BMJ open
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Randomized Controlled Trial Multicenter Study
Bridging the age gap in breast cancer: evaluation of decision support interventions for older women with operable breast cancer: protocol for a cluster randomised controlled trial.
While breast cancer outcomes are improving steadily in younger women due to advances in screening and improved therapies, there has been little change in outcomes among the older age group. It is inevitable that comorbidities/frailty rates are higher, which may increase the risks of some breast cancer treatments such as surgery and chemotherapy, many older women are healthy and may benefit from their use. Adjusting treatment regimens appropriately for age/comorbidity/frailty is variable and largely non-evidence based, specifically with regard to rates of surgery for operable oestrogen receptor-positive disease and rates of chemotherapy for high-risk disease. ⋯ 115550.
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Randomized Controlled Trial Multicenter Study
Fluids in Sepsis and Septic Shock (FISSH): protocol for a pilot randomised controlled trial.
Observational evidence suggests physiological benefits and lower mortality with lower chloride solutions; however, 0.9% saline remains the most widely used fluid worldwide. Given uncertainty regarding the association of lower chloride on mortality, it is unlikely that practice will change without direct randomised clinical trial (RCT) evidence. This pilot RCT will investigate the feasibility of a large-scale trial directly comparing low chloride with high chloride fluids in patients with septic shock. ⋯ This pilot trial will test the feasibility of conducting the main trial, which will examine the effect of high versus low chloride fluids in patients with septic shock on patient-important outcomes.
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Randomized Controlled Trial Multicenter Study
A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial.
Atrial fibrillation (AF) is common and causes impaired quality of life, an increased risk of stroke and death as well as frequent hospital admissions. The majority of patients with AF require control of heart rate. In this article , we summarise the limited evidence from clinical trials that guides prescription, and present the rationale and protocol for a new randomised trial. As rate control has not yet been shown to reduce mortality, there is a clear need to compare the impact of therapy on quality of life, cardiac function and exercise capacity. Such a trial should concentrate on the long-term effects of treatment in the largest proportion of patients with AF, those with symptomatic permanent AF, with the aim of improving patient well-being. ⋯ East Midlands-Derby Research Ethics Committee (16/EM/0178); peer-reviewed publications.
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Multicenter Study Observational Study
Protocol for a prospective observational study to improve prehospital notification of injured patients presenting to trauma centres in India.
Prehospital notification of injured patients enables prompt and timely care in hospital through adequate preparation of trauma teams, space, equipment and consumables necessary for resuscitation, and may improve outcomes. In India, anecdotal reports suggest that prehospital notification, in those few places where it occurs, is unstructured and not linked to a well-defined hospital response. The aim of this manuscript is to describe, in detail, a study protocol for the evaluation of a formalised approach to prehospital notification. ⋯ Ethical approval has been obtained from the All India Institute of Medical Sciences, New Delhi and site-specific approval granted by relevant trauma services. The trial has also been registered with the Monash University Human Research and Ethics Committee; Project number: CF16/1814 - 2016000929. Results will be fed back to prehospital and hospital clinicians via a series of reports and presentations. These will be used to facilitate discussions about service redesign and implementation. It is expected that evidence for improved outcomes will enable widespread adoption of this intervention among centres in all settings with less established tools for prehospital assessment and notification.
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Multicenter Study Pragmatic Clinical Trial
A pragmatic, phase III, multisite, double-blind, placebo-controlled, parallel-arm, dose increment randomised trial of regular, low-dose extended-release morphine for chronic breathlessness: Breathlessness, Exertion And Morphine Sulfate (BEAMS) study protocol.
Chronic breathlessness is highly prevalent and distressing to patients and families. No medication is registered for its symptomatic reduction. The strongest evidence is for regular, low-dose, extended- release (ER) oral morphine. A recent large phase III study suggests the subgroup most likely to benefit have chronic obstructive pulmonary disease (COPD) and modified Medical Research Council breathlessness scores of 3 or 4. This protocol is for an adequately powered, parallel-arm, placebo-controlled, multisite, factorial, block-randomised study evaluating regular ER morphine for chronic breathlessness in people with COPD. ⋯ Ethics approval has been obtained. Results of the study will be submitted for publication in peer-reviewed journals, findings presented at relevant conferences and potentially used to inform registration of ER morphine for chronic breathlessness.