Trials
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Randomized Controlled Trial Multicenter Study Comparative Study
LOCAT (low-dose computed tomography for appendicitis trial) comparing clinical outcomes following low- vs standard-dose computed tomography as the first-line imaging test in adolescents and young adults with suspected acute appendicitis: study protocol for a randomized controlled trial.
Computed tomography is widely used to diagnose acute appendicitis. Many adolescents and young adults are exposed to the associated radiation. A recent single-institution trial has reported promising results for low-dose computed tomography; however, this technique has not yet been widely adopted. LOCAT (low-dose computed tomography for appendicitis trial), a multi-institution randomized controlled non-inferiority trial, aims to compare low-dose computed tomography and standard-dose computed tomography as the first-line imaging tests for adolescents and young adults, and therefore to test the generalizability of the previous single-institution trial results. ⋯ In addition to the study protocol, we elaborate on several challenging or potentially debatable components of the study design, including the broad eligibility criteria, choice of the primary end point, potential effect of using advanced imaging techniques on study results, determining and adjusting the radiation doses, ambiguities in reference standards, rationale for the non-inferiority margin, use of the intention-to-treat approach and difficulties in defining adverse events.
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Randomized Controlled Trial Multicenter Study
Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study.
The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. The model used here was designed to study the multiple-dose safety and efficacy of lozenges containing flurbiprofen at 8.75 mg. ⋯ Utilizing the sore throat pain model with multiple doses over 24 hours, flurbiprofen 8.75 mg lozenges were shown to be an effective, well-tolerated treatment for sore throat pain. Other pharmacologic actions (reduced difficulty swallowing and reduced throat swelling) and overall patient satisfaction from the flurbiprofen lozenges were also demonstrated in this multiple-dose implementation of the sore throat pain model.
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Randomized Controlled Trial Multicenter Study
Antibiotic rotation strategies to reduce antimicrobial resistance in Gram-negative bacteria in European intensive care units: study protocol for a cluster-randomized crossover controlled trial.
Intensive care units (ICU) are epicenters for the emergence of antibiotic-resistant Gram-negative bacteria (ARGNB) because of high rates of antibiotic usage, rapid patient turnover, immunological susceptibility of acutely ill patients, and frequent contact between healthcare workers and patients, facilitating cross-transmission.Antibiotic stewardship programs are considered important to reduce antibiotic resistance, but the effectiveness of strategies such as, for instance, antibiotic rotation, have not been determined rigorously. Interpretation of available studies on antibiotic rotation is hampered by heterogeneity in implemented strategies and suboptimal study designs. In this cluster-randomized, crossover trial the effects of two antibiotic rotation strategies, antibiotic mixing and cycling, on the prevalence of ARGNB in ICUs are determined. Antibiotic mixing aims to create maximum antibiotic heterogeneity, and cycling aims to create maximum antibiotic homogeneity during consecutive periods. ⋯ This trial will determine the effects of antibiotic mixing and cycling on the unit-wide prevalence of ARGNB in ICUs.
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Randomized Controlled Trial Multicenter Study
Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): study protocol for a cluster randomised controlled trial.
Systematic reviews suggest that interventions that address school organisation are effective in reducing victimisation and bullying. We successfully piloted a school environment intervention modified from international studies to incorporate 'restorative justice' approaches. This trial aims to establish the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying in English secondary schools. ⋯ The trial will be run by independent research and intervention teams and supervised by a Trial Steering Committee and a Data Monitoring Committee (DMC).
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The Core Outcome Measures in Effectiveness Trials (COMET) initiative aims to facilitate the development and application of 'core outcome sets' (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The overall aim of the Core Outcome Measurement Instrument Selection (COMIS) project is to develop a guideline on how to select outcome measurement instruments for outcomes included in a COS. As part of this project, we describe our current efforts to achieve a consensus on the methods for selecting outcome measurement instruments for outcomes to be included in a COS. ⋯ Since the Delphi method allows a large group of international experts to participate, we consider it to be the preferred consensus-based method for our study. Based upon this consultation process, a guideline will be developed on instrument selection for outcomes to be included in a COS.