BMJ open
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The ongoing opioid epidemic has necessitated increasing prescriptions of buprenorphine, which is an evidence-based treatment for opioid use disorder, and also shown to reduce harms associated with unsafe opioid administration. A systematic review of perioperative management strategies for patients taking buprenorphine concluded that there was little guidance for managing buprenorphine perioperatively. The aim of this project is to develop consensus guidelines on the optimal perioperative management strategies for this group of patients. In this paper, we present the design for a modified Delphi technique that will be used to gain consensus among patients and multidisciplinary experts in addiction, pain, community and perioperative medicine. ⋯ Institutional research ethics board provided a waiver for this modified Delphi protocol. We plan on developing a national guideline for the management of patients taking buprenorphine in the perioperative period that will be generalisable across three sets of preoperative diagnoses including opioid use disorder and/or co-occurring pain disorders. The findings will be published in peer-reviewed publications and conference presentations.
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Low back pain (LBP) is the leading cause of disability worldwide, with prevalence doubling in the past 14 years. To date, prognostic screening tools display poor discrimination and offer no net benefit of screening over and above a 'treat all' approach. Characteristics of the primary sensory (S1) and motor (M1) cortices may predict the development of chronic LBP, yet the prognostic potential of these variables remains unknown. The Understanding persistent Pain Where it ResiDes (UPWaRD) study aims to determine whether sensorimotor cortex activity, an individual's capacity for plasticity and psychosocial factors in the acute stage of pain, predict LBP outcome at 6 months. This paper describes the methods and analysis plan for the development of the prediction model. ⋯ Ethical approval has been obtained from Western Sydney University Human Research Ethics Committee (H10465) and from Neuroscience Research Australia (SSA: 16/002). Dissemination will occur through presentations at national and international conferences and publications in international peer-reviewed journals.
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Randomized Controlled Trial
Personalised antiplatelet therapy based on pharmacogenomics in acute ischaemic minor stroke and transient ischaemic attack: study protocol for a randomised controlled trial.
Antiplatelet therapy combining aspirin and clopidogrel is considered to be a key intervention for acute ischaemic minor stroke (AIMS) and transient ischaemic attack (TIA). However, the interindividual variability in response to clopidogrel resulting from the polymorphisms in clopidogrel metabolism-related genes has greatly limited its efficacy. To date, there are no reports on individualised antiplatelet therapy for AIMS and TIA based on the genetic testing and clinical features. Therefore, we conduct this randomised controlled trial to validate the hypothesis that the individualised antiplatelet therapy selected on the basis of a combination of genetic information and clinical features would lead to better clinical outcomes compared with the standard care based only on clinical features in patients with AIMS or TIA. ⋯ This protocol has been approved by the ethics committee of Yangpu Hospital, Tongji University School of Medicine (No. LL-2018-KY-012). We will submit the results of this trial for publication in a peer-reviewed journal.
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Pilot and feasibility trials aim to test whether a full trial can be conducted or if any procedures must be changed for the full trial. Pilot trials must be reported in a transparent, accurate and complete way. In this report, we present a protocol for a methodological survey with the following aims: (1) to determine the percentage of physiotherapy trial reports which claim to be pilot or feasibility trials that evaluate feasibility, (2) to determine the aspect of feasibility evaluated in the primary objectives of the pilot or feasibility trials, (3) to describe the completeness of reporting of abstracts and full articles of pilot or feasibility trials using the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials and (4) to investigate factors associated with completeness of reporting of pilot or feasibility trials. ⋯ The results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal. Ethical approval is not necessary for this study.
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To investigate if self-reported high physical demand at work, objective physical workload using a job exposure matrix (JEM) and fear-avoidance beliefs are associated with reported sick leave in the previous year in persons with low back pain (LBP). Second, to investigate if the effects of fear-avoidance and self-reported high physical demand at work on sick leave are modified by the objective physical workloads. ⋯ Occupational interventions to reduce sick leave due to LBP may have to focus more on those with high self-reported physical demands and high fear-avoidance, and less on individuals with the objectively highest physical workload.