Design and intermediate results of the Lower Extremity Arterial Disease Event Reduction (LEADER)* trial of bezafibrate in men with lower extremity arterial disease [ISRCTN41194621]

BACKGROUND: Raised levels of both triglycerides and fibrinogen, each of which are reduced by bezafibrate, may contribute to lower extremity arterial disease (LEAD). This condition is characterized by a particularly high incidence of coronary heart disease (CHD) and stroke, but is little studied thus far in randomised controlled trials. METHOD: Patients were recruited through 85 practices in the British Medical Research Council General Practice Research Framework and through nine hospital vascular clinics. The treatment regimen, which is double-blind and placebo-controlled, is bezafibrate 400 mg/day. The 1568 patients recruited represent 86% of those eligible at screening. RESULTS: None of the anticipated side effects (mainly gastrointestinal) differed between the two groups. Nearly 80% of the total person-years accrued at 3 years were spent on trial treatment. Bezafibrate significantly reduced total cholesterol by approximately 8.0% and low-density lipoprotein (LDL)-cholesterol by approximately 9.0%, and increased high-density lipoprotein (HDL)-cholesterol by approximately 11.0% initially, falling to about 6.0% at 3 years. Triglycerides were significantly reduced by about 23.0% and fibrinogen by about 14.0%. Plasma creatinine rose by approximately 11% in those on active treatment. All of these effects were highly significant (P < 0.0001). Bezafibrate had no effect on the level of C-reactive protein (CRP). CONCLUSION: The trial recruited an unusually high proportion of eligible patients, ensuring the general applicability of its results. The fibrinogen-lowering and lipid-modifying effects of bezafibrate were confirmed. Although bezafibrate lowers fibrinogen, it has no effect on CRP; this suggests that the reduction in fibrinogen is due to an effect on its metabolism rather than suppression of an inflammatory response

Beyond Chapter 4.7

Chapter 4.7 of the National Statement on Ethical Conduct in Human Research refers specifically to Aboriginal and Torres Strait Islander Peoples. It lays out the points at which researchers working with Aboriginal and Torres Strait Islanders must consider their approach, and the engagement with individuals, communities or groups who are involved in or affected by their research. History, of Australia and of research involving Aboriginal and Torres Strait Islander Australians, has informed this approach. The response to that history has been a rational, institutionalised, systematic demand for a different perception of what should direct research and research processes to ensure engagement with and service to the community with whom the researchers wish to do the work. This paper considers whether these principles could inform the approach to other research work.not applicabl

The Effectiveness of the Internet in Improving Breastfeeding Outcomes: A Systematic Review

Breastfeeding is the normal and safest way to nurture an infant, and prolonged exclusive breastfeeding duration to 6 months will yield the greatest gains in optimum infant development. Despite this knowledge fewer than 35% of infants worldwide are exclusively breastfed during the first 4 months of life. With the advent of the Internet has been the development of many varied e-Health interventions. Using the Internet to support breastfeeding is a relatively novel method of health intervention in an area which has traditionally always been face-to-face. The aim of this article is to review the literature on the provision of Internet-based breastfeeding information and support intervention programs. A systematic literature review of current evidence was conducted using the electronic databases CINAHL (via EBSCOhost), Medline, Current Contents, PsycINFO, and Web of Knowledge for English-language publications from 2000 to May 2013. Inclusion criteria limited interventions to those delivered to women of childbearing age who accessed the Internet to source breastfeeding information and support. Only studies reporting breastfeeding outcomes (eg, breastfeeding duration) were included. A total of 1379 articles with citations and abstracts were identified as potentially relevant after searching the identified databases. One study was eligible for inclusion and reported positive outcomes, however methodological issues limit the interpretation of these results. Numerous study limitations and problems with scientific rigor make it difficult to extend study findings to antenatal and postnatal care. More rigorous evidence is needed before breastfeeding Internet interventions replace traditional methods of support and education for women intending to breastfeed

Professorial roles: a study of the professorial populations within nursing and midwifery, social work and allied health professions

The professorial populations in nursing/midwifery, social work and allied health are relatively new in academia compared to longer established professions such as medicine and dentistry. Less is known about the roles, career pathways, characteristics and career aspirations of the professoriate within these emerging professions. A survey was undertaken from sample populations in each of the three professorial groups in order to obtain qualitative and quantitative data on professorial roles and activities, career pathway information and support mechanisms for professorial positions. This paper discusses the findings of the survey which relate specifically to professorial roles and activities and whether the identified roles reflect the professorial activities proposed by the National Conference of University Professors (NCUP) Other aspects of this survey including career pathways, findings relating to gender and support mechanisms will form the basis of future papers. Result

From Theory to Intervention: Mapping Theoretically Derived Behavioural Determinants to Behaviour Change Techniques

Theory provides a helpful basis for designing interventions to change behaviour but offers little guidance on how to do this. This paper aims to illustrate methods for developing an extensive list of behaviour change techniques (with definitions) and for linking techniques to theoretical constructs. A list of techniques and definitions was generated from techniques published in two systematic reviews, supplemented by "brainstorming" and a systematic search of nine textbooks used in training applied psychologists. Inter-rater reliability of extracting the techniques and definitions from the textbooks was assessed. Four experts judged which techniques would be effective in changing 11 theoretical constructs associated with behaviour change. Thirty-five techniques identified in the reviews were extended to 53 by brainstorming and to 137 by consulting textbooks. Agreement for the 53 definitions was 74.7 per cent (15.4% cells completed and 59.3% cells empty for both raters). Agreement about the link between the 35 techniques and theoretical constructs was 71.7 per cent of 385 judgments (12.2% agreement that effective and 59.5% agreement that not effective). This preliminary work demonstrates the possibility of developing a comprehensive, reliable taxonomy of techniques linked to theory. Further refinement is needed to eliminate redundancies, resolve uncertainties, and complete technique definitions.Institute of Applied Health Sciences, Chief Scientist Office of the Scottish Government Health Directive, NHS NIHR Academic Unit Fundin

Adult domiciliary oxygen therapy. Position statement of the Thoracic Society of Australia and New Zealand

The document attached has been archived with permission from the editor of the Medical Journal of Australia (26 April 2007). An external link to the publisher’s copy is included.• Patients with chronic obstructive pulmonary disease and a stable daytime PaO2 of ≤55 mmHg (7.3kPa) live longer and have a better quality of life if provided with long-term continuous oxygen therapy. • It is reasonable to offer continuous oxygen therapy also to patients with other lung diseases that cause chronic hypoxaemia. • Indications for supplemental oxygen therapy during exercise (ambulatory oxygen therapy) and sleep (nocturnal oxygen therapy) are less clear.Christine F McDonald, Alan J Crockett and Iven H Youn

“Should I stay or should I go now?” : A qualitative study of why UK doctors retire

Funding information Our thanks go to the University of Aberdeen Development Trust and the British Medical Association (Scotland) for funding this work. ACKNOWLEDGEMENTS Our thanks to all those doctors who participated in the study. Our thanks also to the BMA (Scotland) for distributing the invitation to take part in the study to their members. No patients or any members of the public were involved in this study.Peer reviewedPostprintPostprin

Usability evaluation of an eHealth intervention for family carers of individuals affected by psychosis: A mixed-method study

Background Existing research suggests that eHealth interventions targeting family carers of individuals with long-term illness offer a promising approach to care delivery. In particular, digital psychoeducational interventions with interactive psychosocial support are well-received with high rates of satisfaction and acceptability. However, development of such interventions for psychosis carers is lacking. We developed a multi-component eHealth intervention specifically for carers of individuals affected by psychosis, called COPe-support (Carers fOr People with Psychosis e-support). Objective Using mixed methods to evaluate usability, system heuristics and perceived acceptability, we conducted a usability study to establish the suitability of the intervention prototype for the target user group. Methods Twenty-three carers were recruited to the study and participated in a think-aloud test or a remote online trial of the intervention. Qualitative feedback, post-use System Usability Scale (SUS) scores, and real-world usage data collected from the tests were analysed. These were also supplemented with heuristic evaluation data provided by an independent eLearning technology expert. Results Participants evaluated the intervention content as useful and helpful, and indicated that the system had satisfactory usability with a mean SUS score of 73%, above the usability quality benchmark threshold. Study results identified some minor usability issues, which were corroborated with the eLearning expert’s heuristic evaluation findings. We used these results to refine the COPe-support intervention. Conclusions The usability study with end-users and service providers identified real-life usage and usability issues. The study results helped us refine COPe-support and its delivery strategy before its launch as part of a large-scale clinical trial

Folate Augmentation of Treatment – Evaluation for Depression (FolATED): protocol of a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Clinical depression is common, debilitating and treatable; one in four people experience it during their lives. The majority of sufferers are treated in primary care and only half respond well to active treatment. Evidence suggests that folate may be a useful adjunct to antidepressant treatment: 1) patients with depression often have a functional folate deficiency; 2) the severity of such deficiency, indicated by elevated homocysteine, correlates with depression severity, 3) low folate is associated with poor antidepressant response, and 4) folate is required for the synthesis of neurotransmitters implicated in the pathogenesis and treatment of depression.</p> <p>Methods/Design</p> <p>The primary objective of this trial is to estimate the effect of folate augmentation in new or continuing treatment of depressive disorder in primary and secondary care. Secondary objectives are to evaluate the cost-effectiveness of folate augmentation of antidepressant treatment, investigate how the response to antidepressant treatment depends on genetic polymorphisms relevant to folate metabolism and antidepressant response, and explore whether baseline folate status can predict response to antidepressant treatment.</p> <p>Seven hundred and thirty patients will be recruited from North East Wales, North West Wales and Swansea. Patients with moderate to severe depression will be referred to the trial by their GP or Psychiatrist. If patients consent they will be assessed for eligibility and baseline measures will be undertaken.</p> <p>Blood samples will be taken to exclude patients with folate and B12 deficiency. Some of the blood taken will be used to measure homocysteine levels and for genetic analysis (with additional consent). Eligible participants will be randomised to receive 5 mg of folic acid or placebo. Patients with B12 deficiency or folate deficiency will be given appropriate treatment and will be monitored in the 'comprehensive cohort study'. Assessments will be at screening, randomisation and 3 subsequent follow-ups.</p> <p>Discussion</p> <p>If folic acid is shown to improve the efficacy of antidepressants, then it will provide a safe, simple and cheap way of improving the treatment of depression in primary and secondary care.</p> <p>Trial registration</p> <p>Current controlled trials ISRCTN37558856</p