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.     

“调任通督”法针刺治疗围绝经期潮热的随机对照研究＊

目的 观察“调任通督法”针刺治疗围绝经期潮热的临床疗效和安全性。方法 将符合纳入标准的72例围绝经期潮热患者，按照1∶1的比例随机分为治疗组（针刺组）和对照组（等待组）。治疗组取穴百会、印堂、神庭、关元、气海、中脘、阴郄、太溪、复溜、三阴交。针刺治疗每次持续30 min，每周2次，连续治疗6周。对照组为等待组，试验期间仅给予同针刺组相同的健康宣教，两组分别于治疗前、治疗第3周、治疗第6周以及第10周随访评估其潮热频率和程度，以及更年期生活质量量表（Menopause-specific quality of life questionnaire，Men-QoL）的变化情况，同时记录针刺不良事件的发生。结果 ①潮热频率及潮热程度：在治疗后及随访时，针刺组较等待组有明显改善，差异具有统计学意义（P < 0.01）。与治疗前相比，针刺组第3周即出现了潮热频率明显下降的趋势（P < 0.01），治疗后以及随访期针刺组潮热频率及潮热程度均较治疗前有明显统计学差异（P < 0.01）。而等待组在各时间点潮热频率及潮热程度均无统计学差异（均P > 0.05）。②围绝经期生活质量量表：治疗后针刺组在Men-QoL总分、血管舒缩功能评分、社会心理、体能状况较等待组比较均有统计学差异（均P < 0.01）。在随访期，针刺组在Men-QoL社会心理以及体能方面明显改善，差异均具有统计学意义（P < 0.01，P < 0.05）。两组Men-QoL性功能在治疗后及随访期均无统计学差异（P > 0.05）。与治疗前相比，在治疗后及随访期，针刺组Men-QoL总分、血管舒缩功能、社会心理、体能状况均有统计学差异（均P < 0.05），在Men-QoL性功能方面无统计学差异（P > 0.05）。等待组在Men-QoL总分及四个域方面均无明显改善，无统计学意义（均P > 0.05）。结论 调任通督法针刺治疗围绝经期潮热安全有效，且对围绝经期生活质量有所改善。     

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.     

心理干预对人工流产术妇女焦虑情绪的影响

目的:探讨综合性心理干预对人工流产术妇女焦虑情绪的影响。方法:选取妊娠6周~10周要求终止妊娠而无禁忌证的第一次接受人工流产术的门诊妇女100例,随机分为干预组50例、对照组50例。干预组进行综合心理干预,包括术前的健康教育、放松训练和术中的音乐辅助放松,对照组常规处理。手术前后测量两组心率,评估焦虑情绪(Zung焦虑自评量表SAS)、疼痛程度,并对人工流产综合征进行评价。结果:干预前干预组与对照组一般资料、血压、心率和SAS评分无明显差别。干预后①干预组术中中重度疼痛发生率(18%)明显低于对照组(44%,χ2=7.9,P<0.01);干预组人工流产综合征发生率(4%)低于对照组(16%,χ2=4.0,P<0.05);②干预前、术前、术中、术后脉搏变化两组间差异无统计学意义;③术后1周SAS评分干预组明显低于对照组(37.3±5.6/43.3±4.9,t=-5.61,P<0.01)。结论:综合性心理干预有助于降低人工流产术妇女的焦虑程度,降低人工流产综合征的发生率,减轻术中疼痛程度,是一种行之有效的干预方法。     

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.