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.     

Quantifying physical activity in daily life with questionnaires and motion sensors in COPD.

Accurate assessment of the amount and intensity of physical activity in daily life is considered very important due to the close relationship between physical activity level, health, disability and mortality. For this reason, assessment of physical activity in daily life has gained interest in recent years, especially in sedentary populations, such as patients with chronic obstructive pulmonary disease (COPD). The present article aims to compare and discuss the two kinds of instruments more commonly used to quantify the amount of physical activity performed by COPD patients in daily life: subjective methods (questionnaires, diaries) and motion sensors (electronic or mechanical methods). Their characteristics are summarised and evidence of their validity, reliability and sensitivity is discussed, when available. Subjective methods have practical value mainly in providing the patients' view on their performance in activities of daily living and functional status. However, care must be taken when using subjective methods to accurately quantify the amount of daily physical activity performed. More accurate information is likely to be available with motion sensors rather than questionnaires. The selection of which motion sensor to use for quantification of physical activity in daily life should depend mainly on the purpose of its use.     

Hypoactive sexual desire disorder in postmenopausal women.

Decreases in sex hormone levels with menopause may bring about a number of consequences in women's general health and sexual well-being, especially when levels decline suddenly and prematurely, as in surgical menopause. In addition to the well-established role of estrogens in preserving the biological basis of sexual response, there is emerging evidence that androgens are significant independent determinants affecting sexual desire, activity and satisfaction, as well as mood, energy and other components of women's health. Hypoactive sexual desire disorder (HSDD), a persistent absence of sexual fantasies or thoughts and/or desire for and receptivity to sexual activity that causes personal distress, is experienced by some postmenopausal women. Even though conventional hormone therapy with estrogens or estrogens and progestogens may be effective for vaginal atrophy, increasing vaginal lubrication and reducing dyspareunia, it has not been shown to consistently increase sexual desire or activity and many women with sexual dysfunction remain unresponsive. Several recent, large, phase III studies have shown that the addition of transdermal testosterone to conventional hormone therapy can be helpful in surgically menopausal women presenting with HSDD. After 24 weeks of treatment in these studies, testosterone-treated women experienced significantly greater increases in satisfying sexual activity and sexual desire, and greater decreases in distress, than placebo-treated women. Accurate clinical assessment and individualized management of sexual symptoms are fundamentally important for all menopausal women with HSDD or other sexual problems.     

Notions of child health: mothers' accounts of health in their young babies

This paper is concerned with mothers’ understandings of child health in their young babies. To explore how child health is depicted, explained and contextualised by mothers, altogether 29 mothers in Stockholm and London were interviewed through the baby's first months about day-to-day experiences of the baby's health and well-being. The analysis of the mothers’ accounts reveals how the mothers, in the process of assessing health, try to ‘read’ the bodily signs and reactions in their babies. Some major themes emerge on how the mothers identify and characterise threats to the health of the baby; here described as threats of abnormalities, threats to the survival of the baby, threats to the thriving of the baby and threats from illnesses. Notions of child health are discussed in relation to the ‘bodily’ and the ‘social’, and how the embodied images of child health are intertwined with the mothers’ presentations of themselves as responsible for the health of their children and as ‘worthy’ parents.     

Effect of selected fluorinated drugs in a "ringing" gel on rheological behaviour and skin permeation.

The purpose of the present study was to investigate the influence of different drugs exhibiting different solubility on the viscoelastic properties and on the skin diffusion profile of a ringing gel. In a preliminary rheology study with the placebo gel predominating elastic properties were confirmed and a temperature influence was indicated. Fluconazole, fludrocortisone-acetate, flumethasone-pivalate, flutamide and flufenamic-acid each 1% (w/w) were incorporated into the preparation and oscillatory measurements were performed at temperatures of 25, 28, 32 and 37 degrees C. In all drug containing formulations a high elastic G' value predominated the viscous G' value. The highest G' value could be obtained with the incorporated flumethasone-pivalate. Additionally in almost all cases the G' values decreased with increasing temperature compared to the placebo gel. Additionally in vitro standard diffusion experiments using Franz-type cells and porcine skin were performed. Following rank order of the cumulative drug release after 48 h was obtained: fluconazole>flufenamic-acid>flumethasone-pivalate>flutamide>fludrocortisone-acetate. Furthermore an excellent chemical stability of all incorporated drugs was confirmed over 10 weeks.     

Dysphoric Rumination Impairs Concentration on Academic Tasks

Three studies investigated the effects of dysphoric rumination on concentration during 3 academic tasks—reading a passage from the GRE (Study 1), watching a videotaped lecture (Study 2), and proofreading written text (Study 3). Before performing these tasks, dysphoric and nondysphoric students were induced either to ruminate about themselves or to distract themselves by focusing on neutral images (all three studies) or by planning an event (Study 1). The results supported our hypothesis that dysphoric rumination, relative to distraction, would impair students' concentration. In all 3 studies, dysphoric ruminators reported difficulty concentrating, as well as interfering thoughts, during the relevant academic tasks. Furthermore, dysphoric ruminators were slower than dysphoric distractors in completing the tasks—specifically, reading the GRE passage (Study 1) and answering lecture comprehension questions (Study 2). In addition, dysphoric participants who ruminated showed impaired reading strategies (Study 1), reduced comprehension of academic material (Study 2), and poor proofreading performance (Study 3). These findings suggest that, in addition to its documented adverse effects on mood, thinking, and problem-solving, self-focused rumination interferes with instrumental behavior. Implications for social relationships and job performance are discussed.     

Resection of endobronchial tumors using a tracheoscope and neodymium:YAG laser.

A modified technique for palliative resections of malignant endobronchial tumors with the Nd:YAG laser is described. A special tracheoscope was used in conjunction with the instrument guide of a laser bronchoscope. The main advantage of this technique is easy and simultaneous access to both lungs for ventilation and surgical procedures. The method helps to separate surgical from anesthetic manipulations. The experience of over 70 operations using this technique provides evidence that the use of a tracheoscope is a safe and efficient method of endoscopic resections of larger intrabronchial tumors.