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Reduction of claustrophobia during magnetic resonance imaging: methods and design of the "CLAUSTRO" randomized controlled trial

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      Abstract

      BackgroundMagnetic resonance (MR) imaging has been described as the most important medical innovation in the last 25 years. Over 80 million MR procedures are now performed each year and on average 2.3% (95% confidence interval: 2.0 to 2.5%) of all patients scheduled for MR imaging suffer from claustrophobia. Thus, prevention of MR imaging by claustrophobia is a common problem and approximately 2,000,000 MR procedures worldwide cannot be completed due to this situation. Patients with claustrophobic anxiety are more likely to be frightened and experience a feeling of confinement or being closed in during MR imaging. In these patients, conscious sedation and additional sequences (after sedation) may be necessary to complete the examinations. Further improvements in MR design appear to be essential to alleviate this situation and broaden the applicability of MR imaging. A more open scanner configuration might help reduce claustrophobic reactions while maintaining image quality and diagnostic accuracy.Methods/DesignWe propose to analyze the rate of claustrophobic reactions, clinical utility, image quality, patient acceptance, and cost-effectiveness of an open MR scanner in a randomized comparison with a recently designed short-bore but closed scanner with 97% noise reduction. The primary aim of this study is thus to determine whether an open MR scanner can reduce claustrophobic reactions, thereby enabling more examinations of claustrophobic patients without incurring the safety issues associated with conscious sedation. In this manuscript we detail the methods and design of the prospective "CLAUSTRO" trial.DiscussionThis randomized controlled trial will be the first direct comparison of open vertical and closed short-bore MR systems in regards to claustrophobia and image quality as well as diagnostic utility.Trial RegistrationClinicalTrials.gov: NCT00715806

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          Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation.

           D Moher,  ,  L Lepage (2001)
          The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to help improve the quality of reports of randomized controlled trials (RCTs). To date, a paucity of data exists regarding whether it has achieved this goal. To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs. Comparative before-and-after evaluation in which reports of RCTs published in 1994 (pre-CONSORT) were compared with RCT reports from the same journals published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator). Number of CONSORT items included in a report, frequency of unclear reporting of allocation concealment, and overall trial quality score based on the Jadad scale, a 5-point quality assessment instrument. Compared with 1994, the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998, and this increase was statistically significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7; 95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals, and this change was statistically significant for adopters (pre-CONSORT, 61%; mean change, -22%; 95% CI, -38% to -6%). Similarly, 3 of the 4 journals showed an improvement in the quality score for reports of RCTs, and this increase was statistically significant for adopter journals overall (pre-CONSORT, 2.7; mean change, 0.4; 95% CI, 0.1-0.8). Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs.
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            Author and article information

            Affiliations
            [1 ]Departments of Radiology, Charité, Medical School, Humboldt Universität zu Berlin and Freie Universität Berlin, Germany
            [2 ]Departments of Biostatistics and Clinical Epidemiology, Charité, Medical School, Humboldt Universität zu Berlin and Freie Universität Berlin, Germany
            [3 ]Divisions of Neuroradiology, Charité, Medical School, Humboldt Universität zu Berlin and Freie Universität Berlin, Germany
            [4 ]Departments of Clinical Psychology, Charité, Medical School, Humboldt Universität zu Berlin and Freie Universität Berlin, Germany
            Contributors
            Journal
            BMC Med Imaging
            BMC Medical Imaging
            BioMed Central
            1471-2342
            2011
            10 February 2011
            : 11
            : 4
            3045881
            1471-2342-11-4
            21310075
            10.1186/1471-2342-11-4
            Copyright ©2011 Enders et al; licensee BioMed Central Ltd.

            This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

            Categories
            Study Protocol

            Radiology & Imaging

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