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.     

The practical assessment and management of bladder outflow obstruction

The initial management of bladder outflow obstruction typically related to benign prostatic hyperplasia (BPH) falls to a large extent within the remit of general practice. Referral onwards to secondary care typically arises following the failure to respond to conservative measures or when complications have supervened; the most significant of which is urinary retention. In the hospital setting, anaesthesia, constipation and immobility are the common precipitants. What follows is a practical guide to the management of these situations and provides an overview of the conservative, medical, minimally invasive and surgical treatments available.     

Interactions of angiotensin IV and oxytocin on behaviour in mice.

INTRODUCTION: Angiotensin (Ang) IV enhances learning and memory in rats but there are strain differences in its effects in mice. Oxytocin (OT) also influences learning and memory in rats and mice and, in the light of the proposed effects of Ang IV on oxytocinase, the hypothesis that the effects of Ang IV on cognition in mice involve OT was tested. MATERIALS AND METHODS: The effects of Ang IV and OT, alone and combined, were determined in rat isolated uterine smooth muscle and in object recognition and forced swim tests in BKW mice. RESULTS: Ang potentiated the contractile effects of OT in the uterus. Neither peptide had any effect on object recognition nor locomotor activity. Ang IV had no effect in the forced swim test but abolished the effects of OT. CONCLUSIONS: Ang IV influences the actions of OT in vitro and in vivo, possibly by inhibition of oxytocinase, but the lack of effect of Ang IV on object recognition in BKW mice is unlikely to be a consequence of a deficiency endogenous OT. Unlike OT, Ang IV alone has no effect on learned helplessness in the forced swim test, an effect often used to predict potential antidepressant efficacy in humans.     

Reducing consultations for symptoms of cystitis using a health education leaflet.

This study aims to evaluate the effects of a health education leaflet on the number of general practice consultations for the symptoms of cystitis. Seventy women with symptoms of cystitis were recruited into two groups, only one group received health education leaflets. Twenty-nine per cent of patients who received leaflets re-consulted within 40 weeks from presentation compared with 66% of patients who did not receive leaflets (P < 0.005).     

Women's knowledge, practises, and intentions regarding correct pelvic floor exercises.

AIM: Although research has demonstrated the efficacy of pelvic floor exercises (PFXs) for the prevention and treatment of female urinary incontinence (FUI), adherence to PFX regimens is commonly poor. There is some evidence that this finding is in part due to a lack of knowledge about how to perform PFXs correctly and misconceptions about the required frequency and duration of PFX regimens. METHODS: By using a sample of 720 postpartum women, this study investigates women's PFX regimens both before and during pregnancy and postpartum. RESULTS: Findings demonstrated that most women were aware of the required frequency for PFXs (at least every second day): just over half had done them this often during pregnancy and 91% intended to do so postpartum. However, few had done them at this level before pregnancy and less than half knew that PFXs should be carried out indefinitely throughout the lifetime. Moreover, only two thirds were confident that they were doing PFXs correctly. CONCLUSION: The findings suggest that, despite good knowledge of the required frequency of PFXs, few women practise them regularly over their lifetime, many apparently perceiving PFXs as relevant only to the childbirth years. Implications for health professionals in addressing these gaps in women's knowledge and practises are discussed.     

Factors associated with prolonged prehospital delay of African Americans with acute myocardial infarction.

BACKGROUND: Delays in seeking treatment for signs and symptoms of acute myocardial infarction are longer for African Americans than for whites. OBJECTIVE: To determine factors associated with prolonged delay and the extent to which perceived racism influences prehospital delay in African Americans with acute myocardial infarction. METHODS: Sixty-one African Americans with acute myocardial infarction were interviewed within 1 month of hospital admission. Delay times were calculated on the basis of the interviews. Independent t tests and chi(2) tests were used to determine factors associated with prolonged delays. RESULTS: Median delay was 4.25 hours and did not differ significantly between women and men (4.42 vs 3.50 hours). Most patients (69%) experienced their initial signs and symptoms at home, often witnessed by family members or friends (70%). Delay was longer for insured patients than for uninsured patients (4.45 vs 0.50 hours). Single, widowed, or divorced patients had longer delay times than did married patients (5.33 vs 2.50 hours), and patients with diabetes delayed longer than did those without diabetes (7.29 vs 3.50 hours). Perceived racism did not differ significantly between patients who delayed seeking treatment and those who did not. CONCLUSIONS: Median delay times were substantially longer than the recommended time of less than 1 hour, reducing the benefit from reperfusion therapies. Education and counseling of patients and their families should be a major strategy in optimizing patients' outcomes and decreasing the time to definitive treatment.