Peter T. McCollum

Randomized clinical trial of percutaneous transluminal angioplasty, supervised exercise and combined treatment for intermittent claudication due to femoropopliteal arterial disease.

The aim was to compare percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined treatment (PTA plus SEP) for intermittent claudication due to femoropopliteal arterial disease.

Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined therapy in intermittent claudication.

BACKGROUND To compare angioplasty (PTA), supervised exercise (SEP) and PTA + SEP in the treatment of intermittent claudication (IC) due to femoropopliteal disease. METHODS Over a 6-year period, 178 patients (108 men; median age, 70 years) with femoropopliteal lesions suitable for angioplasty were randomized to PTA, SEP, or PTA + SEP. Patients were assessed prior to and at 1 and 3 months post treatment. ISCVS outcome criteria (ankle pressures, treadmill walking distances) and quality of life (QoL) questionnaires (SF-36 and VascuQoL) were analyzed. RESULTS All groups were well matched at baseline. Twenty-one patients withdrew. Results are as follows: Intragroup analysis: All groups demonstrated significant clinical and QoL improvements (Friedman test, p < 0.05). SEP (60 patients, 8 withdrew)-62.7% of patients (n = 32) improved following treatment [20 mild, 9 moderate, 3 marked], 27.4% (n = 14) demonstrated no improvement, and 9.8% (n = 5) deteriorated. PTA (60 patients, 3 withdrew)-66.6% patients (n = 38) improved following treatment [19 mild, 10 moderate, 9 marked], 22.8% (n = 13) demonstrated no improvement, and 10.5% (n = 6) deteriorated. PTA + SEP (58 patients, 10 withdrew)-81.6% of patients (n = 40) improved following treatment [10 mild, 17 moderate, 3 marked], 14.2% (n = 7) demonstrated no improvement, and 4.0% (n = 2) deteriorated. Intergroup analysis: PTA + SEP produce a much greater improvement in clinical outcome measures than PTA or SEP alone, but there was no significant QoL advantage (Kruskal-Wallis test, p > 0.05). CONCLUSION SEP should be the primary treatment for the patients with claudication and PTA should be supplemented by an SEP.

An analysis of relationship between quality of life indices and clinical improvement following intervention in patients with intermittent claudication due to femoropopliteal disease

OBJECTIVES To establish the relationship between quality of life (QOL) index scores and clinical indicators of lower limb ischemia. METHODS One hundred seventy-eight patients (108 men, median age 70 years) with femoropopliteal lesions suitable for angioplasty were recruited. Assessments were performed prior to and at 1, 3, 6, and 12 months following intervention (angioplasty and/or supervised exercise program). Clinical indicators of lower limb ischemia (treadmill walking distances, ankle pressures), generic (SF36, EuroQol), and disease-specific (Kings College VascuQol) quality of life questionnaires were analyzed. Correlation analysis was performed for index scores (SF-6D, EQ-5D, VascuQol) and individual domain scores using nonparametric tests. RESULTS All clinical indicators of lower limb ischemia and quality of life index scores showed a statistically significant improvement as result of intervention (Friedman test, P < .001). Both generic QOL index scores (SF-6D, EQ-5D) showed moderate but statistically significant correlation (Spearmans rank correlation, P < .001) with treadmill walking distances (SF-6D r = 0.533, EQ-5D r = 0.500) and weak but significant correlation to resting and postexercise ankle-brachial pressure index (SF-6D r = 0.253, EuroQol r = 0.214). Disease-specific index scores (VascuQol) showed similar moderate correlation to treadmill walking distances (r = 0.584, P < .001) and weak but statistically significant correlation with resting and postexercise ABPI (r = 0.377, P < .001). All index scores showed strong and statistically significant (P< .001) correlation with patient-reported walking distance (SF-6D r = 0.604, EQ-5D r = 0.511, VascuQol r = 0.769). All domains of SF36 showed similar correlation with clinical indicators except general health. The strongest correlation was seen with treadmill walking distances in the domains of physical function (r = 0.538) and bodily pain (r = 0.524). CONCLUSION All generic and disease-specific QOL scores show statistically significant improvement with angioplasty and/or supervised exercise in patients with claudication due to femoropopliteal atherosclerosis. However, the degree of improvement seen in clinical indicators of lower limb ischemia is not reflected in these scores. These findings support the use of composite outcome measures with mandatory, independent assessment of QOL as an independent outcome measure in intervention studies in these patients.

Economic analysis of a randomized trial of percutaneous angioplasty, supervised exercise or combined treatment for intermittent claudication due to femoropopliteal arterial disease

The aim was to compare costs and utilities of percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined treatment (PTA + SEP) in patients with intermittent claudication (IC) to establish the most cost‐effective treatment.

Randomized phase II clinical trial of avotermin versus placebo for scar improvement

Scarring is a major problem following skin injury. In early clinical trials, transforming growth factor β3 (avotermin) improved scar appearance. The aim of this study was to determine whether an injection of avotermin at the time of wound closure is effective in improving scar appearance.

Preoperative Supervised Exercise Improves Outcomes After Elective Abdominal Aortic Aneurysm Repair: A Randomized Controlled Trial.

Objective: The aim of the study was to assess the impact of a preoperative medically supervised exercise program on outcomes after elective abdominal aortic aneurysm (AAA) repair. Background: Functional capacity is an important predictor of postoperative outcomes after elective AAA repair. Improving patients’ preoperative fitness with exercise has the potential to positively influence recovery. Methods: A randomized controlled trial was performed at a tertiary vascular unit. Patients scheduled for open or endovascular AAA repair were randomized to either 6 weeks of preoperative supervised exercise or standard treatment using sealed envelopes. The primary outcome measure was a composite endpoint of cardiac, pulmonary, and renal complications. Secondary outcome measures were 30-day mortality, lengths of hospital and critical care stay, Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, reoperation, and postoperative bleeding. Results: One hundred twenty-four patients were randomized (111 men, mean [SD] age 73 [7] y). Fourteen patients sustained postoperative complications in the exercise group (22.6%), compared with 26 in the nonexercise group (41.9%; P = 0.021). Four patients (2 in each group) died within the first 30 postoperative days. Duration of hospital stay was significantly shorter in the exercise group (median 7 [interquartile range 5–9] vs 8 [interquartile range 6–12.3] d; P = 0.025). There were no significant differences between the groups in the length of critical care stay (P = 0.845), APACHE II scores (P = 0.256), incidence of reoperations (P = 1.000), or postoperative bleeding (P = 0.343). Conclusions: A period of preoperative supervised exercise training reduces postoperative cardiac, respiratory, renal complications, and length of hospital stay in patients undergoing elective AAA repair.

A Randomized Placebo Controlled Trial of the Effect of Preoperative Statin Use on Matrix Metalloproteinases and Tissue Inhibitors of Matrix Metalloproteinases in Areas of Low and Peak Wall Stress in Patients Undergoing Elective Open Repair of Abdominal Aortic Aneurysm

BACKGROUND A double-blind, randomized controlled trial was carried out to study the effects of statins on matrix metalloproteinases (MMPs) and tissue inhibitors of matrix metalloproteinases (TIMPs) in areas of peak and low abdominal aortic aneurysm (AAA) wall stress. METHODS A total of 40 patients undergoing elective open AAA repair were randomized to receive either atorvastatin 80 mg (n = 20) or placebo (n = 20) for 4 weeks preoperatively. Finite element analysis was used to determine AAA wall stress distribution. Full thickness aortic samples were obtained at surgery from areas of low and peak wall stress, snap-frozen, and stored at -80°C for subsequent MMP-2, -8, and -9 and TIMP-1 and -2 analyses. Statistical analysis was performed using SPSS 16.0 (SPSS Inc, Chicago, IL). RESULTS Both groups were well matched (p > 0.05) regarding age, gender, comorbidities, and duration of hospital stay. There were no statistically significant differences in levels of MMPs and TIMPs between the statin and placebo group and between areas of low and peak AAA wall stress. CONCLUSION The short-term use of statins is not associated in reducing levels of MMP 2, 8, and 9 and TIMP-1 and -2 in areas of low and peak wall stress in patients with AAA.

Randomized clinical trial of co-amoxiclav versus no antibiotic prophylaxis in varicose vein surgery†

Wound infection rates of up to 16 per cent are reported following varicose vein surgery and the value of antibiotic prophylaxis in clean surgery remains unclear.

Assessment of Arterial Disease Using Digital Systolic Pressure Measurement

Digital systolic pressure measurements were made on 140 big toes using a photoplethysmographic technique before and after extrinsic heating of the foot. Most patients with apparent, critically ischemic feet demonstrated vasomotor activity, suggesting that much of the microcirculation of the foot was in fact intact. Significantly, nine of 21 feet which would have fallen into a critically ischemic category were recategorized after heating into a less severe group. These data confirm the value of toe pressure measurements in the assessment of severe ischemia but show that adequate foot vasodilation is essential to allow accurate conclusions to be drawn and to allow meaningful interpretation of results.

Obstacles in initiating a new research project – Reflection on medical research in UK

Patient recruitment cannot be commenced prior to completion of the above mentioned components. Only the first three components in this list are under direct control of the researcher. Difficulties start arising from this point onwards. Once written, the research protocol has to be discussed within the research team and with all concerned departments. This involves meetings, telephone conversations and prolonged email correspondence. The whole process can be extremely arduous and time consuming. Getting everyone around the table at one time can be extremely difficult due to the number of people involved, their schedules and commitments. Ethics review committees are gatekeepers to human research enterprise. Their main aim is to ensure that research respects the dignity, rights, safety and well being of individual research participants. With the establishment of National Research Ethics Service (NRES), all applications are submitted via online ethics application form using Integrated Research Applications System (IRAS). This form is very extensive; comprising detailed background, justification for research, methods, investigations, procedures, safe guards, timing, trial monitoring and dissemination. Once completed and submitted, it generates a unique ID number which is printed on each page of the application form. This precludes any further amendments to the application even if they are minor spelling errors or missed words. Any amendment results in resubmission and generation of a new ID number. A printout of the submitted form has to be signed by the principal