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.     

Illuminating Negative Results in Evaluation of Smoking Prevention Programs

Evaluation of program implementation can help illuminate negative results of school-based smoking prevention programs. In three conventional quasiexperimental evaluations, no statistically significant impacts of smoking prevention programs on children's knowledge, attitudes, intentions, or behavior were detected. Complementary evaluations of program implementation along several dimensions using naturalistic methods suggested reasons for null effects were different at each site. These data were used to form hypotheses and recommendations for future interventions.     

Genetic diversity and molecular identification of mosquito species in the Anopheles maculatus group using the ITS2 region of rDNA.

The species diversity and genetic structure of mosquitoes belonging to the Anopheles maculatus group in Southeast Asia were investigated using the internal transcribed spacer 2 (ITS2) of ribosomal DNA (rDNA). A molecular phylogeny indicates the presence of at least one hitherto unrecognised species. Mosquitoes of chromosomal form K from eastern Thailand have a unique ITS2 sequence that is 3.7% divergent from the next most closely related taxon (An. sawadwongporni) in the group. In the context of negligible intraspecific variation at ITS2, this suggests that chromosomal form K is most probably a distinct species. Although An. maculatus sensu stricto from northern Thailand and southern Thailand/peninsular Malaysia differ from each other in chromosomal banding pattern and vectorial capacity, no intraspecific variation was observed in the ITS2 sequences of this species over this entire geographic area despite an extensive survey. A PCR-based identification method was developed to distinguish five species of the group (An. maculatus, An. dravidicus, An. pseudowillmori, An. sawadwongporni and chromosomal form K) to assist field-based studies in northwestern Thailand. Sequences from 187 mosquitoes (mostly An. maculatus and An. sawadwongporni) revealed no intraspecific variation in specimens from Thailand, Cambodia, mainland China, Malaysia, Taiwan and Vietnam, suggesting that this identification method will be widely applicable in Southeast Asia. The lack of detectable genetic structure also suggests that populations of these species are either connected by gene flow and/or share a recent common history.     

The role of community pharmacists in health education and disease prevention: a survey of their interests and needs in relation to cardiovascular disease

BACKGROUND: Recently there has been increased interest in broadening the role of community pharmacists to include more health education and disease prevention activities such as patient counseling for risk management and interventions to improve compliance. However, to date, there is little information on interest in prevention among community pharmacists or on their current prevention practices. METHOD: Data on current health education and disease prevention practices, as well as interest in expanding their role in prevention, were collected in a cross-sectional mail survey of a random representative sample of community pharmacists currently practicing in the province of Quebec. RESULTS: Among 597 eligible subjects, 455 (76.2%) completed the questionnaire. Few pharmacists practice prevention routinely. Independent correlates of engaging in prevention included working in a smaller pharmacy (odds ratio (OR) 3. 2 (95% confidence interval 2.0-5.3)), owning the pharmacy (OR 1.9 (1. 2-3.0)), moderate/high job satisfaction (OR 2.1 (1.4-4.3)), and history of prevention activities in the pharmacy (OR 2.2 (1.4-3.6)). Over 90% of respondents reported that integrating prevention into their practices was important. Independent correlates of high perceived importance included working as a salaried pharmacist (OR 2. 3 (1.4-3.8)), high job satisfaction (OR 4.1 (1.7-9.7)), and currently practicing prevention (OR 2.0 (1.2-3.2)). The most important perceived barriers to integrating prevention included lack of time and lack of skills/instrumentation for practicing prevention. CONCLUSIONS: There is considerable interest among community pharmacists in expanding their role to include more prevention, but there are many barriers to actualizing this role. Further work should focus on ways to overcome these barriers because pharmacists are particularly well-situated to make an important contribution to prevention.     

Efficiency of printed materials in worksite health promotion

BACKGROUND. Printed health promotion materials are widely believed to be an efficient means of achieving basic health promotion objectives, such as increasing knowledge of risk factors. This study examined the efficiency of cardiovascular health promotion leaflets in reaching employees in a heterogeneous sample of worksites. METHODS. Two types of distribution were used: copies of the leaflets were either made available centrally or distributed to each individual employee. Interviews were conducted with 272 employees in six worksites. Respondents were asked whether they recognized, had read, and had learned something from the leaflets. RESULTS. Only one-quarter of respondents recognized the leaflets and only 14% stated that they had learned something. The efficiency of the leaflets was therefore much lower than expected. Z-tests for proportions showed that recognition, reading, and learning were significantly greater among those employees who had been given individual copies of the material. Among those who had been given individual copies, 45% reported recognizing the leaflet, 36% reading it, and 23% learning something from it. Among those who had only central access, the respective scores were 11%, 7% and 6%. DISCUSSION. These results suggest that the potential cost-effectiveness of printed materials such as leaflets and brochures should be weighed against alternative forms of intervention, given specific program objectives and characteristics of the target population. They also suggest that the cost and effort required in organizing the distribution of individual copies may be recouped in greater penetration.     

Plastic and Reconstructive Body Contouring in the Post-vertical Banded Gastroplasty Patient: a retrospective review

Class IV obesity (body mass index > 40) is associated with an increased risk of a variety of health problems, many of them potentially life-threatening or life-shortening. Vertical banded gastroplasty (VBG) is currently the most frequently performed surgical procedure used to restrict food intake and assist with weight loss. After massive weight loss, however, redundant abdominal and breast tissue can result in physiological and psychological problems related to an unusual body habitus. Patients complain of difficulties with daily activities, choice of clothing, social acceptance, etc. Body contouring has proven to be an important part of the rehabilitation of the morbidly obese patient, and we have therefore reviewed the records of 55 patients who experienced massive weight loss following VBG and then underwent abdominoplasty with or without mammoplasty/mastopexy, in order to assess the parameters which will be seen more frequently in the future by plastic surgeons as bariatric surgery becomes more widely accepted and performed.     

Intestinal permeability in kwashiorkor

Intestinal permeability can be assessed non-invasively using the lactulose-rhamnose (L-R) test, which is a reliable measure of small intestinal integrity. AIMS: To determine risk factors for abnormal intestinal permeability in kwashiorkor, and to measure changes in L-R ratios with inpatient rehabilitation. DESIGN: A case-control study of 149 kwashiorkor cases and 45 hospital controls. The L-R test was adapted to study kwashiorkor in Malawi, with testing at weekly intervals during nutritional rehabilitation. Urine sugars were measured by thin layer chromatography in London. RESULTS: The initial geometric mean L-R ratios (x100) (with 95% confidence interval) in kwashiorkor were 17.3 (15.0 to 19.8) compared with 7.0 (5.6 to 8.7) for controls. Normal ratios are < 5, so the high ratios in controls indicate tropical enteropathy syndrome. Abnormal permeability in kwashiorkor was associated with death, oliguria, sepsis, diarrhoea, wasting and young age. Diarrhoea and death were associated with both decreased L-rhamnose absorption (diminished absorptive surface area) and increased lactulose permeation (impaired barrier function) whereas nutritional wasting affected only L-rhamnose absorption. Despite, clinical recovery, mean L-R ratios improved little on treatment, with mean weekly ratios of 16.3 (14.0 to 19.0), 13.3 (11.1 to 15.9) and 14.4 (11.0 to 18.8). CONCLUSION: Abnormal intestinal permeability in kwashiorkor correlates with disease severity, and improves only slowly with nutritional rehabilitation.     

One- and two-year predictors of excess weight gain among elementary schoolchildren in multiethnic, low-income, inner-city neighborhoods

Longitudinal studies are needed to increase understanding of the causes of childhood obesity. To identify 1- and 2-year predictors of excess weight gain among preadolescents, the authors conducted a prospective cohort study of fourth- and fifth-grade students in 16 elementary schools located in multiethnic, low-income neighborhoods in Montreal, Quebec, Canada, that were participating in the evaluation of a school-based heart health promotion program. Subjects included 2,318 children aged 9-12 years with baseline and 1-year follow-up data and 633 children aged 9-11 years with baseline and 2-year follow-up data. One-year predictors of highest decile of change in body mass index (BMI) identified in logistic regression analyses included baseline BMI of 90th percentile or more (odds ratio (OR) = 2.66, 95% confidence interval: 1.80, 3.94) in boys and baseline BMI of 90th percentile or more (OR = 2.34, 95% confidence interval: 1.46, 3.76), no sports outside school (OR = 1.90, 95% confidence interval: 1.18, 3.06), and playing video games everyday (OR = 2.48, 95% confidence interval: 1.04, 5.92) in girls. Two-year predictors included baseline BMI of 90th percentile or more (OR = 3.26, 95% confidence interval: 1.52, 7.01), no sports outside school (OR = 2.14, 95% confidence interval: 0.96, 4.77), and least active (OR = 2.18, 95% confidence interval: 1.01, 4.71) in boys; only baseline BMI of 90th percentile or more (OR = 2.22, 95% confidence interval: 1.02, 4.81) was significant in girls. Results suggest the need for interventions to promote increased physical activity in children.