Can exercise delay transition to active therapy in men with low-grade prostate cancer? A multicentre randomised controlled trial

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. Introduction Active surveillance is a strategy for managing low-risk, localised prostate cancer, where men are observed with serial prostate-specific antigen assessments to identify signs of disease progression. Currently, there are no strategies to support active surveillance compliance nor are there interventions that can prevent or slow disease progression, ultimately delaying transition to active treatment before it is clinically required. Recently, we proposed that exercise may have a therapeutic potential in delaying the need for active treatment in men on active surveillance. Methods and analysis A single-blinded, two arm, multicentre randomised controlled trial will be undertaken with 168 patients randomly allocated in a ratio of 1:1 to exercise or usual care. Exercise will consist of supervised resistance and aerobic exercise performed three times per week for the first 6 months in an exercise clinical setting, and during months 7-12, a progressive stepped down approach will be used with men transitioning to once a week supervised training. Thereafter, for months 13 to 36, the men will self-manage their exercise programme. The primary endpoint will be the time until the patients begin active therapy. Secondary endpoints include disease progression (prostate specific antigen), body composition and muscle density, quality of life, distress and anxiety and an economic analysis will be performed. Measurements will be undertaken at 6 and 12 months (postintervention) and at 24 and 36 months follow-up. The primary outcome (time to initiation of curative therapy) will be analysed using Cox proportional hazards regression. Outcomes measured repeatedly will be analysed using mixed effects models to examine between-group differences. Data will be analysed using an intention-to-treat approach. Ethics and dissemination Outcomes from the study will be published in peer-reviewed academic journals and presented in scientific, consumer and clinical meetings. Trial registration number ACTRN12618000225213

RELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practice

BACKGROUND: Many people experience withdrawal symptoms when they attempt to stop antidepressants. Withdrawal symptoms are readily misconstrued for relapse or ongoing need for medication, contributing to long-term use (> 12 months). Long-term antidepressant use is increasing internationally yet is not recommended for most people. Long-term use is associated with adverse effects including weight gain, sexual dysfunction, lethargy, emotional numbing and increased risk of falls and fractures. This study aims to determine the effectiveness of two multi-strategy interventions (RELEASE and RELEASE+) in supporting the safe cessation of long-term antidepressants, estimate cost-effectiveness, and evaluate implementation strategies. METHODS: DESIGN: 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1. SETTING: primary care general practices in southeast Queensland, Australia. POPULATION: adults 18 years or older taking antidepressants for longer than 1 year. Practices will be randomised on a 1.5:1:1 ratio of Usual care:RELEASE:RELEASE+. INTERVENTION: RELEASE for patients includes evidence-based information and resources and an invitation to medication review; RELEASE for GPs includes education, training and printable resources via practice management software. RELEASE+ includes additional internet support for patients and prescribing support including audit and feedback for GPs. OUTCOME MEASURES: the primary outcome is antidepressant use at 12 months self-reported by patients. Cessation is defined as 0 mg antidepressant maintained for at least 2 weeks. SECONDARY OUTCOMES: at 6 and 12 months are health-related quality of life, antidepressant side effects, well-being, withdrawal symptoms, emotional numbing, beliefs about antidepressants, depressive symptoms, and anxiety symptoms; and at 12 months 75% reduction in antidepressant dose; aggregated practice level antidepressant prescribing, and health service utilisation for costs. SAMPLE SIZE: 653 patients from 28 practices. A concurrent evaluation of implementation will be through mixed methods including interviews with up to 40 patients and primary care general practitioners, brief e-surveys, and study administrative data to assess implementation outcomes (adoption and fidelity). DISCUSSION: The RELEASE study will develop new knowledge applicable internationally on the effectiveness, cost-effectiveness, and implementation of two multi-strategy interventions in supporting the safe cessation of long-term antidepressants to improve primary health care and outcomes for patients. TRIAL REGISTRATION: ANZCTR, ACTRN12622001379707p. Registered on 27 October 2022

Modular prevention of heart disease following acute coronary syndrome (ACS) [ISRCTN42984084]

BACKGROUND: Coronary heart disease (CHD) is a major cause of morbidity and mortality in Australia and it is recommended that all persons with unstable angina (UA) or myocardial infarction (MI) participate in secondary prevention as offered in cardiac rehabilitation (CR) programs. However, the majority of patients do not access standard CR and have higher baseline coronary risk and poorer knowledge of CHD than those persons due to commence CR. The objective of this study is to investigate whether a modular guided self-choice approach to secondary prevention improves coronary risk profile and knowledge in patients who do not access standard CR. METHODS/DESIGN: This randomised controlled trial with one year follow-up will be conducted at a tertiary referral hospital. Participants eligible for but not accessing standard CR will be randomly allocated to either a modular or conventional care group. Modular care will involve participation in individualised modules that involve choice, goal-setting and coaching. Conventional care will involve ongoing heart disease management as directed by the participant's doctors. Both modular and conventional groups will be compared with a contemporary reference group of patients attending CR. Outcomes include measured modifiable risk factors, relative heart disease risk and knowledge of risk factors. DISCUSSION: We present the rationale and design of a randomised controlled trial testing a modular approachfor the secondary prevention of coronary heart disease following acute coronary syndrome

Interfaces for science: Conceptualizing an interactive graphical interface

6,849.32 new research journal articles are published every day. The exponential growth of Scientific Knowledge Objects (SKOs) on the Web, makes searches time-consuming. Access to the right and relevant SKOs is vital for research, which calls for several topics, including the visualization of science dynamics. We present an interface model aimed to represent of the relations that emerge in the science social space dynamics, namely through the visualization and navigation of the relational structures between researchers, SKOs, knowledge domains, subdomains, and topics. This interface considers the relationship between the researcher who reads and shares the relevant articles and the researcher who wants to find the most relevant SKOs within a subject matter. This article presents the first iteration of the conceptualization process of the interface layout, its interactivity and visualization structures. It is essential to consider the hierarchical and relational structures/algorithms to represent the science social space dynamics. These structures are not being used as analysis tools, because it is not objective to show the linkage properties of these relationships. Instead, they are used as a means of representing, navigating and exploring these relationships. To sum up, this article provides a framework and fundamental guidelines for an interface layout that explores the social science space dynamics between the researcher who seeks relevant SKOs and the researchers who read and share them.This work has been supported by COMPETE: POCI-01-0145-FEDER- 007043 and FCT - Fundação para a Ciência e Tecnologia within the Project Scope: (UID/CEC/00319/2013) and the Project IViSSEM: ref: POCI-010145-FEDER-28284

Evaluating the feasibility of a web-based weight loss programme for naval service personnel with excess body weight.

Overweight and obesity are a major concern that may influence the operational capacity of the UK Naval Service (NS). This study was conducted to evaluate the feasibility of trialling and implementing a modified web-based weight loss programme for overweight and obese NS personnel.Royal Navy; University of Southampto

The impact of a bariatric rehabilitation service on weight loss and psychological adjustment - study protocol

Bariatric surgery is currently the most effective form of obesity management for those whose BMI is greater than 40 (or 35 with co morbidities). A minority of patients, however, either do not show the desired loss of excess weight or show weight regain by follow up. Research highlights some of the reasons for this variability, most of which centres on the absence of any psychological support with patients describing how although surgery fixes their body, psychological issues relating to dietary control, self esteem, coping and emotional eating remain neglected.The present study aims to evaluate the impact of a health psychology led bariatric rehabilitation service (BRS) on patient health outcomes. The bariatric rehabilitation service will provide information, support and mentoring pre and post surgery and will address psychological issues such as dietary control, self esteem, coping and emotional eating. The package reflects the rehabilitation services now common place for patients post heart attack and stroke which have been shown to improve patient health outcomes

Evaluating the feasibility of a web-based weight loss programme for naval service personnel with excess body weight.

Overweight and obesity are a major concern that may influence the operational capacity of the UK Naval Service (NS). This study was conducted to evaluate the feasibility of trialling and implementing a modified web-based weight loss programme for overweight and obese NS personnel.Royal Navy; University of Southampto