A parallel-group, randomised controlled trial of a multimedia, self-directed, coping skills training intervention for patients with cancer and their partners: design and rationale

Introduction:

Reducing office workers' sitting time: rationale and study design for the Stand Up Victoria cluster randomized trial

Background
Excessive time spent in sedentary behaviours (sitting or lying with low energy expenditure) is associated with an increased risk for type 2 diabetes, cardiovascular disease and some cancers. Desk-based office workers typically accumulate high amounts of daily sitting time, often in prolonged unbroken bouts. The Stand Up Victoria study aims to determine whether a 3-month multi-component intervention in the office setting reduces workplace sitting, particularly prolonged, unbroken sitting time, and results in improvements in cardiometabolic biomarkers and work-related outcomes, compared to usual practice.

Methods/design
A two-arm cluster-randomized controlled trial (RCT), with worksites as the unit of randomization, will be conducted in 16 worksites located in Victoria, Australia. Work units from one organisation (Department of Human Services, Australian Government) will be allocated to either the multi-component intervention (organisational, environmental [heightadjustable workstations], and individual behavioural strategies) or to a usual practice control group. The recruitment target is 160 participants (office-based workers aged 18–65 years and working at least 0.6 full time equivalent) per arm. At each assessment (0- [baseline], 3- [post intervention], and 12-months [follow-up]), objective measurement via the activPAL3 activity monitor will be used to assess workplace: sitting time (primary outcome); prolonged sitting time (sitting time accrued in bouts of ≥30 minutes); standing time; sit-to-stand transitions; and, moving time. Additional outcomes assessed will include: non-workplace activity; cardio-metabolic biomarkers and health indicators (including fasting glucose, lipids and insulin; anthropometric measures; blood pressure; and, musculoskeletal symptoms); and, work-related outcomes (presenteeism, absenteeism, productivity, work performance). Incremental cost-effectiveness and identification of both workplace and individual-level mediators and moderators of change will also be evaluated.

Development of a management algorithm for post-operative pain (MAPP) after total knee and total hip replacement: study rationale and design

Evidence from clinical practice and the extant literature suggests that post-operative pain assessment and treatment is often suboptimal. Poor pain management is likely to persist until pain management practices become consistent with guidelines developed from the best available scientific evidence. This work will address the priority in healthcare of improving the quality of pain management by standardising evidence-based care processes through the incorporation of an algorithm derived from best evidence into clinical practice. In this paper, the methodology for the creation and implementation of such an algorithm that will focus, in the first instance, on patients who have undergone total hip or knee replacement is described.

Protocol and rationale-the efficacy of minocycline as an adjunctive treatment for major depressive disorder: a double blind, randomised, placebo controlled trial

While current pharmacotherapies are efficacious, there remain a clear shortfall between symptom remission and functional recovery. With the explosion in our understanding of the biology of these disorders, the time is ripe for the investigation of novel therapies. Recently depression is conceptualized as an immune-inflammatory and nitro-oxidative stress related disorder. Minocycline is a tetracycline antibiotic that has anti-inflammatory, pro-oxidant, glutamatergic, neurotrophic and neuroprotective properties that make it a viable target to explore as a new therapy. This double blind, randomised, placebo controlled adjunctive trial will investigate the benefits of 200 mg/day of minocycline treatment, in addition to any usual treatment, as an adjunctive treatment for moderate-severe major depressive disorder. Sixty adults are being randomised to 12 weeks of treatment (with a 4 week follow-up post-discontinuation). The primary outcome measure for the study is mean change on the Montgomery-Asberg Depression Rating Scale (MADRS), with secondary outcomes including the Social and Occupational Functioning Assessment Scale (SOFAS), Clinical Global Impressions (CGI), Hamilton Rating Scale for Anxiety (HAM-A), Patient Global Impression (PGI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Range of Impaired Functioning Tool (LIFE-RIFT). Biomarker analyses will also be conducted at baseline and week 12. The study has the potential to provide new treatment targets, both by showing efficacy with a new class of 'antidepressant' but also through the analysis of biomarkers that may further inform our understanding of the pathophysiology of unipolar depression.

Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression

Objective: Bipolar disorder places a significant burden on individuals, caregivers and family, and the broader community. Current treatments are believed to be more effective against manic symptoms, leaving a shortfall in recovery during the depressive phase of the illness. The current study draws on recent evidence suggesting that, in addition to increased oxidative load, alterations in mitochondrial function occur in bipolar disorder. Methods: This 16-week study aims to explore the potential benefits of N-acetylcysteine (NAC) alone or in combination (CT) with selected nutraceuticals believed to enhance mitochondrial function. The study includes adults diagnosed with bipolar disorder currently experiencing an episode of depression. Participants are asked to take NAC, CT, or placebo in addition to any usual treatments. A post-discontinuation visit is conducted 4 weeks following the treatment phase. Results: The primary outcome of the study will be mean change on the Montgomery-Asberg Depression Rating Scale. Secondary outcomes include functioning, substance use, mania ratings, and quality of life. Blood samples will be collected at baseline and week 16 to explore biochemical alterations following treatment. Conclusion: This study may provide a novel adjunctive treatment for bipolar depression. Analysis of biological samples may assist in understanding the therapeutic benefits and the underlying etiology of bipolar depression. Trial registration: Australian and New Zealand Clinical Trial Registry ACTRN12612000830897.

Motivation and cognitive load in the flipped classroom : definition, rationale and a call for research

Flipped classroom approaches remove the traditional transmissive lecture and replace it with active in-class tasks and pre-/post-class work. Despite the popularity of these approaches in the media, Google search, and casual hallway chats, there is very little evidence of effectiveness or consistency in understanding what a flipped classroom actually is. Although the flipped terminology is new, some of the approaches being labelled ‘flipped’ are actually much older. In this paper, we provide a catch-all definition for the flipped classroom, and attempt to retrofit it with a pedagogical rationale, which we articulate through six testable propositions. These propositions provide a potential agenda for research about flipped approaches and form the structure of our investigation. We construct a theoretical argument that flipped approaches might improve student motivation and help manage cognitive load. We conclude with a call for more specific types of research into the effectiveness of the flipped classroom approach.

Effect of exercise training on left ventricular remodeling in diabetic patients with diastolic dysfunction: rationale and design

This study will examine the effects of combined aerobic and resistance training on left ventricular remodeling in diabetic patients with diastolic dysfunction. This is the first randomized controlled trial to look for effects of combined strength training and aerobic exercise on myocardial function as well as other clinical, functional, or psychological parameters in diabetic patients with isolated diastolic dysfunction, and will provide important insights into the potential management strategies for heart failure with preserved ejection fraction.

Youth Depression Alleviation-Augmentation with an anti-inflammatory agent (YoDA-A): protocol and rationale for a placebo-controlled randomized trial of rosuvastatin and aspirin

AIM: There is growing support for the role of inflammation and oxidative stress in the pathophysiology of major depressive disorder (MDD). This has led to the development of novel strategies targeting inflammation in the treatment of depression. Rosuvastatin and aspirin have well-documented, anti-inflammatory and antioxidant properties. The aim of the Youth Depression Alleviation: Augmentation with an anti-inflammatory agent (YoDA-A) study is to determine whether individuals receiving adjunctive anti-inflammatory agents, aspirin and rosuvastatin experience a reduction in the severity of MDD compared with individuals receiving placebo. METHODS: YoDA-A is a 12-week triple-blind, randomized controlled trial funded by the National Health and Medical Research Council, Australia. Participants aged 15-25, with moderate-to-severe MDD, are allocated to receive either 10 mg/day rosuvastatin, 100 mg/day aspirin, or placebo, in addition to treatment as usual. Participants are assessed at baseline and at weeks 4, 8, 12 and 26. The primary outcome is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 12. RESULTS: The study is planned to be completed in 2017. At date of publication, 85 participants have been recruited. CONCLUSION: Timely and targeted intervention for youth MDD is crucial. Given the paucity of new agents to treat youth MDD, adjunctive trials are not only pragmatic and 'real-world', but additionally aim to target shortfalls in conventional medications. This study has the potential to first provide two new adjunctive treatment options for youth MDD; aspirin and rosuvastatin. Second, this study will serve as proof of principle of the role of inflammation in MDD.

Rationale for the use of DC microgrids: feasibility, efficiency and protection analysis

Electrical power systems are undergoing highly significant changes in their structures. The emergence of renewable energy units in the power generation sector, the use of high-voltage DC in the power transmission sector, and the prevalence of islanded or integrated microgrids in the distribution sector are the strongest evidence supporting this claim. These changes are mostly the consequences of the increasing energy demand rate, climate change, and environmental challenges, as well as the high investment and maintenance cost of the previous structures. Considering these new conditions and according to the recent development in DC/DC conversion topologies and control techniques, different studies have been conducted on how and why DC microgrids outperform AC microgrids. This study discusses the feasibility of the DC microgrid system according to recent developments in power systems. The efficiency and power loss reduction in DC distribution systems are then analyzed, some of the common strategies and devices for protection systems in such networks are reviewed, and the possible and existing challenges in developing the DC microgrids are highlighted. The mathematical calculations and theories for this evaluation are presented to determine the reliable justification for selecting the appropriate microgrid systems.

A randomised trial of the Flinders Program to improve patient self-management competencies in a range of chronic conditions : study rationale and protocol

Background: Supporting self management is seen as an important health service strategy in dealing with the large and increasing health burden of chronic conditions. Several types of self-management programs are available. Evidence to date suggests that disease specific and lay-led self management programs provide only part of the support needed for improved outcomes. The Flinders Program is promising as a generic self management intervention, which can be combined with targeted disease specific and lay-led interventions, but it has yet to be evaluated for a range of chronic conditions using a rigorous controlled trial design. This paper gives the rationale for a randomised controlled trial and process evaluation of the Flinders Program of chronic condition self-management in community practice, and details and justifies the design of such a study.Method: The design for a randomised trial and associated process evaluation, suited to evaluation of a complex and behavioural intervention as it is applied in actual practice, is presented and justified.Conclusion: A randomised trial of the Flinders Program is required and a functional design is presented. Results from this trial, currently underway, will test the effectiveness of the Flinders Program in improving patient competencies in self-management of chronic conditions in practice conditions. A process evaluation alongside the trial will explore system, provider and patient factors associated with greater and lesser Program effectiveness.

The getting physical on cigarettes trial: rationale and methods

Smoking cessation success rates are generally dismal amongst self-quitters, with a discrepancy apparent among sexes with women having lower cessation rates than men (Osler, Prescott, Godtfredsen, Hein, & Schnohr, 1999; Royce, Corbett, Sorensen, & Ockene, 1997; Wetter et al., 1999). The Getting Physical on Cigarettes project aims to be the first clinical trial to appropriately evaluate the effectiveness of home-based lifestyle exercise maintenance program in assisting women to prevent smoking relapse and maintain exercise and weight following the termination of a structured and supervised exercise and nicotine replacement therapy (NRT) smoking cessation intervention. This paper outlines the rationale and methods of the trial - a supervised exercise and NRT program lasting 14 weeks, which is followed by a home-based exercise maintenance program. Sedentary female smokers will be randomized into one of four research arms: Exercise Maintenance; Exercise Maintenance + Relapse Prevention Booklets; Relapse Prevention Booklets + Contact; Contact Control. The Exercise Maintenance groups will be counseled on maintaining exercise in their home environment, while the other groups will be counseled on health issues not involving exercise or smoking. The "Forever Free" booklet series (Brandon, Collins, Juliano, & Lazev, 2000) will be distributed to participants in the Relapse Prevention groups. The primary outcome measure is continuous smoking abstinence. Secondary outcomes are exercise behaviour, and selected physiological and psychological variables. Results will assist researchers and health professionals develop and implement similar treatment interventions that are grounded in behaviour change theory.

A rationale for assessing the lower-body power profile in team sport athletes

Training at the load that maximizes peak mechanical power (Pmax) is considered superior for the development of power. We aimed to identify the Pmax load ('optimal load') in the jump squat and to quantify small, moderate, large, and very large substantial differences in power output across a spectrum of loads to identify loads that are substantially different to the optimal, and lastly, to investigate the nature of power production (load-force-velocity profiles). Professional Australian Rules Football (ARF; n = 16) and highly trained Rugby Union (RU; n = 20) players (subdivided into stronger [SP] vs. weaker [WP] players) performed jump squats across incremental loads (0-60 kg). Substantial differences in peak power (W·kg(-1)) were quantified as 0.2-2.0 of the log transformed between-athlete SD at each load, backtransformed and expressed as a percent with 90% confidence limits (CL). A 0-kg jump squat maximized peak power (ARF: 57.7 ± 10.8 W·kg(-1); RU: 61.4 ± 8.5 W·kg(-1); SP: 64.4 ± 7.5 W·kg(-1); WP: 54.8 ± 9.5 W·kg(-1)). The range for small to very large substantial differences in power output was 4.5-55.9% (CL: ×/÷1.36) and 2.8-32.4% (CL: ×/÷1.31) in ARF and RU players, whereas in SP and WP, it was 3.7-43.1% (CL: ×/÷1.32) and 4.3-51.7% (CL: ×/÷1.36). Power declined per 10-kg increment in load, 14.1% (CL: ±1.6) and 10.5% (CL: ±1.5) in ARF and RU players and 12.8% (CL: ±1.9) and 11.3% (CL: ±1.7) in SP and WP. The use of a 0-kg load is superior for the development of jump squat maximal power, with moderate to very large declines in power output observed at 10- to 60-kg loads. Yet, performance of heavier load jump squats that are substantially different to the optimal load are important in the development of sport-specific force-velocity qualities and should not be excluded.