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      Is Open Access

      Initial experience with a group presentation of study results to research participants

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          Abstract

          Background

          Despite ethical imperatives, informing research participants about the results of the studies in which they take part is not often performed. This is due, in part, to the costs and burdens of communicating with each participant after publication of the results.

          Methods

          Following the closeout and publication of a randomized clinical trial of saw palmetto for treatment of symptoms of benign prostatic hyperplasia, patients were invited back to the research center to participate in a group presentation of the study results.

          Results

          Approximately 10% of participants attended one of two presentation sessions. Reaction to the experience of the group presentation was very positive among the attendees.

          Conclusion

          A group presentation to research participants is an efficient method of communicating study results to those who desire to be informed and was highly valued by those who attended. Prospectively planning for such presentations and greater scheduling flexibility may result in higher attendance rates.

          Trial Registration Number

          Clinicaltrials.gov #NCT00037154

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          Most cited references15

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          Disclosing individual results of clinical research: implications of respect for participants.

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            Saw palmetto for benign prostatic hyperplasia.

            Saw palmetto is used by over 2 million men in the United States for the treatment of benign prostatic hyperplasia and is commonly recommended as an alternative to drugs approved by the Food and Drug Administration. In this double-blind trial, we randomly assigned 225 men over the age of 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia to one year of treatment with saw palmetto extract (160 mg twice a day) or placebo. The primary outcome measures were changes in the scores on the American Urological Association Symptom Index (AUASI) and the maximal urinary flow rate. Secondary outcome measures included changes in prostate size, residual urinary volume after voiding, quality of life, laboratory values, and the rate of reported adverse effects. There was no significant difference between the saw palmetto and placebo groups in the change in AUASI scores (mean difference, 0.04 point; 95 percent confidence interval, -0.93 to 1.01), maximal urinary flow rate (mean difference, 0.43 ml per minute; 95 percent confidence interval, -0.52 to 1.38), prostate size, residual volume after voiding, quality of life, or serum prostate-specific antigen levels during the one-year study. The incidence of side effects was similar in the two groups. In this study, saw palmetto did not improve symptoms or objective measures of benign prostatic hyperplasia. (ClinicalTrials.gov number, NCT00037154.). Copyright 2006 Massachusetts Medical Society.
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              Informing clinical trial participants about study results.

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                Author and article information

                Journal
                Trials
                Trials
                BioMed Central
                1745-6215
                2008
                21 March 2008
                : 9
                : 16
                Affiliations
                [1 ]Division of Research, Northern California Kaiser Permanente, Oakland, California, USA
                [2 ]General Internal Medicine Section, San Francisco VA Medical Center, San Francisco, California, USA
                [3 ]Department of Medicine, University of California, San Francisco, California, USA
                [4 ]Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA
                [5 ]Osher Center for Integrative Medicine, Department of Medicine, University of California, San Francisco, California, USA
                [6 ]Urology Section, San Francisco VA Medical Center, San Francisco, California, USA
                Article
                1745-6215-9-16
                10.1186/1745-6215-9-16
                2322950
                18355417
                712f043e-75e8-4996-b6c1-888166d8183b
                Copyright © 2008 Avins 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.

                History
                : 13 November 2007
                : 21 March 2008
                Categories
                Methodology

                Medicine
                Medicine

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