supervised exercise resulted in significantly greater improvement in walking distances and health-related quality-of-life scores compared with supervised exercise only. TRIAL REGISTRATION: Netherlands Trial Registry Identifier: NTR2249.

Supervised walking therapy in patients with intermittent claudication.

OBJECTIVE: Exercise therapy is a common intervention for the management of intermittent claudication (IC). However, considerable uncertainty remains about the effect of different exercise components such as intensity, duration, or content of the exercise programs. The aim of this study was to assess the effectiveness of supervised walking therapy (SWT) as treatment in patients with IC and to update and identify the most important exercise components resulting in an optimal training protocol for patients with IC. METHODS: A systematic literature search using MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases was performed. Randomized controlled trials (RCTs) published between January 1966 and February 2012 were included if they evaluated the effectiveness of SWT. Predefined exercise components were extracted, including treadmill use during training, claudication pain end point used during walking, length of the SWT program, and total training volume. A meta-analysis and meta-regression was performed to evaluate the weighted mean difference in maximum walking distance (MWD) and pain-free walking distance (PFWD) between SWT and noninterventional observation. RESULTS: Twenty-five RCTs (1054 patients) comparing SWT vs noninterventional observation showed a weighted mean difference of 180 meters (95% confidence interval, 130-230 meters) in MWD and 128 meters (95% confidence interval, 92-165 meters) in PFWD, both in favor of the SWT group. In multivariable meta-regression analysis, none of the predefined exercise components were independently associated with significant improvements in MWD or PFWD. CONCLUSIONS: SWT is effective in improving MWD and PFWD in patients with IC. However, pooled results from the RCTs did not identify any of the exercise components including intensity, duration, or content of the program as being independently associated with improvements in MWD or PFWD.

[Vomiting, abdominal pain and weight loss with an acquired anatomical cause: superior mesenteric artery syndrome]. / Braken, buikpijn en gewichtsverlies door verworven anatomische oorzaak: het A.-mesenterica-superiorsyndroom.

Superior mesenteric artery syndrome (SMAS) is a rare and acquired anatomical condition characterized by vomiting, abdominal distension, weight loss and postprandial distress due to compression of the transverse portion of the duodenum between the superior mesenteric artery (SMA) and aorta, which causes duodenal outflow problems. We report a case series of three patients with SMAS. Diagnosis of the syndrome was made by augmenting a high degree of suspicion with repeat gastroscopies, CT scans and hypotonic duodenal contrast series showing compression of the horizontal part of the duodenum located between the vessels specified above. Medical therapy for the condition is aimed at nutritional rehabilitation so that weight gain results in relief of the obstruction. In each of our patients, surgical treatment was necessary during which the ligament of Treitz was divided and a side-to-side duodenojejunostomy was performed. In all, the weight loss seen preoperatively has been corrected.