Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol)

BackgroundA venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines.AimThe aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration.MethodsThrough a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.     

Oral beta2-agonist use by preschool children with asthma in East and Central Harlem, New York.

Although studies have documented underuse of controller medications and overuse of short-acting inhaled ss(2)-agonist among children with persistent asthma in disadvantaged communities, the persistence of oral ss(2)-agonist use in pediatric practice has not been studied since inhaled short-acting ss(2)-agonists became widespread. We describe medications used to treat asthma among children 3 to 5 years of age at 10 Head Start and other subsidized preschool centers in East and Central Harlem, New York City. We interviewed 149 parents/guardians of children who were identified as having probable asthma based on physician's diagnosis, persistent symptoms, hospitalization, and medication use. We classified 86 of the 149 children (58%) as having current persistent asthma. Only 15 of them (17%) were reported to have used controller medications at least 5 days/week in the last 4 weeks-only 2 of whom used inhaled corticosteroids. By contrast, 53 children (62%) used oral ss(2)-agonist in the last 4 weeks, often (72%) in conjunction with nebulized or inhaled short-acting ss(2)-agonist. Use of oral ss(2)-agonist was associated with more severe symptoms. This study documents the continued widespread use of oral ss(2)-agonist for treatment of children in a low-income community with high prevalence of asthma.     

Examination of the effects of hemodynamic and pharmacologic interventions on coronary collateral flow in a patient during cardiac catheterization

The vasomotor response of native human collateral vessels to pharmacologic or hemodynamic vasodilatory stimuli is not well known. We describe a case where retrograde collateral flow velocity was measured both at baseline and following selected hemodynamic and pharmacologic interventions. This index case represents the first in a series of potential human physiologic studies designed to address questions pertaining to control of collateral blood supply in humans. © 1993 Wiley-Liss, Inc.     

Mebendazole retention enema for severe Trichuris trichiura (whipworm) infection: a case report

The authors report a case of massive Trichuris trichiura infection, resulting in severe anaemia and congestive cardiac failure in a 9-year-old Iban boy, who was resistant to the usual oral anthelmintic treatment, but promptly responded to mebendazole retention enema. This patient also had an associated Entamoeba histolytica infection.     

Thromboembolic and inflammatory complications of knee joint alloplasty with cemented endoprostheses]

In the presented paper the authors evaluate the long-term results of treatment for inflammatory and thromboembolic complications in knee joint alloplasty with cemented endoprostheses. The clinical material spanning the years 1998-2003 are 15 patients with analysed complications, it determine 9% of all operated. They have evaluated achieved results using the HSS knee rating scale in their own modification. As far as the authors are concerned, venographic examination is a prerequisite for appropriate care of the patients following knee joint alloplasty who might have deep venous thrombosis. It is necessary to provide similar treatment when developing infections are suspected in the perioperative period and in cases of late infections. Consequently, antibiotic therapy and a possible quick bacteriological checkup for healing a postoperative wound is a prerequisite for successful treatment. Achieved results induce statement, that thromboembolic and inflammatory complications caused at most operated chronic vein insufficiency, deficit of range of motion at operated joint and gait insufficiency. Thromboembolic complications was always related with inflammation of knee joint alloplasty in our own material.     

Interaction of B and T lymphocyte subsets with high endothelial venules in the rat: binding in vitro does not reflect homing in vivo

Lymphocytes continuously migrate through the body, and their efficient extravasation from the blood via high endothelial venules (HEV) is essential for initiating an appropriate immune response. Most investigations have focused on the lymphocyte/HEV interaction in vitro. However, to what extent such systems reflect the situation in vivo is not known. It is also unclear whether lymphocyte subsets immigrate into the HEV in proportion to their presence in the blood, and whether import capacity is limited by the HEV. When rat mesenteric lymph node lymphocytes were incubated in vitro on cryostat sections, the well-known preferential binding of B lymphocytes to HEV of Peyer's patches (PP) and T cells to HEV of axillary lymph nodes (axLN) was observed (axLN vs. PP: B lymphocytes 21.2 ± 5.0% vs. 40.6 ± 11.0%, T lymphocytes 84.6 ± 6.3% vs. 56.5 ± 12.9%). However, when labeled mesenteric lymph node lymphocytes were injected and their location within the HEV was analyzed 15 min later, no preferential interaction was seen. After injection of labeled thoracic duct lymphocytes, the percentage of labeled cells among B and T lymphocytes in the blood was significantly different (4.4 ± 0.9% vs. 8.9 ± 3.6%), whereas that in HEV of axLN (19.0 ± 6.4% vs. 16.6 ± 6.0%) and PP (30.6 ± 6.1% vs. 33.9 ± 4.4%) was comparable. Although the number of injected lymphocytes was similar in magnitude to the total blood lymphocyte pool, after injection there was no increase in lymphocyte numbers in the HEV. Thus, the adhesion assay in vitro does not completely reflect immigration into HEV in vivo. In addition, our data suggest that both the availability of lymphocyte subsets in small venules and the immigration rate into HEV are actively regulated in vivo.     

Respiratory symptoms and ventilatory capacity in swine confinement workers.

A group of 59 workers (41 men and 18 women) employed in swine confinement areas was studied to assess the presence of acute and chronic respiratory symptoms and the prevalence of abnormalities in ventilatory function. A control group of 46 (31 men and 15 women) unexposed workers was studied for the prevalence of chronic respiratory symptoms. For both male and female swine confinement workers complaints of chronic cough, dyspnoea, and chest tightness were significantly more frequent than among control workers. Male workers also complained more of chronic phlegm. Male swine confinement workers who were smokers had significantly higher prevalences of chronic cough, chronic phlegm, and chronic bronchitis than male non-smoking swine confinement workers. The frequency of acute symptoms associated with the workshift was high among the swine confinement workers with more than half of the workers complaining of cough and dyspnoea associated with work. Significant acute across shift reductions in lung function occurred in swine confinement workers, being largest for FEF25. All Monday preshift ventilatory capacity measurements in male confinement workers were significantly lower than predicted values; FVC and FEV1 were found to be lower than predicted values for women. The data indicate that exposure in swine confinement buildings is associated with the development of acute and chronic respiratory symptoms and impairment of lung function. Smoking appears to aggravate these changes.     

Peritoneal morphology in children treated by continuous ambulatory peritoneal dialysis

Fifty peritoneal biopsies (PB) from 35 patients with end-stage renal disease, treated by continuous ambulatory peritoneal dialysis (CAPD) and aged 2 months to 18 years, were examined by light microscopy (n=50) and/or scanning electron microscopy. PB were performed during surgical procedures immediately before the start of, during, or after the cessation of CAPD treatment. PB from 15 children without renal disease undergoing laparatomy were examined similarly. Before the start of CAPD, a scarcity and shortening of the mesothelial microvilli was observed by scanning electron microscopy. During and after CAPD, variable alterations of mesothelium, interstitium and capillaries were found. The mesothelial layer was absent in all 5 PB obtained during episodes of active peritonitis. In patients treated by CAPD for longer than 6 months, mesothelial denudation was observed more frequently (6/11) than in children treated for shorter periods (1/7) (P<0.08). Fibrosis of the peritoneal membrane was present in about 50% of patients during or after the cessation of CAPD without impairment of peritoneal function. No correlation was found between the presence of fibrosis and the frequency of peritonitis or the duration of CAPD treatment.