60 research outputs found
Common statistical and research design problems in manuscripts submitted to high-impact medical journals
Caring for Caregivers (C4C): study protocol for a pilot feasibility randomised control trial of Positive Written Disclosure for older adult caregivers of people with psychosis
Background:
The caregivers of people who experience psychosis are themselves at risk of developing physical and
mental health problems. This risk is increased for older adult caregivers who also have to manage the lifestyle and
health changes associated with ageing. As a consequence, older adult caregivers are in particular need of support;
we propose a Written Emotional Disclosure (WED) intervention, called Positive Written Disclosure (PWD).
Methods/design:
This is a pilot randomised controlled trial of PWD compared to a neutral writing control and a no
writing condition. We aim to recruit 60 participants, 20 in each arm. This study will utilise a mixed-methods
approach and collect quantitative (questionnaires) and qualitative (interviews) data. Quantitative data will be
collected at baseline and 1, 3, and 6 months post baseline. Participants who complete a writing task (PWD or
neutral writing control) will be invited to complete an exit interview to discuss their experiences of the intervention
and study. The study is supported by a patient and public involvement group.
Discussion:
The results of this trial will determine whether a definitive trial is justified. If so, the quantitative and
qualitative findings will be used to refine the intervention and study protocols
Evaluation of expressive writing for postpartum health: A randomized controlled trial
Pregnancy, birth and adjusting to a new baby is a potentially stressful time that can negatively affect the health of women. There is some evidence that expressive writing can have positive effects on psychological and physical health, particularly during stressful periods. The current study aimed to evaluate whether expressive writing would improve women’s postpartum health. A randomized controlled trial was conducted with three conditions: expressive writing (n=188), a control writing task (n=213), or normal care (n=163). Measures of psychological health, physical health and quality of life were measured at baseline (6-12 weeks postpartum), 1 month and 6 months later. Ratings of stress were taken before and after the expressive writing task. Intent-to-treat analyses showed no significant differences between women in the expressive writing, control writing and normal care groups on measures of physical health, anxiety, depression, mood or quality of life at 1 and 6 months. Uptake and adherence to the writing tasks was low. However, women in the expressive writing group rated their stress as significantly reduced after completing the task. Cost analysis suggest women who did expressive writing had the lowest costs in terms of healthcare service use and lowest cost per unit of improvement in quality of life. Results suggest expressive writing is not effective as a universal intervention for all women 6-12 weeks postpartum. Future research should examine expressive writing as a targeted intervention for women in high-risk groups, such as those with mild or moderate depression, and further examine cost-effectiveness
Infiltrating ductal and lobular breast carcinomas are characterised by different interrelationships among markers related to angiogenesis and hormone dependence
To obtain a more integrated understanding of the different breast cancer phenotypes and to investigate whether bio-molecular profiles can distinguish between specific histotypes, we explored the interrelations among several biologic variables indicative of, or related to, hormone dependence, proliferation and apoptosis control, and angiogenesis in ductal and lobular carcinomas, the most common histotypes. Oestrogen and progesterone receptors, tumour proliferative activity, the expression of cyclin A, p16ink4A, p27kip1, p21waf1, p53, bcl-2, and levels of vascular endothelial growth factor and hypoxia-inducible factor-1α (HIF-1α) were evaluated in 190 in ductal and 67 lobular carcinomas. Our findings support the hypothesis that in ductal and lobular carcinomas are two distinct, partially phenotypically unrelated entities, the latter being characterised by the presence of features indicative of differentiation such as oestrogen receptors, low proliferation and lack of p53 expression and associated with low vascular endothelial growth factor content compared to angiogenesis in ductal carcinomas. Conversely, no significant difference was found between lobular carcinomas and in ductal carcinomas considering the frequency distribution of PgR-positive cases, cyclin-dependent kinase inhibitors acting at the G1/S boundary, bcl-2 and HIF-1α protein expression. Although both generally defined as hormone responsive, in ductal and lobular carcinomas are also characterised by biologic patterns in which proteins related to hormone responsiveness, cell-cycle control, apoptosis and angiogenesis were differently associated. This finding suggests the need to refine breast cancer characterisation in order to provide detailed information about individual tumours, or subsets of tumours, that will help in defining optimal treatment approaches
Preoperative Behavioural Intervention versus standard care to Reduce Drinking before elective orthopaedic Surgery (PRE-OP BIRDS):Protocol for a multicentre pilot randomised controlled trial
Background
Evidence suggests that increased preoperative alcohol consumption increases the risk of postoperative complications; therefore, a reduction or cessation in alcohol intake before surgery may reduce perioperative risk. Preoperative assessment presents an opportunity to intervene to optimise patients for surgery. This multicentre, two-arm, parallel group, individually randomised controlled trial will investigate whether a definitive trial of a brief behavioural intervention aimed at reducing preoperative alcohol consumption is feasible and acceptable to healthcare professionals responsible for its delivery and the preoperative elective orthopaedic patient population.
Methods
Screening will be conducted by trained healthcare professionals at three hospitals in the North East of England. Eligible patients (those aged 18 or over, listed for elective hip or knee arthroplasty surgery and scoring 5 or more or reporting consumption of six or more units on a single occasion at least weekly on the alcohol screening tool) who enrol in the trial will be randomised on a one-to-one non-blinded basis to either treatment as usual or brief behavioural intervention delivered in the pre-assessment clinic. Patients will be followed up 1–2 days pre-surgery, 1–5 days post-surgery (as an in-patient), 6 weeks post-surgery, and 6 months post intervention. Feasibility will be assessed through rates of screening, eligibility, recruitment, and retention to 6-month follow-up. An embedded qualitative study will explore the acceptability of study methods to patients and staff.
Discussion
This pilot randomised controlled trial will establish the feasibility and acceptability of trial procedures reducing uncertainties ahead of a definitive randomised controlled trial to establish the effectiveness of brief behavioural intervention to reduce alcohol consumption in the preoperative period and the potential impact on perioperative complications
Anti-angiogenic effect of tamoxifen combined with epirubicin in breast cancer patients
Capsule Commentary on Oslin et al., A Randomized Clinical Trial of Alcohol Care Management Delivered in Department of Veterans Affairs Primary Care Clinics Versus Specialty Addiction Treatment
Translation and Adaptation of the Revised Children\u27s Anxiety and Depression Scale: A Qualitative Study in Belize
BACKGROUND: Adapting data collection instruments using transcultural translation and adaptation processes is essential to ensure that respondents comprehend the items and the original meaning is retained across languages and contexts. This approach is central to UNICEF\u27s efforts to expand the use of standard data collection tools across settings and close the global data gap on adolescent mental health. METHODS: We conducted transcultural translation and adaptation processes in Belize using the Revised Children\u27s Anxiety and Depression Scale (RCADS). Items from the original scale were translated into Belizean English and Kriol, reviewed by local mental health experts, and discussed in focus groups. Cognitive interviews were conducted with adolescents and parents. The information collected was analyzed with cultural equivalence domains: comprehensibility, acceptability, relevance, completeness, and technical equivalence. Bilingual discussions of findings informed the final item wordings, and the adapted tool was back-translated. RESULTS: Adaptation of terms and specific expressions were done to improve comprehensibility and to ensure the appropriate clinical meaning. For example, the expression \u27feeling scared\u27 was perceived to imply immaturity or threaten masculinity and was adapted to \u27feeling afraid.\u27 Expressions like shaky were modified to trimble in Kriol. Statements were reworded as questions to enhance acceptability and comprehensibility. DISCUSSION: A culturally adapted version of the RCADS was developed for use among adolescents in Belize in Belizean English and Kriol. The transcultural translation and adaptation procedure can be applied for other settings or tools to design contextual adaptations of mental health instruments prior to their validation or use in new settings
Historical compliance rates for providing postoperative radiotherapy in oral cavity squamous cell carcinoma
Barriers and facilitators to pharmacotherapy for alcohol use disorders in primary care: results of a qualitative study in 4 va primary care clinics
- …