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.     

Anticoagulation Strategies in Patients With Cancer: JACC Review Topic of the Week

Patients with active cancer are at an increased risk of arterial and venous thromboembolism (VTE) and bleeding events. Historically, in patients with cancer, low molecular weight heparins have been preferred for treatment of VTE, whereas warfarin has been the standard anticoagulant for stroke prevention in patients with atrial fibrillation (AF). More recently, direct oral anticoagulants (DOACs) have been demonstrated to reduce the risk of venous and arterial thromboembolism in large randomized clinical trials of patients with VTE and AF, respectively, thus providing an attractive oral dosing option that does not require routine laboratory monitoring. In this review, we summarize available clinical trial data and guideline recommendations, and outline a practical approach to anticoagulation management of VTE and AF in cancer.     

Economic appraisal of laser applications in health care. Report of a project

This article reports on the results of a project evaluating effectiveness and cost-effectiveness of laser applications in health care. The literature was collected, emphasizing well-designed clinical trials and cost-effectiveness analyses. Few randomized clinical trials (RCTs) have been done outside the specialty of ophthalmology. Even fewer cost-effectiveness studies have been done, despite the frequent claims of cost-effectiveness in the medical literature. Review papers were commissioned, and a group of laser experts, economists, and policy-analysts met for 2 days to discuss the policy implications of lasers. The main conclusion from the conference is that inappropriate and unskilled use of lasers is presently the greatest problem with their application in health care.     

Do insecticide-treated curtains reduce all-cause child mortality in Burkina Faso?

To evaluate whether insecticide-treated netting (ITN) reduces child mortality in different epidemiological settings, 4 large, randomized, controlled trials were conducted in Africa. Here we report the findings from the trial in Burkina Faso, in an area of hyperendemic and markedly seasonal malaria transmission. The trial involved 158 villages, with a total population of some 90,000, grouped into 16 geographical clusters. Ascertainment of mortality among children aged 6–59 months began in early 1993. In June/July 1994, 8 of the clusters, randomly selected, received permethrin-treated curtains. Follow-up of children and ascertainment of mortality continued until May 1996. A 15% reduction in all-cause mortality among children aged 6–59 months was observed over the 2-year period following the installation of the curtains (95% c.i. – 4% to 30%). In the first year, post-intervention mortality was substantially lower in the clusters receiving curtains compared with the control clusters (rate ratio = 0.74; 95% c.i. 0.57, 0.95) but in the second year, there was no difference between mortality in the two groups (rate ratio = 0.99). The overall two-year impact of the intervention is consistent with the impacts observed in other trials which have demonstrated reductions in child mortality of from 17% to 33%. However, the year-by-year analysis raises some concerns about the long-term effect of ITN. Further follow-up of this population is warranted.     

A lower ongoing pregnancy rate can be expected when GnRH agonist is used for triggering final oocyte maturation instead of HCG in patients undergoing IVF with GnRH antagonists

BACKGROUND: Eliciting an endogenous LH surge by GnRH-agonist for the induction of final oocyte maturation may be more physiological compared with the administration of HCG. However, the efficacy of this intervention in patients treated for IVF with GnRH antagonists remains to be assessed. METHODS: 106 patients were randomized to receive either 10 000 IU urinary HCG or 0.2 mg Triptorelin for triggering final oocyte maturation. Ovarian stimulation for IVF was performed with a fixed dose of 200 IU recombinant FSH and GnRH antagonist was started on stimulation day 6. Luteal phase was supported with micronized vaginal progesterone and oral estradiol. The study was monitored continuously for safety and stopping rules were established. RESULTS: No significant differences were present in the number of cumulus-oocyte complexes retrieved, in the proportion of metaphase II oocytes, in fertilization rates or in the number and quality of the embryos transferred between the two groups. However, a significantly lower probability of ongoing pregnancy in the GnRH agonist arm prompted discontinuation of the trial, according to the stopping rules established (odds ratio 0.11; 95% confidence interval 0.02-0.52). CONCLUSIONS: Lower probability of ongoing pregnancy can be expected when GnRH agonist is used for triggering final oocyte maturation instead of HCG in patients undergoing ovarian stimulation for IVF with GnRH antagonists.     

Direct infant UV light exposure is associated with eczema and immune development

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High-Protein,Low-Glycaemic Meal Replacement Decreases Fasting Insulin and Inflammation Markers—A 12-Month Subanalysis of the ACOORH Trial

Lifestyle interventions, including meal replacement, are effective in the prevention and treatment of type-2-diabetes and obesity. Since insulin is the key weight regulator, we hypothesised that the addition of meal replacement to a lifestyle intervention reduces insulin levels more effectively than lifestyle intervention alone. In the international multicentre randomised controlled ACOORH (Almased Concept against Overweight and Obesity and Related Health Risk) trial, overweight or obese persons who meet the criteria for metabolic syndrome (n = 463) were randomised into two groups. Both groups received nutritional advice focusing on carbohydrate restriction and the use of telemonitoring devices. The intervention group substituted all three main meals per day in week 1, two meals per day in weeks 2–4, and one meal per day in weeks 5–26 with a protein-rich, low-glycaemic meal replacement. Data were collected at baseline and after 1, 3, 6 and 12 months. All datasets providing insulin data (n = 446) were included in this predefined subanalysis. Significantly higher reductions in insulin (−3.3 ± 8.7 µU/mL vs. −1.6 ± 9.8 µU/mL), weight (−6.1 ± 5.2 kg vs. −3.2 ± 4.6 kg), and inflammation markers were observed in the intervention group. Insulin reduction correlated with weight reduction and the highest amount of weight loss (−7.6 ± 4.9 kg) was observed in those participants with an insulin decrease > 2 µU/mL. These results underline the potential for meal replacement-based lifestyle interventions in diabetes prevention, and measurement of insulin levels may serve as an indicator for adherence to carbohydrate restriction.     

Teacher Evaluation of an Experiential Vegetable Education Program for Australian Primary Schools: Does Face-to-Face Training Add Value above Digital Training?

The teacher-led implementation of healthy eating programs in schools is cost-effective and potentially impactful. Teacher acceptability is important for uptake; however, process evaluations are scarce. This study evaluated the effect of two intensities of teacher training on the evaluation of a vegetable education program for Australian primary schools by teachers. The teachers (n = 65) who implemented the program as part of a cluster RCT (25 schools in two states, New South Wales and South Australia) received either low- (provision with materials and online training) or high (additional face-to-face (F2F) training)-intensity training prior to implementing a 5-week vegetable education program. They evaluated the acceptability of a digital training module and program by indicating the level of agreement with 15 and 18 statements, respectively, using 5-point Likert scales. The average item scores ranged from 3.0 to 4.2. All but one item, including student engagement, alignment to the curriculum and intent for reuse of the program, had a rounded average or median score of 4. The level of training intensity did not impact the teacher acceptability ratings. In conclusion, the teacher acceptability was good, and additional F2F training does not add value above the solely digital training of the teachers.     

Polyphenols intervention is an effective strategy to ameliorate inflammatory bowel disease: a systematic review and meta-analysis

Abstract

Whether polyphenols could ameliorate inflammatory bowel disease (IBD) is still conflicting. To explore the efficacy of polyphenols as an adjuvant therapy for IBD, we conducted this systematic review and meta-analysis. Literature search was performed using PubMed, Web of Science, Scopus and Cochrane databases. Finally, 12 randomized controlled trials (RCTs) were included. In contrast to control group, curcumin treatment significantly improved clinical remission in intention-to-treat (ITT) (OR = 3.36, 95% CI: 1.09–10.37) and per-protocol (PP) analysis (OR = 5.13, 95% CI: 1.84–14.27). Meanwhile, curcumin could significantly ameliorate endoscopic remission (OR = 5.69, 95% CI: 1.28–25.27) and clinical response (OR = 4.69, 95% CI: 1.03–21.47) in PP analysis. Heterogeneity was present across the studies. In conclusions, polyphenols might be an effective adjuvant treatment for ameliorating IBD. Considering the relatively few studies included in our present study, further clinical trials are required to verify the effects of polyphenols on IBD.