BMJ open
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Randomized Controlled Trial Multicenter Study
The effect on quality of life of vitamin D administration for advanced cancer treatment (VIDAFACT study): protocol of a randomised controlled trial.
Vitamin D is related to resistance to chronic diseases, physiological parameters and functional measures. All of these relationships underscore the potential benefits of cholecalciferol or D3 (nutritional vitamin D) in cancer. This is the first study designed to obtain conclusive evidence on the effect of cholecalciferol in advanced patients with cancer. The main goal is to assess its effects on the patient's perceived quality of life. Cholecalciferol's impact on fatigue and physical performance, as well as its cost utility, will also be assessed. ⋯ Ethical approval was received from the Medical Ethical Commitee of the HUAV (CEIC-1169). Participants and their families will receive the research findings which will also be disseminated on local and national media, presented at national and international meetings of the specialty, and published in peer-reviewed scientific journals.
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Randomized Controlled Trial Multicenter Study
A cross-sectional examination of the mental health of homeless mothers: does the relationship between mothering and mental health vary by duration of homelessness?
This study draws on baseline data from the At Home/Chez Soi demonstration project to examine the association between parenting status and mental health among homeless women and whether the association varies by duration of homelessness. ⋯ Overall, the findings from this study suggest that there is a relationship between long-term homelessness and mothers' risk of poor mental health. Given the multiple demands mothers face, a failure to recognise their unique needs is likely to contribute to intergenerational legacies of homelessness and mental health problems.
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Randomized Controlled Trial Multicenter Study
Effectiveness of cognitive behavioural therapy augmentation in major depression treatment (ECAM study): study protocol for a randomised clinical trial.
Major depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society. Although antidepressant treatment is the most common therapy provided in routine practice, there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants. The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy (CBT) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care. ⋯ All protocols and the informed consent form comply with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethics review committees at the Keio University School of Medicine and the Sakuragaoka Memorial Hospital approved the study protocol. The results of the study will be disseminated at several research conferences and as published articles in peer-reviewed journals. The study will be implemented and reported in line with the CONSORT statement.
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Multicenter Study
Examining different measures of multimorbidity, using a large prospective cross-sectional study in Australian general practice.
Prevalence estimates of multimorbidity vary widely due to inconsistent definitions and measurement methods. This study examines the independent effects on prevalence estimates of how 'disease entity' is defined-as a single chronic condition or chapters/domains in the International Classification of Primary Care (V.2; ICPC-2), International Classification of Disease (10th revision; ICD-10) or the Cumulative Illness Rating Scale (CIRS), the number of disease entities required for multimorbidity, and the number of chronic conditions studied. ⋯ Multimorbidity defined as 2+ disease entities can be measured using different definitions of disease entity with as few as 12 prevalent chronic conditions, but lacks specificity to be useful, especially in older people. Multimorbidity, defined as 3+, requires more measurement conformity and inclusion of all chronic conditions, but provides greater specificity than the 2+ definition. The proposed concept of "complex multimorbidity", the co-occurrence of three or more chronic conditions affecting three or more different body systems within one person without defining an index chronic condition, may be useful in identifying high-need individuals.
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To explore views of service providers caring for injured people on: the extent to which services meet patients' needs and their perspectives on factors contributing to any identified gaps in service provision. ⋯ Service providers envisage an 'ideal' model of trauma care which is timely, equitable, effective and holistic, but this can differ from the care currently provided. Their experiences provide many suggestions for service improvements to bridge the gap between 'real' and 'ideal' care. Using service provider views to inform service design and delivery could enhance the quality, patient experience and outcomes of care.